Rulemaking History for OTC Sunscreen Drug Products
Sunscreen Drug Products for Over-the-Counter Human Use
OTC Sunscreen Drug Products found on this page:
- Original Active Ingredients and Labeling
- Time and Extent Applications
- Avobenzone
- UVA Protection
- Dosage Forms
- Zinc Oxide
- Insect Repellent
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 |
|
Request for Data: Bisoctrizole and bemotrizonol |
12/5/2005 |
|
Request for Data: Diethylhexyl butamido triazone |
7/26/2006 |
|
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 |