On April 19th, 2022, the FDA issued warnings to 12 companies for selling over-the-counter (OTC) skin-lightening products containing hydroquinone.

Hydroquinone is an active ingredient in Tri-Luma, an FDA approved prescription product approved for the short-term treatment of dark spots associated with moderate-to-severe melasma of the face. However, serious side effects, including skin rash, facial swelling, and discoloration of the skin, which can be permanent, have been reported with the use of this drug, and it should only be used under physician supervision. The FDA has not approved any over-the-counter products containing hydroquinone or any other ingredient for the purpose of skin lightening.

For more details, use the links below to read the full warning letter issued to each company:

• AMBI Enterprises LLC (AMBI Skincare Fade Cream Oily Skin and AMBI Skincare Fade Cream Normal Skin)
• Clinical Formula LLC (Clinical Formula Bleaching Lotion)
• Dr. Thomas Balshi/Intilight (Intilight Intimate Lightening Treatment)
• Elements Brands Inc. (eb5 Skin Lightening Cream)
• Genomma Lab USA, Inc. (cicatricure Medical Lightening Skin Lightening Cream and teatrical Pro-Aclarant Skin Lightening Night Cream)
• M & M Beauty and Wellness, LLC (Best age spot remover lightening perfection crème)
• Neoteric Cosmetics, Incorporated/Scott’s Liquid Gold, Inc. (Alpha Skin Care Dual Action Fade Cream)
• Skin Authority, L.L.C. (skinauthority Hyperpigmentation Treatment)
• SkinPro (SkinPro Ultra Brightener Hydroquinone)
• Skin PS Brands (Dark Spot Fix)
• True Earth Health Products, LLC (Plexaderm Skincare Dark Spot Fade Gel)
• Ultimark Products (Porcelana Day Skin Lightening Cream)

The agency has advised that each company respond within 15 days of receipt of the warning, outlining any steps taken to correct violations.

Health care professionals and consumers who wish to report adverse reactions or quality problems experienced with the use of these products may do so through the FDA’s MedWatch Adverse Event Reporting.

For more information about skin lightening ingredients, see ConsumerLab’s answer to the question: Do glutathione supplements work to prevent aging or for other conditions?

Also see our article about safe and effective sunscreens.

For more information, use the link below.

FDA works to protect consumers from potentially harmful OTC skin lightening products

See related recalls and warnings:

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Herbal Skin Remedy Recalled, Can Cause Serious Injury

FDA Warns Companies Selling "Sun Protection" Supplements