Sunscreen in the Spotlight: FDA Illuminates New Sunscreen Regulations


On June 14, 2011 the U.S. Food and Drug Administration (FDA) announced new requirements for sunscreens and sunscreen-containing products currently sold over-the-counter. These changes are covered in a Federal Register notice to be published on June 17, 2011. The Final Rule will have a significant impact on producers of sunscreens and cosmetics and will result in changes to labeling, advertising and formulation of a vast array of products containing sunscreen and making sunscreen claims. In addition to the Final Rule, which will take effect for most producers on June 18, 2012, the FDA has also developed a Proposed Rule, an Advance Notice of Proposed Rulemaking and a Draft Guidance for Industry regarding these products.

The Final Rule imposes a number of new labeling, testing and formulation requirements on consumer products that contain sunscreen. According to Dr. Janet Woodcock, Director of the FDA’s Center for Drug Evaluation and Research, the FDA developed these requirements in an effort to “modernize . . . product information” about sunscreens. These changes come after over thirty years of development and delays in revising the previous requirements.

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