FDA Postpones Implementation Date of Sunscreen Label Changes

Henry W. Lim, MD

Dr. Lim is Chairman of the Department of Dermatology, Henry Ford Hospital, Detroit, Michigan. Dr. Lim also is the Immediate Past Chair of the American Academy of Dermatology’s Council on Science and Research.

Dr. Lim is a consultant for Clinuvel Pharmaceuticals, La Roche-Posay Laboratoire Pharmaceutique/L’Oréal, and Procter & Gamble, and an investigator for Clinuvel Pharmaceuticals and Estée Lauder.

On June 17, 2011, the US Food and Drug Administration (FDA) published the Final Rule on labeling and effectiveness testing of sunscreens (Fed Registr. 2011;76[117]:35620-35665). It is a major advancement for the regulation of sunscreens in the United States because for the first time the FDA specified the exact guidelines on the testing for UVA protection of sunscreens, and the labeling that is allowable on the package.