Status of sunscreen regulations in the US

Key Takeaways

  • Review a summary of the status of sunscreen regulation in the US per the current FDA guidance 
  • Insights into the historical timeline of sunscreen regulation
  • Learn how your company can stay ready to adapt to the future of sunscreen regulation in the US

What is changing

Currently, the US FDA has deemed only two sunscreen active ingredients as GRASE (Generally Recognized as Safe and Effective), Zinc Oxide and Titanium Dioxide (both up to 25%), based on new data and changed conditions since the issuance of the 1999 monograph. The FDA has requested additional safety information for other sunscreen active ingredients that have been historically used in the US. All other sunscreen active ingredients are currently allowed to continue to be used, but require more safety data to be considered GRASE by the FDA.

It is important to note that some of the testing that is being required by the FDA for sunscreens are reproductive and developmental toxicity tests on animals. These tests expose hundreds of animals to certain chemicals for the duration of their entire lives. In response to these FDA testing requirements, PETA has stated that these tests often don’t translate to humans and also has accused the FDA of going against its own advice per the FDA Modernization Act 2.0.  If animal testing were to be required to determine safety, it would be done on the active ingredients and not final formulations of sunscreens. Also, if raw material companies commission animal testing to provide the FDA with additional safety data, the FDA may still not approve the active ingredients. 

What you need to know

Pending safety data for the other active ingredients (other than Titanium Dioxide and Zinc Oxide), their status could change to approved or unapproved. Sunscreens containing cinoxate, dioxybenzone, ensulizole, homosalate, meradimate, octinoxate, octisalate, octocrylene, padimate O, sulisobenzone, oxybenzone, and avobenzone are currently not GRASE. The administrative order process required by the CARES Act will be used to finalize GRASE determinations for the 12 active ingredients previously mentioned.

Prior to the FDA’s nominee for Commissioner’s confirmation hearing, PETA was calling to reverse the FDA’s position on animal testing for sunscreens. The FDA made a statement via the publication Beauty Matters, saying that “the current science does not allow for the replacement of all animal studies with non-animal methods.” PETA is calling for the agency to change this historical testing method.

Definitions

  • US FDA: United States Food & Drug Administration
  • GRASE: Generally Recognized as Safe and Effective
  • CARES Act: Coronavirus Aid, Relief, and Economic Security Act, “includes statutory provisions to reform and modernize the way over-the-counter (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.”
  • PETA: People for the Ethical Treatment of Animals
  • FDA Modernization Act 2.0: Set an expectation that the FDA would seek the expertise needed to accept non-animal replacements for tests on animals.
  • Beauty Without Bunnies: A PETA program that identifies cruelty-free cosmetics and personal care brands.

Timeline

CARES Act was signed into law
FDA posted the deemed final order for sunscreens.
- FDA posted the proposed order for sunscreens to revise the deemed final order.

- The FDA issued a deemed final order regarding OTC sunscreen products and then shortly after, issued a proposed order because when the CARES Act was signed into law, it replaced the monograph rulemaking process with an administrative order process. The CARES Act directed the FDA to amend and revise the deemed final order and required that the revised sunscreen order be issued no later than 18 months after the CARES Act was signed (September 27, 2021).
Confirmation hearing for FDA Commissioner Martin Makary

Impacts

  • The sunscreen industry may see a shift in consumers purchasing products that contain only the two GRASE active ingredients.  However, many brands still utilize the other 12 active ingredients that are deemed not GRASE. For now, companies and consumers will have to wait for the FDA to make a decision regarding the 12 not GRASE active ingredients. Companies can reformulate to only use Titanium Dioxide and Zinc Oxide as active ingredients in their products, as well as keep up to date with the FDA regarding animal testing requirements for active ingredients.
  • Ahead of the FDA Commissioner’s hearing, PETA is removing all non-mineral sunscreens from its Beauty Without Bunnies list.
  • In January 2025, US senators reintroduced the FDA Modernization Act 3.0, to help reduce unnecessary animal testing while advancing scientific innovation.
  • A possible option to compel the FDA to use non-animal testing methods would be the reauthorization of the OTC Monograph User Fee Program (OMUFA), which can often serve as a starting point for other FDA initiatives. Under OMUFA, “industry-paid fees help support FDA’s regulatory activities related to OTC monograph drugs and FDA agrees to adhere to performance goals negotiated by FDA and industry, including specific time frames for conducting certain OTC monograph activities.” Current authorization will expire in late September, but reauthorization of OMUFA II would cover the years 2026-2030.

Our expert advice

Ithos expert advice
Need help understanding these requirements?

Contact Ithos today have our regulatory team help in your next review!

Companies and brands can advocate to the FDA that valid safety testing does not have to include animal testing. This can be done through lobbyists, trade councils, and NGOs. It is also important to note that Historically, the FDA has taken a long time to publish any final decisions on big issues or sometimes not at all.  This adds to the complexity of the situation as Brands need to prepare for anything or nothing to happen.  Another piece of advice would be to contact PETA and get their stance on this issue, ask what they are doing to combat this issue, and to discuss how their Beauty Without Bunnies Program listing may impact products. Continue to formulate sunscreens as it aligns with your brand, or if animal testing is not a negotiable issue, consider removing SPFs from your portfolio or formulation with the GRASE actives only. 

Reference links

Related Posts