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FDA’s latest labeling rules for sunscreens welcomed by the industry

By Andrew McDougall , 21-Jun-2011

The U.S. Food and Drug Administration has announced that sunscreen products must be tested and labeled with new information that help consumers find effective sun protection measures to reduce the risk of skin cancer and aging.

The final announcement has been welcomed throughout the industry and allows sunscreen products that pass the FDA's test for protection against both UVA and UVB rays to be labeled as "Broad Spectrum."

Under the new labeling, sunscreens labeled as both Broad Spectrum and SPF 15 (or higher), if used regularly, and in combination with other sun protection measures will help prevent sunburn, reduce the risk of skin cancer, and reduce the risk of early skin aging, according to the FDA.

"FDA has evaluated the data and developed testing and labeling requirements for sunscreen products, so that manufacturers can modernize their product information and consumers can be well-informed on which products offer the greatest benefit," said Janet Woodcock, M.D., director of the FDA's Center for Drug Evaluation and Research.

Important source of information for consumer

"These changes to sunscreen labels are an important part of helping consumers have the information they need so they can choose the right sun protection for themselves and their families."

Every year, more than 3.5 million new cases of skin cancer affecting more than 2 million people will be diagnosed in the United States. Exposure to ultraviolet (UV) radiation is the most preventable cause of skin cancer.

And dermatologist Ronald L. Moy, president of the American Academy of Dermatology supports the new regulation put in place by the FDA.

"For the first time, the FDA has clearly defined the testing required to make a broad-spectrum protection claim in a sunscreen and indicate which type of sunscreen can reduce skin cancer risk," he said.

UV exposure should still be limited

Dr Moy continued to explain it is a great tool to implement, but it is just one step to increasing sun protection as UV exposure should still remain limited; a view which the FDA’s Woodcock agrees with.

"Not only should consumers regularly apply and reapply sunscreens with Broad Spectrum and SPF of 15 or higher, they should also limit sun exposure,” she said.

According to the regulations, products that have SPF values between 2 and 14 may be labeled as Broad Spectrum if they pass the required test, but only products that are labeled both as Broad Spectrum with SPF values of 15 or higher may state that they reduce the risk of skin cancer and early skin aging, when used as directed.

Any product that is not Broad Spectrum, or that is Broad Spectrum but has an SPF between 2 to 14, will be required to have a warning stating that the product has not been shown to help prevent skin cancer or early skin aging.

Extensive research

According to the Personal Care Products Council (PCPC) who was quick to announce its support of the FDA, the safety and efficacy of sunscreen products have been thoroughly studied and tested by scientists and regulatory bodies throughout the world, with research demonstrating the safety and efficacy of sunscreens.

"We are also pleased that FDA reaffirmed there are no safety issues with any of the sunscreen active ingredients, including nanoscale titanium dioxide and zinc oxide. The agency confirmed that it evaluated available scientific literature, tested sunscreen nanoscale ingredients and concluded they do not penetrate the skin.", commented Farah Ahmed Chair, Sunscreen Task Force PCPC.

The new regulations will become effective for most manufacturers in one year, however manufacturers with annual sales less than $25,000 have two years to comply.