Sun care products are OTC drugs under FDA. 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 three 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 run the testing and document to specification.
Sunscreens are regulated under FDA's OTC monograph system (21 CFR Part 352 and subsequent). Active ingredients, permitted concentrations, SPF testing methods, labeling requirements (Drug Facts panel), and water-resistance claims are all regulated. FDA's 2019 Proposed Rule proposed reclassifying some active ingredients; brands should be aware of the evolving regulatory status of oxybenzone and other actives. Our regulatory team builds your formulation to the current monograph and flags forthcoming 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.