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  1. Guidance, Compliance, & Regulatory Information

Regulatory Policy Information for the Sunscreen Innovation Act

Deliverable Type Deliverable Description Statutory Deadline Date Issued Additional Information Next Steps
Federal Register (FR) notice FR Notice of Availability of Proposed Orders for six sunscreen ingredients that were previously issued feedback letters  1/10/2015  1/7/2015

Sunscreen Feedback Letters; Notice of Availability Under the Sunscreen Innovation Act

OTC Sunscreen Feedback Letters Deemed To Be SIA Proposed Orders

 
Time and Extent Application Feedback Letter (November 13, 2014): Bemotrizinol Industry to provide information to fill data gaps to meet GRASE standards
Time and Extent Application Feedback Letter (September 3, 2014): Bisoctrizole Industry to provide information to fill data gaps to meet GRASE standards
Time and Extent Application Feedback Letter (August 29, 2014): Drometrizole Trisiloxane Industry to provide information to fill data gaps to meet GRASE standards
Time and Extent Application Feedback Letter (June 23, 2014): Octyl Triazone Industry to provide information to fill data gaps to meet GRASE standards
Time and Extent Application Feedback Letter (Feb 25, 2014): Amiloxate Industry to provide information to fill data gaps to meet GRASE standards
Time and Extent Application Feedback Letter (Feb 21, 2014): Diethylhexyl Butamido Triazone Industry to provide information to fill data gaps to meet GRASE standards
Proposed Order 2 proposed orders for pending sunscreen requests  2/24/2015  2/24/2015 Over-the-Counter Sunscreen Drug Products--Regulatory Status of Ecamsule Industry to provide information to fill data gaps to meet GRASE standards
Over-the-Counter Sunscreen Drug Products--Regulatory Status of Enzacamene Industry to provide information to fill data gaps to meet GRASE standards
Process Timelines for review to sponsors of pending nonsunscreen applications who request a review framework  11/26/2015  11/24/2015

Implementation of SIA requirements for pending non-sunscreen TEA for sodium shale oil sulfonate (SSAS) from Ichthyol-Gesellschaft

Implementation of SIA requirements for pending non-sunscreen TEA piroctone olamine from Clariant Corporation and Clariant Produkte (Deutschland) GmbH (Clariant)

Implementation of SIA requirements for pending non-sunscreen TEA sodium picosulfate from Boehringer Ingelheim Pharmaceuticals Inc.

Sponsors responded within 60 days. FDA is reviewing each submission according to the option selected by the sponsor.
Draft Guidance Draft guidance: format and content (Refuse To File) 11/26/2015 11/20/2015 Sunscreen Innovation Act:  Nonprescription Sunscreen Drug Products--Content and Format of Data Submissions SIA requires final guidance to publish by 11/26/2016
Draft Guidance Draft guidance: sunscreen safety and efficacy standard 11/26/2015 11/20/2015 Over-the-Counter Sunscreens:  Safety and Effectiveness Data SIA requires final guidance to publish by 11/26/2016
Draft Guidance Draft guidance: withdrawal of pending request 11/26/2015 11/20/2015 Sunscreen Innovation Act; Withdrawal of a 586A Request or Pending Request SIA requires final guidance to publish by 11/26/2016
Draft Guidance Draft guidance: Use of Advisory Committees 11/26/2015  11/20/2015 Sunscreen Innovation Act:  Section 586C(c) Advisory Committee Process SIA requires final guidance to publish by 11/26/2016
Report Letter to Congress on review of nonsunscreen requests  5/26/2016  5/26/2016

Letter to Senate Health, Education, Labor and Pensions Committee and House Energy and Commerce Committee

 
Proposed Rule Proposed rule on framework for review of nonsunscreen requests  5/26/2016  4/1/2016 Food and Drug Administration Proposed Rule on Over-the-Counter Time and Extent Applications SIA requires final rule to publish by 2/26/2017
Report Report to Congress  5/26/2016  5/25/2016 Report to Senate Health, Education, Labor and Pensions Committee and House Energy and Commerce Committee  
Final Guidance Final guidance: format and content (Refuse to File)  11/26/2016  11/22/2016 Nonprescription Sunscreen Drug Products - Content and Format of Data Submissions The FDA has fulfilled the requirements of the SIA for this guidance
Final Guidance Final guidance: sunscreen safety and efficacy standard  11/26/2016  11/22/2016 Over-the-Counter Sunscreens: Safety and Effectiveness Data The FDA has fulfilled the requirements of the SIA for this guidance
Final Guidance Final guidance: withdrawal of pending request  11/26/2016  10/07/2016 Sunscreen Innovation Act: Withdrawal of a 586A Request or Pending Request The FDA has fulfilled the requirements of the SIA for this guidance
Final Guidance Final guidance: Use of Advisory Committees  11/26/2016  10/7/2016 Sunscreen Innovation Act: Section 586C(c) Advisory Committee Process The FDA has fulfilled the requirements of the SIA for this guidance
Final Rule Final rule on framework for review of nonsunscreen requests  2/26/2017  11/22/2016 Food and Drug Administration Final Rule on Over-the-Counter Time and Extent Applications The FDA has finalized this rule in advance of the statutory deadline of 2/26/2017.
Report Report to Congress  5/26/2018  5/21/2018 Report to the Committee on Health, Education, Labor, and Pensions, U.S. Senate, and the Committee on Energy and Commerce, U.S. House of Representatives  
Report GAO Report #1  11/26/2017  11/19/2017 SUNSCREEN: FDA Reviewed Applications for New Active Ingredients and Determined that it Needs Additional Data (GAO-18-61) The GAO report has come out in advance of the statutory deadline of 11/25/2017. The second GAO report is due no later than 5/26/2019
Report GAO Report #2  5/26/2020      
Report 3rd report to Congress  5/26/2020      
Final Rule Finalize sunscreen monograph 11/26/2019      

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