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Posted June 19, 2024

DBH Beverly Hills Sunscreen Falsely Promoted as Octinoxate Free, Says FDA

On June 12, 2024, the FDA issued a Warning Letter to Aqualex Co., Ltd.following inspection of the company’s website, manufacturing facility, and sunscreen products, which found its DBH Beverly Hills, EGF FGE DNA, UV Shield sunscreen to be misbranded.

(See ConsumerLab’s about safe sunscreens for more information about related products, including less problematic sunscreens.)

According to the warning, the company’s promotion of its DBH Beverly Hills, EGF FGF DNA, UV Shield sunscreen on its website was misleading because it’s marketed as “OCTINOXATE FREE,” but the product label’s Drug Facts panel lists ethylhexyl cinnamon, otherwise called octinoxate. The agency also advised the company to consult the FDA’s guidance documents to ensure proper testing of products that contain glycerin, which has the potential to be contaminated with diethylene glycol (DEG), or ethylene glycol (EG), which can cause poisoning.

Inspection of the company’s manufacturing facility also found the company’s products to be adulterated because they were prepared, packed, or held under conditions that do not meet Current Good Manufacturing Practices (CGMP). Violations noted by the FDA include failure to establish written procedures for production and process control, failure to exercise responsibility to ensure drug products are in compliance with CGMP, failure to use equipment in the manufacture, processing, packing, or holding of drug products, and more.

The company must respond to the FDA in writing within 15 days of receipt of the warning explaining the specific steps taken to address these violations.

For more information, use the link below.

Warning: Aqualex Co., Ltd.

See related recalls and warnings:

Suntegrity Tinted Sunscreen Lotion Recalled Due to Presence of Mold

Some OTC Skin Lighteners Contain Potentially Harmful Ingredient, Warns FDA

FDA Warns Companies Selling "Sun Protection" Supplements