THE toxics watchdog group EcoWaste Coalition has alerted consumers about the side effects of using an unauthorized facial cream, which has been flagged by UK authorities for containing prescription drug ingredients.
The group issued the warning after monitoring the unlawful sale of imported Carotone Clarifying Cream, which is sold online despite lacking the required market authorization from the Food and Drug Administration (FDA).
Based on the investigation conducted by the group, UK’s Office for Product Safety and Standards on February 14, 2025 flagged a similar product for posing “a serious chemical risk as it contains hydroquinone and clobetasol propionate.”
According to the Product Safety Report, “hydroquinone is a skin sensitiser and may cause allergic contact dermatitis, (while) clobetasol propionate is a glucocorticoid (corticosteroid) and exposure to it may cause skin irritation.” As per analysis, the product was found to contain 3.7 percent hydroquinone and 0.01 percent clobetasol propionate.
As a corrective action, “the import has been rejected at the border and destroyed,” the report stated.
According to the FDA, products containing hydroquinone and/or tretinoin (retinoic acid) are classified as home remedy, over-the-counter or prescription drug depending on the amount present.
As per Department of Health (DOH) Administrative Order No. 13, series of 1999: “All preparations containing more than two percent (2.0%) but less than three percent (3.0%) hydroquinone are classified as over-the-counter drugs. All preparations containing more than 3.0% Hydroquinone are considered prescription drugs. Appropriate labeling as to its proper use, and warnings as to its possible adverse effects, must be indicated.
The same order states: “All preparations containing less than or equal to two percent (2.0%) hydroquinone are to be classified as home remedies and therefore can be sold without the supervision of a pharmacist. Provided however, that labeling as to its proper use is adhered to.”
According to the FDA, “the use of adulterated cosmetic products may result in adverse reactions, including but not limited to, skin irritation, itchiness, anaphylactic shock and organ failure.”
Health Canada, which has also flagged a number of unauthorized cosmetics containing hydroquinone, said “side effects include skin reactions such as redness, dryness, cracked skin, burning, stinging, peeling, itching, increased sensitivity to sunlight, sunburn, blisters and scarring. It may cause skin discoloration (i.e., blue or black discoloration or white patches or spots) that, in some cases, can be disfiguring,” adding “in laboratory animals, it has been associated with cancer after long-term exposure.”
The EcoWaste Coalition has already notified the FDA about its latest discovery, which has been endorsed to the Field Regulatory Operations Office (FROO) for appropriate action.
