Standard record

What "FDA Approved" Does and Doesn't Mean for a U.S. Sunscreen: The OTC Monograph Route vs. NDA Approval

FDA OTC Sunscreen Monograph M020 (21 CFR 352 origin, CARES Act order): GRASE-listed actives may market without FDA NDA approval - not 'FDA approved.'

Checked

Scope

Nonprescription (OTC) sunscreen drug products marketed in the United States without an approved New Drug Application, under the FD&C Act's OTC drug monograph system as reformed by the CARES Act (2020). Covers: (1) what marketing under the monograph legally requires - using only listed GRASE active ingredients at listed concentrations, in permitted combinations, in eligible dosage forms, with monograph-conforming labeling and SPF/broad-spectrum/water-resistance testing per 21 CFR 352 Subpart D methodology; (2) that FDA does not review or approve individual sunscreen products under this route - it sets ingredient/product-class conditions, and any manufacturer whose product conforms may market without submitting an application to FDA; (3) that this is categorically different from FDA 'approval' of a New Drug Application, which involves FDA review and approval of a specific product's own safety/efficacy data; (4) current GRASE status of sunscreen active ingredients: zinc oxide and titanium dioxide proposed GRASE/Category I (up to 25%); PABA and trolamine salicylate proposed not-GRASE/Category II; 12 other legacy actives - avobenzone, cinoxate, dioxybenzone, ensulizole, homosalate, meradimate, octinoxate, octisalate, octocrylene, oxybenzone, padimate O, sulisobenzone - proposed Category III (insufficient data), status still formally unresolved since these categories came from a 2019 proposed rule that was never finalized; bemotrizinol newly added and GRASE as of Aug. 9, 2026. Unresolved conflict, stated plainly rather than averaged: the 2019 proposed GRASE categories (I/II/III) are not part of the same document as the operative CARES Act 'Deemed Final Order,' which carried forward the broader pre-2020 ingredient list; FDA's 2021 Proposed Order (OTC000008), which would import the stricter 2019 categories into the operative order, remains pending as of Aug. 2026 - so sunscreens with Category III ingredients continue to be marketed under the still-operative Deemed Final Order while their final GRASE status is undetermined. Out of scope: prescription sunscreens, sunscreens marketed as cosmetics outside the U.S., sunscreen-insect repellent combination products, and any specific brand or product - this record names no brand.

Issuer

U.S. Food and Drug Administration (FDA), Center for Drug Evaluation and Research, Office of Nonprescription Drugs - U.S. Department of Health and Human Services

Version
  • 21 CFR 352 as published in the 1999 final rule (64 FR 27666), stayed by 68 FR 33381 (June 4, 2003) - never took independent legal effect
  • Deemed Final Order for OTC sunscreens, created automatically upon CARES Act enactment (March 27, 2020) under FD&C Act §505G(c), carrying forward the pre-2020 tentative final monograph conditions as OTC Monograph M020
  • Proposed Order OTC000008 (Sept. 24, 2021 / 86 FR 53322) - would replace the Deemed Final Order's GRASE conditions entirely; comment period closed Dec. 27, 2021; NOT finalized as of Aug. 2026
  • Proposed Rule 84 FR 6204 (Feb. 26, 2019, Docket FDA-1978-N-0018, RIN 0910-AF43) - FDA's GRASE Category I/II/III classification of the 16 legacy sunscreen actives; issued before the CARES Act reform and never finalized as a rule
  • Final Administrative Order OTC000039 - adds bemotrizinol as a new active ingredient to Monograph M020; issued June 9, 2026, effective Aug. 9, 2026
Standard name
  • 21 CFR Part 352 - Sunscreen Drug Products for Over-the-Counter Human Use (1999 final monograph, stayed indefinitely since 2003)
  • OTC Monograph M020 - Sunscreen Drug Products for Over-the-Counter Human Use (the 'Deemed Final Order,' created by CARES Act §505G, administered via the OTC Monograph Order system)
  • New Drug Application (NDA) approval pathway - FD&C Act §505(b)/(c) (the route FDA does NOT use for monograph sunscreens)
Effective date
  • 21 CFR 352: adopted May 21, 1999, effective date stayed indefinitely from June 4, 2003 - the text of Part 352 itself is not currently in force
  • CARES Act Deemed Final Order (OTC Monograph M020, the operative document): effective March 27, 2020
  • Proposed Order OTC000008 (revised GRASE conditions for the 16 legacy actives): still proposed/pending, not effective as of Aug. 23, 2026
  • Final Order OTC000039 (bemotrizinol addition): effective Aug. 9, 2026

Sources

  1. primary-regulatory eCFR - 21 CFR Part 352, Sunscreen Drug Products for Over-the-Counter Human Use [Stayed Indefinitely]
  2. primary-regulatory Cornell LII - 21 CFR Part 352 full text (subparts, §352.10 active ingredients, §352.20 permitted combinations, stay history)
  3. primary-regulatory Federal Register - Sunscreen Drug Products for Over-the-Counter Human Use, Proposed Rule, 84 FR 6204 (Feb. 26, 2019), Docket FDA-1978-N-0018, RIN 0910-AF43 - GRASE Category I/II/III ingredient classification
  4. primary-regulatory Federal Register - Amending Over-the-Counter Monograph M020: Sunscreen Drug Products for OTC Human Use; Proposed Order (OTC000008), Notice of Availability, 86 FR 53322 (Sept. 27, 2021)
  5. primary-regulatory FDA News Release - "FDA Expands Sunscreen Options for the First Time in 20 Years" (June 9, 2026): states an OTC monograph drug 'can enter the market without an approved drug application' if it meets monograph conditions; announces Final Order OTC000039 adding bemotrizinol, effective Aug. 9, 2026
  6. primary-regulatory FDA consumer page - "Sunscreen: How to Help Protect Your Skin from the Sun" (content current as of 06/09/2026): current list of active ingredients, bemotrizinol addition, expiration and labeling rules
  7. primary-regulatory FDA - Over-the-Counter (OTC) Drug Review: OTC Monograph Reform (CARES Act)
  8. primary-regulatory FDA Final Administrative Order OTC000039 (bemotrizinol addition to OTC Monograph M020)
  9. secondary-media Congressional Research Service - "FDA Regulation of Over-the-Counter (OTC) Drugs: Overview and Issues for Congress" (R46985)

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