FDA Requires OTC Sunscreen Drug Labeling, Drafts Guidance, Etc.
The Food and Drug Administration has issued a final rule, effective June 18, 2012, to require over-the counter sunscreen products to comply with certain content and format requirements for OTC drug labeling. FDA also announces the availability of a draft…
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guidance for industry, “Enforcement Policy-OTC Sunscreen Drug Products Marketed Without an Approved Application," available here, and a proposed information collection on SPF labeling and testing requirements for OTC sunscreen products containing specified ingredients and marketed without approved applications, and on compliance with Drug Facts labeling requirements, available here. Comments on the draft guidance and on the proposed information collection are due by August 16, 2011. FDA's Web page on sunscreen products is available here.