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 Rulemaking	Date	FR Citation
Advance Notice of Proposed Rulemaking [PDF]	8/25/1978	43FR38206
Extension of Comment Period [PDF]	12/1/1978	43FR56249
Correction [PDF]	12/12/1978	43FR58097
Correction [PDF]	12/29/1978	43FR60957
Reopening of Administrative Record [PDF]	3/21/1980	45FR18403
Public Meeting: SPF testing [PDF]	9/4/1987	52FR33598
Extension of Comment Period: SPF testing [PDF]	12/4/1987	52FR46095
Reopening of Administrative Record: SPF testing [PDF]	5/4/1988	53FR15853
Proposed Rule	Date	FR Citation
Tentative Final Monograph [PDF]	5/12/1993	58FR28194
Extension of Comment Period [PDF]	10/15/1993	58FR53460
Reopening of Comment Period [PDF]	2/11/1994	59FR6606
Notice: Public meeting [PDF]	8/15/1996	61FR42398
Final Rule	Date	FR Citation
Final Monograph [PDF]	5/21/1999	64FR27666
Extension of Effective Date [PDF]	6/8/2000	65FR36319
Partial Stay of Effective Date [PDF]	12/31/2001	66FR67485
Delay of Drug Fact Implementation [PDF]	9/3/2004	69FR53801
Technical Amendment: Incorporates 4 U.S.P. name changes [PDF]	6/20/2002	67FR41821
Notice: Guidance on 4 U.S.P. name changes [PDF]	6/3/2003	68FR33164

**Sunscreen Drug Products: Time and Extent Applications**
Advance Notice Of Proposed Rulemaking	Date	FR 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]	9/12/2008	73FR53029
Request for Data: Drometrizole Trisiloxane [PDF]	6/2/2010	75FR30838

**Sunscreen Drug Products: Avobenzone**
Proposed Rule	Date	FR Citation
Proposed Rule [PDF]	9/16/1996	61FR48645
Correction [PDF]	10/11/1996	61FR53340
Correction [PDF]	2/26/1997	62FR8663
Enforcement of Policy: Allows avobenzone marketing [PDF]	4/30/1997	62FR23350
Final Rule	Date	FR Citation
Final Monograph [PDF]	5/21/1999	64FR27666
Extension of Effective Date [PDF]	6/8/2000	65FR36319
Partial Stay of Effective Date [PDF]	12/31/2001	66FR67485
Delay of Drug Fact Implementation [PDF]	9/3/2004	69FR53801
Technical Amendment: Incorporates 4 U.S.P. name changes [PDF]	6/20/2002	67FR41821
Notice: Guidance on 4 U.S.P. name changes [PDF]	6/3/2003	68FR33164

**Sunscreen Drug Products: UV Protection**
Advance Notice Of Proposed Rulemaking	Date	FR Citation
Notice: Public Meeting [PDF]	4/5/1994	59FR16042
Proposed Rules	Date	FR Citation
Proposed Rule: UV Testing and Labeling [PDF]	8/27/2007	72FR49070
Extension of Comment Period [PDF]	11/28/2007	72FR67264
Proposed Rule: SPF 50 Maximum Labeled Value [PDF]	6/17/2011	76FR35672

Final Rule	Date	FR Citation
Final Rule 39: Testing and Labeling	6/17/2011	76FR35619
Paperwork Reduction Act, 60-day Notice [PDF]	6/17/2011	76FR35678
Correction	7/5/2011	76FR38975

Sunscreen Drug Products: Dosage Forms

Advances Notice of Proposed Rulemaking	Date	FR Citation
Request for Data and Information: Dosage Forms [PDF]	6/17/2011	76FR35669
Extension of Comment Period [PDF]	9/14/2011	76FR56682

**Sunscreen Drug Products: Zinc Oxide**
Proposed Rules	Date	FR Citation
Proposed Rule [PDF]	10/22/1998	63FR56584
Final Rule	Date	FR Citation
Final Monograph [PDF]	5/21/1999	64FR27666
Extension of Effective Date [PDF]	6/8/2000	65FR36319
Partial Stay of Effective Date [PDF]	12/31/2001	66FR67485
Delay of Drug Fact Implementation [PDF]	9/3/2004	69FR53801
Technical Amendment: Incorporates 4 U.S.P. name changes [PDF]	6/20/2002	67FR41821
Notice: Guidance on 4 U.S.P. name changes [PDF]	6/3/2003	68FR33164

**External Analgesic Products: Insect Repellent**
Advance Notice Of Proposed Rulemaking	Date	FR Citation
Request for Data [PDF]	2/22/2007	72FR7941
EPA Request for Data [PDF]	2/22/2007	72FR7979