Rulemaking History for OTC Sunscreen Drug Products
On March 27, 2020, the Coronavirus Aid, Relief, and Economic Security Act (CARES Act) was signed into law. The CARES Act includes provisions that governs and modernizes the way certain over-the-counter (OTC) drugs are regulated in the United States. Learn more about the CARES Act and OTC monograph reform. This webpage reflects sunscreen information from prior to the passage of the CARES Act. The latest version of the applicable sunscreen monograph and any related proposed or final orders to ensure can be found at OTC Monographs@FDA.
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
| 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 |
| 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 |
| 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 |
| 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 | 76FR35620 |
| 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 |
| 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 |