Drugs

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 Rulemaking8/25/197843FR38206disclaimer icon
    Extension of Comment Period12/1/197843FR56249disclaimer icon
    Correction12/12/197843FR58097disclaimer icon
    Correction12/29/197843FR60957disclaimer icon
    Reopening of Administrative Record3/21/198045FR18403disclaimer icon
Public Meeting: SPF testing9/4/198752FR33598disclaimer icon
    Extension of Comment Period: SPF testing12/4/198752FR46095disclaimer icon
    Reopening of Administrative Record: SPF testing5/4/198853FR15853disclaimer icon
Proposed RuleDateFR Citation
Tentative Final Monograph5/12/199358FR28194disclaimer icon
Extension of Comment Period10/15/199358FR53460disclaimer icon
Reopening of Comment Period2/11/199459FR6606
Notice: Public meeting and Reopening of Administrative Record 8/15/199661FR42398
Final RuleDateFR Citation
Final Monograph5/21/199964FR27666
    Extension of Effective Date and Reopening of Administrative Record6/8/200065FR36319
    Partial Stay of Effective Date12/31/200166FR67485
    Delay of Drug Fact Implementation9/3/200469FR53801
Technical Amendment: Incorporates 4 U.S.P. name changes6/20/200267FR41821
    Notice: Guidance on 4 U.S.P. name changes6/3/200368FR33164

Sunscreen Drug Products: Time and Extent Applications

Advance Notice Of Proposed RulemakingDateFR Citation

Request for Data: Amiloxate, enzacamene, and octyl triazone

7/11/2003

68FR41386

Request for Data: Bisoctrizole and bemotrizonol

12/5/2005

70FR72449

Request for Data: Diethylhexyl butamido triazone

7/26/2006

71FR42405

Request for Data:Terephthalylidene dicamphor sulfonic acid (ecamsule)9/12/200873FR53029
Request for Data: Drometrizole Trisiloxane6/2/201075FR30838

Sunscreen Drug Products: Avobenzone

Proposed RuleDateFR Citation
Proposed Rule9/16/199661FR48645
    Correction10/11/199661FR53340
    Correction2/26/199762FR8663
Enforcement of Policy: Allows avobenzone marketing4/30/199762FR23350
Final RuleDateFR Citation
Final Monograph5/21/199964FR27666
    Extension of Effective Date and Reopening of Administrative Record6/8/200065FR36319
    Partial Stay of Effective Date12/31/200166FR67485
    Delay of Drug Fact Implementation and Reopening of Administrative
    Record
9/3/200469FR53801
Technical Amendment: Incorporates 4 U.S.P. name changes6/20/200267FR41821

Sunscreen Drug Products: UV Protection

Advance Notice Of Proposed RulemakingDateFR Citation
Notice: Public Meeting4/5/199459FR16042
Proposed RulesDateFR Citation
Proposed Rule: UV Testing and Labeling8/27/200772FR49070
Extension of Comment Period11/28/200772FR67264 
Proposed Rule: SPF 50 Maximum Labeled Value6/17/201176FR35672
Notice: Draft Guidance on Enforcement Policy6/17/201176FR35665
Final RuleDateFR Citation
Final Rule 39: Testing and Labeling6/17/201176FR35619
Paperwork Reduction Act, 60-day Notice6/17/201176FR35678
    Correction7/5/201176FR38975
Notice: Draft Guidance on Enforcement Policy 6/17/201176FR35665

Sunscreen Drug Products:  Dosage Forms

Advances Notice of Proposed RulemakingDateFR Citation
Request for Data and Information: Dosage Forms6/17/201176FR35669
    Extension of Comment Period9/14/201176FR56682
Notice: Draft Guidance on Enforcement Policy6/17/2011 76FR35665 

Sunscreen Drug Products: Zinc Oxide

Proposed RulesDateFR Citation
Proposed Rule10/22/199863FR56584
Final RuleDateFR Citation
Final Monograph5/21/199964FR27666
    Extension of Effective Date and Reopening of Administrative Record6/8/200065FR36319
    Partial Stay of Effective Date12/31/200166FR67485
    Delay of Drug Fact Implementation9/3/200469FR53801

External Analgesic Products: Insect Repellent

Advance Notice Of Proposed RulemakingDateFR Citation
Request for Data2/22/200772FR7941
EPA Request for Data2/22/200772FR7979

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