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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 RulemakingDateFR Citation
Advance Notice of Proposed Rulemaking [PDF]8/25/197843FR38206
    Extension of Comment Period [PDF]12/1/197843FR56249
    Correction [PDF]12/12/197843FR58097
    Correction [PDF]12/29/197843FR60957
    Reopening of Administrative Record [PDF]3/21/198045FR18403
Public Meeting: SPF testing [PDF]9/4/198752FR33598
    Extension of Comment Period: SPF testing [PDF]12/4/198752FR46095
    Reopening of Administrative Record: SPF testing [PDF]5/4/198853FR15853
Proposed RuleDateFR Citation
Tentative Final Monograph [PDF]5/12/199358FR28194
Extension of Comment Period [PDF]10/15/199358FR53460
Reopening of Comment Period [PDF]2/11/199459FR6606
Notice: Public meeting and Reopening of Administrative Record [PDF]8/15/199661FR42398
Final RuleDateFR Citation
Final Monograph [PDF]5/21/199964FR27666
    Extension of Effective Date and Reopening of Administrative Record [PDF]6/8/200065FR36319
    Partial Stay of Effective Date [PDF]12/31/200166FR67485
    Delay of Drug Fact Implementation [PDF]9/3/200469FR53801
Technical Amendment: Incorporates 4 U.S.P. name changes [PDF]6/20/200267FR41821
    Notice: Guidance on 4 U.S.P. name changes [PDF]6/3/200368FR33164

Sunscreen Drug Products: Time and Extent Applications
Advance Notice Of Proposed RulemakingDateFR 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]9/12/200873FR53029
Request for Data: Drometrizole Trisiloxane [PDF]6/2/201075FR30838

Sunscreen Drug Products: Avobenzone
Proposed RuleDateFR Citation
Proposed Rule [PDF]9/16/199661FR48645
    Correction [PDF]10/11/199661FR53340
    Correction [PDF]2/26/199762FR8663
Enforcement of Policy: Allows avobenzone marketing [PDF]4/30/199762FR23350
Final RuleDateFR Citation
Final Monograph [PDF]5/21/199964FR27666
    Extension of Effective Date and Reopening of Administrative Record [PDF]6/8/200065FR36319
    Partial Stay of Effective Date [PDF]12/31/200166FR67485
    Delay of Drug Fact Implementation and Reopening of Administrative Record [PDF]9/3/200469FR53801
Technical Amendment: Incorporates 4 U.S.P. name changes [PDF]6/20/200267FR41821

Sunscreen Drug Products: UV Protection
Advance Notice Of Proposed RulemakingDateFR Citation
Notice: Public Meeting [PDF]4/5/199459FR16042
Proposed RulesDateFR Citation
Proposed Rule: UV Testing and Labeling [PDF]8/27/200772FR49070
Extension of Comment Period [PDF]11/28/200772FR67264
Proposed Rule: SPF 50 Maximum Labeled Value [PDF]6/17/201176FR35672
Notice: Draft Guidance on Enforcement Policy [PDF]6/17/201176FR35665
Final RuleDateFR Citation
Final Rule 39: Testing and Labeling6/17/201176FR35619
Paperwork Reduction Act, 60-day Notice [PDF]6/17/201176FR35678
    Correction7/5/201176FR38975
Notice: Draft Guidance on Enforcement Policy [PDF]6/17/201176FR35665

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
Notice: Draft Guidance on Enforcement Policy [PDF]6/17/2011 76FR35665 

 

Sunscreen Drug Products: Zinc Oxide
Proposed RulesDateFR Citation
Proposed Rule [PDF]10/22/199863FR56584
Final RuleDateFR Citation
Final Monograph [PDF]5/21/199964FR27666
    Extension of Effective Date and Reopening of Administrative Record [PDF]6/8/200065FR36319
    Partial Stay of Effective Date [PDF]12/31/200166FR67485
    Delay of Drug Fact Implementation [PDF]9/3/200469FR53801
External Analgesic Products: Insect Repellent
Advance Notice Of Proposed RulemakingDateFR Citation
Request for Data [PDF]2/22/200772FR7941
EPA Request for Data [PDF]2/22/200772FR7979