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HHS/FDA RIN: 0910-AF43 Publication ID: Fall 2019 
Title: Sunscreen Drug Products For Over-The-Counter-Human Use; Final Monograph  

The final rule will describe the conditions of use under which OTC sunscreen monograph products are generally recognized as safe and effective (GRASE) and not misbranded. Consistent with the Sunscreen Innovation Act, we expect that these conditions will include sunscreen dosage forms and maximum SPF values. The preamble of the final rule will also indicate which sunscreen active ingredients FDA has deferred further rulemaking on while data supporting the GRASE status of those ingredients is developed.

Agency: Department of Health and Human Services(HHS)  Priority: Economically Significant 
RIN Status: Previously published in the Unified Agenda Agenda Stage of Rulemaking: Final Rule Stage 
Major: Yes  Unfunded Mandates: Private Sector 
EO 13771 Designation: Regulatory 
CFR Citation: 21 CFR 201    21 CFR 310    21 CFR 330 to 358   
Legal Authority: 21 U.S.C. 321p    21 U.S.C. 331    21 U.S.C. 351 to 353    21 U.S.C. 355    21 U.S.C. 360    21 U.S.C. 371   
Legal Deadline:
Action Source Description Date
Final  Statutory  Sunscreen Innovation Act  11/26/2019 
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    
NPRM  02/26/2019  84 FR 6204   
NPRM Comment Period End  06/27/2019 
NPRM Extension of Comment Period  04/18/2019  84 FR 16222   
NPRM Extension of Comment Period End  06/27/2019 
Final Rule  09/00/2020 
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:
Kristen Hardin
Department of Health and Human Services
Food and Drug Administration
Center for Drug Evaluation and Research, 10903 New Hampshire Avenue, WO 22, Room 5491,
Silver Spring, MD 20993
Phone:240 402-4246
Fax:301 796-9841