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

Rulemaking History for OTC Sunscreen Drug Products

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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