Anti-Acne Ingredients and FDA Declaration

Based on the feedback from the FDA and the information available, Salicylic Acid is a key ingredient that is officially recognized by the FDA for anti-acne claims. It is effective for treating clogged pores due to its ability to exfoliate within the pore lining. The FDA permits Salicylic Acid in cosmetics up to a concentration of 2% for leave-on products.

Your original formula included other ingredients known for their benefits for acne-prone skin, such as Azelaic Acid (Liquid Azelaic™), Niacinamide (Safe-B3™), and AcneBee™ Extra. While these ingredients offer benefits like reducing oiliness, inflammation, and improving skin condition, the FDA may require specific documentation to support anti-acne claims for products containing only these ingredients. Adding Salicylic Acid provides a recognized active ingredient for your anti-acne claim.

Declaring Salicylic Acid EZ™ to the FDA

You are considering using Salicylic Acid EZ™ at 5% in your formula. It's important to understand that Salicylic Acid EZ™ is a blend of several components. According to the product information, Salicylic Acid EZ™ is composed of:

• Coco-Dimethylamine (40%)
• Propylene Glycol (40%)
• Salicylic Acid (20%)

When you use 5% of Salicylic Acid EZ™ in your final product, the actual concentration of each component will be:

• Coco-Dimethylamine: 5% * 40% = 2%
• Propylene Glycol: 5% * 40% = 2%
• Salicylic Acid: 5% * 20% = 1%

For your FDA submission, you should declare the individual components of Salicylic Acid EZ™ and their percentages in the final formula, not just "Salicylic Acid EZ™ 5%". Therefore, you would list:

• Salicylic Acid 1%
• Coco-Dimethylamine 2%
• Propylene Glycol 2%

Using 5% Salicylic Acid EZ™ results in 1% Salicylic Acid in your final product, which is well within the FDA's allowed limit of 2% for Salicylic Acid in cosmetics.

It is strongly recommended to obtain the official documentation for Salicylic Acid EZ™ from customer service. This documentation will provide the correct INCI names and composition breakdown needed for your FDA submission.

In summary, incorporating Salicylic Acid (such as via Salicylic Acid EZ™) is a direct way to include an FDA-recognized anti-acne ingredient for clogged pores. Remember to declare the individual components of Salicylic Acid EZ™ with their calculated percentages in your final formula when submitting to the FDA.