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Latest FDA Sunscreen Regulations

SpecialChem / Nick Morante – Nov 23, 2011

The United States Food and Drug and Administration released its final Sunscreen Monograph on June 22, 2011. It has taken over 30 years to create this final ruling. These changes include much simpler product labeling, with clarification on SPF numbers, as well as "water resistance" and "broad spectrum" claims. The FDA has also removed any confusion that may have existed between the terms SPF and UVB, and has replaced the UVA/UVB test requirement with a test similar to the COLIPA/ISO/Proposed Australian standard. Even though there are claims made for UVA protection for products in the EU and a seal is placed on those products, there is still no requirement for UVA in-vivo testing in the US. Finally, the FDA is proposing to cap the highest SPF claim at 50, since it is generally believed that 50 is the maximum sun protection you can achieve.

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