11/05/12

Sunscreen Regulation Update

In June 2011, the FDA unveiled its long-awaited final rule on sunscreen regulations. Implementation of these rules was delayed this past summer (2012).

The sunscreen rules address a number of things that dermatologists have deemed problematic regarding the marketing claims and labeling of sunscreens:

1. “Only broad spectrum sunscreens with an SPF value of 15 or higher can claim to reduce the risk of skin cancer and early skin aging if used as directed with other sun protection measures.”
2. Manufacturers cannot label sunscreens as “waterproof” or “sweatproof,” or even identify their products as “sunblocks,” as these claims overstate their effectiveness.
3. Water resistance claims on the front label must now indicate whether the sunscreen remains effective for 40 minutes or 80 minutes while swimming or sweating, based on standard testing.
4. Sunscreens cannot claim to provide sun protection for more than two hours without reapplication or to provide protection immediately after application without FDA approval.

On December 17th, the new rules take effect for all products with annual sales over $25,000. Companies with lower sales have an additional full year to comply.