What the classification means
Sunscreen products are governed by the FDA's OTC sunscreen monograph rather than by cosmetic regulation. Because they are drugs, manufacturing must take place under drug Good Manufacturing Practice, not cosmetic GMP. This is a materially higher bar and it is the single most common reason a Chinese-made sunscreen cannot enter the US market — not the formula, but the facility.
It also means the marketing authorisation route is a drug listing, and labelling must include a Drug Facts panel in the prescribed format.
Zinc oxide status
Zinc oxide is recognised as a generally recognised as safe and effective sunscreen active ingredient under the OTC monograph, within specified concentration limits. This is a long-established position, unaffected by the more recent regulatory attention on certain organic filters.
The advantage for a mineral-only formulation is that it relies on an ingredient with decades of monograph history rather than on a filter awaiting administrative order.
What we can and cannot do
Contract production for the US market requires a facility operating under drug GMP. We are explicit about this rather than glossing over it: our current manufacturing arrangement is built around cosmetic GMP production, and a US OTC drug project would require a qualified drug-GMP facility, which we would need to source per project.
What we can do today is develop the formula and prepare the technical documentation. The facility question is a commercial decision that depends on the volume and the market entry plan, and it should be discussed early rather than discovered at the end.
This page describes regulatory structure, not legal advice. Confirm requirements with a qualified US regulatory consultant for your specific product before committing to a market entry route.