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FDA Sunscreen Labeling Requirements, Proposed Rule, and Consumer Information Released
FDA will require sunscreen manufacturers to include in labels accurate information as to whether the product does or does not help protect against skin cancer and early skin aging. Specifically, products that pass the FDA test for protection against both ultraviolet A (UVA) and ultraviolet B (UVB) rays may be labeled as “Broad Spectrum.” The label may indicate that the product reduces the risk of skin cancer and early skin aging, if the product is both Broad Spectrum and has an SPF value of 15 or higher. Further, any product that is not Broad Spectrum, or that is Broad Spectrum but has an SPF between 2 and 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. FDA explains that “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.” FDA notes that while sunburn is primarily caused by UVB radiation, both UVB and UVA radiation contribute to sunburn, skin cancer, and premature skin aging.
FDA advises consumers that in addition to using as directed sunscreens with Broad Spectrum protection and an SPF of 15 or higher, they should limit sun exposure. FDA also has developed a consumer Web page explaining the changes in sunscreen labels, and provides consumers a Web page with sun protection tips.
FDA has also released a Proposed Rule that would limit the maximum SPF value that may be indicated on a label to 50, and a draft Guidance for Industry (PDF) that outlines information to help sunscreen product manufacturers understand how to label and test their products in light of the new final rule and other regulatory initiatives. On June 14, 2011, FDA published the new sunscreen Final Rule (PDF), the Proposed Rule (PDF) regarding indicated SPF values, and the Advance Notice of Proposed Rulemaking (PDF) in the Federal Register.
