FDA Proposes New Rules for Nonprescription Sunscreens Under the Reformed Monograph System (2021)

Table of Contents

1. What the FDA Did in September 2021
2. Key Terms: OTC Monographs, GRASE and Administrative Orders
3. The Law Behind It: The CARES Act and the Deemed Final Order
4. The Sixteen Active Ingredients in Three Proposed Groups
5. Maximum SPF and Broad-Spectrum Protection
6. Dosage Forms, Sprays and Sunscreen–Insect Repellent Combinations
7. Proposed Label Changes and Testing Records
8. The Environmental Review Announced in May 2021
9. Public Comments and the Next Steps the FDA Described
10. What the Proposed Order Does Not Do
11. Dates and Legal Status as of October 18, 2026
12. How It Fits Earlier and Later FDA Sunscreen Actions
13. Primary Documents
14. Key Research Papers
15. Connections
16. Featured Videos

1. What the FDA Did in September 2021

Two steps were taken on the same day, September 24, 2021, according to the timeline on the FDA’s sunscreen question-and-answer page:

• OTC000006, the deemed final order. The FDA posted the sunscreen order that, in its words, “came into existence by operation of law on March 27, 2020 through the enactment of the CARES Act and established the OTC monograph for sunscreen drug products.” It is titled “Over-the-Counter Monograph M020: Sunscreen Drug Products for Over-the-Counter Human Use.”
• OTC000008, the proposed order. The FDA issued a proposed order titled “Amending Over-the-Counter Monograph M020: Sunscreen Drug Products for Over-the-Counter Human Use,” setting out its proposed revisions to OTC000006.

The Federal Register notice announcing the proposed order appeared on September 27, 2021 (86 FR 53322, Docket No. FDA-1978-N-0018). It states that 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),” and that it “also sets forth certain characteristics that would establish that a sunscreen drug product is not GRASE.”

A few days earlier, on September 21, 2021, a separate Federal Register notice (86 FR 52474, Docket No. FDA-2021-N-0952) announced that the FDA was making available on its website the final orders for over-the-counter drug monographs that the CARES Act had deemed into existence, and set out the agency’s plan for withdrawing the regulations that had established final over-the-counter drug monographs before the law passed.

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2. Key Terms: OTC Monographs, GRASE and Administrative Orders

• OTC (over-the-counter) drug. A medicine sold without a prescription. The FDA documents treat nonprescription sunscreens as OTC drugs.
• OTC monograph. A set of conditions — allowed active ingredients and their strengths, dosage forms, labeling and testing — under which a type of OTC drug can be sold without the FDA approving each product individually. The sunscreen monograph is numbered M020. Sunscreens that do have their own approved application (a new drug application, or NDA) are outside it.
• GRASE. “Generally recognized as safe and effective,” the legal standard (section 201(p)(1) of the Federal Food, Drug, and Cosmetic Act, as the FDA’s page cites it) a product must meet to be sold under a monograph.
• Administrative order. Since the CARES Act of 2020, the FDA issues, revises and amends OTC monographs by administrative order instead of by rulemaking. A proposed order is open for public comment; a final order changes the monograph.
• Federal Register and docket. The Federal Register is the U.S. government’s daily publication of rules and official notices. A docket is the public file for an action, where its documents and public comments are kept on regulations.gov; the sunscreen monograph’s docket is FDA-1978-N-0018.

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3. The Law Behind It: The CARES Act and the Deemed Final Order

The FDA’s question-and-answer page explains that the Coronavirus Aid, Relief, and Economic Security Act (CARES Act), signed into law on March 27, 2020, included provisions “to reform and modernize the way OTC monograph drugs are regulated in the United States.” It amended the Federal Food, Drug, and Cosmetic Act “to replace the monograph rulemaking process with an administrative order process for issuing, revising, and amending OTC monographs.”

For sunscreens, the new section 505G of that Act created a “final administrative order” — the deemed final order — made up of two older documents, as the FDA describes them:

• the requirements of the 1999 final sunscreen monograph, which the FDA describes as “stayed (not in effect)”; and
• the requirements on labeling and effectiveness from a final labeling and effectiveness testing rule for sunscreens published in 2011.

The FDA page states that these requirements “largely correspond to the conditions under which sunscreens that do not have approved NDAs were marketed prior to the enactment of the CARES Act.” Sunscreens that met them were deemed GRASE.

The same law directed the FDA to amend and revise the deemed final order, and required the proposed revision to be issued no later than 18 months after the law was enacted — by September 27, 2021. The September 24, 2021 proposed order met that deadline.

The FDA describes the 2021 proposed order as a vehicle to move its ongoing review from the old rulemaking process to the new order process. Because “The CARES Act did not change the scientific standards for making a GRASE determination,” the FDA writes, the proposed order’s proposals “are substantively the same as those that FDA issued in the 2019 proposed rule.”

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4. The Sixteen Active Ingredients in Three Proposed Groups

The deemed final order treats sunscreens containing 16 active ingredients as GRASE, consistent with the 1999 monograph. “Based on new data and changed conditions since issuance of the 1999 monograph,” in the FDA’s words, the proposed order sorted them into three groups:

• Proposed GRASE: zinc oxide and titanium dioxide. The FDA states that its review of publicly available evidence “found sufficient safety data on both zinc oxide and titanium dioxide” to support the proposal, at concentrations of up to 25%. (Zinc as a nutrient is described on the site’s Zinc page.)
• Proposed not GRASE because of safety concerns: aminobenzoic acid (PABA) and trolamine salicylate. The FDA states that the evidence shows these sunscreens are not GRASE “due to safety issues.”
• Proposed not GRASE because additional data are needed: cinoxate, dioxybenzone, ensulizole, homosalate, meradimate, octinoxate, octisalate, octocrylene, padimate O, sulisobenzone, oxybenzone and avobenzone. The FDA states that the public record “did not currently contain sufficient data to support positive GRASE determinations” for these twelve.

The FDA added its own caveat about the third group: the proposed order “does not represent a conclusion by the FDA that the sunscreen active ingredients proposed as having insufficient data are unsafe for use in sunscreens.” Instead, it requested more information so it could evaluate their status “in light of changed conditions, including substantially increased sunscreen usage and evolving information about the potential risks associated with these products since they were originally evaluated.”

Oxybenzone, one of the twelve, is also discussed on the site’s Household Chemicals page.

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5. Maximum SPF and Broad-Spectrum Protection

SPF (sun protection factor) is the number shown on a sunscreen label; the proposals below concern how high it may be labeled and when a product must also meet broad-spectrum requirements for UVA protection.

• Maximum labeled SPF. The deemed final order sets no maximum. The FDA had proposed in 2011 a maximum labeled value of SPF 50+. In 2021 it proposed SPF 60+ instead, stating that “Since 2011, evidence shows additional meaningful clinical benefit associated with broad spectrum sunscreen products with an SPF up to 60.” Products could still be formulated with SPF values up to 80. The FDA wrote that it hoped this margin would help the development of products with greater UVA protection and account for variability in SPF test results.
• Broad spectrum for SPF 15 and above. Under the deemed final order, broad-spectrum testing is required only for products that make a broad-spectrum claim. Citing “the growing evidence of significant harms associated with UVA exposure,” the FDA proposed that every sunscreen with an SPF of 15 or higher meet broad-spectrum requirements, including a new requirement that broad-spectrum products reach a UVA I/UV ratio of 0.7 or higher.

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6. Dosage Forms, Sprays and Sunscreen–Insect Repellent Combinations

A dosage form is the physical form of a product, such as a lotion or a spray. The FDA page notes that the deemed final order does not address the GRASE status of particular dosage forms, and that by a separate part of the CARES Act, sunscreens in forms other than oils, lotions, creams, gels, butters, pastes, ointments, sticks, sprays or powders need an approved application to be sold. The proposed order would treat them as follows:

• Proposed GRASE: oils, lotions, creams, gels, butters, pastes, ointments and sticks.
• Sprays: proposed GRASE, subject to testing and labeling requirements.
• Powders: additional data needed before they could be found GRASE.

The proposed order also proposed that products combining a sunscreen with an insect repellent are not GRASE. The FDA’s stated reason is that “incompatibilities between FDA and EPA labeling requirements prevent these products from being labeled in a manner that sufficiently ensures safe and effective use of the sunscreen component and provides adequate directions for use.”

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7. Proposed Label Changes and Testing Records

The deemed final order keeps the labeling requirements in effect for sunscreens since 2011. The FDA states that its 2021 labeling proposals were informed by published studies of consumer behaviour showing that many consumers “do not turn a sunscreen bottle around to read the Drug Facts section of the label,” where the active ingredients and the Skin Cancer/Skin Aging alert currently appear. It proposed adding information to the principal display panel, the most prominent part of the label visible on the shelf:

• an alphabetical list of the product’s sunscreen active ingredients, followed by “Sunscreen” and the dosage form (such as lotion or spray);
• for products not shown to help prevent skin cancer or early skin aging caused by the sun, an asterisk (*) after the SPF statement directing readers to the “Skin Cancer/Skin Aging alert” elsewhere on the label;
• revised format requirements for the SPF, broad-spectrum and water-resistance statements, so that required information is not obscured by other label features.

The FDA notes that most other OTC drugs already list their active ingredients on the principal display panel, so the change would bring sunscreens in line with them.

Testing records. The deemed final order does not address record-keeping. The proposed order would require records of required final-formulation testing to be kept for one year after the product’s expiration date or, for products exempt from expiration dating (which the FDA says most sunscreens are), for three years after distribution of the last lot labeled in reliance on that testing. The FDA also proposed requiring responsible persons to keep records of formulation testing, and clarified that the records would be subject to FDA inspection.

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8. The Environmental Review Announced in May 2021

Before the proposed order, on May 13, 2021, the FDA published a notice of intent to prepare an environmental impact statement (EIS) (86 FR 26224, Docket No. FDA-2021-N-0352). The notice was issued under the National Environmental Policy Act of 1969 (NEPA). It states that the EIS would “evaluate the potential environmental effects of revised conditions for marketing certain sunscreen products for over-the-counter (OTC) use without prior approval of a new drug application (NDA).”

The notice opened a public scoping period, which it describes as a process “to solicit public comments and identify issues to be analyzed in this EIS,” closing June 14, 2021. The FDA reopened it twice to give interested persons more time: on June 25, 2021 (86 FR 33712), with comments due July 14, 2021, and on September 9, 2021 (86 FR 50538), with comments due September 23, 2021. The May notice said that any public scoping meetings, if needed, would be held virtually because of the COVID-19 pandemic, and that a draft EIS would bring further opportunities for public participation. The FDA documents read for this page do not report a draft or final EIS.

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9. Public Comments and the Next Steps the FDA Described

The September 27, 2021 notice set a comment deadline of November 12, 2021. On November 22, 2021, the FDA extended it to December 27, 2021 (86 FR 66318), “in response to a request for an extension to allow interested persons additional time to submit comments.” The FDA later reported receiving “over 15,000 public comments” on the proposed order, “many of which are substantive and require extensive scientific review.”

For the ingredients needing more data, the FDA’s page explains that the comment period gave the public a chance to submit information that had become available since the 2019 proposed rule, including on eight active ingredients that had been the subject of timely requests for deferral so that studies could be carried out. The FDA described what would happen next:

• If the data available at the close of the comment period did not resolve the outstanding questions about an ingredient, but the FDA received “satisfactory indication of timely and diligent progress” on the needed studies, it would be prepared to defer a final order on that ingredient for up to one year, with a possible extension depending on further progress.
• If studies for an ingredient did not appear to be proceeding in a timely or productive way, the FDA expected to proceed to a revised final order on sunscreens containing it after the initial deferral.

The FDA’s sun-safety statements. On the same page the FDA states that sun safety is important for all skin tones, and that broad-spectrum sunscreens with an SPF of at least 15 are “only one element of a skin-cancer prevention strategy,” alongside protective clothing, sunglasses, a hat that shades the whole head, and shade during peak sunlight; it says the Centers for Disease Control and Prevention and major medical associations endorse similar recommendations, and it encourages people concerned about sunscreen use on infants or children, or during pregnancy, to consult a health care professional. These are the FDA’s statements, reported here as such.

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10. What the Proposed Order Does Not Do

• It did not change any sunscreen in 2021. The FDA states plainly: “The 2021 proposed order is a proposal.” Until a final order takes effect, the deemed final order’s conditions apply.
• It is not a finding that the twelve “more data needed” ingredients are unsafe. The FDA says the proposal “does not represent a conclusion” that they are unsafe; it is a request for data.
• It does not cover sunscreens with their own approved application. The monograph governs sunscreens marketed without an approved NDA.
• It sets no deadline for its own completion. The FDA notes that the CARES Act “does not establish a deadline for finalization of the proposed order.”
• It does not change the scientific standard. The GRASE standard is the same as before the CARES Act; only the procedure changed.

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11. Dates and Legal Status as of October 18, 2026

• March 27, 2020: the CARES Act is signed; the sunscreen deemed final order comes into existence by operation of law.
• May 13, 2021: notice of intent to prepare an environmental impact statement; scoping reopened June 25 and September 9, 2021.
• September 21, 2021: notice that the deemed final orders for OTC monographs are being made available on the FDA website.
• September 24, 2021: the FDA posts deemed final order OTC000006 and issues proposed order OTC000008 (notice published September 27, 2021, 86 FR 53322).
• December 27, 2021: extended close of the comment period (originally November 12, 2021).
• December 12, 2025, and June 10, 2026: in a separate proceeding begun at an outside party’s request (an OTC monograph order request), the FDA proposes and then finalizes order OTC000039, adding bemotrizinol as a sunscreen active ingredient at up to 6% (90 FR 57765 and 91 FR 35220, Docket No. FDA-2025-N-6494).
• September 10, 2026: the FDA issues final order OTC000008-1, removing PABA and trolamine salicylate as sunscreen active ingredients; the Federal Register notice appeared September 11, 2026 (91 FR 57892). The FDA states that it “is not aware of any sunscreen drug products currently sold in the U.S. that contain PABA or trolamine salicylate.”

Status as of October 18, 2026: mostly still a proposal; one part final. The part of OTC000008 on PABA and trolamine salicylate was finalized in September 2026. The FDA explains that it finalized those two proposals then “rather than delay action on these proposals,” and that it is “actively working through the remaining provisions — including labeling, dosage forms, and maximum SPF levels” to be addressed “in future order(s), as appropriate.” The status of the twelve “more data needed” ingredients, the SPF and broad-spectrum proposals, the dosage-form proposals and the label changes therefore remains proposed. The CARES Act provides that a sunscreen final order cannot take effect sooner than one year after it is issued. A check of the Federal Register through October 18, 2026 found no other document changing the 2021 proposed order.

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12. How It Fits Earlier and Later FDA Sunscreen Actions

The FDA documents place the 2021 proposed order in a long sequence:

• 1999. A final sunscreen monograph is published and then stayed, so it never took effect.
• 2011. A final rule on sunscreen labeling and effectiveness testing is published (its requirements still apply under the deemed final order), and the FDA proposes a maximum labeled SPF of 50+.
• 2019. The FDA publishes a proposed sunscreen rule under the old rulemaking process; the 2021 proposed order carries its proposals forward.
• 2020. The CARES Act creates the administrative order system and the deemed final order.
• 2021. The environmental review notice, the posting of the deemed final orders, and proposed order OTC000008.
• 2025–2026. Bemotrizinol added (OTC000039) and PABA and trolamine salicylate removed (OTC000008-1).

The same administrative order process is used for other nonprescription medicines. A later example is the 2024 proposal to remove oral phenylephrine as a decongestant, a proposed order amending a different monograph. Among the 2021 actions, the FDA’s hand-sanitizer actions also concern products sold without a prescription, and the lead acetate hair dye action and the talc cosmetics testing results concern cosmetics applied to the skin and hair.

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13. Primary Documents

1. U.S. Food and Drug Administration. Questions and Answers: FDA’s regulatory actions on over-the-counter sunscreen. Content current as of September 10, 2026 — fda.gov sunscreen questions and answers
2. Food and Drug Administration, HHS (2021). Amending Over-the-Counter Monograph M020: Sunscreen Drug Products for Over-the-Counter Human Use; Over the Counter Monograph Proposed Order; Availability. Notice of availability. Federal Register 86 FR 53322, September 27, 2021. Docket No. FDA-1978-N-0018 — FR Doc. 2021-20780
3. Food and Drug Administration, HHS (2021). 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. Federal Register 86 FR 66318, November 22, 2021. Docket No. FDA-1978-N-0018 — FR Doc. 2021-25371
4. Food and Drug Administration, HHS (2021). Final Administrative Orders for Over-the-Counter Monographs; Availability. Notice. Federal Register 86 FR 52474, September 21, 2021. Docket No. FDA-2021-N-0952 — FR Doc. 2021-20393
5. Food and Drug Administration, HHS (2021). Intent To Prepare an Environmental Impact Statement for Certain Sunscreen Drug Products for Over-the-Counter Use. Notice of intent. Federal Register 86 FR 26224, May 13, 2021. Docket No. FDA-2021-N-0352 — FR Doc. 2021-10091
6. Food and Drug Administration, HHS (2021). Intent To Prepare an Environmental Impact Statement for Certain Sunscreen Drug Products for Over-the-Counter Use; Reopening of Comment Period. Federal Register 86 FR 33712, June 25, 2021. Docket No. FDA-2021-N-0352 — FR Doc. 2021-13568
7. Food and Drug Administration, HHS (2021). Intent To Prepare an Environmental Impact Statement for Certain Sunscreen Drug Products for Over-the-Counter Use; Reopening of the Comment Period. Federal Register 86 FR 50538, September 9, 2021. Docket No. FDA-2021-N-0352 — FR Doc. 2021-19402
8. Food and Drug Administration, HHS (2025). Amending Over-the-Counter Monograph M020: Sunscreen Drug Products for Over-the-Counter Human Use (proposed order OTC000039). Federal Register 90 FR 57765, December 12, 2025. Docket No. FDA-2025-N-6494 — FR Doc. 2025-22649
9. Food and Drug Administration, HHS (2026). Amending Over-the-Counter Monograph M020: Sunscreen Drug Products for Over-the-Counter Human Use, and Related Information (final order OTC000039). Federal Register 91 FR 35220, June 10, 2026. Docket No. FDA-2025-N-6494 — FR Doc. 2026-11578
10. Food and Drug Administration, HHS (2026). Amending Over-the-Counter Monograph M020: Sunscreen Drug Products for Over-the-Counter Human Use, and Related Information; Aminobenzoic Acid (PABA) and Trolamine Salicylate (final order OTC000008-1). Notice of availability. Federal Register 91 FR 57892, September 11, 2026. Docket No. FDA-1978-N-0018 — FR Doc. 2026-18551
11. Public docket FDA-1978-N-0018 — regulations.gov FDA-1978-N-0018

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Key Research Papers

1. Matta MK, Zusterzeel R, Pilli NR, Patel V, Volpe DA, Florian J, Oh L, Bashaw E, Zineh I, Sanabria C, Kemp S, Godfrey A, Adah S, Coelho S, Wang J, Furlong LA, Ganley C, Michele T, Strauss DG (2019). Effect of Sunscreen Application Under Maximal Use Conditions on Plasma Concentration of Sunscreen Active Ingredients: A Randomized Clinical Trial. JAMA 321(21):2082-2091 — PubMed PMID: 31058986
2. Matta MK, Florian J, Zusterzeel R, Pilli NR, Patel V, Volpe DA, Yang Y, Oh L, Bashaw E, Zineh I, Sanabria C, Kemp S, Godfrey A, Adah S, Coelho S, Wang J, Furlong LA, Ganley C, Michele T, Strauss DG (2020). Effect of Sunscreen Application on Plasma Concentration of Sunscreen Active Ingredients: A Randomized Clinical Trial. JAMA 323(3):256-267 — PubMed PMID: 31961417
3. Green A, Williams G, Neale R, Hart V, Leslie D, Parsons P, Marks GC, Gaffney P, Battistutta D, Frost C, Lang C, Russell A (1999). Daily sunscreen application and betacarotene supplementation in prevention of basal-cell and squamous-cell carcinomas of the skin: a randomised controlled trial. Lancet 354(9180):723-729 — PubMed PMID: 10475183
4. Green AC, Williams GM, Logan V, Strutton GM (2011). Reduced melanoma after regular sunscreen use: randomized trial follow-up. Journal of Clinical Oncology 29(3):257-263 — PubMed PMID: 21135266
5. Hughes MC, Williams GM, Baker P, Green AC (2013). Sunscreen and prevention of skin aging: a randomized trial. Annals of Internal Medicine 158(11):781-790 — PubMed PMID: 23732711
6. Monteiro-Riviere NA, Wiench K, Landsiedel R, Schulte S, Inman AO, Riviere JE (2011). Safety evaluation of sunscreen formulations containing titanium dioxide and zinc oxide nanoparticles in UVB sunburned skin: an in vitro and in vivo study. Toxicological Sciences 123(1):264-280 — PubMed PMID: 21642632
7. Schneider SL, Lim HW (2019). Review of environmental effects of oxybenzone and other sunscreen active ingredients. Journal of the American Academy of Dermatology 80(1):266-271 — PubMed PMID: 29981751

The first two papers are randomized clinical trials that measured how much of several sunscreen active ingredients reaches the bloodstream after application. The next three report a randomized trial of daily sunscreen application and its follow-up reports on melanoma and skin aging. The sixth is a laboratory and animal study of zinc oxide and titanium dioxide nanoparticle sunscreens on sunburned skin, and the last is a review of the environmental effects of sunscreen ingredients, the subject of the FDA’s 2021 environmental review.

PubMed Topic Searches

1. PubMed: sunscreen active ingredients and systemic absorption
2. PubMed: sunscreen and skin cancer prevention trials
3. PubMed: zinc oxide and titanium dioxide sunscreen safety
4. PubMed: sunscreen UVA and broad-spectrum protection

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Connections

• FDA Actions of 2021
• FDA and Regulation
• UV Radiation
• Skin Cancer
• Melanoma
• Dermatology
• Household Chemicals
• Zinc
• Astaxanthin for Skin Photoprotection
• Hand-Sanitizer Oversight and Warnings (2021)
• Lead Acetate in Hair Dyes Ended (2021)
• Talc Cosmetics Tested for Asbestos (2021)
• Propylhexedrine Inhaler Abuse Warning (2021)
• Oral Phenylephrine Removal Proposal (2024)

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