OTC Actives Testing for Sunscreen

I am working with a CM to manufacture a sunscreen product. We have already completed the FDA required UVB testing, resulting in an SPF 37, so we can claim SPF 35. The CM is validating a method for us to measure the active levels and is asking for a spec range for each active. Is there an industry standard used in this instance? I looked through the FDA's website and could only find very vague answers. I know industry standard for batching is within 1% but does it need to be tighter for OTC actives since they are called out on pack?

Any advice would be much appreciated!

Comments

  • BobzchemistBobzchemist Member, PCF student
    OTC Sunscreen actives are always +/- 10% of the Active amount. The assays aren't that accurate, so you need every bit of that room.
    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."
  • CW6724CW6724 Member
    Thank you so much!
  • BobzchemistBobzchemist Member, PCF student
    The requirements for the +/- 10% for sunscreen actives aren't in the sunscreen monograph or anywhere on the FDA website if you look for sunscreen information.

    Where to find the regs for this, if you need them, is in the general requirements for all OTC drugs. A lot of people don't realize that the general regulations also apply to sunscreens, because they're not in the monograph - but they do.
    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."
  • Mike_MMike_M Member
    What bobz said. Take the regulations very, very seriously. The FDA considers sunscreen to be just as much a drug as aspirin or cold medication. And if they coming poking around they DO NOT take kindly to the sentiment "Well it's not a real drug"
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