FDA Provides New Procedure for Sunscreen Labeling

June 14, 2011

The FDA issued new guidelines for sunscreen labeling in the efforts of providing consumers with better information concerning the effectiveness of the product.

Today, the Food and Drug Administration (FDA) issued new rules for sunscreen labeling in the efforts of providing consumers with better information concerning the effectiveness of the product. Also, for the first time, the FDA will allow the labeling to claim that sunscreens protect against skin cancer and early skin aging.

New protocols have also been developed for testing the effectiveness of the products at blocking harmful UV rays.

According to Dr. Ronald L. Moy, president of the American Academy of Dermatology, an estimated 3.5 million Americans develop skin cancer each year.

"Every hour, an American dies of melanoma," Moy said.

Moy said that all types of skin cancers are increasing in adolescents and young adults, particularly females. Researchers have attributed this adverse trend to the tendency of young women to frequent dangerous indoor tanning beds, or simply to sit outside in the sunlight with little to no sun protection.

The changes are meant "to reduce consumer confusion," said Dr. Janet Woodcock, director of the FDA's Center for Drug Evaluation.

Reportedly, the FDA has been considering such regulation changes since 1978. They released some proposed rules in 2007, but later on decided that the new labeling proposed at the time would be too confusing for consumers.

Sunscreens may be labeled "broad spectrum" if they block UVB radiation—a major cause of sunburn—and a percentage of UVA radiation. Both UVA and UVB cause early skin aging and skin cancer. Products that are broad spectrum and have a sun protection factor (SPF) higher than 15 may claim they reduce the risk of skin cancer and premature skin aging on their labels.

Products that are not broad spectrum or that have an SPF value lower than 15 must now bear a label warning that they have not been found to reduce risk of sunburn, premature aging, or skin cancer.

Further, the FDA ruled that sunscreens will no longer be able to carry an SPF value higher than 50. From now on, the highest category will be 50+.

"We don't have sufficient data to show that those with an SPF higher than 50 provide greater protection," Woodcock said.

Finally, sunscreen will no longer be allowed to be labeled as “sun block,” as there is no evidence that they block all the radiation in sunlight. Also, sunscreen products are not permitted to be labled as “waterproof” or “sweat proof” anymore, and can only be labled as “water resistant”. All labels must also clearly state how long the protection will last, either forty minutes of eighty minutes.

Woodcock stated that the new labels must be in place by the summer of 2012, but the FDA hopes that companies will take it upon themselves to apply them sooner.