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  7. Rulemaking History for OTC Sunscreen Drug Products
  1. Historical Status of OTC Rulemakings

Rulemaking History for OTC Sunscreen Drug Products

https://www.federalregister.gov/documents/2019/02/26/2019-03019/sunscreen-drug-products-for-over-the-counter-human-useFinal 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 8/25/1978 43FR38206
    Extension of Comment Period 12/1/1978 43FR56249
    Correction 12/12/1978 43FR58097
    Correction 12/29/1978 43FR60957
    Reopening of Administrative Record 3/21/1980 45FR18403
Public Meeting: SPF testing 9/4/1987 52FR33598
    Extension of Comment Period: SPF testing 12/4/1987 52FR46095
    Reopening of Administrative Record: SPF testing 5/4/1988 53FR15853
Proposed Rule Date FR Citation
Tentative Final Monograph 5/12/1993 58FR28194
Extension of Comment Period 10/15/1993 58FR53460
Reopening of Comment Period 2/11/1994 59FR6606
Notice: Public meeting and Reopening of Administrative Record  8/15/1996 61FR42398
Final Rule Date FR Citation
Final Monograph 5/21/1999 64FR27666
    Extension of Effective Date and Reopening of Administrative Record 6/8/2000 65FR36319
    Partial Stay of Effective Date 12/31/2001 66FR67485
    Delay of Drug Fact Implementation 9/3/2004 69FR53801
Technical Amendment: Incorporates 4 U.S.P. name changes 6/20/2002 67FR41821
    Notice: Guidance on 4 U.S.P. name changes 6/3/2003 68FR33164
Proposed Rule Date FR Citation
Proposed Rule 2/21/2019 84 FR 6204

Sunscreen Drug Products: Time and Extent Applications

Advance Notice Of Proposed Rulemaking Date FR 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) 9/12/2008 73FR53029
Request for Data: Drometrizole Trisiloxane 6/2/2010 75FR30838

Sunscreen Drug Products: Avobenzone

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

Sunscreen Drug Products: UV Protection

Advance Notice Of Proposed Rulemaking Date FR Citation
Notice: Public Meeting 4/5/1994 59FR16042
Proposed Rules Date FR Citation
Proposed Rule: UV Testing and Labeling 8/27/2007 72FR49070
Extension of Comment Period 11/28/2007 72FR67264 
Proposed Rule: SPF 50 Maximum Labeled Value 6/17/2011 76FR35672
Notice: Draft Guidance on Enforcement Policy 6/17/2011 76FR35665
Final Rule Date FR Citation
Final Rule 39: Testing and Labeling 6/17/2011 76FR35619
Paperwork Reduction Act, 60-day Notice 6/17/2011 76FR35678
    Correction 7/5/2011 76FR38975
Notice: Draft Guidance on Enforcement Policy  6/17/2011 76FR35665

Sunscreen Drug Products:  Dosage Forms

Advances Notice of Proposed Rulemaking Date FR Citation
Request for Data and Information: Dosage Forms 6/17/2011 76FR35669
    Extension of Comment Period 9/14/2011 76FR56682
Notice: Draft Guidance on Enforcement Policy 6/17/2011  76FR35665 

Sunscreen Drug Products: Zinc Oxide

Proposed Rules Date FR Citation
Proposed Rule 10/22/1998 63FR56584
Final Rule Date FR Citation
Final Monograph 5/21/1999 64FR27666
    Extension of Effective Date and Reopening of Administrative Record 6/8/2000 65FR36319
    Partial Stay of Effective Date 12/31/2001 66FR67485
    Delay of Drug Fact Implementation 9/3/2004 69FR53801

External Analgesic Products: Insect Repellent

Advance Notice Of Proposed Rulemaking Date FR Citation
Request for Data 2/22/2007 72FR7941
EPA Request for Data 2/22/2007 72FR7979

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