FDA Publishes New Rules on Sun Screens

The FDA, which regulates drugs and medical devices, announced updated rules that will govern sun screens sold in the U.S. The rules will not go into effect until the summer of 2012, but the proposal does offer interesting insight to Sunscreens and their true sun protective qualities.

The new rules will require sunscreens to:

A. Define the term "Broad Spectrum." To carry the term "Broad Spectrum" sunscreens must:

1. Provides a minimum level of UVA protection.

2. Must undergo both an SPF test and a UVA test.

3. Must provide adequate protection from both UVA and UVB rays.

B. The FDA is forbidding sun screen makers from using the terms: Waterproof, Sweat proof and Sunblock.

1. Sunscreen labels may use the terms "water resistant" and "sweat resistant."

Sun screens will be tested and labeling must communicate the number of minutes (a maximum of 40 minutes or 80 minutes) assessed by the testing.

2. A sunscreen that isn't water resistant or sweat resistant needs to caution users to apply often when swimming or sweating.

C. A sunscreen cannot claim to provide sun protection for more than 2 hours without reapplication or to provide protection immediately after application (for example- "instant protection") without submitting data to support these claims and obtaining FDA approval.

D. A sunscreen with an SPF of less than 15 will be required to have warnings and cannot make a skin cancer prevention claim. These sunscreens can only make a sunburn claim.

E. In other proposed guidance, the FDA is recommending a cap of 50+ SPF, unless a manufacturer can show that a higher number is defensible to help consumers and patients.

F. Spray Sunscreens labeling will require information on application doses.

G. SPF measures the time a person can stay in the sun without burning. For instance, if you are able to stay in the sun for 1 minute with-out sun protection and not burn, a sun protective product with an SPF factor of 15 would allow 15x's the exposure, or 15 minutes without burning.