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HHS/FDA RIN: 0910-AF43 Publication ID: Spring 2010 
Title: Over-the-Counter (OTC) Drug Review--Sunscreen 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 action addresses active ingredients reviewed under Time and Extent Applications. The second action addresses other effectiveness issues for OTC sunscreen drug products. The third action finalizes sunscreen formulation, labeling, and testing requirements for both ultraviolet B and ultraviolet A radiation protection. The last action addresses combination products containing sunscreen and insect repellent ingredients. 
Agency: Department of Health and Human Services(HHS)  Priority: Other Significant 
RIN Status: Previously published in the Unified Agenda Agenda Stage of Rulemaking: Proposed Rule Stage 
Major: No  Unfunded Mandates: No 
EO 13771 Designation: uncollected 
CFR Citation: 21 CFR 201    21 CFR 310    21 CFR 330 to 358   
Legal Authority: 21 USC 321p    21 USC 331    21 USC 351 to 353    21 USC 355    21 USC 360    21 USC 371   
Legal Deadline:  None
Timetable:
Action Date FR Cite
ANPRM (Sunscreen and Insect Repellent)  02/22/2007  72 FR 7941   
ANPRM Comment Period End  05/23/2007    
NPRM (UVA/UVB)  08/27/2007  72 FR 49070   
NPRM Comment Period End  12/26/2007    
NPRM (Time and Extent Applications)  07/00/2010    
NPRM (Effectiveness)  10/00/2010    
Final Action (UVA/UVB)  10/00/2010    
NPRM (Sunscreen and Insect Repellent)  To Be Determined    
Regulatory Flexibility Analysis Required: Yes  Government Levels Affected: Local, State 
Small Entities Affected: Businesses  Federalism: Yes 
Included in the Regulatory Plan: No 
RIN Data Printed in the FR: Yes 
Related RINs: Split from 0910-AA01 
Agency Contact:
Walter J. Ellenberg
Regulatory Project Management Officer
Department of Health and Human Services
Food and Drug Administration
Center for Drug Evaluation and Research, WO-22, Room 5488, 10903 New Hampshire Avenue,
Silver Spring, MD 20993
Phone:301 796-2090
Fax:301 796-9899
Email: walter.ellenberg@fda.hhs.gov