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New FDA Sunscreen Rules: What You Need to Know in a Snapshot


On June 14, 2011, the FDA announced new labeling rules for sunscreens. These rules were developed with significant help from The American Academy of Dermatology (AAD).  The AAD provided scientific information to the FDA as it was developing these rules in the form of extensive, evidence-based recommendations to the proposed FDA sunscreen regulations in 2007.  The final results are dramatically different from the initial “star rating system” that the FDA originally considered.  Over 3,000 individuals and organizations provided comments and information to the FDA during the formation of the new standards. These new standards will be mandatory in Summer 2012.


Dermatology providers believe that these new rules will help Americans reduce their risk of skin cancer by guiding them to the most effective sunscreens and advising them about other sun protection measures.  The following are some key changes you and your patients will see.   


“Broad Spectrum”

The biggest change is that you will see labels toting “broad spectrum” in addition to listing their SPF level.  That means protection not just from UVB radiation — which the old SPF rating measured — but from UVA radiation. The FDA now requires sunscreens claiming to protect against both UVA and UVB radiation to undergo standardized testing to prove their claims.  


For a sunscreen to claim that it can prevent skin cancer and sunburn, it must offer both broad spectrum coverage and a SPF of 15 or higher. If the sunscreen does not offer both these things, the label must carry the following warning: “This product has been shown only to help prevent sunburn, not skin cancer or early skin aging.”


“Waterproof” vs. “Water Resistant”

We know that no sunscreen can be water or sweat proof, as all sunscreens will eventually wash off. Therefore companies will be banned from using the terms “sunblock,” “waterproof,” or “sweat proof.”  If a sunscreen is not water resistant, the label must carry a warning telling you to use a water resistant sunscreen if you are likely to sweat or be in water.


Additional Labels on Moisturizers and Makeup

The new rules will also apply to cosmetic products that contain sunscreen.  Any products claiming to offer protection against the sun must include the drug facts on the label.   



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