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OTC Sunscreen Compliance Dates Delayed

05/11/2012

Federal Register Final rule: FDA is delaying the compliance dates for the 6/17/11 final rule for OTC sunscreen drug products that establishes labeling and effectiveness testing for certain products containing specified active ingredients and marketed without approved applications. It also amends labeling claims that are not currently supported by data and lifts the previously-published delay of implementation of the Drug Facts labeling requirements for OTC sunscreens. Information received after publication of the 2011 final rule indicates that full implementation of the requirements for all affected products will require an additional six months. To view this final rule, click here.

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