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Sunscreen Drug Products

Abstract: The OTC drug review establishes conditions under which OTC drugs are considered generally recognized as safe and effective, and not misbranded. After a final monograph (i.e., final rule) is issued, only OTC drugs meeting the conditions of the monograph, or having an approved new drug application, may be legally marketed. The first of the future actions will address the safety of sunscreen active ingredients.
RIN: 0910-AF43
Type: Rule Making
Related RINs 0910-AF43,0910-ZA40
KeyWord(s) UVA, OTC, sunscreen, sunburn, monograph, anti-rheumatic, avobenzone, "human use", UVB, formulation, labeling, 0910-ZA40, open, 2005-N-0453
Short title Sunscreen Drug Products
Docket Item Code N
Center CDER
Government Level Affected Local, State

Primary Documents (21)