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;76:35620-35665). 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. For a broad-spectrum claim, sunscreens must have an in vitro critical wavelength of 370 nm or greater (ie, 90% of the sunscreen’s UV absorbance, as measured from 290–400 nm, must be ≥370 nm; it is a pass/fail system). For broad-spectrum sunscreens with sun protection factor 15 or greater, the label may state that “if used as directed with other sun protection measures (see Directions), [it] decreases the risk of skin cancer and early skin aging caused by the sun.” Furthermore, “waterproof” and “sweatproof” claims will no longer be allowed. Instead, water-resistant products will be labeled as “Water Resistant (40 minutes)” or “Water Resistant (80 minutes).”
Because the manufacturers desired to have more time to comply with these testing and labeling requirements, the FDA has agreed to postpone the implementation date by 6 months, from June 18, 2012, to December 17, 2012 (December 17, 2003, for products with annual sales <$25,000)(Fed Registr. 2012;77:27591-27593). Consumers should be aware that there are going to be a few months of transition after December 2012; the newly shipped sunscreens will need to comply with the new FDA Final Rule, while those that are already on the shelf are not required to be removed. Therefore, consumers need to look for broad-spectrum sunscreens that have sun protection factor 30 or above. Continued education of general consumers is therefore necessary. What can you do to help educate consumers?