Sun care products are OTC drugs under FDA (Food and Drug Administration). That means monograph compliance, OTC labeling requirements, SPF testing protocols, and facility standards that most cosmetic contract manufacturers can't meet. PMG's partner facilities are FDA-registered for OTC drug manufacturing, and our regulatory team has spent decades building sunscreen products to standard.
From mineral-only daily-wear SPF to FDA-tested sport sunscreens, we manufacture the full sun care range across formats and active systems.
Sun care products are regulated as OTC drugs, not cosmetics. That means the manufacturing facility must be FDA-registered as a drug establishment, and GMP compliance must meet 21 CFR Part 210/211 pharmaceutical standards, not just cosmetic GMP.
Finished SPF values must be substantiated by FDA-accepted SPF testing conducted at accredited labs. We coordinate SPF testing with our accredited testing partners and build the testing timeline into your production schedule.
'Water resistant (40 minutes)' and 'water resistant (80 minutes)' are regulated claims that require specific FDA-protocol testing. We coordinate the testing with accredited labs and document to specification.
Sunscreens are OTC drugs regulated under FDA's OTC sunscreen monograph (M020). Since the 2020 CARES Act, that monograph is maintained through FDA administrative orders instead of the old 21 CFR Part 352 rulemaking. The deemed final order that took effect with the CARES Act in March 2020 sets today's rules for permitted active ingredients and concentrations, SPF and broad-spectrum testing, Drug Facts labeling, and water-resistance claims. FDA's 2021 proposed order would update those rules, including the status of some active ingredients such as oxybenzone, so brands should watch where it lands. In June 2026, FDA added bemotrizinol at up to 6%, the first new sunscreen active ingredient in more than 20 years, effective August 9, 2026. Our regulatory team builds your formulation to the current order and flags pending changes so your product doesn't launch into a reformulation cycle.
Sun care is the most regulated category we work in. The brands that win in it are the ones who started with a manufacturer who treats it accordingly.
