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