Skip to main content
          Skip to FDA Search
          Skip to in this section menu
          Skip to footer links


U.S. flagAn official website of the United States government

					Here’s how you know
          			Dot gov**The .gov means it’s official.**Federal government websites often end in .gov or .mil. Before sharing sensitive information, make sure you're on a federal government site.
							      SSL**The site is secure.** The **https://** ensures that you are connecting to the official website and that any information you provide is encrypted and transmitted securely. 
			U.S. Food and Drug Administration
				
        Search
            Menu
							
						Search FDA
									
									Submit search 
		Featured
							Contact FDA
	                FDA Guidance Documents
	                Recalls, Market Withdrawals and Safety Alerts
	                Press Announcements
	                Warning Letters
	                Advisory Committees
	                En Español

					Products
            Food
							Drugs
							Medical Devices
							Radiation-Emitting Products
							Vaccines, Blood, and Biologics
							Animal and Veterinary
							Cosmetics
							Tobacco ProductsTopics
            About FDA
							Combination Products
							Regulatory Information
							Safety
							Emergency Preparedness
							International Programs
							News and Events
							Training and Continuing Education
							Inspections and Compliance
							Science and ResearchInformation For
            Consumers
	            Patients
	            Industry
	            Health Professionals
	            Federal, State and Local Officials 
 In this section:

                Historical Status of OTC Rulemakings

Historical Status of OTC Rulemakings Home
          Drugs
          Development & Approval Process | Drugs
          How Drugs are Developed and Approved
          Over-the-Counter OTC | Nonprescription Drugs
          Historical Status of OTC Rulemakings
          Rulemaking History for OTC Sunscreen Drug ProductsHistorical Status of OTC Rulemakings Rulemaking History for OTC Sunscreen Drug Products
  
  	
    Share
    Post
    Linkedin

    Email
    Print**https://www.federalregister.gov/documents/2019/02/26/2019-03019/sunscreen-drug-products-for-over-the-counter-human-useFinal Monograph**(21 CFR part 352)**:***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* CitationAdvance Notice of Proposed Rulemaking
			8/25/1978
			43FR38206Extension of Comment Period
			12/1/1978
			43FR56249Correction
			12/12/1978
			43FR58097Correction
			12/29/1978
			43FR60957Reopening of Administrative Record
			3/21/1980
			45FR18403Public Meeting: SPF testing
			9/4/1987
			52FR33598Extension of Comment Period: SPF testing
			12/4/1987
			52FR46095Reopening of Administrative Record: SPF testing
			5/4/1988
			53FR15853Proposed Rule
			Date
			*FR* CitationTentative Final Monograph
			5/12/1993
			58FR28194Extension of Comment Period
			10/15/1993
			58FR53460Reopening of Comment Period
			2/11/1994
			59FR6606Notice: Public meeting and Reopening of Administrative Record
			8/15/1996
			61FR42398

Final Rule
			Date
			*FR* CitationFinal Monograph
			5/21/1999
			64FR27666Extension of Effective Date and Reopening of Administrative Record
			6/8/2000
			65FR36319Partial Stay of Effective Date
			12/31/2001
			66FR67485Delay of Drug Fact Implementation
			9/3/2004
			69FR53801Technical Amendment: Incorporates 4 U.S.P. name changes
			6/20/2002
			67FR41821Notice: Guidance on 4 U.S.P. name changes
			6/3/2003
			68FR33164

Proposed Rule
			Date
			FR CitationProposed Rule
			2/21/2019
			84 FR 6204**Sunscreen Drug Products: Time and Extent Applications**

Advance Notice Of Proposed Rulemaking
			Date
			*FR* CitationRequest for Data: Amiloxate, enzacamene, and octyl triazone
			7/11/2003
			68FR41386Request for Data: Bisoctrizole and bemotrizonol
			12/5/2005
			70FR72449Request for Data: Diethylhexyl butamido triazone
			7/26/2006
			71FR42405Request for Data:Terephthalylidene dicamphor sulfonic acid (ecamsule)
			9/12/2008
			73FR53029Request for Data: Drometrizole Trisiloxane
			6/2/2010
			75FR30838

**Sunscreen Drug Products: Avobenzone**

Proposed Rule
			Date
			*FR* CitationProposed Rule
			9/16/1996
			61FR48645Correction
			10/11/1996
			61FR53340Correction
			2/26/1997
			62FR8663Enforcement of Policy: Allows avobenzone marketing
			4/30/1997
			62FR23350

Final Rule
			Date
			*FR* CitationFinal Monograph
			5/21/1999
			64FR27666Extension of Effective Date and Reopening of Administrative Record
			6/8/2000
			65FR36319Partial Stay of Effective Date
			12/31/2001
			66FR67485Delay of Drug Fact Implementation and Reopening of Administrative
			    Record
			9/3/2004
			69FR53801Technical Amendment: Incorporates 4 U.S.P. name changes
			6/20/2002
			67FR41821

**Sunscreen Drug Products: UV Protection**

Advance Notice Of Proposed Rulemaking
			Date
			*FR* CitationNotice: Public Meeting
			4/5/1994
			59FR16042

Proposed Rules
			Date
			*FR* CitationProposed Rule: UV Testing and Labeling
			8/27/2007
			72FR49070Extension of Comment Period
			11/28/2007
			72FR67264Proposed Rule: SPF 50 Maximum Labeled Value
			6/17/2011
			76FR35672Notice: Draft Guidance on Enforcement Policy
			6/17/2011
			76FR35665

Final Rule
			Date
			*FR* CitationFinal Rule 39: Testing and Labeling
			6/17/2011
			76FR35619Paperwork Reduction Act, 60-day Notice
			6/17/2011
			76FR35678Correction
			7/5/2011
			76FR38975Notice: Draft Guidance on Enforcement Policy
			6/17/2011
			76FR35665

**Sunscreen Drug Products:  Dosage Forms**

Advances Notice of Proposed Rulemaking
			Date
			*FR* CitationRequest for Data and Information: Dosage Forms
			6/17/2011
			76FR35669Extension of Comment Period
			9/14/2011
			76FR56682Notice: Draft Guidance on Enforcement Policy
			6/17/2011
			76FR35665

**Sunscreen Drug Products: Zinc Oxide**

Proposed Rules
			Date
			*FR* CitationProposed Rule
			10/22/1998
			63FR56584

Final Rule
			Date
			*FR* CitationFinal Monograph
			5/21/1999
			64FR27666Extension of Effective Date and Reopening of Administrative Record
			6/8/2000
			65FR36319Partial Stay of Effective Date
			12/31/2001
			66FR67485Delay of Drug Fact Implementation
			9/3/2004
			69FR53801

**External Analgesic Products: Insect Repellent**

Advance Notice Of Proposed Rulemaking
			Date
			*FR* CitationRequest for Data
			2/22/2007
			72FR7941EPA Request for Data
			2/22/2007
			72FR7979

Back to Top

                                                                                  Content current as of:
      08/30/2019Historical Status of OTC Rulemakings
 
 Footer Links
    FDA Archive
          About FDA
          Accessibility
      Visitor Information
          Website Policies / Privacy
          No FEAR Act
          Vulnerability Disclosure Policy
      FOIA
          HHS.gov
          USA.gov
    Contact FDA
      Follow FDA on Facebook
      Follow FDA on X
      Follow FDA on Instagram
      Follow FDA on LinkedIn
      View FDA videos on YouTube
      Subscribe to FDA RSS feeds
    FDA Homepage
    Contact Number
      1-888-INFO-FDA (1-888-463-6332) Back toTop