PlainBillCongress, translated.Legislation. Context. Public interest.Congressional Research Service
Version 49 · Public Law · Nov 26, 2014
(This measure has not been amended since it was reported to the Senate on September 17, 2014. The summary of the Senate passed version is repeated here.)
Sunscreen Innovation Act - (Sec. 2) Amends the Federal Food, Drug, and Cosmetic Act to establish a process for the review and approval of over-the-counter (OTC) sunscreen active ingredients.
Allows any person to request that the Secretary of Health and Human Services (HHS) determine whether an OTC sunscreen active ingredient or combination of ingredients is safe and effective.
Showing the opening paragraphs of the official summary.
Requires the Secretary to review any request regarding a sunscreen active ingredient or combination of ingredients that has been in use and that is not included in the stayed sunscreen monograph published by the Food and Drug Administration (FDA).
Directs the Secretary to invite the sponsor of the request to provide data and other information on the safety and efficacy of the sunscreen active ingredient or combination of ingredients. Requires the Secretary to determine whether the provided information is sufficient to conduct a review, and if so, file the request, and if not, explain to the sponsor why the provided information is insufficient.
Requires the Director of the Center for Drug Evaluation and Research to complete a review of a filed request and determine the safety and efficacy of the sunscreen active ingredient or combination of ingredients within 300 days for new requests or a shorter timeframe for requests pending before enactment of this Act. Directs the Commissioner of Food and Drugs to make the determination if the Director does not make a determination in the allowed timeframe.
Allows sunscreen active ingredients that are determined to be safe and effective to be used in OTC sunscreen products.
Allows the Secretary to amend a determination if additional information becomes available.
(Sec. 3) Allows sponsors of eligible non-sunscreen OTC drug applications to request that the Secretary provide a framework for review of their application. Requires the Secretary to respond with framework options, including options that follow the review process set forth in this Act for sunscreen active ingredients. (Sec. 4) Directs the Comptroller General (GAO) to report on the progress of the Secretary in establishing this process and the role of the Commissioner of Food and Drugs in issuing determinations on pending requests. Requires the Secretary to report on the decisions made about the safety and efficacy of sunscreen active ingredients, the amount of time between submission and decision for each request, the cost of the review process, and recommended improvements to the review process.
People & committees
Sen. Reed, Jack [D-RI] · D–RI
Legislative record
A procedural vote is different from passage. Passage in one chamber does not establish enactment. Explore the glossary.
Became Public Law No: 113-195.
Became Public Law No: 113-195.
Signed by President.
Signed by President.
Presented to President.
Presented to President.
Motion to reconsider laid on the table Agreed to without objection.
On passage Passed without objection. (text: CR H7959-7964)
Passed/agreed to in House: On passage Passed without objection.(text: CR H7959-7964)
Considered by unanimous consent. (consideration: CR H7959-7964)
Mr. Latta asked unanimous consent to take from the Speaker's table and consider.
Held at the desk.
Received in the House.
Message on Senate action sent to the House.
Passed Senate with an amendment by Unanimous Consent. (consideration: CR S5715-5720; text as passed Senate: CR S5715-5720)
Passed/agreed to in Senate: Passed Senate with an amendment by Unanimous Consent.(consideration: CR S5715-5720; text as passed Senate: CR S5715-5720)
Placed on Senate Legislative Calendar under General Orders. Calendar No. 568.
Committee on Health, Education, Labor, and Pensions. Reported by Senator Harkin with an amendment in the nature of a substitute. Without written report.
Committee on Health, Education, Labor, and Pensions. Reported by Senator Harkin with an amendment in the nature of a substitute. Without written report.
Committee on Health, Education, Labor, and Pensions. Ordered to be reported with an amendment in the nature of a substitute favorably.
Read twice and referred to the Committee on Health, Education, Labor, and Pensions.
Introduced in Senate
Primary sources
Text links open the official source. We currently store references to these documents.
Source last updated: Dec 3, 2025. Consult Congress.gov for the current record.
AI Conversation Starters
Choose a perspective, copy a prompt, and paste it into your preferred AI. Each prompt includes the bill version and available official source links, and asks for counterarguments as well as supporting evidence.
Analyze S.2141 as objectively as possible. Explain its main provisions, who would be affected, possible benefits and harms, implementation, exceptions, and uncertainties. Present the strongest arguments for and against it, and identify evidence needed to assess its public impact.
Examine S.2141 through a progressive lens, focusing on fairness, access, economic inequality, and effects on vulnerable communities. Explain potential benefits, costs, and unintended consequences. Consider the strongest counterarguments and distinguish stated goals from demonstrated outcomes.
Examine S.2141 through a conservative lens, focusing on fiscal responsibility, institutional stability, federalism, and the scope of government. Explain potential benefits, costs, and unintended consequences. Consider the strongest counterarguments and any provisions that challenge this perspective.
Examine S.2141 through a civil-liberties and limited-government lens. Consider individual rights, privacy, voluntary choice, accountability, and government power. Explain tradeoffs, possible safeguards, and the strongest counterarguments without assuming the proposal is beneficial or harmful.