New Sunscreen Labeling Rules Issued

A new Broad Spectrum label and SPF 15 or higher means the product are beneficial against skin cancer, early skin aging, and sunburn.

The U.S. Food and Drug Administration announced a new regulation June 14 that allows sunscreen products meeting modern standards for effectiveness to be labeled with new information to help consumers reduce the risk of skin cancer, early skin aging, and sunburn. The regulation allows sunscreen products that pass FDA's test for protection against both ultraviolet A (UVA) and ultraviolet B (UVB) rays to be labeled "Broad Spectrum."

Both UVB and UVA contribute to sunburn, skin cancer, and premature skin aging, but sunburn mainly reults from UVB radiation. Sunscreens labeled as both Broad Spectrum and SPF 15 or higher, if used regularly as directed and in combination with other sun protection measures, will be beneficial against all of these, FDA said.

"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 FDA's Center for Drug Evaluation and Research. "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."

Products with SPF values between 2 and 14 may be labeled as Broad Spectrum if they pass the required test, but only products labeled 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. A product that is not Broad Spectrum (or 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.

"Most skin cancers are caused by sun exposure. FDA encourages consumers to protect themselves," Woodcock said. "Not only should consumers regularly apply and reapply sunscreens with Broad Spectrum and SPF of 15 or higher, they should also limit sun exposure."

A companion proposed rule would limit the maximum SPF value on sunscreen labels to "50 +" because there is not sufficient data to show that products with SPF values higher than 50 provide greater protection for users than products with SPF values of 50, according to the agency.

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

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