FDA declares new labeling norms for sunscreen


Avoiding painful sunburn and deadly skin cancer should get easier next summer.

The U.S. Food and Drug Administration announced new requirements Tuesday for sunscreen labels that officials hope will provide simpler but more thorough information on how to avoid sunburn, skin cancer, and the wrinkles of aging.

By next summer, the FDA suggests, be wary of any product that has an SPF number above 50. And regardless of the label, wear a hat.

"I think this is great," said Thomas Jefferson University Hospital's Steven Greenbaum, a third-generation dermatologist. "You had companies going wild and trying to outdo each other with SPFs of 80 or 100. There's never been any evidence to show that above a certain level it offers more protection."

SPF stands for Sun Protection Factor, which will still be used. But many people guessed - wrongly - that a sunscreen with SPF 30 was twice as protective as one with SPF 15. There is only an incremental difference. The new limit will be 50, though the FDA set up a plan to allow manufacturers to do clinical studies to prove that a mixture could warrant a higher figure on the label.

The FDA will now test for protection against ultraviolet A (UVA) and ultraviolet B (UVB) rays, with those passing both tests being labeled "broad spectrum." Both types of rays contribute to sunburn, skin cancer, and premature skin aging. Sunburn is mainly caused by UVB rays.

Products with SPF values between 2 and 14 may be labeled as broad spectrum if they pass the required test, but only products that are labeled "broad spectrum" and have SPF values of 15 or higher may state that they reduce the risk of skin cancer and early skin aging, when used as directed. Those products not meeting both standards will need a warning stating that the product has not been shown to help prevent skin cancer or early skin aging.

"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, director of the FDA's Center for Drug Evaluation and Research.

An estimated 3.5 million new cases of skin cancer are diagnosed each year.

"My entire practice is devoted to removing skin cancer and reconstructing afterward," said Joseph Sobanko, an assistant professor and dermatologic surgeon at the Hospital of the University of Pennsylvania. "Every week, a number of patients say, 'I wish that I knew years ago how the sun would damage my skin.' "

Staying out of the sun at the hottest times (10 a.m. to 2 p.m.) and wearing hats and more clothes still matter in helping to avoid sunburn and cancer.

The sunscreen industry reacted to the proposed new requirements and labeling.

"Coppertone welcomes the FDA's new sunscreen-labeling rules and supports efforts that make it easier for people to choose sun protection for themselves and their families," Merck & Co. Inc., the maker of Coppertone, said in a statement.

Johnson & Johnson markets the Neutrogena and Aveeno sunscreen products, but the company differed with the FDA on the value of sunscreens beyond SPF 50.

"While we support the FDA's efforts, we continue to believe that SPF products over 50 provide additional sun protection for consumers and we have submitted data in support of our position," Johnson & Johnson said in a statement. "We believe that limiting labeling for SPF values higher than 50 may deter consumers from receiving the highest levels of sun protection."

Highlights of the FDA's New Rules

SPF: Sun Protection Factor. Without proof, the new limit will be 50.

SPF math: A product with an SPF of 15 gives a person 15 times more protection from ultraviolet B rays than someone wearing nothing. A higher number will give longer protection but not necessarily more protection.

Broad spectrum: Labels can use the term if the product also meets FDA testing rules for ultraviolet A light rays, which contribute to cancer and aging wrinkles.

Waterproof? Sunscreens on the market are NOT waterproof or sweat proof. New labels will say how water resistant the product is.

Advice: Read the label, apply early and often. Stay out of the sun between 10 a.m. and 2 p.m.

source: philly

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