Marijuana SPF Products and Regulatory Compliance

In the United States, sunscreens are regulated as over-the-counter (OTC) drugs, not cosmetics. This classification means that any SPF product—whether infused with cannabis or not—must follow the U.S. Food and Drug Administration’s (FDA) OTC drug framework and the sunscreen monograph system. These rules establish the approved active UV filters, dosage forms, labeling requirements, and testing methods to ensure that a sunscreen is considered generally recognized as safe and effective (GRASE).

Currently, zinc oxide and titanium dioxide are among the few mineral UV filters that are recognized as GRASE. If a product does not comply with every requirement in the FDA’s OTC monograph, it is considered an unapproved new drug. Additionally, all sunscreens must undergo standardized SPF and broad-spectrum testing to validate UVA and UVB protection levels. Each product must display the Drug Facts label, specific warnings, and detailed usage instructions.

When it comes to product innovation, any deviation from the FDA-approved dosage forms—such as mousse or foam sunscreens—can render the product misbranded. This has led to warning letters and enforcement actions for products that stray from approved categories.

The introduction of cannabis-derived ingredients, such as cannabidiol (CBD), into SPF formulations introduces additional regulatory complications. The FDA has stated that CBD is not an approved active ingredient in any OTC drug category, nor is it considered a “safe and suitable” inactive ingredient. Products that combine SPF actives with CBD or other cannabinoids fall outside of the approved OTC drug framework and are therefore regarded as unapproved and misbranded drugs.

While the 2018 Farm Bill removed hemp (defined as containing less than 0.3% delta-9 THC) from the federal Controlled Substances Act, it did not affect the FDA’s oversight of drugs and personal care products. As a result, any sunscreen containing cannabinoids—especially intoxicating ones such as delta-8 or delta-9 THC—may also violate federal and state-level laws. Regulations surrounding hemp-derived ingredients vary widely across states, making national distribution particularly complex for marijuana SPF brands.

However, if a product uses hemp seed oil, which contains no cannabinoids, it may remain compliant as long as it adheres to all FDA OTC sunscreen requirements. This includes manufacturing under current Good Manufacturing Practices (cGMP), proper labeling, and truthful marketing claims. Every sunscreen marketed in the United States must also be listed and registered with the FDA’s drug database.

The Federal Trade Commission (FTC) adds another layer of oversight by regulating product marketing and advertising. Any claims related to health benefits—such as “anti-inflammatory,” “skin repair,” or “cannabinoid-enhanced protection”—must be truthful, not misleading, and supported by reliable scientific evidence. Misleading statements can result in FTC enforcement actions, even if the formulation itself meets FDA requirements.

In summary, marijuana SPF products face stringent regulatory barriers. While traditional sunscreens can legally include hemp seed derivatives, the inclusion of cannabinoids such as CBD or THC places them outside the FDA’s approved drug framework. For now, compliant cannabis-branded sunscreens must focus on non-cannabinoid formulations, strict adherence to monograph standards, and transparent marketing practices.