FDA Announces Changes to Better Inform Consumers About Sunscreen

The U.S. Food and Drug Administration announced today that sunscreen products meeting modern standards for effectiveness may be labeled with new information to help consumers find 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.

The final regulation allows sunscreen products that pass the FDA’s test for protection against both ultraviolet A (UVA) and ultraviolet B (UVB) rays to 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.

Under the new labeling, 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 help prevent sunburn, reduce the risk of skin cancer, and reduce the risk of early skin aging.

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.

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