Sunscreen Innovation Act
Public Law 113-195 · S. 2141 · 113th Congress · began in the Senate
Signed by Barack Obama (D) on Nov 26, 2014 · Health
Sponsor: Sen. Jack Reed (D-RI)
Cosponsors (19): Sen. Johnny Isakson, Sen. Christopher Coons,
Passage votes
- HouseUnanimous consent
- SenateUnanimous consent
Data notes
The final version of the law, as each chamber passed it. A chamber that passed it by voice vote or unanimous consent has no count. “Method not stated” means the record does not say how the chamber voted. Where the record has a member-by-member vote, the “Who voted for it” section shows who voted yea.
Summary
The Congressional Research Service’s plain-language summary of what the law does.
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.
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.
Committees
The committees the bill was sent to, and what each did with it.
Data notes
A committee links to its page only where it exists in the current Congress; older and renamed committees are named without a link.
Related bills
1 bill the Library of Congress relates to this one.
H.R. 4250Identical billRelated bill
Sunscreen Innovation Act
Data notes
Related bills are identified by the Congressional Research Service, the House and the Senate: companion and identical bills, bills with similar text, bills that were folded into this law, and rules that brought it to the floor. A bill that is itself a public law in this site’s data links here; the others link to Congress.gov.
Timeline
From introduction to signing, newest first: the committees, the floor and the president. 16 actions.
- Nov 26, 2014Became lawBecame law · Became Public Law No: 113-195.
- Became lawBecame law · Signed by President.
- Nov 19, 2014FloorFloor · Presented to President.
- Nov 13, 2014FloorFloor · Motion to reconsider laid on the table Agreed to without objection.
- FloorFloor · On passage Passed without objection.
- FloorFloor · Considered by unanimous consent.
- FloorFloor · Mr. Latta asked unanimous consent to take from the Speaker's table and consider.
- Sep 18, 2014FloorFloor · Held at the desk.
- FloorFloor · Received in the House.
- FloorFloor · Message on Senate action sent to the House.
- Sep 17, 2014FloorFloor · Passed Senate with an amendment by Unanimous Consent.
- CalendarCalendar · Placed on Senate Legislative Calendar under General Orders. Calendar No. 568.
- CommitteeCommittee · Committee on Health, Education, Labor, and Pensions. Reported by Senator Harkin with an amendment in the nature of a substitute. Without written report.
- CommitteeCommittee · Committee on Health, Education, Labor, and Pensions. Ordered to be reported with an amendment in the nature of a substitute favorably.
- Mar 13, 2014CommitteeCommittee · Read twice and referred to the Committee on Health, Education, Labor, and Pensions.
- IntroducedIntroduced · Introduced in Senate
Data notes
Every action the Library of Congress lists for the bill, from introduction to signing, plus the dated committee hearings. The source lists many steps twice (the chamber’s own entry and the Library of Congress copy, or a presidential and a became-law entry with the same words); those are shown once. Amendments are listed in their own section.
Amendments
No amendments to this bill are on record.
Data notes
Amendments offered to this bill in either chamber, as the Library of Congress records them: each with a status read from its last recorded step: agreed to, rejected, withdrawn, ruled out of order, fell with another amendment, or offered with no vote recorded (most Senate amendments are only ever offered). The wording of each amendment is the source’s. Amendments to amendments and amendments to other bills are not listed.
Official record
The bill’s full text is on Congress.gov. Data through Oct 7, 2026.