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  Specifications and acceptable range for OTC sunscreen actives

  Posted by _marit on June 5, 2024 at 1:46 pm

  In formulating a sunscreen - I am wondering about the specification for actives should be. I’ve heard that the industry standard is that a +/- 10 % range for actives (Titanium Dioxide / Zinc Oxide). Meaning that as long as the assay is within that range it is an acceptable specification, but I am having trouble finding a source for this “industry standard”. Does anyone have pointers on this/ a source to direct me to?

  PhilGeis replied 6 months, 2 weeks ago 2 Members · 1 Reply

  • actives
  • specification
  • sunscreens
• 1 Reply

• 

  PhilGeis

  Member

  June 5, 2024 at 6:13 pm

  https://www.accessdata.fda.gov/drugsatfda_docs/omuf/OTCMonograph_M020-SunscreenDrugProductsforOTCHumanUse09242021.pdf

  please note Part D

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