FDA Notification for Potassium Azeloyl Diglycinate and Ingredient Mixtures
Question
When registering a cosmetic product with the FDA, how should the following ingredients be listed:
Liquid Azelaic™(Potassium azeloyl diglycinate)Light Cream Maker™(INCI Name: Sodium Polyacrylate (and) Polyisobutene), which is a mixture.
Answer
FDA Notification for Azelaic Acid and Potassium Azeloyl Diglycinate
Based on the information, when notifying the FDA for cosmetic products containing Liquid Azelaic™, which is Potassium azeloyl diglycinate, you should list it as a single substance under its chemical name:
- Potassium azeloyl diglycinate
Azelaic Acid itself is typically classified as a drug ingredient and is not permitted for use in cosmetics in the same way that Potassium azeloyl diglycinate is. Potassium azeloyl diglycinate is a modified form that is suitable for cosmetic use.
Therefore, you should not list it as Azelaic Acid, nor as a combination of Azelaic Acid and Potassium azeloyl diglycinate. It is one substance, Potassium azeloyl diglycinate.
Regarding ingredients that are mixtures, such as Light Cream Maker™ (INCI Name: Sodium Polyacrylate (and) Polyisobutene), you need to list each component separately by its chemical name and its percentage in the final product. You would need the breakdown percentage of each component within the mixture from the Certificate of Analysis (COA). For example, if Light Cream Maker™ is 75% Sodium Polyacrylate and 25% Polyisobutene, and you use 1% Light Cream Maker™ in your formula, you would list:
- Sodium Polyacrylate (0.75%)
- Polyisobutene (0.25%)
Always list ingredients by their chemical names (INCI names) and in descending order of their concentration in the final product.
