Obtaining Ingredient Percentages for Global Guard™ and Phenonip® P4 for FDA Registration
Question
How can I obtain the exact percentage breakdown of each ingredient within the preservative products Global Guard™ and Phenonip® P4, as required for FDA (อย.) registration? Specifically, if I use a blend like Phenonip® P4 at 1% in my formula, does the FDA require the percentage of each component (e.g., Phenoxyethanol, Methylparaben, etc.) within that 1%? Where can I find this detailed information?
Answer
Hello,
I understand that the FDA (อย.) requires the percentage breakdown of each ingredient within the Global Guard™ and Phenonip® P4 preservative products for product registration purposes.
The exact percentage composition of each ingredient within these finished preservative products is technical information typically provided in documents such as the Certificate of Analysis (CoA) or product specification sheets.
My available tools cannot directly access this specific percentage information within finished products.
Therefore, the correct and standard procedure for obtaining this information for FDA registration is to contact customer support to request the Certificate of Analysis (CoA) for Global Guard™ and Phenonip® P4. This aligns with the advice provided by the staff member in the previous message.
You can contact them to request the documents via email at: care@myskinrecipes.com
Regarding your example of using Phenoxyethanol, Methylparaben, Ethylparaben, Propylparaben, and Butylparaben together at a total of 1% in your formula, the FDA requires to know the percentage of each individual component within that 1% you added (e.g., what percentage of that 1% is Phenoxyethanol, what percentage is Methylparaben, etc.). This information is specified in the CoA of that particular preservative blend. The same applies to Global Guard™ and Phenonip® P4; you need to refer to their respective CoA documents to find the proportion of each ingredient within those finished products.
I hope this information is helpful.