Any sunscreen in the US is an OTC. If you claim SPF, it is an OTC and you have to follow the monograph.
Relevant. https://www.fda.gov/drugs/status-otc-rulemakings/rulemaking-history-otc-sunscreen-drug-products
Hey Perry,
how can I find a consultant ? or do you have a consultant that you could recommend? or do you offer this service?