Preservative-Free Claim for a Formula with Specific Ingredients

Question

Can a formula with the following ingredients be claimed as "preservative-free" for FDA registration?

DMAE 3%
Acetyl Tyrosine 2%
FruitPeel 3%
Laurocapram 2%
Ethoxydiglycol 2%
Xanthan Gum 0.5%
Mild Preserved Eco 1%
Water

I understand some liquid actives might contain preservatives like Phenoxyethanol. My concern is whether I can make the "preservative-free" claim during FDA registration with this specific formula.

MySkinRecipes Expert · Accepted Answer

Based on the ingredients in your formula and the information available, your formula cannot be claimed as "preservative-free".

Here's why:

Mild Preserved Eco: The description for Mild Preserved Eco states that it is not classified as a preservative according to FDA regulations and allows for a "preservative-free" claim for a formula using it. Its INCI names are Ethylhexylglycerin and 1,3 Propanediol, which are often used for their multi-functional properties, including boosting preservation.
FruitPeel: The description for FruitPeel explicitly lists its INCI names as Water (and) Glycerin (and) Olive Bark Extract Spondias Mombim (and) Mango Bark Extract Mangifera Indica (and) Banana Peel Extract Musa Sapientum Preserved by Benzyl Alcohol, Potassium Sorbate. Benzyl Alcohol and Potassium Sorbate are preservatives.

Since the FruitPeel ingredient itself contains preservatives (Benzyl Alcohol and Potassium Sorbate), the final formula will contain these preservatives, even if other ingredients like Mild Preserved Eco are not classified as preservatives or allow a "preservative-free" claim.

Therefore, you cannot claim that your formula is preservative-free when registering with the FDA because it contains preservatives from the FruitPeel ingredient.