Skin Creams May Have Potent Ingredients Not Found on the Label

Some over-the-counter (OTC) skin creams have undeclared pharmacologically active ingredients (UPAIs) that could be harmful to consumers, an observational study found.

Out of 18 preselected products, UPAIs were identified in six (33.3%); when researchers purchased and analyzed two additional units of these six products, UPAIs were found in all three analyzed units, according to Zaur Abilov, MD, of Beth Israel Deaconess Medical Center and Harvard Medical School in Boston, and colleagues.

The superpotent prescription-only corticosteroid clobetasol propionate was detected in six products at concentrations ranging from about 0.01% to 0.46%, with the highest concentrations exceeding those in FDA-approved topical formulations (0.05%) by 9.2-fold, they reported in a research letter published in JAMA Network Open.

Two of these products also contained the antifungals miconazole or terbinafine, and none of these active ingredients were disclosed on the product labels, the researchers noted.

The study results suggest that “regulatory and surveillance approaches remain insufficient,” the authors wrote. “Products that tested positive had substantial consumer reach, with more than 10,000 combined user reviews across online platforms, and several were ranked among the top-selling items in their respective categories at the time of analysis.”

The presence of clobetasol was particularly worrisome, they said, because chronic exposure to that drug “may cause skin atrophy, steroid acne, dyspigmentation, hypothalamic-pituitary-adrenal axis suppression, and other adverse outcomes.” In particular, periocular exposure has been associated with glaucoma.

“Patients and the medical community should be aware of the potential risks associated with UPAI exposure from the use of OTC products for chronic skin conditions,” they wrote.

Pieter Cohen, MD, of Harvard Medical School and Cambridge Health Alliance in Somerville, Massachusetts, who was not involved in the study, called the findings significant.

“Consumers might turn to these products instead of seeing their doctors, which could cause serious damage to their skin,” Cohen said in an email to MedPage Today. “The superpotent steroids hidden in these creams can easily damage sensitive skin on the face and other parts of the body.”

“While these steroids might initially clear up a rash, they may do so while causing permanent harm,” he added. “It is essential that consumers exercise caution when purchasing any rash cream that does not list its individual ingredients and their specific quantities. Creams with long ingredient lists or advertising claims suggesting quick resolution of rashes should be avoided.”

Cohen added that the FDA “should take immediate action to remove these products from the market.”

About 85 million people in the U.S. suffer from skin conditions, the investigators wrote, noting that many OTC skin products marketed online claim to ease conditions like psoriasis, eczema, and hyperpigmentation. The inclusion of UPAIs “may explain apparent efficacy but may also pose substantial risks when used without medical supervision,” they wrote.

Drugs that go through the FDA approval process are subject to premarket review, but nonprescription products do not undergo similar testing. Because the FDA’s health fraud database only covers a small fraction of contaminated products, those that have UPAIs “may remain available to consumers until they are identified through targeted surveillance or adverse-event reporting.”

“To our knowledge, no widely adopted standardized approach exists to systematically identify UPAIs in OTC skin products,” they wrote.

To examine the issue further, the investigators performed a targeted assessment for the presence of UPAIs in 18 OTC skin products marketed online. They picked the products using the following criteria: efficacy claims for inflammatory or persistent skin conditions, including dermatitis, psoriasis, eczema, or hyperpigmentation; absence of listed clinically proven ingredients for these conditions; and consumer engagement, defined as 100 or more reviews on at least one platform.

Analytical screening for 28 corticosteroids and antifungals was performed using high-resolution liquid chromatography-mass spectrometry with tandem mass spectrometry confirmation. Products were purchased from February through December 2025 and analyzed from April 2025 through April 2026. When a UPAI was detected, two additional units of the same product were purchased and analyzed, which resulted in three samples evaluated per product.

Limitations of the study included the small sample size, possible failure to detect alternative chemical forms of UPAIs, and lack of data on actual population exposure.

“Because we selected products that are more likely to contain UPAIs, our results (33.3%) represent a yield of a targeted assessment rather than true U.S. market prevalence,” the authors concluded. “Nevertheless, our results show that this approach can be highly effective in UPAI detection and may aid regulatory evaluation and surveillance.”