Questions and Answers: FDA’s regulatory actions on over-the-counter sunscreen
On September 10, 2026 FDA issued a final administrative order removing two active ingredients — aminobenzoic acid (PABA) and trolamine salicylate — from the list of ingredients that can be used in over-the-counter (OTC) sunscreens marketed under the sunscreen OTC monograph. FDA’s review of the available safety data for PABA and trolamine salicylate shows that the risks associated with use of these active ingredients in sunscreen drug products outweigh their benefits.
Q. What does today’s announcement mean for consumers?
Consumers do not need to take any action as a result of today's announcement. FDA is not aware of any sunscreen drug products currently sold in the U.S. that contain PABA or trolamine salicylate. Given the recognized public health benefits of sunscreen use, Americans should use sunscreen in combination with other sun protective measures. Additional consumer information about sunscreens can be found on FDA’s consumer website.
Q. Why is FDA issuing a final administrative order on just PABA and trolamine salicylate and not addressing all the other pieces of the OTC monograph for sunscreens at the same time, such as labeling, dosage forms, and maximum SPF levels?
FDA received over 15,000 public comments for the 2021 sunscreen proposed order (OTC000008), many of which are substantive and require extensive scientific review. FDA is finalizing the PABA and trolamine salicylate proposals in September 2026 rather than delay action on these proposals. FDA is actively working through the remaining provisions — including labeling, dosage forms, and maximum SPF levels — and will address those provisions in future order(s), as appropriate.
A brief timeline of sunscreen- OTC monograph related actions since the passage of the CARES Act in 2020 is shown in the chart below. Additional information about the OTC sunscreen monograph and administrative orders pertaining to sunscreens can be found at OTC Monographs@FDA.
| Date | Order ID and Title | Description |
|---|---|---|
| 09/24/2021 | OTC000006 Final Order Over-the-Counter Monograph M020: Sunscreen Drug Products for Over-the-Counter Human Use | Posting of the deemed final order that 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 incorporated certain final monograph requirements for sunscreen drug products from 21 CFR part 352 requirements (as published on May 21, 1999) and requirements for labeling and effectiveness for sunscreens from 21 CFR 201.327 |
| 09/24/2021 | OTC000008 Proposed Order Amending Over-the-Counter Monograph M020: Sunscreen Drug Products for Over-the-Counter Human Use | The CARES Act directed FDA to amend and revise the deemed final order for OTC sunscreen drug products and required that the proposed version of this revised sunscreen order be issued no later than 18 months after the enactment of the CARES Act (i.e., by September 27, 2021). The proposed order set out FDA’s proposed revisions to OTC000006 and reflects certain proposed requirements for OTC sunscreen products. |
| 06/10/2026 | OTC000039 Final Order Amending Over-the-Counter Monograph M020: Sunscreen Drug Products for Over-the-Counter Human Use, and Related Information | This order added bemotrizinol as an active ingredient to OTC Monograph M020 for sunscreens |
| 09/10/2026 | OTC000008 – 1 Final Order 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 order removes PABA and trolamine salicylate as sunscreen active ingredients from OTC Monograph M020 |
The following questions and answers provide more information on the deemed final order and the 2021 proposed order (OTC000008).
Q1. Why did the FDA a deemed final order for OTC sunscreen products and then issue the 2021 proposed order (OTC000008) shortly after?
On March 27, 2020, the Coronavirus Aid, Relief, and Economic Security Act (CARES Act) was signed into law. The CARES Act includes statutory provisions to reform and modernize the way OTC monograph drugs are regulated in the United States. Specifically, the CARES Act amended the Federal Food, Drug, and Cosmetic (FD&C Act) to replace the monograph rulemaking process with an administrative order process for issuing, revising, and amending OTC monographs.
Section 505G of the FD&C Act, which was enacted by the CARES Act, created a “final administrative order” for sunscreens (the deemed final order) consisting of the requirements specified in the 1999 stayed (not in effect) final monograph for OTC sunscreen products, except for requirements governing labeling and effectiveness, which are described in a final labeling and effectiveness testing rule for sunscreens published in 2011. The CARES Act specified that sunscreens that conform to these requirements (and to the other requirements specified by section 505G of the FD&C Act, including the general requirements for nonprescription drugs) are deemed to be GRASE and not new drugs.
The CARES Act also directed FDA to amend and revise this deemed final order for OTC sunscreens drug products and required that the proposed version of this revised sunscreen order be issued no later than 18 months after the enactment of the CARES Act (i.e., by September 27, 2021).
Q2. Is the 2021 proposed order (OTC000008) the same as the 2019 proposed rule?
FDA is using the 2021 proposed order as a vehicle to efficiently transition its ongoing consideration of the appropriate requirements for OTC sunscreens marketed without approved applications from the previous rulemaking process to the order process created by new section 505G of the FD&C Act. The CARES Act did not change the scientific standards for making a GRASE determination. Because of this, the proposed order’s proposals are substantively the same as those that FDA issued in the 2019 proposed rule.
Q3. When will the 2021 proposed order (OTC000008) be in effect?
The 2021 proposed order is a proposal. A 45-day public comment period began when FDA issued the proposed order, which was subsequently extended an additional 45 days. FDA reviewed and considered comments relevant to the PABA and trolamine salicylate proposals and issued the first sunscreen final order to remove the active ingredients PABA and trolamine salicylate from the sunscreen monograph, which includes information on the effective date of that final order. The CARES Act specifies that the effective date for these sunscreen final orders cannot be earlier than one year after issuance of the final order. Other provisions in the 2021 proposed order will be addressed in subsequent final order(s).
Q4. What are the differences in the requirements between the deemed final order for OTC sunscreen products (OTC000006) and the 2021 proposed order (OTC000008)?
The requirements of the deemed final order (OTC000006) are those set forth in the 1999 stayed (not in effect) final sunscreen monograph, except for the requirements governing labeling and effectiveness, which are described in a final 2011 labeling and effectiveness testing rule. 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. In contrast, the 2021 proposed order (OTC000008), which proposes to amend the sunscreens monograph embodied in the deemed final order, reflects proposals for future requirements (that were also set forth in the 2019 proposed rule). Thus, there are a number of differences between the two orders.
Some differences between the deemed final order and the proposed order include:
- Maximum SPFs: The deemed final order for sunscreens established by the CARES Act does not include a limit on maximum SPF values. The proposed order proposes that the maximum labeled SPF value should be SPF 60+. While the proposed maximum labeled SPF value is 60+, the proposed order permits the marketing of sunscreen products formulated with SPF values up to 80.
- Active ingredients: The deemed final order considers sunscreens containing 16 sunscreen active ingredients to be GRASE, consistent with the 1999 stayed (not in effect) sunscreen monograph. Based on new data and changed conditions since issuance of the 1999 monograph, the proposed order proposes GRASE status for sunscreens containing zinc oxide and/or titanium dioxide; not GRASE status for sunscreens containing PABA or trolamine salicylate, because the evidence shows that these sunscreens are not GRASE due to safety issues (finalized in Final Order OTC000008-1); and not GRASE status for sunscreens containing cinoxate, dioxybenzone, ensulizole, homosalate, meradimate, octinoxate, octisalate, octocrylene, padimate O, sulisobenzone, oxybenzone, or avobenzone, because additional data is needed to show that these sunscreens are GRASE.
- Broad spectrum requirements: Consistent with the requirements in a labeling and effectiveness rule for sunscreens issued in 2011, the deemed final order does not require broad spectrum testing but creates an optional broad spectrum labeling claim and broad spectrum testing that is required for inclusion of this claim on labeling. To address the growing evidence of significant harms associated with UVA exposure, the proposed order proposes a requirement that all sunscreens with SPF values of 15 and above satisfy broad spectrum requirements, including a proposed new requirement that broad spectrum products meet a UVA I / UV ratio of 0.7 or higher.
- Dosage forms: The deemed final order does not address the GRASE status of sunscreens in specific dosage forms. By operation of a separate section of the CARES Act, sunscreens in dosage forms other than oils, lotions, creams, gels, butters, pastes, ointments, sticks, sprays, or powders, require an approved application to be marketed. The proposed order proposes the following dosage forms as GRASE for use in sunscreens: oils, lotions, creams, gels, butters, pastes, ointments, and sticks. FDA proposes GRASE status for spray sunscreens, subject to testing and labeling requirements, and proposes that additional data are needed to determine that powders are GRASE.
- Labeling: The deemed final order contains the same labeling requirements that have been in effect for sunscreen products since 2011. In the proposed order, FDA has proposed adding certain information to the main part of the product label, including an alphabetical listing of the sunscreen active ingredients in the product, followed by “Sunscreen” and the product’s dosage form (such as lotion or spray). Also, for sunscreen products that have not been shown to help prevent skin cancer or early skin aging caused by the sun, the SPF statement on the main part of the product label would be followed by an asterisk (*) directing consumers to see the “Skin Cancer/Skin Aging alert” elsewhere on the label.
- Final formulation testing and recordkeeping: The deemed final order does not address record keeping. The proposed order requires records of required final formulation testing of sunscreen products to be maintained for one year after the product expiration date, or, if the product is exempt from expiration dating (as most sunscreens are), for three years after distribution of the last lot labeled in reliance on that testing. In addition, we are proposing to require responsible persons to keep records of sunscreen formulation testing, and we are clarifying that required records would be subject to FDA inspection.
- Sunscreen-insect repellent combinations: The deemed final order does not address sunscreen-insect repellent combinations. The proposed order proposes to classify these products as not GRASE because 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.
Q5. When will the 2021 proposed order (OTC000008) become a final order?
The CARES Act does not establish a deadline for finalization of the proposed order. It does specify, however, that a final order cannot go into effect sooner than one year after issuance of the final order. When issued, any final order will include information regarding implementation and the effective date.
The 2026 final order on PABA and trolamine salicylate (OTC000008 – 1) finalizes FDA’s proposal from the 2021 proposed order that PABA and trolamine salicylate are not GRASE for use in sunscreens and removes them as sunscreen active ingredients from OTC Monograph M020. FDA will address the other proposals in the 2021 proposed order (OTC000008) in a future order or orders.
Q6. What sunscreen active ingredients were addressed in the 2021 proposed order (OTC000008) and what did FDA propose regarding their GRASE status?
FDA proposed the following categories of sunscreen ingredients:
| GRASE* for use in sunscreens | Not GRASE for use in sunscreens because of safety concerns | Not GRASE for use in sunscreens because additional data needed |
|---|---|---|
| Zinc oxide and titanium dioxide | Aminobenzoic acid (PABA) and trolamine salicylate | Cinoxate, dioxybenzone, ensulizole, homosalate, meradimate, octinoxate, octisalate, octocrylene, padimate O, sulisobenzone, oxybenzone, avobenzone |
*GRASE= Generally Recognized as Safe and Effective under section 201(p)(1) of the FD&C Act,
Q7. Why are titanium dioxide and zinc oxide the only proposed GRASE ingredients in the 2021 proposed order (OTC000008)?
FDA’s review of publicly available evidence has found sufficient safety data on both zinc oxide and titanium dioxide to support a proposal that sunscreen products containing these ingredients (at concentrations of up to 25%) are GRASE.
Because the public record did not currently contain sufficient data to support positive GRASE determinations for cinoxate, dioxybenzone, ensulizole, homosalate, meradimate, octinoxate, octisalate, octocrylene, padimate O, sulisobenzone, oxybenzone or avobenzone, we proposed that these ingredients are not GRASE because they require additional data.
Since the 2021 proposed order (OTC000008), in June 2026, FDA published final order OTC000039, adding bemotrizinol as a new active ingredient in the OTC monograph for sunscreens.
Q8. FDA is asking for safety data on 12 active ingredients that will take a long time to gather. What will the next steps be for issuing further final or proposed orders based on the data?
FDA is committed to working with industry and public health stakeholders to help ensure that the sunscreens consumers use every day on themselves and their families are safe and effective for daily, life-long use. The comment period on the 2021 proposed order (OTC000008) afforded an opportunity for the public to submit information that had become available since the closure of the comment period on the 2019 proposed rule. This includes information that had become available regarding the eight sunscreen active ingredients that, in the pre-CARES rulemaking context, were the subject of timely requests for deferral in order to conduct studies to generate data first identified as lacking in the 2019 proposed rule.
In the 2021 proposed order, however, we noted that if at the close of the comment period on that proposed order, the available data did not resolve the outstanding questions about each of these ingredients, but the agency received satisfactory indication of timely and diligent progress on the necessary studies for a specific ingredient, FDA would be prepared to initially defer issuance of a revised final order on the GRASE status of sunscreens containing that particular active ingredient. Such a deferral would be for a period of not more than one year, with a possibility of extension depending on further satisfactory progress with the studies. However, if, in FDA's judgment, studies for any active ingredient do not appear to be proceeding in a timely manner or otherwise do not appear to be productive, the agency expects that it will proceed to a revised final order on sunscreens containing this ingredient after this initial deferral. FDA will determine whether the sum of the data, if timely submitted, is likely to be adequate to provide all the data that are necessary to make a determination of general recognition of safety and effectiveness.
To finalize the GRASE determinations for OTC sunscreen products containing these active ingredients, the agency will continue to utilize the administrative order process required by the CARES Act.
Q9. Should consumers only use sunscreens with zinc oxide, titanium dioxide, or bemotrizinol?
The 2021 proposed order (OTC000008) does not represent a conclusion by the FDA that the sunscreen active ingredients proposed as having insufficient data are unsafe for use in sunscreens. Rather, we requested additional information on these ingredients so that we can evaluate their GRASE 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.
In response to an OTC monograph order request (OMOR), on June 10, 2026, FDA issued a final order (OTC000039) to add bemotrizinol as a sunscreen active ingredient to the sunscreen OTC monograph. To do so, FDA evaluated data on the safety and efficacy of bemotrizinol that was submitted by DSM Nutritional Products LLC in an OMOR as well as data from FDA’s literature reviews. The final order, scientific review, supporting documents and other documents can be found OTC Monographs@FDA.
Sun safety is important for everyone and all skin tones, and consumers can reduce risks from sun exposure with continued use of sun protection measures, including sunscreen. Broad spectrum sunscreens with SPF values of at least 15 are only one element of a skin-cancer prevention strategy that should also include other sun protective behaviors such as wearing protective clothing that adequately covers the arms, torso, and legs; wearing sunglasses and a hat that provides adequate shade to the whole head; and seeking shade whenever possible during periods of peak sunlight. Medical authorities such as the Centers for Disease Control and Prevention, the American Academy of Dermatology, and major physicians’ associations endorse similar recommendations. More about sun protection and sunscreens can be found on the FDA website. People concerned about using sunscreens on infants or children, or while pregnant, are encouraged to consult their health care professional.
Q10. Why is FDA proposing changes to the maximum SPF level shown on sunscreen labels in the proposed order?
FDA had previously proposed (in 2011) that the maximum permissible labeled SPF value should be SPF 50+.
Since 2011, evidence shows additional meaningful clinical benefit associated with broad spectrum sunscreen products with an SPF up to 60. For this reason, the agency proposed that the maximum labeled SPF value should be SPF 60+ rather than 50+. While the proposed maximum labeled SPF value is 60+, we proposed to permit the marketing of sunscreen products formulated with SPF values up to 80. We hope this formulation margin will (1) help facilitate the development of products with greater UVA protection and (2) more fully account for the range of variability in SPF test results (discussed in more detail in the proposed order).
Q11. Are there any changes to labeling of sunscreens in the 2021 proposed order (OTC00008)?
FDA’s labeling proposals were informed by published scientific studies on consumer behavior and choice of sunscreens. These studies show that many consumers do not turn a sunscreen bottle around to read the Drug Facts section of the label, which is currently where the active ingredients and Skin Cancer/Skin Aging alert warning appear. Because FDA wants to ensure that consumers are aware of critical information about the protections that are (or are not) provided by sunscreen products and can readily evaluate and compare sunscreen products before purchasing, FDA has proposed adding certain information to the main portion of the product label.
Currently, most OTC drug products list the active ingredients in the product on the principal display panel (the label panel that is most prominent and is visible on the retail shelf). This proposed change in the labeling for sunscreens brings sunscreens in line with most other OTC drug products.
Q12. How would the proposed labeling requirements in the 2021 proposed order (OTC000008) benefit consumers?
FDA believes that the proposed modifications to the principal display panel will improve consumer awareness of important information on sunscreen labels. These proposed changes include:
- The addition of an alphabetical listing of the sunscreen active ingredients in the product, followed by “Sunscreen” and the product’s dosage form (such as lotion or spray).
- For sunscreen products that have not been shown to help prevent skin cancer or early skin aging caused by the sun, the SPF statement would be followed by an asterisk (*) directing consumers to see the “Skin Cancer/Skin Aging alert” elsewhere in the label.
- To prevent required information from being obscured or overwhelmed by other labeling features, we are revising the format requirements for the SPF, broad spectrum, and water resistance statements on the label.