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HHS/FDA RIN: 0910-AF43 Publication ID: Spring 2014 
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 of the future actions will address the safety of sunscreen active 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 
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    
Final Action (UVA/UVB)  06/17/2011  76 FR 35620   
NPRM (Effectiveness)  06/17/2011  76 FR 35672   
NPRM (Effectiveness) Comment Period End   09/15/2011    
ANPRM (Dosage Forms)  06/17/2011  76 FR 35669   
ANPRM (Dosage Forms) Comment Period End  09/15/2011    
Proposed Rule  03/00/2015 
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:
Janice Adams-King
Regulatory Health Project Manager
Department of Health and Human Services
Food and Drug Administration
Center for Drug Evaluation and Research, WO 22, Room 5416, 10903 New Hampshire Avenue,
Silver Spring, MD 20993
Phone:301 796-3713
Fax:301 796-9899
Email: janice.adams-king@fda.hhs.gov