Sunscreen Drug Products for Over-the-Counter Human Use; Final Monograph; Technical Amendment
other · Food and Drug Administration · Rule · Published 2002-06-20 · Effective 2002-09-01 · 67 FR 41821
Document
Document number
01-15632
Federal Register citation
67 FR 41821
CFR reference
21 CFR 352
Type
Rule
Action
Final rule; technical amendment.
Category
other
Sub-agency
Food and Drug Administration
Publication date
2002-06-20
Effective date
2002-09-01
HHS docket
Docket No. 78N-0038
Abstract
The Food and Drug Administration (FDA) is amending the regulation that established conditions under which over-the-counter (OTC) sunscreen drug products are generally recognized as safe and effective and not misbranded. This amendment updates the monograph to incorporate United States Pharmacopeia (U.S.P.) name changes for four active ingredients included in the monograph. This final rule is part of FDA's ongoing review of OTC drug products.