FDA Registration Details for Sunscreen using SPF Protect Ultra™ II
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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