Changes in Sunscreen Regulation & Litigation are Heating Up: Updates from Congress to the Courts

In an effort to update and modernize the FDA’s regulation of sunscreen, Representative John Joyce (R-Ohio) and a group of bipartisan members of Congress introduced in June the Supporting Accessible, Flexible, and Effective Sunscreen (SAFE) Standards Act.  If enacted, the bill would establish a more flexible regulatory scheme at the FDA, decrease the cost in the approval process and expand the array of sunscreen available for purchase.

The Current Process

The agency currently regulates sunscreen as an “over the counter,” nonprescription drug, which means sunscreen companies must prove their products are safe through lengthy and expensive clinical trials, including animal testing. Under the FDA’s current approach, companies must wait years and spend millions—potentially tens or hundreds of millions—on clinical trials to shepherd a drug through the agency’s exacting scrutiny. But under the SAFE Standards Act, non-traditional and less expensive methods of demonstrating a product’s safety would be deemed as acceptable alternative methods of gaining the FDA’s approval.

As a result of these stringent testing requirements and safety standards, the FDA has not approved a new active sunscreen ingredient since 1999. Policymakers are concerned that the agency’s current regulatory approach is outdated and has fallen behind the rest of the world.  As a result. proponents of this bill seek to modify that approval process, facilitate the introduction of new active ingredients, and expand the kinds of sunscreen products available to American consumers.

The Proposed Legislation

Specifically, the legislation would change the FDA’s current regulatory approach by:

• Allowing for the use of real-world evidence, observational studies, and “other scientifically valid approaches” to establish a sunscreen’s safety, as opposed to requiring standard clinical trials and animal testing.
• Requiring annual reports to Congress detailing the status of new sunscreen ingredient applications and the standards employed in the agency’s review process.
• Mandating that the agency issue an updated final administrative order on active sunscreen ingredients that incorporates the new testing and approval standards detailed in the bill.

The bill could also potentially move American regulation of sunscreen closer to the approach employed elsewhere around the world—and thereby lead to an expanded array of sunscreen options at American stores. The legislation is still in its earliest stages; it must first pass through the House Energy and Commerce Committee, then both chambers of Congress, and finally be signed into law by the President before it would ever take effect. But the bill’s cosponsors are equally represented by both major political parties, and Congress passed similar legislation in 2014, so its chances of becoming law are considerable even in this political climate.

Aligning with the Rest of the World

Compared to the current U.S. regulations which consider sunscreen a “drug”, many European and Asian countries regarded sunscreen as a “cosmetic.”

As a consequence of this lighter regulatory touch given to cosmetics, European authorities have approved 27 active sunscreen ingredients, whereas the FDA has only approved just 16. European regulations leave more room for innovation in sunscreen composition by allowing for a range of ingredient combinations, while the FDA restricts such activities more tightly. Critically, experts regard Europe’s expanded array of approved ingredients as better at protecting against harmful UVA rays. The end result is that European producers can sell a wider array of more desirable product offerings than their American counterparts.

Moving the American regulatory approach closer to this model would therefore potentially open exciting new business opportunities for companies currently unable to offer the kinds of products that regularly appear on European and Asian store shelves. However, new opportunities come with potential risks.

Recent Litigation Provides Insight into the Risks Facing Sunscreen Companies

There has been a flurry of litigation in recent years related to how sunscreens are marketed and advertised, including:

• State enforcement. Local governments have started taking action against what they perceive to be false advertising in the sunscreen industry, particularly related to environmental claims:
  • State v. Sun Bum, LLC, No. 25-cv-463994 (Cal. Super. Ct. May 2, 2025): In California, the Santa Clara County District Attorney’s Office recently reached a $300,000 settlement with Sun Bum after it brought false advertising charges against the company. The government alleged that Sun Bum marketed its products as “reef friendly,” when in fact they contained environmentally unsafe chemicals like oxybenzone and octinoxate. As part of the settlement agreement, Sun Bum was ordered “to not advertise any of its chemical sunscreens as ‘reef friendly,’ ‘reef compliant,’ or with a drawing, symbol, or photo of a coral reef.” The company further had to remove products which featured such advertising from store shelves and pay $25,000 to help fun reef restoration efforts in California.
  • State v. Supergoop, LLC, No. 25-cv-466622 (Cal. Super. Ct. June 13, 2025): The same prosecutor’s office also recently reached a $350,000 settlement with Supergoop after it brought similar charges against the company. As with Sun Bum, the government alleged the company falsely advertised its product as being safe for endangered reefs despite including unsafe substances within its chemical composition. As part of the settlement agreement, Supergoop was barred from advertising its products as environmentally friendly in the future.
  • State v. Edgewell Personal Care, LLC, 25-cv-461660 (Cal. Super. Ct. Mar. 24, 2025): The Santa Clara County District Attorney’s office has recently brought similar charges of false “reef friendly” advertising against Banana Boat and Hawaiian Tropic, suggesting a possible emerging trend in terms of state enforcement actions.
• Class action lawsuits. Beyond local prosecutors, large groups of plaintiff-consumers have also started to join forces in class action lawsuits seeking civil damages against sunscreen producers for similar conduct—with potentially millions in looming liability:
  • In re Johnson & Johnson Aerosol Sunscreen Mktg., Sales Practices & Prods. Liab. Litig., 2024 WL 3065907 (11th Cir. June 20, 2024): In 2021, plaintiffs filed a class action suit against Johnson & Johnson, alleging, in part, that the company had engaged in deceptive advertising by failing to warn consumers about unsafe benzene levels in its Neutrogena sunscreen. Johnson & Johnson agreed to settle the lawsuit for $1.75 million in 2023, but the Eleventh Circuit vacated that settlement last year after it determined that the lower court should more closely scrutinize the agreement’s attorneys’ fees provisions. The matter remains pending before the Southern District of Florida.
  • Bangoura v. Beiersdorf, Inc. et al., No. 22-cv-00291 (E.D.N.Y. Jan. 18, 2022): In 2023, Coppertone settled a similar class action for $2.3 million after plaintiffs alleged the company engaged in false advertising by failing to disclose unsafe levels of benzene in its product. The consumers claimed they wouldn’t have purchased Coppertone’s sunscreen if the company had properly advertised the unsafe benzene levels on the sunscreen’s packaging.

Takeaways

Given the state of flux in the sunscreen market, and the recent attention both legislators and plaintiff lawyers have given, companies face new daily challenges on how they choose to market their sunscreens, especially when making claims about a particular product’s environmental friendliness, general protective capabilities, and ingredient composition.