Here’s what I’ve found so far: Amalabs one of the top Google results will do SPF30, 80 min waterproof and broad spectrum testing for $4633. If you only need SPF testing, not making any waterproof or broad spectrum claims that number goes down to $2167.
@bobzchemist I’m not sure what you mean by active ingredient assay, I didn’t see any mention of it in the FDA final sunscreen monograph. You only need 10 subjects for the SPF test.
@pma: makes sense, I wonder if there are labs that do this though? I can’t find any through searching on Google, what search strategy would you use?
The FDA Sunscreen monograph is not the only regulation that sunscreens must follow. Sunscreens must also follow all the other regulations that apply to drugs/OTC drugs. The big one is that you have to be able to prove that you have the claimed amount of active ingredient in your product, and you have to test every batch before you can sell it.
Other littler ones include having to follow pharmaceutical instead of cosmetic cGMP, having to register your facility with the FDA, having to assay/run incoming QC checks on all incoming drug raw materials, having to qualify all of your suppliers of all drug raw materials, having to train all of your employees that work on or affect the OTC drug on cGMP yearly, having to use the correct form of batch record and file all related information correctly, and on and on. I would seriously suggest getting a consultant to work with you on this.
It’s actually a major pain to make sunscreens if you’re not already set up to make OTC drugs, to the point where the company I work for is thinking of giving it up as a bad investment.
@bobzchemist I’m fully aware and I’m not a production facility, already working with a couple of contract manufacturers set up to do OTC drugs. It adds some expense, but API active ingredient testing, depending on the ingredient, is typically only in the low hundreds pr. ingredient, in my case using silicone coated zinc oxide exclusively should help keep the cost down, I’ve contacted my manufacturers to verify cost. Thanks for the rec of Allied Analytical
@bobzchemist I’ll talk to my CMOs about this, for previous OTC formulas there were no method development/validation costs, presumably because the API tests/formulas were standard enough to be handled without any method development specific to the project.