Sunscreens Set to Reflect New FDA Guidelines

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


Livermore, CA (MMD Newswire) May 3, 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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