Tuesday, June 14, 2011

FDA Issues New Labeling Rules for Sunscreen

After 33 years of consideration, the FDA today announced new labeling requirements for sunscreen OTC drug products.  The new requirements are effective June 18, 2012.  However, the compliance date for products with annual sales less than $25,000 is June 17, 2013.

Under the new rules, sunscreens must protect equally against UVB and UVA to earn the designation of offering "broad spectrum" protection.   UVB causes burns, and UVA causes wrinkles.  Both forms of radiation can cause skin cancer.

Products that have SPF values between 2 and 14 may be labeled "broad spectrum" if they protect against both UVB and UVA, but only those with a SPF value of 15 or greater may state that they reduce the risk of skin cancer and early skin aging.  Products that are not broad spectrum, or that are broad spectrum but which don't have an SFP of at least 15, will have to carry a warning stating that they have not been shown to help prevent skin cancer or early skin aging.

The new rules will also bar the use of the terms “sun block,” “waterproof” and “sweatproof."  Instead, sunscreens can be labeled as “water resistant” and must specify if they work for 40 or 80 minutes. Those that are not water resistant must carry a warning label advising people to use a water resistant product if they are going to be exposed to water or sweat.

The agency also proposed a new regulation that would limit the maximum SPF value on sunscreen labels to “50 +.”  The agency said there is insufficient evidence to show that products with SPF values higher than 50 provide greater protection than those with SPF values of 50.

Sunscreen makers could, however, submit data to support including higher SPF values.

In addition, the agency will begin accepting data about the safety and effectiveness of sunscreen sprays and comments on possible warnings for sprays.