Salicylic acid is a multifunctional ingredient that addresses many of the systemic causes of acne, helping to remove dead skin cells and reduce breakouts. It’s one of the most popular OTC treatments for specific cases of the skin condition, due to its accessibility and low cost. This quarter, we feature this active ingredient in a gentle, alcohol-free regimen.
What Is Salicylic Acid?
Salicylic acid is considered a beta hydroxy acid (BHA) that naturally occurs in the bark of the white willow tree, Salix Alba.
The salts and esters of salicylic acid may be used in personal care and cosmetic products at different levels depending on the desired treatment.
Salicylic acid is known as a compound that is chemically very similar – but not identical – to the active component of aspirin (acetylsalicylic acid), which is commonly used to treat pain and fever.¹
How Does Salicylic Acid Work?
The primary benefit of salicylic acid is as an exfoliant, helping to remove dead skin cells. As a chemical exfoliant, it has the ability to penetrate into the pore lining and remove debris inside the pore, as well as outside of it. It is especially effective at removing blackheads and whiteheads, but for more inflamed or deep cystic acne, other treatments such as benzoyl peroxide or prescription topical medication should be considered.
Salicylic Acid & FDA Guidance
Salicylic acid is a powerful ingredient that is closely regulated by the U.S. Department of Health and Human Services Food and Drug Administration (FDA).
The FDA provides guidance that is intended to help small business comply and understand their regulation regarding over-the-counter (OTC) topical acne drug products, and under the FDA’s monograph, permits the use of salicylic acid as a single active ingredient in concentrations of 0.5% to 2.0%.
For this active ingredient, the FDA requires specific directions to be associated with the product, which should be carefully considered when developing packaging and marketing collateral for any product that falls under this monograph.²
For additional guidance around regulatory claims and formulating OTC products with salicylic acid, please contact us.
Alcohol-Free Salicylic Acid Acne Treatments
Some forms of salicylic acid require solubility in alcohol, but research shows that alcohol-based anti-acne products can increase irritation and dryness as it can damage the skin’s barrier.
Our Innovation Team has developed a line of alcohol-free anti-acne products with salicylic acid to explore development opportunities with our customers for shoppers who want gentle, clean, and effective skincare options to address cases of acne with blackheads and whiteheads.
Clarifying Skincare Products to Treat Acne
All of these clarifying products feature 2.0% salicylic acid, which classifies them as Over-the-Counter (OTC) topical acne treatment and requires additional testing and labeling for stability and regulatory requirements.
Clarifying Foaming Cleanser
This foaming cleanser features 2.0% salicylic acid to treat acne and reduce the appearance of blemishes on the skin.
In its bottle, the cleanser is a water-thin product, and when dispensed through a foamer packaging component, it froths into a fluffy foam for quick and easy application.
To use, apply directly to damp skin with hands, avoiding contact with the eye area. Massage in to skin and rinse with warm water. Follow with additional clarifying skincare products, moisturizer and sunscreen for daytime. Product can also be used on the body.
This product contains 2.0% salicylic acid, which qualifies it as an over-the-counter (OTC) drug that requires specific testing, labeling, and regulation by the FDA.
To learn more about exploring opportunities in OTC products, please contact our Sales Team: