Preservative for Apple Stem Cell and Water Calculation for FDA Notification

Asked by: tanik_fu On: March 21, 2015 Product Type: Cosmetics

Question

I have questions regarding a cosmetic formulation using an ingredient with a detailed INCI name and calculating total water content for FDA notification.

1. The INCI name for the Apple Stem Cell ingredient is listed as: `INCI Name : Malus Domestica Fruit Cell Culture Extract (and) Xanthan Gum (and) Glycerin (and) Lecithin (and) Phenoxyethanol (and) Water`.
Does the term `(and)` indicate the components present within this Apple Stem Cell ingredient?
Since Phenoxyethanol is listed, do I still need to add an additional preservative to my final formulation?

2. When calculating the total water percentage for FDA notification, should I sum the water I add separately (e.g., 80%) with the water already present in the Apple Stem Cell ingredient (e.g., 2%)? For example, would the total water content be 80% + 2% = 82%?

Answer

Hi,

Thank you for your questions. Let's address them one by one.

1. Do you need to add a preservative if your formula contains Apple Stem Cell?

Yes, generally you will still need to add a preservative system to your final formulation, even though the Apple Stem Cell ingredient itself contains Phenoxyethanol. Here's why:

  • Preserving the Final Product: Cosmetic formulations, especially those containing water, are susceptible to microbial contamination (bacteria, mold, yeast) during manufacturing, storage, and consumer use. A preservative system is essential to prevent this growth, which can spoil the product and pose a health risk to the user.
  • Preserving the Ingredient: The Phenoxyethanol listed in the INCI name of the Apple Stem Cell ingredient is primarily there to preserve the ingredient itself and maintain its stability before it is incorporated into a larger formula. The concentration of Phenoxyethanol within the ingredient is typically low relative to the total volume of your final product.
  • Insufficient Concentration: The small amount of preservative coming from the ingredient is usually not sufficient to protect the entire final formulation, which contains a much larger amount of water and other nutrients that microbes can feed on.

Therefore, you should formulate your product with an appropriate preservative system designed to protect the entire finished product throughout its intended shelf life.

2. Calculating total water percentage for FDA notification:

Yes, your understanding and calculation method are correct.

  • When calculating the total water percentage for regulatory purposes (like FDA notification), you must sum the water content from all sources in your formulation.
  • This includes the water you add separately (e.g., purified water) plus any water that is present as a component within other ingredients (like the 2% water in the Apple Stem Cell ingredient).

So, in your example:
Water from Apple Stem Cell: 2%
Water added separately: 80%
Total Water Content: 2% + 80% = 82%

This is the correct way to calculate the total water percentage in your formula.

Hope this clarifies your questions!

Tags

Amount Calculation FDA Registration INCI Name Preservation Water Content