FDA Releases Sunscreen Final Rule

On Friday, June 17, 2011, FDA released a final rule on Sunscreen Drug Products for Over-the-Counter (OTC) use. The new rule outlines several new requirements and modifications to previously released FDA guidelines. The final rule addresses labeling, broad spectrum designations, regulations for water resistance, and prohibited claims. The rule encompasses not only traditional sunscreens, but also any cosmetics marketed with SPF values.

Perhaps the biggest change is that all sunscreens must contain a traditional Drug Facts information panel with new warnings and directions requirements.

Several modifications to the front panels of sunscreens were also made by this final rule designed to simplify choices for consumers. Front panels will now be required to carry either “Broad Spectrum SPF [value]" or merely “SPF [value]" depending on whether the sunscreen passes a required single in-vitro test of at least 10 subjects to demonstrate broad spectrum protection. The broad spectrum test is a pass/fail test based on the critical wavelength value of 370 nm2. The rules previously required an in-vitro as well as an in-vivo test, and 20 subjects were required.

The front panel will also indicate water resistance claims, which are now restricted to one of two designations—“water resistant (40 minutes)" or “water resistant (80 minutes)"—depending on their performance in a water resistance test. The drying period for the water resistance test has been reduced from 20 to 15 minutes to improve accuracy and reproducibility. Other proposed front panel claims and/or education statements have been eliminated.

Finally, the new rule also outlines several prohibited claims that will render sunscreen products misbranded, including “waterproof," “sweatproof" or “sunblock." Sunscreens also can no longer claim to provide sun protection for more than two hours without reapplication (“all-day" protection) or provide protection immediately after application (“instant" protection) without obtaining FDA approval through the submission of data in a new drug application (NDA).

The new final rule will be effective June 18, 2012; but, for all products with annual sales of less than $25,000, the compliance date will be delayed an additional year until June 17, 2013. Sunscreen manufacturers and distributors should review the new rules and implement all changes as soon as possible.