Get to Know These 5 Critical Changes That Can Make or Break a SPF Product
November 21, 2011 – Next summer, consumers will soon see the first wave of many changes to their favorite sunscreen products as the FDA’s new SPF product regulations take effect. In particular, five key changes will ultimately shape the future of suncare. Whether you’re a consumer or a company marketing a SPF brand, don’t get burned! Familiarize yourself with these industry-changing regulations before the new products hit the shelves.

1. Make it Broad-Spectrum
Theoretically, a sunscreen can have an SPF of 50 but still have zero Ultraviolet A (UVA) protection. In other words, a person could spend two hours in the sun and show no signs of sunburn. Meanwhile, the longer UVA rays are attacking her skin, leading to cell DNA damage, hyperpigmentation, wrinkles, loss of elasticity, and, in ever-increasing numbers, skin cancer.
For years, the FDA has only required sunscreen manufacturers to test the Ultraviolet B (UVB) protection that gives a sunscreen its SPF, or Sun Protection Factor. But that number only indicates the amount of time a UVB sunscreen will prevent the skin from reddening when exposed to ultraviolet light.
For a sunscreen to be truly effective, it needs to afford broad-spectrum protection by covering a significant percentage of the UVA range, 320-400 nanometers, as well as the Ultraviolet B (UVB) range, 290-320 nanometers.
Earlier this year, the FDA revised its sunscreen monograph to implement new standards that establish a broad-spectrum test for determining a sunscreen’s UVA protection level proportionate to its UVB protection.
Look for a mix of UV filters that, when used in combination, will give your sunscreen both UVA and UVB protection:

UVA filters (320-400 nm)
Zinc Oxide
Titanium Dioxide
Avobenzone
Oxybenzone (Benzophenone)
Dioxybenzone
Ecamsule

UVB filters (290-320 nm)
Zinc Oxide
Titanium Dioxide
Trolamine Salicylate
Homosalate
Octinoxate
Octocrylene
Dioxybenzone
Octisalate
Oxybenzone
Cinoxate

2. Set Your SPF Goals High… But Not Too High
Sunscreens can range from 2 to 50+. The FDA’s newly revised monograph grants products with an SPF 15 or higher certain privileges that lower-rated products do not have. For instance, only products of SPF 15 or greater that pass the broad-spectrum test will be able to state that they are “broad spectrum” on the front label and feature certain label claims attesting to their ability to reduce the risk of skin cancer and early skin aging when used as directed.
On the other hand, products that are either not broad-spectrum or are broad-spectrum but have SPFs lower than 15 will need to carry a skin cancer/skin aging warning statement. “The objective is to encourage manufacturers to produce products that screen both UVA and UVB rays at a sufficient level to guard against skin cancer and the premature signs of aging,” says Gogi Sangha, CEO and president of G.S. Cosmeceutical USA, a Bay Area-based, FDA-registered, cGMP-compliant custom contract manufacturer of facial, body and OTC skincare products, including sunscreens.
While some sunscreen products on the market advertise SPFs of 80, 90 or even 100, the FDA has proposed a new rule capping SPF claims at “50+” or less. The percentage differences between SPF 15 and 30 and particularly between SPF 30 and 50 are negligible. According to the FDA, no sufficient studies to date have demonstrated that SPF values greater than 50 confer any significant extra protection.

3. Add Antioxidants and Other Skin Protectants
The sun assaults the skin daily with a high dose of free radicals that can damage DNA and age the skin faster than any other single factor. Some evidence suggests that even certain ingredients in sunscreens might produce Reactive Oxygen Species (ROS) when ultraviolet light reacts with ingredients that have penetrated the skin. One solution is to continue reapplying sunscreen to prevent UV light from reaching the UV filters that have penetrated the skin.
Certain antioxidants and other ingredients can also help to counteract the damaging effects. Red algae contains natural UV-screening compound known as mycosporine-like amino acids that actually absorb UVA light. Studies have shown that this natural material:
 Boosts SPF
 Reduces UV-induced DNA damage in human fibroblasts (the source of our collagen which gives our skin its firmness)
 Prevents loss of firmness
 Increases skin smoothness
 Decreases wrinkles depth
In addition, some published peer-reviewed studies demonstrate that Vitamins C and E work synergistically with sunscreen to offer more protection than sunscreen alone.

4. Select a Proven OTC Manufacturer
Sunscreens making SPF claims fall within the over-the-counter (OTC) category of skincare products. Because the FDA regulates this class of product, sunscreens must be registered as OTC products and contain a label following the accepted Drug Facts format. A contract manufacturer of sunscreens must be FDA-registered, cGMP (Good Manufacturing Practices)-compliant.
In addition, broad-spectrum products must undergo the new FDA SPF testing requirements, which subject each sunscreen to a 10-subject UVB in vivo test and a UVA in vitro test.
Make sure your contract manufacturer has the experience to successfully formulate a SPF product that will pass these rigorous tests, contain your desired ingredients and comply with the FDA’s guidelines.

5. Make Sure Your Product is Covered
Many manufacturers were caught off guard when the FDA announced it would no longer allow companies that market towelettes, wipes, powders, body washes and shampoos to continue making SPF claims.
The agency also prohibited the use of claims referring to products as “waterproof” or “sweatproof.” Rather, these products may bear a “water-resistant” claim and must specify effectiveness against sweating or swimming based on specified testing methods. Sunscreens that are not water-resistant must advise use of a water-resistant sunscreen after swimming or sweating.
Make sure you stay informed with the latest FDA developments and partner with an experienced sunscreen contract manufacturer who can help you navigate the many changes affecting this critical product category.

Filed under: Contract Manufacturing, Cosmeceutical Manufacturing, Cosmetic Chemistry and Formulation, Cosmetics, Health and Wellness, OTC Drug Manufacturing, Personal Care Products, Retail Skincare, SPF's and Sun Care Products, Skincare Technology, Uncategorized | Comments Off

August 5, 2010 — Now that the U.S. Food and Drug Administration (FDA) has announced its new requirements for the labeling and testing of all sunscreens marketed as over-the-counter (OTC) products, many questions still persist on how these impending changes will directly affect the products Americans turn to for preventing burns and guarding against skin cancer. Here, G.S. Cosmeceutical USA, Inc., a Bay Area-based custom contract manufacturer of sunscreens and other skin care products, answers the most commonly asked questions:

What Type of Sunscreens Are Affected?
The new regulatory documents affect all currently manufactured and future sunscreen products claiming to offer SPF protection. The products affected will include all sunscreens, including facial moisturizers with SPF claims.
Under the new rule, towelettes, wipes, powders, body washes and shampoos may not make SPF claims. The FDA has called for more data and feedback regarding spray sunscreen products, though properly labeled spray products will be permitted pending further action. According to the FDA, current data and information about spray sunscreens is not comparable to that for sunscreen oils, creams and lotions. The manner of application also differs significantly, thus the regulatory agency is requesting additional data to address these questions.

How Do the New Standards Differ from Previous Rules?
Whereas in the past, FDA rulings dealt mainly with sunburn protection caused by ultraviolet B (UVB) radiation, the FDA’s recent rulings focus on ultraviolet A (UVA) radiation, the main contributor to skin cancer and early skin aging. In an effort to present a higher standard of safety and effectiveness, these new standards establish a “broad spectrum” test for determining a sunscreen’s UVA protection and whether the product provides UVA protection proportionate to its UVB protection. Therefore, under the new rule, a broad spectrum sunscreen SPF 30 will indicate a higher level of protection from UVA radiation as well as UVB radiation than a SPF 15.

How Will The New Rule Affect a Product’s Label Claims?
Broad-Spectrum Claims. Under the new rule, claims, warnings and indications must be stated on the label, depending on the results of the broad spectrum and SPF tests. Companies with products of SPF 15 or greater that have passed the broad spectrum test will now be able to claim “broad spectrum” with the SPF value on the front label and be able to make claims regarding skin cancer and early skin aging, using specific phrases authorized by the FDA’s new rule. Sunscreens passing the test as both broad spectrum and SPF 15 (or higher) may now state “If used as directed with other sun protection measures, this product reduces the risk of skin cancer and early skin aging, as well as helps prevent sunburn.”

“Other sun protection measures” include:
• Limiting time in the sun, especially between the hours of 10 a.m. and 2 p.m.
• Wearing clothing to cover skin exposed to the sun
• Using a water-resistant sunscreen if swimming or sweating
• Reapplying sunscreen, even if it is labeled as water resistant, at least every 2 hours
Products that pass the test as broad spectrum but have an SPF between 2 and 14 may be labeled “broad spectrum” but will be required to have the following warning statement that the product has not been shown to help prevent skin cancer or early skin aging: “Skin Cancer/Skin Aging Alert: Spending time in the sun increases your risk of skin cancer and early skin aging. This product has been shown only to help prevent sunburn, not skin cancer or early skin aging.” Products that are not broad spectrum will be required to carry the same warning statement.

Water-Resistance vs. Waterproof. In addition, sunscreens may not be labeled “waterproof,” “sweatproof,” or as a “sunblock.” Products labeled as “water-resistant” on the front label must specify the effectiveness against sweating or swimming based on specified testing methods. For instance, sunscreens labeled “water-resistant” will need to state whether the sunscreen remains effective for 40 minutes or 80 minutes when swimming or sweating, based on standard testing.
Products that are not water-resistant must advise use of a water-resistant sunscreen if swimming or sweating.
Longevity of Efficacy. Sunscreens cannot claim to provide sun protection for more than 2 hours without reapplication, nor can they purport to provide protection immediately after application.
SPF Claims Capped at 50. The FDA has also proposed a new rule limiting SPF claims to “50+” or less. The rationale is that no sufficient data exists to demonstrate that products with SPF values greater than 50 afford any greater protection. This proposed regulation is available for public comment at www.regulations.gov until September 15, 2011.
Drug Facts Format. Lastly, all sunscreens must include the standard “Drug Facts” panel on the back and/or side of the container.

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May 9, 2011 – Fewer people are getting cancer today — with one exception. Melanoma is on the rise, particularly among young people. In fact, melanoma is the most common cancer among those 25 to 29 years old, and, according to the American Cancer Society, more skin cancer cases are diagnosed than breast, prostate, lung and colon cancer combined.
Yet, melanoma is also highly preventable. If detected and treated early enough, melanoma can be almost 100% curable.
You can do much to prevent melanoma and other skin cancers from forming. Here’s how.

The Changing Phases of Melanoma
Characterized by the uncontrolled growth of pigment cells, melanoma results in three-quarters of all skin cancer deaths. Incredibly, between 40% and 50% of Americans who live to age 65 will have skin cancer at least once in their life time, according to the National Cancer Institute, Bethesda, MD. Melanomas can evolve from seemingly insignificant moles to potentially fatal growths if left unchecked.

Melanoma goes through four stages:
Stage 0 (in situ): Melanoma is confined to the epidermis.
Stage 1-II: Melanoma is still confined to the skin but is increasing in thickness.
Stage III: Melanoma spreads to one or more nearby lymph nodes.
Stage IV: Melanoma spreads to an internal organ.

A biopsy report can provide an exact diagnosis of melanoma and may also determine its current stage. A dermatologist must assess how deeply the melanoma has traveled and whether it’s spread to other parts of the body. Then, treatment may involve excision to surgically extract the melanoma and cut the skin around it. More serious cases may require Mohs surgery, which is conducted by a specialist with a microscope to remove the growth layer by layer until only healthy tissue remains.

Who’s At Risk?
The first step in prevention is to recognize the risk factors.
Genetic predisposition. A family history of skin cancer, a fair complexion and light eyes are all factors that characterize a genetic predisposition toward melanoma. Specifically, redheads and blondes and blue or green eyes characterize the skin cancer profile. Any immune system deficiency or a previous cancer history can also heighten your risk.
Unusual Moles. Almost everyone has some moles on their body, but if you have more than 50 you may be at substantially increased risk of developing melanoma. A suspicious mole often has irregular borders and color. One half of the mole typically does not match the other half.
An easy way to screen suspicious moles is to use the ABCDE rule:
Asymmetry: If you were to fold the two sides of the mole together, they would not match.
Border irregularity: The edges of the mole are jagged or blurred.
Color: There is a non-uniform color to the mole, which may be tan, brown, black or even white, red or blue in color.
Diameter: Melanomas usually exceed 6 mm in size (about the size of an eraser on a pencil).
Evolving: Any mole that is changing in size, shape or color should be presented to a physician for review.

How to Prevent Melanoma from Forming
Avoid Excess UV Exposure. By far, the greatest step you can take to prevent melanoma is to avoid excessive exposure to ultraviolet radiation. Those who live closest to the equator, where the sunlight is most intense, are at further risk.
Check Your Birthday Suit On Your Birthday. The American Academy of Dermatology recommends everyone perform regular skin self-examinations, even checking your scalp, palms, soles, toenails and between your toes. A seemingly innocent bruise that fades and then reappears or a brown to black streak under a nail can both be signs of melanoma. If you fall into a high-risk group or have a suspicious melanoma, it’s advisable to get a full-body exam at least annually.
Always Wear a Broad-Spectrum Sunscreen. Get in the habit of wearing a broad-spectrum sunscreen of at least SPF 15 daily, even on cloudy, rainy and snowy days. A broad-spectrum sunscreen will filter both UVB (think “B” for burning rays) and UVA rays (think “A” for aging rays). Apply the sunscreen on all exposed skin and reapply every 2 hours while outdoors.
While most sunscreens with a SPF 15 and 30 are capable of preventing you from burning, they may not be affording you the protection against UVA you need to prevent premature signs of aging. Studies show that UVA can penetrate glass, so even those with office jobs who sit by a window all day are not safe from the dangers of UVA rays.
According to Gogi Sangha, CEO and President of G.S. Cosmeceutical USA, Inc., a FDA-registered, cGMP-compliant custom contract manufacturer in Livermore, CA, a good broad-spectrum sunscreen will contain either mineral UV filters, such as zinc oxide and titanium dioxide, or chemical filters, including avobenzone, a FDA-approved UVA-filtering agent.
For best results, choose a sunscreen that is photostable, meaning it won’t break down upon exposure, and is stable under normal conditions as well. At G.S. Cosmeceutical, sunscreens undergo stability testing over 2 to 3 years with accelerated tests for up to 6 months.
Avoid Tanning Beds. Ultraviolet light from tanning beds can cause skin cancer and premature aging. In fact, research shows that indoor tanning can increase a person’s melanoma risk by 75%. If you crave a deeper skin tone, it’s better to use a sunless self-tanner, like a DHT formula that works with the skin’s natural melanin content, says Sangha. Just be aware that a sunless tan does not afford any UV protection. A good broad-spectrum sunscreen is still highly recommended.
Wear Protective Clothing. Wide-brimmed hats, long-sleeved shirts and pants, and UV-protectant sunglasses will help to protect your skin for extended times outdoors.
Take Cover in the Shade. The sun’s rays are strongest between 10 a.m. and 4 p.m. Seek cover indoors or at least in a shaded spot during those hours when the UV index is at its most intense.
Boost Immunity Through Diet. Lastly, you can increase your natural defenses against skin cancer through diet. Citrus fruits, such as lemons, oranges, tangerines and grapefruits, for instance, have been linked to a lowered incidence of skin cancer. Foods high in beta carotene, including sweet potatoes and carrots; cruciferous vegetables like cabbage, broccoli and cauliflower; garlic; and green tea are all great immune boosters.
By practicing good prevention and diagnostic measures, you can protect yourself against skin cancer and be among the other half living life skin cancer-free.

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Over the past 10 years, natural skincare and age-defying cosmeceuticals have been running a tight race to claim their lead in the personal care market.
In 2004, natural facial and body care products topped the $5 billion mark. By 2007, they were fast-tracking at a 12.5% annual growth rate. Today, natural personal care products are growing five times faster than the standard personal care product sector, according to Mintel Research, Chicago.
On the other end of the spectrum, cosmeceutical sales surged 7% in 2009 — despite a worldwide recession and a sluggish overall global beauty category. The trend only seems likely to continue with cosmeceutical sales expected to climb to more than $5 billion between 2009 and 2014, according to Euromonitor analysis firm.
While these two trends may appear diametrically opposed, skincare actives, such as retinol, peptides and DNA-repairing growth hormones, are also showing up in many of the same products flaunting a more natural and/or organic side.
The source of their demand can be traced largely to an aging baby boomer market split between a desire for real results and a concern over toxic ingredients. More women in their early 20s are also seeking new ways to head off aging — yet with a natural twist.
“Hybrid skincare is about blending the newest innovations of science with the natural extracts and oils of the plant world for one truly efficacious product,” says Gogi Sangha, CEO and Chief Scientific Officer of G.S. Cosmeceutical USA, Inc., a Bay Area-based custom contract manufacturer that specializes in both cosmeceutical actives and certified organic skincare. “Today,” Sangha says, “you can truly have the both of best worlds.”

Blending the Best of Science and Nature
Many of today’s actives continue to pull rank on their more natural counterparts in ingredients’ listing to help firm skin; stimulate collagen and elastin production; and smooth the appearance of lines and wrinkles. Yet in the consumers’ quest for more natural ingredients, many raw material suppliers are finding plant-based alternatives for conventional ingredients. For example, Cognis’ Laboratoires Serobiologiques recently introduced Actiwhite, a natural whitener and hydroquinone alternative derived from green peas, and Myoxinol, a hibiscus-derived peptide offering a Botox-like, muscle-relaxing effect.
Likewise, Lipotec of Spain has come out with Antarctacine, a natural, Ecocert-certified moisturizer and collagen/elastin booster derived from microorganisms found in Antarctic glaciers.
Most recently, Iceland-based ORF Genetics launched the first plant-based growth factors produced from barley seeds, offering an alternative to traditional growth factors derived from E. coli, yeast and animal cells.
Organics too are becoming more readily available; however, formulating a certified organic water-based formula that meets the USDA National Organics Program (NOP) 95% certified organic standards can be challenging. For instance, with water-based formulations, you must have a preservative that is capable of killing the microbes that grow in a water environment. However, as Sangha explains, many such preservatives, such as phenoxyethanol, are not permitted by the USDA on their approved non-organic list, and those organic preservatives that are permitted, such as organic alcohol or potassium sorbate, are beset by other issues, such as odor or lack of efficacy in a hydrous formula.
For this reason, more skincare companies are formulating to a 70% “made with organics” level or are turning to hybrid formulations that combine organic plant extracts with the heavy lifters of the cosmeceutical world.
Manufacturing such products requires a formulator experienced in both organics and actives, notes Sangha, who is well-versed in formulating with both certified organic ingredients as well as actives including retinol, peptides, plant stem cells and lightening agents.
For best results, also look for a manufacturer who is FDA registered, compliant with Good Manufacturing Practices (cGMP) and accredited as a USDA NOP certified organic handler. These areas of distinctions will help hold the contract manufacturer to a higher standard in their formulation and manufacturing practices.

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Selecting a Contract Manufacturer:
The Most Critical Decision You Can Make

August 24, 2010 - As a skincare company preparing to launch a new product, the selection of a contract manufacturer can present one of the most daunting tasks in the product development process. .All choices may look good on paper, but the results can vary widely — sometimes at great risk and expense to the unsuspecting startup.

Whereas a good contract manufacturer will help ensure the timely launch of a quality product formulated with cutting-edge ingredients, the wrong decision can result in a product line lacking consumer appeal or, worse, one that is unstable and contaminated.

To be sure your product launch runs smoothly and exceeds expectations, look for these characteristics in a skincare contract manufacturer:

FDA-Registered, cGMP-Compliant. The recent introduction of the Safe Cosmetics Act of 2010 will present new challenges to some skincare contract manufacturers who are not prepared to weather the changes. This critical new legislation proposes full ingredient disclosure, data sharing and, most importantly, closer FDA control over the cosmetics industry.

To be sure you’re in capable hands, look for an FDA-registered, cGMP-compliant contract manufacturer. Only these facilities are required to ascribe to federally regulated “Good Manufacturing Practices” as set forth by the FDA. The “c” before the GMP symbolizes “current,” meaning cGMP-compliant contract manufacturers stay abreast of the latest changes in manufacturing and quality processes and must pass the most current, stringent FDA audits to remain compliant.

GMP facilities are required to keep detailed logs of all raw materials and packaging components used during the manufacturing process. Under this process, manufacturers must quarantine and test incoming materials and packaging components for quality; abide by Standard Operating Procedures (SOPs) for consistency; and staff each procedure with two employees to attain the highest level of accuracy when weighing materials and conducting other important tasks.

In addition, GMP facilities write detailed step-by-step procedures; follow written procedures to prevent contamination; document work for compliance and traceability; and protect products against contamination by making cleanliness a daily ritual in the manufacturing plant.

Stays Current on Emerging Technologies. If your contract manufacturer is still pushing AHAs as the latest, greatest anti-aging technology, then you’re most likely experiencing a disconnect between the trends of today’s skincare market and what your R&D department is stirring up in the lab. A good contract manufacturer will maintain constant communication with suppliers and industry organizations to stay on top of the latest developments in raw materials and treatment of skin conditions.

Most importantly, the contract manufacturer must be willing to share this information with its current and prospective clients to allow brand developers the opportunity to seize the most current technology and bring it to market. G.S. Cosmeceutical USA, Inc., of Livermore, CA, for instance, shares the latest data on brighteners, wrinkle relaxers, peptides and anti-aging topicals with a wide array of clientele, ranging from spa startups and physicians to pharmaceutical corporations looking to roll out a new OTC line.

Financially Stable. A good contract manufacturer is financially stable and willing to expand based on client requirements. The manufacturer should have a growth plan in place and sustain growth by providing the latest equipment, space and training as needed.

Won’t Compete with Your Product Line. Many contract manufacturers sport a private label division in addition to their custom contract manufacturing operation. While the manufacturer may purport to keep these two divisions separate, many custom clients, unfortunately, find their concepts ending up as a private label product — even after they signed a confidentiality disclosure agreement. To be sure, look for a contract manufacturer who only formulates custom products for its clients — not its catalog — and maintains a track record for the highest level of client retention and integrity.

Provides Marketing Support. Most contract manufacturers stick to the science of product formulation and manufacturing, leaving the marketing of the product to the brand. While traditional marketing tasks, such as advertising and press releases, are indeed typically handled by the brand, a well-rounded contract manufacturer will help you develop your marketing “story” by tailoring ingredients to your individual concept. Some contract manufacturers, such as G.S. Cosmeceutical, will even help finesse your label copy, source packaging and provide other marketing tasks as a comprehensive service.

In today’s competitive skincare market, the selection of a contract manufacturer is more important than ever. Learn all of your options and take the time to develop a relationship with the chemists and support staff members who will help guide your product along its journey to success.

About G.S. Cosmeceutical USA, Inc.
G.S. Cosmeceutical USA, Inc. is a privately-owned contract manufacturing company. Headquartered in Livermore, California, the company is a leader in providing R&D, manufacturing and warehousing services to physicians, cosmetic entrepreneurs, corporate manufacturers, beauty start-ups and leading professionals in the spa and beauty industry. The company formulates across a broad range of categories, including anti-aging skincare, body care and hair care, organic- and natural-based products, paraben-free cosmetics and over-the-counter (OTC) cosmeceutical products.
For additional information on the release, please contact Andrea Sercu, Marketing Manager, at G.S. Cosmeceutical USA, Inc. at andrea@gscos.com or by calling 925-583-1426.

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August 20, 2010 - Nothing reveals the state of our inner health like our skin. When we’re stressed, dehydrated or hormonally imbalanced, the symptoms can manifest in breakouts, dryness or inflammation.
“The skin is a barometer of what’s going on internally with our bodies,” says Gogi Sangha, CEO and Chief Scientific Officer of G.S. Cosmeceutical USA, Inc., a Bay Area-based custom contract manufacturer specializing in anti-aging, OTC and natural- and organic-based skincare products. “The best way to keep our skin looking healthy and young is to take an inside-outside approach.”
Many skin-friendly nutrients can be found in both topical and oral form. Here are a few of the most effective nutrients from A to Zinc.

A to Zinc Skin Nutrients

COQ10: With age, the body’s natural COQ10 levels start to deplete. UV exposure, stress and poor diet can all contribute to lower stores of this critical energy source. COQ10 produces ATP biological energy inside the cells, enabling cells to grow and divide into healthy new cells. Without COQ10, the body cannot produce sufficient levels of collagen and elastin.
Oral supplements can help skin improve on all of these levels as well as aid weight management. Topically, you can find COQ10 (also known as ubiquinone) in many skincare products. It’s important to note that the level of COQ10 will play a determining role in its efficacy.

Essential Fatty Acids: The typical consumer gets more than their fair share of omega-6 fatty acids through foods like baked goods and potato chips, but these foods lack the vital essential omega 3 fatty acids, which possess natural anti-inflammatory properties and help repair and hydrate skin. Supplements, including fish oil capsules (preferably wild-harvested), borage and evening primrose oils, and foods like flaxseed, salmon and mackerel offer good sources of omega-3 oils. A study published in the March 2009 issue of the British Journal of Nutrition reported that both flax and borage oil increased hydration while reducing inflammation and sensitivity after 12 weeks of consumption.
Topically, evening primrose and borage oils can also help keep skin hydrated while soothing inflammation and reducing redness associated with dermatitis, rosacea and eczema.

Silica: This trace mineral may be only needed in small amounts, but silica’s benefits stretch far and wide to maintain skin elasticity and heal wounds. You can obtain silica from foods, such as leeks, green beans, strawberries, cucumber and mango. Topically, silica is often added to skin formulations to improve the viscosity, texture and feel of a product.

Vitamin A: One of the most potent anti-aging actives available, Vitamin A addresses a wide range of conditions, including acne, wrinkles, collagen, hyperpigmentation and dry skin. Most significantly, Vitamin A ensures proper cell turnover and repairs and maintains the skin.
Chili peppers, carrots, apricots, sweet potatoes, spinach and cantaloupe all make great Vitamin A-rich food sources, while retinol (without a prescription) and retinoic acid (Tretinoin with a prescription) are the preferred topical forms, says G.S. Cosmeceutical’s Sangha. Other retinoic derivatives include retinyl palmitate, or retinyl acetate, and retinaldehyde. While stable, some of these retinoids take a long time to convert to the bioactive retinoic acid form and may be rendered useless to the skin. For that reason, retinol is the most bioavailable form of topical Vitamin A, says Sangha, an expert in retinol product manufacturing.

Vitamin B Complex: Biotin and niacin offer the most significant skin benefits among the B vitamins. Biotin forms the very basis of skin, nail and hair cells and without the correct amounts, dermatitis and hair loss can result even with a mild deficiency. Bananas, eggs, oatmeal and rice provide a ready supply of biotin.
Topical niacinamide has also gained much attention over the years for its ability to hydrate the skin and give skin an immediate glow. By retaining moisture, niacinamide enables skin to appear plumper and younger in as little as six days. Niacinamide also has anti-inflammatory, circulatory and antioxidant properties and can even help lighten an uneven skin tone. In a 12-week, double-blind, placebo-controlled study of 50 women, researchers found that 5% topical niacinamide improved fine lines and wrinkles, hyperpigmentation, skin texture and red blotchiness.

Vitamin C: Vitamin C benefits skin on many levels from brightening and helping generate collagen to reducing free radical damage. In clinical trials, topical Vitamin C, especially when combined with Vitamin E, demonstrated an ability to offer “appreciable photoprotection” against UV damage, according to Duke University researchers. And a 2005 study published in The Journal of Investigative Dermatology found that people who consume Vitamins C and E reduce their sunburns from UVB exposure and mitigate those factors linked to DNA damage within skin cells.
Vitamin C-rich foods include bell peppers, guava, broccoli, citrus fruits, kiwi and leafy greens. Topically, Vitamin C is highly unstable and requires formulary expertise to remain stable and absorbent for optimal efficacy.
G.S. Cosmeceutical has achieved excellent results working with Vitamin C forms, including pure L-ascorbic acid; esters such as magnesium ascorbyl phosphate and tetrahexyldecyl ascorbate, a stable, oil-soluble form with excellent absorption and shelf-life properties.

Vitamin E: An oil-soluble vitamin, Vitamin E can reduce fines lines and wrinkles, hydrate dry or rough skin and help protect against UV damage. This potent antioxidant is best taken orally in the form of natural tocopherol supplements at 400 mg daily or in foods, such as wheat germ oil, sunflower seeds, safflower and sunflower oils, almonds, olives, spinach, tomatoes and avocados. Topically, Vitamin E can help prevent the breakdown of collagen and elastin due to free radicals and protect against sun damage. In skincare products, look for natural d-alpha tocopherol or tocopheryl acetate to provide the best benefits.

Zinc: This mineral plays an important role in skin health, particularly for those prone to acne breakouts. Oral supplements or foods rich in zinc sulfate and zinc gluconate can help regulate sebum (oil) production and proper immune function and may interact with the hormones that lead to acne. Zinc-rich foods include fresh oysters, pumpkin seeds, ginger, Brazil nuts, oats, eggs and pecans.
Topically, you’ll find zinc oxide in mineral sunblocks to protect against UV light. However, neither this form of zinc nor the zinc sulfate and zinc gluconate forms have demonstrated any significant value in treating acne topically. A double-blind study published in the International Journal of Dermatology found that topically applied 2% zinc sulfate demonstrated no effect in improving acne lesions between a placebo group and zinc-treated acne sufferers, though the treated patients experienced significantly greater irritancy.

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July 8, 2010 – Only women get it. Diet and even liposuction won’t get rid of it. And contrary to popular belief, body weight has nothing to do with the cause, while hormones and genetics have everything to do with it. What is it?
Cellulite, and it affects millions of women. Cellulite is not a “fat” issue; it’s a skin disorder that occurs within the connective tissue where fat cells push up through fibrous bands of tissue known as septa and form the characteristic bulging that we identify as orange peel skin, or cellulite.
While losing weight and invasive medical procedures won’t help, certain topicals can help increase circulation and metabolism and strengthen the dermis to improve the condition, says Gogi Sangha, CEO and Chief Scientific Officer of G.S. Cosmeceutical USA, Inc., a Bay Area-based contract manufacturer of anti-aging cosmeceuticals, OTC skin care and natural/organic-based skin products. Here are a few helpful topical ingredients, many of which G.S. Cosmeceutical uses in its anti-cellulite formulations:

COQ10 – Critical to cell respiration, Coenzyme Q10 (also known as ubequinone) helps restore mitochondrial activity by increasing the body’s energy production known as ATP.

L-Carnitine – Enhances hormonal metabolism and helps reduce the body’s fat storage cell count.

Caffeine – A form of methylxanthine, caffeine is thought to induce lipolysis (breakdown of stored fat) when applied topically. Caffeine tightens the blood vessels, stimulates the breakdown of fat cells and helps rid the body of toxins. One study published in Dermatologic Surgery found that a caffeine-based, liposome-encapsulated cream reduced fat cells over a 2-month period. However, these topicals need a good delivery system like liposomes to enable penetration.

Escin (Edemine) – Escin, or edemine, is an extract from the horse chestnut tree (see “Horse Chestnut Extract” below), which has been shown to exhibit potent vasoconstricting, anti-inflammatory and circulation-boosting properties.

Goji Berry – This supercharged antioxidant fruit provides the essential fatty acids, antioxidants and anti-inflammatories to strengthen and fortify skin cells and connective tissue from succumbing to the weakening effects that lead to cellulite.

Guarana – A tropical berry from the Amazon, guarana dilates the blood vessels and thereby increases blood flow. Guarana has also demonstrated some antioxidant activity within the body.

Horse Chestnut Extract – A potent vasoprotective, horse chestnut extract helps reduce edema associated with cellulite in the thighs. Horse chestnut seed supports blood circulation, wound healing and provides anti-inflammatory action.

Pro-Sveltyl – A derivative of the lotus flower, Pro-Sveltyl reduces fat by breaking down stored fat (lipolysis), reducing the fat storage cell differentiation (adipocyte) and stimulating the caloric restriction gene, SIRT-1, which limits the formation of new fat cells. Pro-Sveltyl also reduces tissue inflammation while inhibiting the MMP enzymes responsible for the degradation of the skin’s collagen and elastin matrix. When tested at 1%, Pro-Sveltyl reduced the MMP-9 enzyme by 73%.

Retlactyl D – This black pepper extract normalizes the expression of matrix proteins, thereby improving skin firmness and tone.

Retinoids – Vitamin A derivatives, such as retinol, can help thicken and strengthen the dermis. Some evidence suggests that retinoids may also help increase circulation to the area.

Filed under: Contract Manufacturing, Cosmeceutical Manufacturing, Cosmetic Chemistry and Formulation, Cosmetics, Health and Wellness, Personal Care Products, Skincare Technology | Comments Off

June 22, 2010, Livermore, California – You might liken the state of the male grooming category to the women’s category in the early 1900s, when the typical beauty regimen consisted of soap and cold cream. When it comes to grooming habits, men are slow-evolving creatures who largely prefer simple regimens — no more than 3 steps, thank you — and products that perform the basic necessities: cleanse, moisturize, maybe prep their beard for a shave and, for the really adventurous, something to impede hair loss.
Yet as the industry continues to widen its offerings in hair care, skin care, body care and shaving, today’s average male consumer is becoming increasingly hip to new grooming rituals.
With global sales of male skin, hair and body care products topping nearly $27 billion last year*, Unilever, L’Oreal, Beiersdorf AG and Procter & Gamble’s Gillette are all stepping up to plate in the male category. Gillette is making a play on its guy-friendly brand name as it launches the new ProSeries line, including a pre-shave thermal scrub, which the company compares to a hot towel service at the barber shop; a cooling after-shave moisturizer; a face wash for sensitive skin; and a UV protectant/moisturizer.
Other mass brands like Nivea for Men and Axe are targeting the male consumer with demo-specific lines at the grocery store and drugstore level, while more mid- to high-end lines are delivering on what former American Crew president John Mulgrew calls “affordable luxury.”
“Today’s baby boomer represents the aging male population and is more consumed and educated about his appearance,” says Mulgrew, who is now the managing director of The Grooming Lounge, a small chain of Washington D.C.-based, high-end barbering salons with a growing line of skin and hair care products.
“About 15 years ago, it was taboo for a guy to say to his buddies that he uses moisturizer, but today, surprisingly, there’s so much information out about UV rays and melanoma, it’s OK to say that. Although, I don’t know that it’s yet OK for them to admit they use an eye cream!” he says.
Gary Whitfield, owner of the Australian-based men’s line, Himself27, agrees, noting that men are still “firefighters” when it comes to buying grooming products. They purchase out of need and to put out a specific problem, like irritation from shaving. “I think at the moment, men are interested in problem-solving products. In the longer term, premium ‘anti-age’ product will do well as the average guy becomes more educated to the benefits of regular skin care,” Whitfield says.
Some of the newer offerings for men include hair enhancement serums formulated with technologically advanced peptides that stop hair loss and encourage new growth, says Gogi Sangha, CEO and Chief Scientific Officer of G.S. Cosmeceutical USA. This Bay Area-based contract manufacturer of anti-aging cosmeceuticals and OTC skincare has also formulated anti-aging serums, antioxidant-rich eye treatments and oil control treatments specifically geared to the male consumer.

Speaking the Same Language
Research shows that men require a vastly different marketing approach than women. They like straightforward language that clearly outlines the product’s function and main benefit. They don’t want fluff — just simple, no-nonsense talk. “When you label products like Taffy and Putty, I don’t think men get it,” says Mulgrew, who cites the names of his two new products, Some Hair Gel and Some Hair Pomade, as examples of a more direct approach.

The Royal Loyal
Unlike their “beauty junkie” counterparts, men will gladly concede more than their share of room on the bathroom counter with just a few SKUs taking up space in their daily grooming ritual. Yet, men also comprise some of the most loyal customers when it comes to buying retail products at the salon level. Experience shows that they are more likely to follow a hairstylist’s recommendation to buy a particular home-care product, and they will continue to use that product as long as it’s being offered. With worldwide sales up approximately 40% over six years ago, it looks as if the male personal grooming category may just hit a double play this year with no strikes in an otherwise recessionary economy.

*Source: Euromonitor International Plc.

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The Paraben Paradox: Are These Cosmetic Ingredients Worth Preserving?
Contract Manufacturer G.S. Cosmeceutical USA Weighs in on the Controversy

May 18, 2010, Livermore, California – When a group of British researchers analyzed a small sample of breast cancer tumors and discovered parabens in 18 of the 20 samples, their 2004 published study set off a public outcry against the preservatives found commonly in topical cosmetics and body care products.
As a result of the study, manufacturers scrambled to reformulate their cosmetic products. Parabens, such as methylparaben, propylparaben, ethylparaben and butylparaben, as well as their iso derivatives, were stricken from INCI lists and replaced with paraben-free preservative systems. Companies parlaying a paraben-containing shampoo, conditioner, facial moisturizer or cleanser were black-listed by some cosmetic bloggers, and consumers scoured cosmetic labels for the “P” word.
Despite the implications of that Journal of Applied Toxicology study, many questions remain today. Are parabens really that hazardous to our health, or are these once-popular preservatives just getting a bad rap?

The Paraben Paradox
On one hand, the UK-based study demonstrated that parabens are capable of penetrating the skin and accumulating in the body’s tissue fully intact. In general, parabens are known to exert weak estrogen-like activity and may lead to gene expression that causes breast tumor cells to grow.
However, the British study did not examine potential paraben levels in normal tissue. And while it is true that parabens can mimic estrogen activity, a 1998 Toxicology and Applied Pharmacology study concluded that the most potent paraben, butylparaben, demonstrated 10,000- to 100,000-fold less activity than naturally occurring estradiol. Furthermore, a 2005 Critical Reviews in Toxicology report found that parabens — even at maximum daily exposure estimates — could not increase the risk associated with estrogenic chemicals.

Parabens and Alternative Preservatives
Since the 1920s, parabens have been used widely as highly effective preservative systems in cosmetics to maintain product shelf life and to protect consumers against microbial growth.
These broad-spectrum preservatives can be found in a wide variety of food and products. They are found naturally in blueberries and even the human bloodstream as a byproduct of the amino acid tyrosine.
In cosmetics, parabens are used at low levels – generally at less than 0.2%, though they are often used in combination and, as demonstrated by the British study, may bioaccumulate in the body.
With all of the questions surrounding parabens, more contract manufacturers such as Livermore, California-based G.S. Cosmeceutical USA, Inc., are now offering safe, alternative preservatives as an option to maintain product safety, stability and shelf life.
According to G.S. Cosmeceutical CEO and Chief Scientific Officer Gogi Sangha, several variables, including a product’s pH level and water content, help determine the preservative system best suited for any given product.
Where parabens are not an option, one good alternative is a preservative system that incorporates phenoxyethanol, a synthetic preservative with a chemical makeup based on a natural antibacterial chemical found in the sage plant.
Ethylhexylglycerin is another choice, though this synthetic compound also must be paired with another preservative to maintain a high enough efficacy of microbial protection.
In recent years, the organic and natural ingredient movement has sparked a demand for food-grade and organic preservatives. Grain alcohol, for instance, is available in an organic version and can work independently in a formulation. Grain alcohol is also accepted by many associations, including the Natural Products Association (NPA).
The only downside is the perception of the word “alcohol,” which many equate with drying of the skin, though this can be countered by increasing the moisturizing ingredients in the formula.
Sodium dehydroacetate, potassium sorbate and sodium benzoate are popular “food-grade” choices. While these popular “safe enough to eat” choices tell a great marketing story, it’s important that consumers and skincare companies know that they can be ineffective in some formulations, particularly water-based products where the potential for microbial growth is much higher than anhydrous formulations. In those cases, “natural” is not always best. While you might have a cream or serum that’s free of parabens, the product could pose even greater danger to a consumer’s health if it’s contaminated with microbial organisms!
To date, major U.S. health, regulatory and cancer organizations, including the FDA and the American Cancer Society, have not found enough evidence to warrant a ban on parabens.
Nevertheless, the preliminary findings offer some cause for concern, and most agree that larger studies are needed to elucidate the long-term implications of parabens as cosmetic preservatives and what effect they might have on our health.

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Sunscreens Set to Reflect New FDA Guidelines

G.S. Cosmeceutical Explains the Proposed Regulations and What They Mean to Manufacturers

Livermore, CA, April 30, 2010 — The dangers of outdoor UV exposure have been well-documented for years. But did you know that for the past 70 years, melanoma has been steadily on the rise among fair-skinned, indoor workers?

While the hazards of outdoor solar exposure have long been blamed for skin cancer and premature signs of aging, an FDA study may have us now taking cover in our homes and workplaces as new light is shed on the dangers of indoor UVA exposure.

In their research, Dianne Godar and colleagues from the FDA’s Center for Devices and Radiological Health noted that although indoor workers with lighter skin types typically receive 3 to 9 times less solar UV exposure than their outdoor counterparts, only the indoor group demonstrated an increased incidence of malignant skin cancer. As a result, the scientists theorize that the UVA light penetrating building windows may lead to mutations and a breakdown in Vitamin D(3), which would otherwise help protect the skin against melanoma.

“For years, we’ve known that UVB promotes sunburns, and we now know that UVA light is the ultraviolet wavelength responsible for the deeper skin damage that promotes premature signs of aging,” says Gogi Sangha, CEO and Chief Scientific Officer of G.S. Cosmeceutical USA, a San Francisco Bay Area-based contract manufacturer of anti-aging cosmeceuticals, broad-spectrum sunscreens, and bath and body products. “This new research only serves to further emphasize the importance of broad-spectrum sunscreens that protect against both UVA and UVB light.”

Still, only about one in five all-day moisturizers that advertise SPF protection actually guard against UVA rays, according to the Environmental Working Group (EWG), a non-profit environmental watchdog organization.

That could change, however, with an impending new set of FDA-proposed sunscreen guidelines, which, for the first time in history, will require manufacturers to disclose their products’ UVA protection levels.

The FDA 4-Star Rating System
Among the more significant changes the FDA plans to implement include a four-star rating system for UVA protection that would be based on both in vitro and in vivo tests and incorporate a measurement of photostability.

Manufacturers would be required to include the four-star rating on their sunscreen labels and would face new restrictions in what they can and cannot say on labels. For instance, the proposed guidelines would prohibit claims such as “chemical-free,” “waterproof,” “helps prevent skin damage,” or any SPF designation greater than 50.

SPF would no longer stand for “Sun Protection Factor” but, rather, “Sunburn Protection Factor” to clarify its use as a measurement of only UVB, the rays responsible for sunburns but not the premature signs of aging or skin cancer, which is mostly attributed to UVA.

According to Sangha, more cutting-edge ingredients are becoming available, enabling the development of true broad-spectrum sunscreens that go beyond UV protection to afford real anti-aging benefits. For instance, G.S. Cosmeceutical, a FDA-registered, cGMP (Good Manufacturing Practices)-compliant contract manufacturer authorized to produce OTC sunscreens, formulates with good-for-you skin ingredients like phytomelanin, a plant-based, antioxidant-rich melanin source derived from the date palm; HelioGuard™ from the red algae Porphyra umbilicalis; and photosomes with encapsulated DNA repair enzymes derived from plankton.

Because certain sea life, including the aforementioned plankton and algae, must adapt to a harsh environment of constant UV exposure, they possess a natural photoprotection that has real human applications. Photosomes, for example, have demonstrated an ability to improve sun-damaged skin in clinical research.

Vitamins C and E can also provide a natural boost to the photoprotection, Sangha says. Researchers from Duke University found a combination of 15% L-ascorbic acid and 1% α-tocopherol exhibited excellent protection against erythema and sunburn cell formation. While each vitamin demonstrated photoprotection independently, a combination demonstrated superior performance.

Covering the Sunscreen Spectrum
For the highest level of protection, choose a sunscreen that covers a wide range across the UVB (290-320 nanometers) and UVA (320-400 nm) wavelength spectrum. You’ll also want to make sure the formula is photostable, meaning it won’t break down readily upon exposure, and stable under normal conditions. At G.S. Cosmeceutical, sunscreens are tested via standardized accelerated tests for 2-3 months and verified over 1 1/2 to 3 years.
A good sunscreen will offer anti-aging protection as well. Following are a few commonly used sunscreen ingredients and their protective range in nanometers:

Avobenzone 340-375 nm
Mexoryl 290-400 nm
Octinoxate 280-320 nm
Oxybenzone 288-326 nm
Titanium Dioxide 290-340 nm
Zinc Oxide 290-380 nm

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How Sunscreen Savvy Are You?
Many misconceptions persist in sunscreen labeling today. Test your sunscreen savvy with this true/false quiz:

True or False: The higher the SPF, the more likely the sunscreen will protect against both UVA and UVB rays.
False! Many consumers today unwittingly purchase SPF 30 products, believing they’re receiving “broad-spectrum” UVA and UVB sun protection when they’re often receiving inadequate, if any, protection against UVA rays. That’s because the SPF (Sun Protection Factor) only measures UVB rays, a short-wave radiation that causes sunburn with wavelengths of 290-320 nanometers on the UV spectrum, whereas the longer UVA rays cause most premature skin aging and skin cancer. To get a true broad-spectrum sunscreen, look for a product with ingredients that specifically protect against UVA rays, such as avobenzone, zinc oxide and, to some extent, titanium dioxide.

True or False: A SPF 50 sunscreen will provide significantly more protection than an SPF 30.
False! A sunscreen rating higher than SPF 30 does not necessarily equate to significant higher protection. A SPF 30 confers about 97% protection against UVB rays, whereas a SPF 50 only nets you about 1 to 2 additional percentage points.

True or False: Only “waterproof” sunscreens will truly last all day and need no reapplication.
False! All sunscreens need to be reapplied. The simple acts of sweating and chafing of skin make reapplication of between 20 minutes and every two hours necessary.

True or False: Micronized and nano-scale zinc oxide and titanium dioxide offer strong UVA protection and do not pose a health hazard.
True! According to the EWG, repeated studies have found that these ingredients do not penetrate healthy skin when applied topically. Micronized and non-scale minerals enable formulators to create sunscreens with comprehensive protection and a less white topical appearance.

For the highest level of protection, consumers need to always complement sunscreen use with protective clothing, including a wide-brimmed hat, and limited exposure.

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