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U.S. Department of Health and Human Services

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Rulemaking History for OTC Sunscreen Drug Products

Final Monograph (21 CFR part 352):
Sunscreen Drug Products for Over-the-Counter Human Use
 

OTC Sunscreen Drug Products found on this page:


Sunscreen Drug Products: Original Active Ingredients and Labeling
Advance Notice Of Proposed Rulemaking Date FR Citation
Advance Notice of Proposed Rulemaking [PDF] 8/25/1978 43FR38206
    Extension of Comment Period [PDF] 12/1/1978 43FR56249
    Correction [PDF] 12/12/1978 43FR58097
    Correction [PDF] 12/29/1978 43FR60957
    Reopening of Administrative Record [PDF] 3/21/1980 45FR18403
Public Meeting: SPF testing [PDF] 9/4/1987 52FR33598
    Extension of Comment Period: SPF testing [PDF] 12/4/1987 52FR46095
    Reopening of Administrative Record: SPF testing [PDF] 5/4/1988 53FR15853
Proposed Rule Date FR Citation
Tentative Final Monograph [PDF] 5/12/1993 58FR28194
Extension of Comment Period [PDF] 10/15/1993 58FR53460
Reopening of Comment Period [PDF] 2/11/1994 59FR6606
Notice: Public meeting [PDF] 8/15/1996 61FR42398
Final Rule Date FR Citation
Final Monograph [PDF] 5/21/1999 64FR27666
    Extension of Effective Date [PDF] 6/8/2000 65FR36319
    Partial Stay of Effective Date [PDF] 12/31/2001 66FR67485
    Delay of Drug Fact Implementation [PDF] 9/3/2004 69FR53801
Technical Amendment: Incorporates 4 U.S.P. name changes [PDF] 6/20/2002 67FR41821
    Notice: Guidance on 4 U.S.P. name changes [PDF] 6/3/2003 68FR33164

Sunscreen Drug Products: Time and Extent Applications
Advance Notice Of Proposed Rulemaking Date FR Citation
Request for Data: Amiloxate, enzacamene, and octyl triazone [PDF]

7/11/2003 

68FR41386

Request for Data: Bisoctrizole and bemotrizonol [PDF] 12/5/2005

70FR72449

Request for Data: Diethylhexyl butamido triazone [PDF]

7/26/2006

71FR42405

Request for Data:Terephthalylidene dicamphor sulfonic acid (ecamsule) [PDF] 9/12/2008 73FR53029
Request for Data: Drometrizole Trisiloxane [PDF] 6/2/2010 75FR30838

Sunscreen Drug Products: Avobenzone
Proposed Rule Date FR Citation
Proposed Rule [PDF] 9/16/1996 61FR48645
    Correction [PDF] 10/11/1996 61FR53340
    Correction [PDF] 2/26/1997 62FR8663
Enforcement of Policy: Allows avobenzone marketing [PDF] 4/30/1997 62FR23350
Final Rule Date FR Citation
Final Monograph [PDF] 5/21/1999 64FR27666
    Extension of Effective Date [PDF] 6/8/2000 65FR36319
    Partial Stay of Effective Date [PDF] 12/31/2001 66FR67485
    Delay of Drug Fact Implementation [PDF] 9/3/2004 69FR53801
Technical Amendment: Incorporates 4 U.S.P. name changes [PDF] 6/20/2002 67FR41821
    Notice: Guidance on 4 U.S.P. name changes [PDF] 6/3/2003 68FR33164

Sunscreen Drug Products: UV Protection
Advance Notice Of Proposed Rulemaking Date FR Citation
Notice: Public Meeting [PDF] 4/5/1994 59FR16042
Proposed Rules Date FR Citation
Proposed Rule: UV Testing and Labeling [PDF] 8/27/2007 72FR49070
Extension of Comment Period [PDF] 11/28/2007 72FR67264
Proposed Rule: SPF 50 Maximum Labeled Value [PDF] 6/17/2011 76FR35672
     
     
Final Rule Date FR Citation
Final Rule 39: Testing and Labeling 6/17/2011 76FR35619
Paperwork Reduction Act, 60-day Notice [PDF] 6/17/2011 76FR35678
    Correction 7/5/2011 76FR38975

 

Sunscreen Drug Products:  Dosage Forms

Advances Notice of Proposed RulemakingDateFR Citation
Request for Data and Information: Dosage Forms [PDF]6/17/201176FR35669
    Extension of Comment Period [PDF]9/14/201176FR56682


Sunscreen Drug Products: Zinc Oxide
Proposed Rules Date FR Citation
Proposed Rule [PDF] 10/22/1998 63FR56584
Final Rule Date FR Citation
Final Monograph [PDF] 5/21/1999 64FR27666
    Extension of Effective Date [PDF] 6/8/2000 65FR36319
    Partial Stay of Effective Date [PDF] 12/31/2001 66FR67485
    Delay of Drug Fact Implementation [PDF] 9/3/2004 69FR53801
Technical Amendment: Incorporates 4 U.S.P. name changes [PDF] 6/20/2002 67FR41821
    Notice: Guidance on 4 U.S.P. name changes [PDF] 6/3/2003 68FR33164
External Analgesic Products: Insect Repellent
Advance Notice Of Proposed Rulemaking Date FR Citation
Request for Data [PDF] 2/22/2007 72FR7941
EPA Request for Data [PDF] 2/22/2007 72FR7979