With peak sun care season in full swing, FDA looks to revise sunscreen product regulations

SILVER SPRING, Md. — One month after the observance of Skin Cancer Awareness Month, the Food and Drug Administration announced Tuesday it is taking measures to assure all sunscreen products are safe and effective.

By next year, the FDA said, all over-the-counter sunscreen products will be required to meet certain standards. For example, sunscreens may be labeled as "broad spectrum" if they protect against both ultraviolet A and ultraviolet B radiation, and pass a broad spectrum test developed by the FDA. UVB is primarily responsible for causing sunburn, while UVA contributes to sunburn, skin cancer and premature skin aging. Additionally, for sunscreen products that are labeled with sun protection factor values of 15 or higher, but not as broad spectrum, the SPF value only will indicate the amount of protection against sunburn, the agency noted.

Also among the proposed regulations: Sunscreen products that have SPF values higher than 50 will be labeled as "SPF 50+." The FDA said that it does not have adequate data demonstrating that products with SPF values higher than 50 provide additional protection, compared with products with SPF values of 50.

What's more, manufacturers that tout such sunscreen product claims as "waterproof," "sweatproof" or "sunblocks" will be required to remove these claims because they overstate effectiveness, the FDA said.

The changes were lauded by the Skin Cancer Foundation, which said that updating regulations associated with sunscreens was much needed.

"Although science and technology has advanced over the past several years to dramatically improve the efficacy of sunscreens, there has long been a need to update the governmental regulations associated with them — particularly in the areas of UVA protection and product labeling," the Skin Cancer Foundation’s Photobiology Committee chairman Warwick Morison said. "This announcement is a significant advancement for the FDA, which brings awareness to and acknowledges the importance of UVA protection in the prevention of skin cancer."

Additional information about these regulations can be found here.

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