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.

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.

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.

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.

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.

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.

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.

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.

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.

Gogi Sangha, CEO & President, G.S. Cosmeceutical USA, Inc.

For years, humans have been preoccupied with altering their skin tone. In the 1970s when Americans were baking in the sun to achieve a sun-bronzed glow (before the dangers of sun exposure were fully understood), skin whiteners were a burgeoning business in Asia.
Today, skin lighteners are sought worldwide for their ability to not only lighten darker complexions but also to control age-related hyperpigmentation.
Some estimates place the skin lightening market in Asia at a total worth of $7 billion, while, over the last year alone, sales have increased by 14% in non-European markets.
As the compendium of ingredients grows so too has the availability of safer, more effective, natural and science-based lightening options.

Pathways to Lighter Skin
Sun exposure and hormones are the two biggest causes of hyperpigmentation in skin, yet blemishes, wounds and rashes can also lead to abnormal discoloration, especially in darker skin tones.
Fortunately, we can offset unwanted skin pigmentation by targeting two principal pathways: By inhibiting the production of skin pigment, or melanin, and by rendering melanin and its precursors colorless. To inhibit melanin production, we must target the enzyme tyrosinase, which converts the amino acid phenylalanine into the precursors of melanin. Or, we can formulate with ingredients that compete against tyrosine to block the activity of the tyrosinase enzyme.
At G.S. Cosmeceutical USA in Livermore, CA, researchers are on the front lines of tapping new technologies that perform as well as mainstay lighteners like hydroquinone yet without the potential side effects.
A relatively new skin brightener, Chromabright™ has demonstrated significant brightening properties in in vivo clinical trials by inhibiting melanin production on par with hydroquinone and more effectively than the common skin brightening agents arbutin, magnesium ascorbyl phosphate (MAP) and kojic acid. Furthermore, unlike other depigmenting agents that can cause photoirritation, Chromabright can help prevent UV-induced skin damage.
G.S. Cosmeceutical has also experienced favorable results with a new colorless curcumin material, which, like Chromabright, has been found in some studies to be more efficacious than hydroquinone in inhibiting melanin. Research shows that this material can inhibit 80% of melanin production and scores higher on the antioxidant ORAC (Oxygen Radical Absorbance Capacity) scale than grapeseed extract and green tea.
In addition, some newer whitening peptides have demonstrated tyrosinase-inhibiting action by targeting the protein component of the tyrosinase enzyme and other constituents. β-White™, a biomimetic encapsulated whitening peptide, for instance, decreases proteins involved in the pigmentation process, thus inhibiting tyrosinase activity and melanin synthesis. An in vitro comparative study showed that β-White induced significant skin lightening effects on 23 Asian volunteers with at least one hyperpigmented spot after four weeks.
Other skin brightening/whitening agents continue to engage the attention of formulators for their natural approach to whitening and brightening the skin. Some commonly used ingredients include:

Arbutin: Popular in Japan for skin depigmentation, arbutin is an extract from the bearberry plant that inhibits tyrosinase activity and protects the skin against free radical damage.

Azelaic Acid: Found in wheat, rye and barley grains, azelaic acid has been shown to inhibit melanin, to treat skin discoloration and to fight acne. Some studies demonstrate that topical azelaic acid in 15% to 20% concentrations may be as effective as hydroquinone without the irritation.

Bearberry (Uva ursi): This plant leaf extract contains arbutin and methyl arbutin, both hydroquinone derivatives with skin-whitening properties.

Chinese Flower (Osmanthus fragrans): Used extensively in Asia as a flavoring for tea and as a fragrance, the Osmanthus fragrans flower is showing promise in reducing tyrosinase activity and melanin-formation in a dose-dependent manner. The flower’s high phenolic and flavonoid content also point to its potential as an antioxidant treatment.

Glutathione: This natural tripeptide targets pigmentation on two fronts via competitive binding with melanin’s color-forming precursors and by reducing the pigmenting potential of the melanin.

Hexylresorcinol: This crystalline phenol offers several anti-aging benefits, including the ability to target pathways in the skin that lead to hyperpigmentation. In vivo studies have demonstrated that hexylresorcinol has the same lightening effect as 2% hydroquinone over an eight-week period of time. It is also thought that hexylresorcinol can reduce the appearance of fine lines and wrinkles and increase UV protection.

Kojic Acid: By itself or combined with glycolic acid, kojic acid has demonstrated favorable results in inhibiting tyrosinase. While kojic acid can present stability challenges, G.S. Cosmeceutical has been successful in extending the typical shelf life of this material from less than three months to more than two years.

Licorice Root (Glycyrrhetinic acid): Used commonly by natural ingredients advocates, licorice root is an ancient skin remedy that, with the aid of recent research, has now entered the modern age as an effective skin whitener.

Mulberry (Morus bombycis): The root and bark extracts of the mulberry plant might also play a useful role in inhibiting the tyrosinase enzyme that converts tyrosine into melanin’s precursors. Mulberry contains arbutin, which inhibits melanin production.

Niacinamide (Vitamin B3): In addition to providing a safe whitening alternative, niacinamide, or Vitamin B3, is helpful in treating acne, increasing hydration and reducing fine wrinkles.

Vitamin C: This water-soluble antioxidant is a commonly used anti-aging ingredient, favored, among other uses, for its skin brightening properties. Common forms include pure L-ascorbic acid, tetrahexyldecyl ascorbate, and sodium or magnesium ascorbyl phosphate (MAP).

Yellow Dock (Rumex crispus): Although the chemical constituents are unknown, yellow dock has proven its worth as a potent weapon in diminishing the effects of tyrosinase.

Skin formulations typically fare best when more than one ingredient is incorporated. For instance, we can use a tyrosinase inhibitor, a tyrosine competitor and an agent to render pigmented substances into non-pigmented forms. The addition of retinol can also boost efficacy in treating skin discolorations, and some research indicates that the alpha hydroxy acids lactic and glycolic acids can inhibit melanin production aside from their chief use as exfoliants.
In the future, the demand for effective skin whiteners is expected to only increase. Global Industry Analysts (GIA) predicts the lightening market to reach $10 billion by 2015 worldwide, a growth fueled partially by a growing ethnic population and more demand for whiteners among men. With new peptides and plant-based ingredients expanding the range of whitening options, formulators will be able to keep pace with this increasing consumer demand and continue to offer safer, more effective options.

Gurpreet “Gogi” Sangha is the CEO and Chief Scientific Officer of G.S. Cosmeceutical USA, Inc., a Livermore, CA-based contract manufacturer of anti-aging skin care, body care, hair care, natural and organic-based products, and OTC cosmeceuticals. G.S. Cosmeceutical provides 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 will celebrate its 12th anniversary May 5, 2010.
For more information about G.S. Cosmeceutical USA, Inc., please visit www.gscos.com. You may also contact Marketing Manager Andrea Sercu at 925-583-1426 or andrea@gscos.com.