FDA Registration for Delentigo & INCI for Pro Polymer (Gel Maker)
Question
What information is required for FDA registration of the ingredient blend Delentigo, which contains:
- Lepidium Sativum Sprout Extract
- Lecithin
- Soy Isoflavones
- Polysorbate 80
- Alcohol
- Glycerin
- Phenoxyethanol
- Aqua / Water
Additionally, what is the INCI name for the ingredient Pro Polymer (Gel Maker)?
Answer
Answer to Your Questions
Here are the answers to your questions regarding FDA registration for Delentigo and the INCI name for Pro Polymer (Gel Maker):
1. Delentigo FDA Registration
Delentigo is a trade name for a blend of ingredients. Regulatory bodies like the FDA require the INCI names of the individual components in the blend for registration, not just the trade name. As provided by the staff, the full INCI name list for Delentigo is:
- Lepidium Sativum Sprout Extract
- Lecithin
- Soy Isoflavones
- Polysorbate 80
- Alcohol
- Glycerin
- Phenoxyethanol
- Aqua / Water
You should submit this complete list of INCI names to the FDA. This provides the necessary detail about the chemical composition of the product for their review.
2. INCI Name for Pro Polymer (Gel Maker)
The INCI name for Pro Polymer (Gel Maker) is:
ACRYLATES/C10-30 ALKYL ACRYLATE CROSSPOLYMER
This information is found in the product details for Pro Polymer (Gel Maker).
I hope this helps with your FDA submission and formulation work!
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