Formulating 3% Salicylic Acid Cream: Challenges and Alternatives

Question

I am attempting to create a cream formulation containing 3% Salicylic Acid (BHA). My planned approach involves dissolving the Salicylic Acid in Propylene Glycol before adding it to the cream base. Could you please advise on the potential challenges or issues I might encounter with this method, particularly concerning the solubility of Salicylic Acid, the resulting texture of the cream, and its overall stability? Are there alternative methods or ingredients that would be more suitable for formulating a stable and pleasant 3% Salicylic Acid cream?

MySkinRecipes Expert · Accepted Answer

Based on the information provided, while your proposed method for creating a Salicylic Acid cream might technically dissolve the ingredients, it has some potential drawbacks and issues as pointed out in the reply:

Solubility and Texture: Dissolving Salicylic Acid (BHA) at 3% in Propylene Glycol requires a significantly high concentration of Propylene Glycol (tens of percent), which can result in a formula with an unpleasant texture.
Regulatory Limit: A concentration of 3% Salicylic Acid exceeds the maximum limit (2%) allowed for cosmetic products by the FDA. Products with over 2% Salicylic Acid are typically classified as drugs and require different registration.
Stability and Usability: The suggested alternative method and ingredients (using water-soluble Salicylic Acid EZ™ and adjusting silicone components) are proposed to create a more stable and user-friendly formulation.

The alternative approach suggested involves using Salicylic Acid EZ™ (water-soluble type) and a different mixing technique (adding the water phase to the silicone phase gradually) for better stability and texture.

Therefore, while your steps outline a possible way to combine the ingredients, it is not the recommended method for achieving a stable, pleasant, and compliant Salicylic Acid cream, especially at a 3% concentration.