FDA Registration Details for Sunscreen using SPF Protect Ultra™ II

Asked by: nupookca On: December 16, 2021 Product Type: Cosmetics

Question

When formulating a sunscreen product using SPF Protect Ultra™ II and needing to register with the FDA, what are the required INCI names and the percentage breakdown of each chemical component within the SPF Protect Ultra™ II blend itself?

Answer

Information for FDA Registration of Sunscreen using SPF Protect Ultra™ II

Based on the product description for SPF Protect Ultra™ II, the following chemical names (INCI names) are listed and should be used for FDA registration:

  • Octyl methoxycinnamate
  • C12-15 Alkyl Benzoate
  • Bis-Ethylhexyloxyphenol Methoxyphenyl Triazine
  • Diethylamino Hydroxybenzoyl Hexyl Benzoate
  • Neopentyl Glycol Diheptanoate
  • Ethylhexyl Triazone

Important Note: The product description provides the INCI names of the components within SPF Protect Ultra™ II, but it does not provide the specific percentage composition of each individual chemical within the SPF Protect Ultra™ II blend itself. This information is typically proprietary to the manufacturer.

For FDA registration, you will need to declare the percentage of the total SPF Protect Ultra™ II blend used in your final sunscreen formulation. The recommended usage rate for SPF Protect Ultra™ II is 1-30%.

The description includes example formulations:

  • Using 15% SPF Protect Ultra™ II resulted in SPF 50.95, PA++.
  • Using 30% SPF Protect Ultra™ II resulted in SPF 90.81, PA++.

You should use the percentage of SPF Protect Ultra™ II that you include in your specific formula when submitting for FDA registration, along with the list of INCI names provided above.

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