Drugs

Regulatory Policy Information for the Sunscreen Innovation Act

Deliverable TypeDeliverable DescriptionStatutory DeadlineDate IssuedAdditional InformationNext Steps
Federal Register (FR) noticeFR 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): BemotrizinolIndustry to provide information to fill data gaps to meet GRASE standards
Time and Extent Application Feedback Letter (September 3, 2014): BisoctrizoleIndustry to provide information to fill data gaps to meet GRASE standards
Time and Extent Application Feedback Letter (August 29, 2014): Drometrizole TrisiloxaneIndustry to provide information to fill data gaps to meet GRASE standards
Time and Extent Application Feedback Letter (June 23, 2014): Octyl TriazoneIndustry to provide information to fill data gaps to meet GRASE standards
Time and Extent Application Feedback Letter (Feb 25, 2014): AmiloxateIndustry to provide information to fill data gaps to meet GRASE standards
Time and Extent Application Feedback Letter (Feb 21, 2014): Diethylhexyl Butamido TriazoneIndustry to provide information to fill data gaps to meet GRASE standards
Proposed Order2 proposed orders for pending sunscreen requests 2/24/2015 2/24/2015Over-the-Counter Sunscreen Drug Products--Regulatory Status of EcamsuleIndustry to provide information to fill data gaps to meet GRASE standards
Over-the-Counter Sunscreen Drug Products--Regulatory Status of EnzacameneIndustry to provide information to fill data gaps to meet GRASE standards
ProcessTimelines 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.

Implementation of SIA requirements for pending non-sunscreen TEA for climbazole from Syrmise, Inc

Sponsors responded within 60 days. FDA reviewed each submission according to the option selected by the sponsor. If a sponsor did not respond, the submission is being reviewed according to the timelines established in the final rule for nonsunscreen TEAs.
Draft GuidanceDraft guidance: format and content (Refuse To File)11/26/201511/20/2015Sunscreen Innovation Act:  Nonprescription Sunscreen Drug Products--Content and Format of Data SubmissionsSIA requires final guidance to publish by 11/26/2016
Draft GuidanceDraft guidance: sunscreen safety and efficacy standard11/26/201511/20/2015Over-the-Counter Sunscreens:  Safety and Effectiveness DataSIA requires final guidance to publish by 11/26/2016
Draft GuidanceDraft guidance: withdrawal of pending request11/26/201511/20/2015Sunscreen Innovation Act; Withdrawal of a 586A Request or Pending RequestSIA requires final guidance to publish by 11/26/2016
Draft GuidanceDraft guidance: Use of Advisory Committees11/26/2015 11/20/2015Sunscreen Innovation Act:  Section 586C(c) Advisory Committee ProcessSIA requires final guidance to publish by 11/26/2016
ReportLetter 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 RuleProposed rule on framework for review of nonsunscreen requests 5/26/2016 4/1/2016Food and Drug Administration Proposed Rule on Over-the-Counter Time and Extent ApplicationsSIA requires final rule to publish by 2/26/2017
ReportReport to Congress 5/26/2016 5/25/2016Report to Senate Health, Education, Labor and Pensions Committee and House Energy and Commerce Committee 
Final GuidanceFinal guidance: format and content (Refuse to File) 11/26/2016 11/22/2016Nonprescription Sunscreen Drug Products - Content and Format of Data SubmissionsThe FDA has fulfilled the requirements of the SIA for this guidance
Final GuidanceFinal guidance: sunscreen safety and efficacy standard 11/26/2016 11/22/2016Over-the-Counter Sunscreens: Safety and Effectiveness DataThe FDA has fulfilled the requirements of the SIA for this guidance
Final GuidanceFinal guidance: withdrawal of pending request 11/26/2016 10/07/2016Sunscreen Innovation Act: Withdrawal of a 586A Request or Pending RequestThe FDA has fulfilled the requirements of the SIA for this guidance
Final GuidanceFinal guidance: Use of Advisory Committees 11/26/2016 10/7/2016Sunscreen Innovation Act: Section 586C(c) Advisory Committee ProcessThe FDA has fulfilled the requirements of the SIA for this guidance
Final RuleFinal rule on framework for review of nonsunscreen requests 2/26/2017 11/22/2016Food and Drug Administration Final Rule on Over-the-Counter Time and Extent ApplicationsThe FDA has finalized this rule in advance of the statutory deadline of 2/26/2017.
ReportReport to Congress 5/26/2018 5/21/2018Report to the Committee on Health, Education, Labor, and Pensions, U.S. Senate, and the Committee on Energy and Commerce, U.S. House of Representatives 
ReportGAO Report #1 11/26/2017 11/19/2017SUNSCREEN: 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
Proposed RuleProposed rule to finalize sunscreen monographNo statutory deadline   2/21/2019Sunscreen Drug Products for Over-The-Counter-Human Use; Proposal to Amend and Lift Stay on MonographComment period ends 90 days after proposed rule publication. SIA requires final rule to publish by 11/26/2019.
ReportGAO Report #2 5/26/2019   
Report3rd report to Congress 5/26/2020   
Final RuleFinalize sunscreen monograph11/26/2019   

Return to the Sunscreen Innovation Act (SIA) page

More in Guidance, Compliance & Regulatory Information

Good Review Practices (GRPs)

Page Last Updated: 02/21/2019
Note: If you need help accessing information in different file formats, see Instructions for Downloading Viewers and Players.
Language Assistance Available: Español | 繁體中文 | Tiếng Việt | 한국어 | Tagalog | Русский | العربية | Kreyòl Ayisyen | Français | Polski | Português | Italiano | Deutsch | 日本語 | فارسی | English