FDA Changes Rules For Sunscreen Labeling

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WASHINGTON, D.C. — The U.S. Food and Drug Administration issued new regulations yesterday that are intended to help consumers find sunscreen products that, when used with other sun protection measures, reduce the risk of skin cancer and early skin aging, as well as help prevent sunburn.

Sunscreen products that pass the FDA’s test for protection against both ultraviolet A (UVA) and ultraviolet B (UVB) rays may be labeled as “Broad Spectrum.” Both UVB and UVA radiation contribute to sunburn, skin cancer, and premature skin aging. Sunburn is primarily caused by UVB radiation.

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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.

“Most skin cancers are caused by sun exposure. FDA encourages consumers to protect themselves,” said Janet Woodcock, M.D., director of the FDA’s Center for Drug Evaluation and Research. “Not only should consumers regularly apply and reapply sunscreens with Broad Spectrum and SPF of 15 or higher, they should also limit sun exposure.”

The FDA also proposed a 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. The proposal creates the opportunity for the submission of data to support including higher SPF values in the final rule.

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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