Cost of Broad Spectrum UV testing required by the FDA for new sunscreen formulas?

The only number I've heard is around $5000, let me know if you know any labs that could do it, ideally for less.
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  • MicroformulationMicroformulation Member, Professional Chemist
    Good luck finding it for less than that. Last week a client paid $6250 for testing with Suncare Research Laboratories out of Winston Salem. They shopped around and this was the best they found.
    markfuller@microformulation.com Microformulation.com Microformulation Cosmetic Consulting provides Custom Formulations for both large Commercial accounts as well as smaller entrepreneurs. We can provide Naturally compliant Formulations under the NSF, NPA, Whole Foods and USDA Organic Certifications. BS.Pharm Albany College of Pharmacy, Union University.
  • BobzchemistBobzchemist Member, PCF student
    If you're having trouble with the idea of $5,000 for the 20-person SPF test, you really need to drop the idea of selling a sunscreen until you have more working capital.

    The more expensive test that's required is actually the active ingredient assay. Depending on which lab you use, the method development part of the assay could cost between $10,000 and $25,000
    Robert Zonis, Sr. Formulation Chemist, Beaumont Products "All opinions and comments expressed are my own, have no relation to Beaumont Products, are fully copyrighted, and may not be used without written permission."
  • pmapma Member
    edited September 2015
    You can choose another country to test, it could be less expensive. If they use the FDA methodology, I guess you don t need to test in the US. 
  • ZinkZink Member
    edited September 2015
    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?
  • BobzchemistBobzchemist Member, PCF student
    @Zink,

    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.




    I would recommend Allied Analytical Laboratory Services, in Millington TN. He was the cheapest we found for this.Contact Vernell Stornes for more information.


    Robert Zonis, Sr. Formulation Chemist, Beaumont Products "All opinions and comments expressed are my own, have no relation to Beaumont Products, are fully copyrighted, and may not be used without written permission."
  • MicroformulationMicroformulation Member, Professional Chemist
    Great explanation.

    markfuller@microformulation.com Microformulation.com Microformulation Cosmetic Consulting provides Custom Formulations for both large Commercial accounts as well as smaller entrepreneurs. We can provide Naturally compliant Formulations under the NSF, NPA, Whole Foods and USDA Organic Certifications. BS.Pharm Albany College of Pharmacy, Union University.
  • ZinkZink Member
    edited September 2015
    @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 :)



  • BobzchemistBobzchemist Member, PCF student
    @Zink, it's not the cost per test, it's the cost of method development and validation that's so expensive.
    Robert Zonis, Sr. Formulation Chemist, Beaumont Products "All opinions and comments expressed are my own, have no relation to Beaumont Products, are fully copyrighted, and may not be used without written permission."
  • @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.
  • "As for Silicone-coated Zinc Oxide, the API Fee for this is $160.00 because we outsource this." no development needed.
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