WTO notification · TBT
United StatesAdopted, according to its latest notice
Official title
Sunscreen Drug Products for Over-the-Counter Human Use
The United States issued an addendum on 15 September 2026 to the earlier TBT notification G/TBT/N/USA/1443. Addenda often report that a measure was adopted, changed, postponed or withdrawn. The measure was first notified on 4 March 2019. The comment period closed on 26 January 2026.
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Sunscreen drug products
Latest notice (G/TBT/N/USA/1443/Add.6, 15 September 2026)
The latest notice says the measure was adopted or published.
Amending Over-the-Counter Monograph M020: Sunscreen Drug Products for Over-the-Counter Human Use, and Related Information; Aminobenzoic Acid (PABA) and Trolamine Salicylate
The Food and Drug Administration (FDA or Agency) is announcing the availability on its website of the final administrative order (final order) (OTC000008-1) titled ''Amending Over-the-Counter Monograph M020: Sunscreen Drug Products for Over-the-Counter Human Use, and Related Information; Aminobenzoic Acid (PABA) and Trolamine Salicylate.'' This final order amends ''Over-the-Counter Monograph M020: Sunscreen Drug Products for Over-the-Counter Human Use'' (Over-the-Counter (OTC) Monograph M020) to remove PABA and trolamine salicylate as sunscreen active ingredients. A sunscreen drug product containing PABA or trolamine salicylate is not generally recognized as safe and effective (GRASE). The announcement of the availability on FDA's website of the final order is published in the Federal Register on 11 September 2026. 91 Federal Register (FR) 57892, 11 September 2026: This notice of availability is identified by Docket Number FDA-1978-N-0018. The Docket Folder is available on Regulations.gov at and provides access to primary documents as well as comments received. Documents are also accessible from Regulations.gov by searching the Docket Number. Previous actions notified under the symbol G/TBT/N/USA/1443 are identified by Docket Numbers FDA-1978-N-0018 and FDA-2025-N-6494.
The Food and Drug Administration (FDA or Agency) is issuing this proposed rule to put into effect a final monograph for nonprescription, over-the-counter (OTC) sunscreen drug products. This proposed rule describes the conditions under which FDA proposes that OTC sunscreen monograph products are generally recognized as safe and effective (GRASE) and not misbranded. It is being published as part of the ongoing review of OTC drug products conducted by FDA. It is also being published to comply with the Federal Food, Drug, and Cosmetic Act (FD&C Act), as amended by the Sunscreen Innovation Act (SIA).
Every notice about this measure published here, newest first. Each one is the notifying member's own text.
AddendumG/TBT/N/USA/1443/Add.6
Amending Over-the-Counter Monograph M020: Sunscreen Drug Products for Over-the-Counter Human Use, and Related Information; Aminobenzoic Acid (PABA) and Trolamine Salicylate
The Food and Drug Administration (FDA or Agency) is announcing the availability on its website of the final administrative order (final order) (OTC000008-1) titled ''Amending Over-the-Counter Monograph M020: Sunscreen Drug Products for Over-the-Counter Human Use, and Related Information; Aminobenzoic Acid (PABA) and Trolamine Salicylate.'' This final order amends ''Over-the-Counter Monograph M020: Sunscreen Drug Products for Over-the-Counter Human Use'' (Over-the-Counter (OTC) Monograph M020) to remove PABA and trolamine salicylate as sunscreen active ingredients. A sunscreen drug product containing PABA or trolamine salicylate is not generally recognized as safe and effective (GRASE). The announcement of the availability on FDA's website of the final order is published in the Federal Register on 11 September 2026. 91 Federal Register (FR) 57892, 11 September 2026: This notice of availability is identified by Docket Number FDA-1978-N-0018. The Docket Folder is available on Regulations.gov at and provides access to primary documents as well as comments received. Documents are also accessible from Regulations.gov by searching the Docket Number. Previous actions notified under the symbol G/TBT/N/USA/1443 are identified by Docket Numbers FDA-1978-N-0018 and FDA-2025-N-6494.
AddendumG/TBT/N/USA/1443/Add.5
Amending Over-the-Counter Monograph M020: Sunscreen Drug Products for Over-the-Counter Human Use, and Related Information
In response to an over-the-counter (OTC) monograph order request (OMOR), the Food and Drug Administration (FDA) is announcing the availability on its website of the final administrative order (final order) (OTC000039) titled ''Amending Over-the-Counter Monograph M020: Sunscreen Drug Products for Over-the-Counter Human Use, and Related Information.'' This final order amends ''Over-the-Counter Monograph M020: Sunscreen Drug Products for Over-the-Counter Human Use'' (OTC Monograph M020) to add bemotrizinol at concentrations up to 6 percent as a sunscreen active ingredient. A sunscreen drug product containing bemotrizinol is generally recognized as safe and effective (GRASE) if it meets the conditions described in OTC Monograph M020 as amended by this final order. The announcement of the availability on FDA's website of the final order is published in the Federal Register on 10 June 2026. 91 Federal Register (FR) 35220, 10 June 2026: This notice of availability is identified by Docket Number FDA-2025-N-6494. The Docket Folder is available on Regulations.gov at and provides access to primary documents as well as comments received. Documents are also accessible from Regulations.gov by searching the Docket Number. Previous actions notified under the symbol G/TBT/N/USA/1443 are identified by Docket Numbers FDA-1978-N-0018 and FDA-2025-N-6494.
AddendumG/TBT/N/USA/1443/Add.4
Comment deadline: Closed on 26 January 2026
Amending Over-the-Counter Monograph M020: Sunscreen Drug Products for Over-the-Counter Human Use Sunscreen Drug Products for Over-the-Counter Human Use
In response to an over-the-counter (OTC) monograph order request (OMOR), the Food and Drug Administration (FDA) is announcing the availability on its website of the proposed administrative order (proposed order) (OTC000039) entitled ''Amending Over-the-Counter Monograph M020: Sunscreen Drug Products for Over-the-Counter Human Use.'' This proposed order, if finalized, will amend Over-the-Counter Monograph M020: Sunscreen Drug Products for Over-the-Counter Human Use (OTC Monograph M020) to add bemotrizinol at concentrations up to 6 percent as a sunscreen active ingredient. A sunscreen drug product containing bemotrizinol would be generally recognized as safe and effective (GRASE) if it meets the conditions described in OTC Monograph M020 as amended by this proposed order, if finalized. Submit electronic comments on the proposed order by 26 January 2026. 90 Federal Register (FR) 57765, 12 December 2025: This notice of availability is identified by Docket Number FDA-2025-N-6494. The Docket Folder is available on Regulations.gov at and provides access to primary documents as well as comments received. Documents are also accessible from Regulations.gov by searching the Docket Number. WTO Members and their stakeholders are asked to submit comments to the USA WTO TBT Enquiry Point by 4:00 p.m. Eastern Time 26 January 2026. Comments received from WTO Members and their stakeholders will be shared with FDA and will also be submitted to the Docket on Regulations.gov if received within…
AddendumG/TBT/N/USA/1443/Add.3
Comment deadline: Closed on 27 December 2021
Sunscreen Drug Products for Over-the-Counter Human Use
TITLE: Amending Over-the-Counter Monograph M020: Sunscreen Drug Products for Over-The-Counter Human Use; Over-The-Counter Monograph Proposed Order (OTC 000008) Extension of Comment Period AGENCY: Food and Drug Administration, HHS ACTION: Proposed order; extension of comment period. SUMMARY: The Food and Drug Administration (FDA or Agency) has extended the comment period for the over-the-counter (OTC) monograph proposed order (order ID OTC000008) entitled 'Amending Over-the-Counter (OTC) Monograph M020: Sunscreen Drug Products for OTC Human Use' (Proposed Order), which was issued on 24 September 2021. A notice of availability for the Proposed Order appeared in the Federal Register of 27 September 2021. FDA issued the Proposed Order to amend and revise the deemed final administrative order concerning nonprescription sunscreen drug products (Deemed Final Order) established by the enactment of the Coronavirus Aid, Relief, and Economic Security Act (CARES Act). The Proposed Order, if finalized, would replace the Deemed Final Order in its entirety with new conditions under which nonprescription sunscreen drug products would be determined to be generally recognized as safe and effective (GRASE) under the Federal Food, Drug, and Cosmetic Act (FD&C Act). It would also set forth certain characteristics that would establish that a sunscreen drug product is not GRASE. FDA has extended the comment period for the Proposed Order in response to a request for an extension to allow…
AddendumG/TBT/N/USA/1443/Add.2
Sunscreen Drug Products for Over-the-Counter Human Use
TITLE: Amending Over-the-Counter Monograph M020: Sunscreen Drug Products for Over-the-Counter Human Use; Over the Counter Monograph Proposed Order; Availability AGENCY: Food and Drug Administration, HHS ACTION: Notice of availability SUMMARY: The Food and Drug Administration (FDA, Agency, or we) is announcing the availability of an over-the-counter (OTC) monograph proposed order (order ID OTC000008) entitled 'Amending Over-the- Counter (OTC) Monograph M020: Sunscreen Drug Products for OTC Human Use.' FDA is issuing this proposed order to amend and revise the deemed final administrative order concerning nonprescription sunscreen drug products (Deemed Final Order) established by the enactment of the Coronavirus Aid, Relief, and Economic Security Act (CARES Act). This proposed order, if finalized, would replace the Deemed Final Order in its entirety with new conditions under which nonprescription sunscreen drug products would be determined to be generally recognized as safe and effective (GRASE) under the Federal Food, Drug, and Cosmetic Act (FD&C Act). It also sets forth certain characteristics that would establish that a sunscreen drug product is not GRASE. DATES: Submit electronic comments on the proposed order by 11:59 p.m. Eastern Time at the end of 12 November 2021. This notice of availability and previous actions notified under the symbol G/TBT/N/USA/1443 are identified by Docket Number FDA-1978-N-0018. The Docket Folder is available on Regulations.gov at and provides…
AddendumG/TBT/N/USA/1443/Add.1
TITLE: Sunscreen Drug Products for Over-the-Counter Human Use; Extension of Comment Period AGENCY: Food and Drug Administration, HHS ACTION: Proposed rule; extension of comment period SUMMARY: The Food and Drug Administration (FDA or the Agency) is extending the comment period for the proposed rule that appeared in the Federal Register of 26 February 2019. In the proposed rule, FDA requested comments on its proposals relating to the regulation of over- the-counter (OTC) sunscreen monograph produ
CorrigendumG/TBT/N/USA/1443/Corr.1
TITLE: Sunscreen Drug Products for Over-the-Counter Human Use; Correction AGENCY: Food and Drug Administration, HHS ACTION: Proposed rule; correction SUMMARY: The Food and Drug Administration (FDA) is correcting a proposed rule relating to the regulation of over-the-counter (OTC) sunscreen monograph products that appeared in the Federal Register of 26 February 2019. The document was published with formulas that were illegible. These corrections are being made to improve the accuracy of the propo
Regular notificationG/TBT/N/USA/1443
Comment deadline: Closed on 28 May 2019
Sunscreen Drug Products for Over-the-Counter Human Use
The Food and Drug Administration (FDA or Agency) is issuing this proposed rule to put into effect a final monograph for nonprescription, over-the-counter (OTC) sunscreen drug products. This proposed rule describes the conditions under which FDA proposes that OTC sunscreen monograph products are generally recognized as safe and effective (GRASE) and not misbranded. It is being published as part of the ongoing review of OTC drug products conducted by FDA. It is also being published to comply with the Federal Food, Drug, and Cosmetic Act (FD&C Act), as amended by the Sunscreen Innovation Act (SIA).
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