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


Date Federal Register Citation Description
8/25/1978 43FR38206 PDF document Advance Notice of Proposed Rulemaking
12/1/1978 43FR56249 PDF document Extension of Comment Period: Advance Notice of Proposed Rulemaking
12/12/1978 43FR58097 PDF document Correction: Advance Notice of Proposed Rulemaking
12/29/1978 43FR60957 PDF document Correction: Advance Notice of Proposed Rulemaking
3/21/1980 45FR18403 PDF document Reopening of Administrative Record
9/4/1987 52FR33598 PDF document Notice: Public meeting on SPF testing
12/4/1987 52FR46095 PDF document Extension of Comment Period: SPF testing
5/4/1988 53FR15853 PDF document Reopening of Administrative Record: SPF testing
5/12/1993 58FR28194 PDF document Tentative Final Monograph
10/15/1993 58FR53460 PDF document Extension of Comment Period: Tentative Final Monograph
2/11/1994 59FR6606 PDF document Reopening of Comment Period: Tentative Final Monograph
4/5/1994 59FR16042 PDF document Notice: Public Meeting
8/15/1996 61FR42398 PDF document
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Notice: Public meeting
9/16/1996 61FR48645 PDF document
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Proposed Rule: Adds avobenzone as GRASE active ingredient
10/11/1996 61FR53340 PDF document
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Correction: 9/16/1996 Proposed Rule
2/26/1997 62FR8663 PDF document
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Correction: 9/16/1996 Proposed Rule
4/30/1997 62FR23350 PDF document
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Enforcement of Policy: Allows avobenzone marketing
10/22/1998 63FR56584 PDF document
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Proposed Rule: Zinc oxide
5/21/1999 64FR27666 PDF document
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Final Monograph
6/8/2000 65FR36319 PDF document
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Extension of Effective Date: Final Monograph
12/31/2001 66FR67485 PDF document
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Partial Stay of Effective Date: Final Monograph
6/20/2002 67FR41821 PDF document
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Technical Amendment: Incorporates 4 U.S.P. name changes
6/3/2003 68FR33164 PDF document
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Notice: Guidance on 4 U.S.P. name changes

7/11/2003 

68FR41386 PDF document
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Request for Data: Time and Extent Applications (amiloxate, enzacamene, and octyl triazone)
9/3/2004 69FR53801 PDF document
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Delay of Drug Fact Implementation: Final Monograph
12/5/2005

70FR72449 PDF document
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Request for Data: Time and Extent Applications (bisoctrizole and bemotrizonol)

7/26/2006

71FR42405 PDF document
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Request for Data: Time and Extent Applications (Diethylhexyl butamido triazone)
2/22/2007 72FR7941 PDF document
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Request for Data: Insect Repellent-Sunscreen Combinations

2/22/2007

71FR7979 PDF document
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EPA Request for Data: Insect Repellent-Sunscreen Combinations
8/27/2007 72FR49070 PDF document
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Proposed Rule: UVA Testing and Labeling

11/28/2007

72FR67264 PDF document
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Extension of Comment Period
9/12/2008 73FR53029 PDF document
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Request for Data: Time and Extent Applications
(Terephthalylidene dicamphor sulfonic acid [ecamsule])

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Last updated: September 16, 2008

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