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SPOTLIGHT ON SUN PROTECTON 24 MARCH 2015 | Med Esthetics When the FDA fi nalized its long-awaited Final Sun- screen Monograph in June 2011, many industry experts expected it to include approval of several new active ingredients. It did not. As months went by without further additions to the sunscreen formulary, dermatologists joined with product manufacturers and organizations such as the Prevent Cancer Foundation to push for approval of at least some of these time-tested new ingredients. The Sunscreen Innovation Act requires the FDA to review and report back on new TEA applications within 11 months and mandates that the FDA report back to Congress on its progress toward review of the current backlog of TEA submissions within eight months. Some of these applications have been under review since 2003 (see "Awaiting FDA Approval" on page 26). "At its core, the Sunscreen Innovation Act is a step in the right direction in the fi ght to eradicate skin cancer," says Brett M. Coldiron, MD, president of the American Academy of Dermatology (AAD). "A more timely review process for sunscreen ingredients could help alleviate our nation's grow- ing skin cancer burden by providing consumers with more choices to fi t their individual needs and preferences." Great Expectations Europe has 28 approved active ingredients and Japan has 42. In contrast, only 17 actives are FDA-approved for use in sunscreens in the U.S., and the FDA has not approved a new sunscreen active since 1990. "Many of the ingre- dients awaiting FDA review have been in use for more than a decade in Europe and Asia, and there are no data to suggest that any of them are dangerous," says Darrell Rigel, MD, New York dermatologist and medical director at Schweiger Dermatology Group. Most of the ingredients approved for use in the U.S. only protect against UVB rays. While seven of the ingredients say they protect against UVA radiation, only avobenzone and zinc oxide provide long-wavelength UVA protection. Other chemical ingredients—oxybenzone and methyl anthranilate, for example—provide only partial broad- spectrum UVA protection. Avobenzone (Parsol 1789) does provide broad-spectrum UVA protection, but it quickly loses potency when exposed to UV radiation un- less it is combined with a photostabilizing agent. Both titanium dioxide and zinc oxide provide excellent UVA and UVB protection and they are often blended with their chemical counterparts to create cosmetically elegant formulations that are easy to apply, feel good on the skin and provide broad-spectrum protection. Ecamsule (Mexoryl SX, L'Oreal), was approved by the FDA in July 2006, but because L'Oreal went through the traditional drug-approval process rather than getting ecamsule approved under the sunscreen monograph, it cannot be used in other sunscreen products. This short- wavelength UVA absorber has been a popular photosta- bilizer in European sunscreens for years, allowing fragile ingredients like avobenzone to go from losing potency within 20 minutes of sun exposure to providing UVA protection for up to three hours. "We strongly support having a wide variety of sun- screen ingredients, which, in turn, provides manufacturers with the ability to innovate and develop products that people enjoy using," says Lisa Powers, executive vice president of the Personal Care Products Council. Formulators like Robert Manzo of Skinprint, a company that develops sunscreen products for sale in both the U.S. and Europe, fi nd current restrictions frustrating. "Some of the ingredients available in Europe and other countries allow us to formulate more appealing products with greater effi cacy," he says. "For example, Tinosorb S covers the UVA 1, UVA 2 and UVB ranges of ultraviolet light. It's pho- tostable so it doesn't break down in UV light, and it can ac- tually stabilize other sunscreen ingredients. It also increases the aesthetics of the sunscreen formula, which can lead to more tolerated use by consumers for reapplication." "The sunscreens we have now are not bad, but some ingredients could potentially be better," says Dr. Rigel. "UVA Europe has 28 approved active ingredients and Japan has 42. In contrast, the U.S. has just 17. © GETTY IMAGES