Undisclosed Active Drug Ingredients in Nonprescription Skin Products

By
Zaur Abilov
Michael J. James
Martina L. Porter
Yury V. Popov
October 8, 2026

Jama Network Open

At a Glance

Category	Detail
Condition	Undeclared pharmacologically active ingredients in nonprescription skin products marketed for inflammatory skin conditions or hyperpigmentation
Key Mechanisms	Products contained undeclared clobetasol propionate, a superpotent prescription corticosteroid; some also contained the antifungals miconazole or terbinafine. Corticosteroid absorption is increased in facial skin.
Target Population	Consumers using online nonprescription skin products marketed for dermatitis, psoriasis, eczema, or hyperpigmentation, particularly products without listed clinically proven active ingredients
Care Setting	Online retail and consumer use; the study supports targeted product evaluation and regulatory surveillance, not a clinical treatment trial.

Key Highlights

UPAIs were detected in 6 of 18 targeted products (33.3%); all 3 tested units of each positive product contained a UPAI.
Clobetasol propionate was detected in all 6 positive products, at approximately 0.01% to 0.46%; the maximum was 9.2 times the 0.05% concentration in FDA-approved topical formulations.
Two clobetasol-containing products also contained miconazole or terbinafine, and product labels disclosed none of these active ingredients.
Positive products had more than 10,000 combined online reviews; three skin-lightening products contained a superpotent corticosteroid.
The 33.3% finding is the yield of a targeted assessment, not an estimate of prevalence across the US market.

Guideline-Based Recommendations

Diagnosis

The study screened products for 28 corticosteroids and antifungals using high-resolution liquid chromatography–mass spectrometry, with tandem mass spectrometry confirmation.
The authors note that screening focused on known or registered compounds may miss alternative chemical forms of undeclared ingredients.

Management

The authors state that patients and the medical community should recognize the potential risks of UPAI exposure through OTC products used for chronic skin conditions.
The article notes that facial topical therapy is typically restricted to low- or medium-potency corticosteroids to avoid local adverse reactions.

Monitoring & Follow-up

The authors state that targeted surveillance and adverse-event reporting can lead to detection of products containing UPAIs.
The study does not provide a patient-level monitoring protocol.

Risks

Chronic unsupervised exposure to potent corticosteroids may cause skin atrophy, steroid acne, dyspigmentation, hypothalamic-pituitary-adrenal axis suppression, and other adverse outcomes.
Periocular corticosteroid exposure has been associated with glaucoma.
The authors identify facial and periocular exposure as a particular concern for skin-lightening products containing superpotent corticosteroids.

Patient & Prescribing Data

No human participants were included. The products were selected from online retail platforms based on claims for inflammatory or persistent skin conditions or hyperpigmentation, absence of listed clinically proven ingredients, consumer engagement, or prior reports or product features associated with UPAIs.

This was a product-testing quality improvement study, not a treatment study. The article reports no patient prescribing, dosing, or treatment outcomes.

Clinical Best Practices

Recognize that product labels may not disclose pharmacologically active ingredients detected in nonprescription skin products.
Consider the potential for undeclared potent corticosteroid exposure when evaluating use of online products for chronic skin conditions.
Account for the article's stated risks of facial and periocular exposure to potent corticosteroids.
Interpret the 33.3% detection result as the yield from a small, targeted product sample, not as market-wide prevalence.