Vitamin C Serum Formulation Inquiry

Regarding the Vitamin C serum formulation you provided:

1. Can these ingredients be mixed?
   Yes, the ingredients listed (Purified Water, Disodium EDTA, Phenoxyethanol, Ascorbyl Tetraisopalmitate, Vitamin E (Tocopheryl Acetate), and Light Cream Maker™ which contains Sodium Polyacrylate and Polyisobutene) are commonly used together in cosmetic formulations. Ascorbyl Tetraisopalmitate and Vitamin E are oil-soluble, while Purified Water, Disodium EDTA, and Phenoxyethanol are water-soluble. Light Cream Maker™ acts as an emulsifier and thickener that can combine these oil and water phases without needing heat, creating a serum or light cream texture. The formulation should be done carefully, ensuring proper mixing techniques and achieving the recommended pH range of 5.0-5.5 for Ascorbyl Tetraisopalmitate stability. The presence of Disodium EDTA is also beneficial, as recommended for formulas containing water and Ascorbyl Tetraisopalmitate.

2. Can this formula be registered with the FDA (อย.)?
   Whether a cosmetic formulation can be registered with the Thai FDA (อย.) depends on several factors beyond just the ingredient list. While the ingredients themselves are generally permitted in cosmetics, successful registration requires:

   • Compliance with Regulations: Ensuring all ingredients and their concentrations adhere to the limits and requirements set by the Thai FDA and ASEAN Cosmetic Directive.
   • Safety and Stability: Demonstrating the safety of the final product for its intended use and proving its stability over time through testing.
   • Manufacturing Standards: Production must occur in a facility that follows Good Manufacturing Practice (GMP).
   • Accurate Information: Labeling and any claims made about the product's efficacy must be truthful and comply with regulations.

   Based solely on the ingredient list and percentages, it is not possible to definitively confirm eligibility for FDA registration. You would need to verify compliance with all regulatory aspects and potentially conduct necessary tests. Consulting with a regulatory expert or the Thai FDA directly is recommended for accurate guidance on product registration.