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Sunscreen Drug Products For Over-The-Counter Human Use; Final Monograph
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DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration 21 CFR Parts 310, 352, 700, and 740 [Docket No. 78N–0038] RIN 0910–AA01 Sunscreen Drug Products For Over- The-Counter Human Use; Final Monograph AGENCY: Food and Drug Administration, HHS. ACTION: Final rule. SUMMARY: The Food and Drug Administration (FDA) is issuing a final rule in the form of a final monograph establishing conditions under which over-the-counter (OTC) sunscreen drug products are generally recognized as safe and effective and not misbranded as part of FDA’s ongoing review of OTC drug products. FDA is issuing this final rule after considering public comments on the agency’s proposed regulation, which was issued in the form of a tentative final monograph, and new data and information on sunscreen drug products that have come to the agency’s attention. FDA is also issuing final rules regarding the labeling of certain cosmetic products to inform consumers that these products do not provide protection from the sun. EFFECTIVE DATES: This regulation is effective May 21, 2001 for parts 310, 352, and 700 and is effective May 22, 2000 for part 740. FOR FURTHER INFORMATION CONTACT: John D. Lipnicki, Center for Drug Evaluation and Research (HFD–560), Food and Drug Administration, 5600 Fishers Lane, Rockville, MD 20857, 301–827– 2222. [search]Sunscreen[/search] [ Last edited by chemredox on 2007-12-18 at 11:39 ] |
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