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Senators have added a provision to FDA’s fiscal 2015 funding bill (S. 2389) that would direct the agency to finalize a 2011 proposed rule on sunscreen labels. It would also order FDA to issue regulations related to testing and labeling of sunscreen sprays. The Senate Appropriations Committee approved the bill on May 22. FDA’s proposed rule would require sunscreens that claim to have sun protection factor (SPF) values higher than 50 to be labeled as 50+. The agency says there is insufficient evidence to show that SPF values higher than 50 provide more protection than sunscreens with SPF 50. FDA says it has requested additional safety and efficacy data from manufacturers of spray sunscreens. The agency is evaluating whether spray sunscreens present health concerns if they are inhaled.
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