Getting a sunscreen to market and keeping it on shelf is a laborious project. Luckily, the Society of Cosmetic Chemists has a cadre of experts to help indie brands and established players succeed. Prior to last month’s Sunscreen Symposium, the SCC held a one-day Continuing Education Program (CEP). The course was designed to help attendees understand the scope and significance of launching a compliant sunscreen product.

Ronie Schmelz Esq., partner, K&L Gates, reviewed regulatory and compliance responsibilities to ensure a successful product launch. But first, she offered a caveat: “It’s a long, slow march to regulating sunscreens, and it seems like it’s just getting started.”

Schmelz reminded attendees that sunscreens are classified as drugs in the US. She compared cosmetic claims versus drug claims, according to FDA.

Cosmetic Claims          Drug Claims

Cleansing                    Redness

Moisturizing                Anti-inflammatory

Renewing                    Acne

Rejuvenating               Eczema

Firming/Lifting            Psoriasis

Reducing puffiness      Scars/Wounds

Tightening                   Anti-septic/Anti-bacterial

Hydrating                    Anti-microbial

                                    Blood/Muscle Circulation

Schmelz noted that the difference between cosmetics and OTCs is their intended use, which is based on the product’s ingredients, consumer perception and the brand’s claims.

“Some cosmetics can be considered OTCs, if they contain active ingredients or make claims that could lead consumers to think the product is a drug,” she explained.

A Review of Current Pathways

Schmelz reviewed the two regulatory pathways for marketing OTC drugs—New Drug Application/Abbreviated New Drug (NDA/ANDA) and the OTC Monograph. The Coronavirus Aid, Relief and Economic Safety Act (CARES Act) reformed the FDA’s OTC drug product review process. The CARES Act includes an Administrative Order Process that replaces the rulemaking process. It gives FDA the authority to issue an administrative order that adds, removes or changes GRASE conditions for an OTC drug monograph.

The CARES Act created the Deemed Final Order (DFO), which incorporates requirements from 1999 (stayed) Final Monograph for OTC sunscreen products. The DFO does not include a limit on maximum SPF values and SPF labeling is the same as tested results. In contrast, the Proposed Order caps SPF value at 60+. It permits marketing of sunscreen products formulated with SPF up to 80, and SPF labeling using the lowest number in a range of tested results; e.g., SPF determined 15-19, is labeled SPF 15.

“The DFO does not require broad spectrum testing, but creates optional spectrum labeling claim and testing that is required to include claim on label,” said Schmelz. “Under the Proposed Order all sunscreens with SPF values of 15and above must satisfy broad spectrum requirements, including a proposed new requirement that broad spectrum products meet a UVA I/UVB ratio of 0.7 or higher.”

Further, under the DFO permissible dosage forms are oil, lotion, cream, gel, butter, pastes, ointment, stick, spray and powder. Under the Proposed Order, GRASE includes oils, lotion, cream, gel, butter, paste, ointments and sticks. Sprays are subject to particle size, flammability testing, and related safety labeling requirements. Powders are deemed not GRASE due to insufficient data. Still, it doesn’t change new drug status of sunscreens in all other forms.

Why does it all matter? Because FDA Warning Letters are turning up in corporate mailboxes more than ever. Sunscreen companies that received Warning Letters in 2025 include Supergoop!, K & Care Organics, Vacation Inc., Kalani Sunwear and Fallian Cosmeceuticals. Vacation and Supergoop!, both received FDA Warning Letters for selling foam sunscreens.

A Host of Regulatory Agencies & Acts

But the FDA isn’t the only Agency keeping an eye on sunscreen marketers. The Federal Trade Commission (FTC) Act prohibits unfair or deceptive acts or practices. Ads are deemed deceptive if it contains a statement or omits information that is likely to mislead consumers acting reasonable under the circumstances and is material or important to a consumer’s decision to buy or use the product. Importantly, the test is based on perceptions of the “reasonable consumer.”

Want to read the latest on formulating sunscreens? Click here!

The Fair Packaging and Labeling Act defines labels as “any written, printed or graphic matter affixed to any consumer commodity or affixed to or appearing upon a package containing any consumer commodity” and restricts the FTC’s enforcement to a product’s label or packaging.

Substantiation is claims-driven. Schmelz warned the “stronger the claims, the more rigorous the science required.” Stronger claims include “brand X treats skin cancer” or “brand X prevents hyperpigmentation.” Weaker claims include “brand X makes skin soft and smooth” or “brand X comes in three delightful scents.”

Types of Claims

Schmelz reviewed types of claims, which include:

            • Express—claim likely to influence a consumer’s decision and can be objectively proven (example: “mineral-based”).

            • Implied—indirect claim or inference about a product’s characteristics or preferences (example: “X blocks rays that cause sunburns”).

            • Visual demonstration—product demonstration that depicts how product will perform under normal use (example: before and after photos showing reduction in sun damage).

            • Data- or survey-based—claims that imply scientific or survey basis require adequate prior substantiation (example: “leaves skin hydrated for 5 five straight days”).

FTC’s wide-ranging regulatory oversight includes traditional print and broadcast, social media, influencers, consumers, endorsements, emails, recurring subscriptions, and contests and sweepstakes. Schmelz warned FTC’s targeted focus these days include “made in the USA” claims, environmental and health claims (green washing), pricing and artificial intelligence.

The National Advertising Division (NAD) of the Better Business Bureau provides independent self-regulation overseeing truthfulness of advertising across the US. NAD’s biggest concerns in the personal care products industry includes before and after photos, customer reviews and testimonials, and ingredient and superiority claims.

Schmelz provided examples of several challenges. In one of them, Charlotte Tilbury challenged Huda Beauty’s “strongest setting spray ever” claim. Ultimately, Huda Beauty voluntarily discontinued the claim.

State-Level Regulations

Schmelz reviewed state chemical bans, too. California’s 2020 Toxic Free Chemical Act bans over 20 chemicals. Colorado’s restricts PFAS (perfluoroalkyl and polyfluoroalkyl substances) from personal care products that contain intentionally added PFAS. In 2026, Vermont will ban 17 chemicals. Schmelz called Washington State’s Toxic-Free Cosmetics Act “the most aggressive cosmetic ingredient ban to date.” It includes PFAS, phthalates and formaldehyde-releasing agents. The bans took effect January 1, 2025. Among all the states, the most common banned ingredients include phthalates, PFAS, formaldehyde and formaldehyde-releasing agents, and methylene glycol.

States implement environmental and packaging laws, too. Extended Producer Responsibility (EPR) laws are intended to reduce packaging to meet state recycling and climate goals. EPR shifts responsibility for end-of-life management of products to producers. The structure includes one or more Producer Responsibility Organization (PRO). The list of states with packaging-related laws include California, Colorado, Maine, Maryland, Minnesota, Oregon and Washington. More than half a dozen states are considering EPR laws, too.

Lots of Litigation

Finally, Schmelz reviewed some of the class action lawsuits impacting the personal care industry. Recent lawsuits involving Shiseido, Coty, Noxell and L’Oréal contended “clean” should equal “free of.” Plaintiffs alleged products contained disclosed or undisclosed PFAS or purported indicators of PFAS. Another suit, Noohi v. Johnson & Johnson Consumer Products, alleged an “oil-free” claim was made for a product that contains oils and oil-based ingredients ethylhexyl palmitate and soybean sterols. In another free-of lawsuit, Sexy Hair Concepts and Ulta paid $2.33 million to settle a “sulfate-free” claim.

Emerging contaminants lawsuits led Johnson & Johnson to pay nearly $6.5 billion to settle asbestos contamination in talc suits. Benzene was in the news, too. Neutrogena and Aveeno paid $1.75 million to settle lawsuits, while Coppertone paid $2.3 million to settle a similar suit.

“Emerging contaminants is the Wild West of allegations,” warned Schmelz.