FDA Announces Sunscreen Label Changes

Labels of certain products will state that they help reduce skin cancer risk, prevent sunburn

TUESDAY, June 14 (HealthDay News) -- The U.S. Food and Drug Administration has announced that sunscreen products that meet modern standards of effectiveness may be labeled with new information to help consumers reduce the risk of skin cancer, prevent sunburn, and lower the risk of early skin aging.

The new FDA regulation allows sunscreen products that pass the agency's test for protection against both ultraviolet A and ultraviolet B rays to be labeled as "Broad Spectrum." Under this new labeling, sunscreens labeled as both Broad Spectrum and SPF 15 or higher, if used regularly, as directed, and along with other sun protection measures, will help prevent sunburn, reduce the risk of skin cancer, and lower the risk of early skin aging. Products with SPF values between 2 and 14 may be labeled as Broad Spectrum if they pass the required test; however, the labels of these products cannot state they reduce the risk of skin cancer and early skin aging when used as directed.

According to the FDA, any product that is not Broad Spectrum, or that is Broad Spectrum but has an SPF between 2 and 14, must have a warning stating that the product has not been shown to help prevent skin cancer or early skin aging. The new regulations will become effective for most manufacturers in one year. The FDA also released three additional regulatory documents: a Proposed Rule that limits the maximum SPF value on sunscreen labels to "50+", an Advance Notice of Proposed Rulemaking for Dosage Forms, and a Draft Enforcement Guidance for Industry.

According to the FDA, "to ensure that sunscreen products meet modern safety standards, FDA is also currently reexamining the safety information available for active ingredients included in sunscreens marketed today. The ingredients in sunscreens marketed today have been used for many years and FDA does not have any reason to believe these products are not safe for consumer use."

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