Mineral sunscreen recalled due to manufacturing control deviations
Sugared+Bronzed Tinted Mineral Sunscreen SPF 50 is being voluntarily recalled due to manufacturing control deviations. The recall affects 2,090 tubes distributed to California, Colorado, Florida, Puerto Rico, and Washington.
What this means for you
Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.
Our severity reasoning: FDA Class II recall with no reported illnesses or injuries. CGMP deviations on a drug product constitute a risk-of-harm situation meeting the High severity criterion for risk-of-harm products where injury has not yet been reported.
Plain-English summary
Sugared+Bronzed Tinted Mineral Sunscreen SPF 50, a mineral sunscreen containing 21% zinc oxide, is being voluntarily recalled due to Current Good Manufacturing Practice (CGMP) deviations. The product is distributed by Sugared+Bronzed, located at 929 Montana Ave, Santa Monica, California.
The recall affects 2,090 tubes of product lot D53797 with expiration date 04/30/27. The affected product was distributed to California, Colorado, Florida, Puerto Rico, and Washington. The manufacturer voluntarily initiated the recall, which was reported to the FDA on December 3, 2025.
The FDA classified this as a Class II recall. No health incidents have been reported in connection with this product.
The recalled product
- Product
- Sugared+Bronzed Tinted Mineral Sunscreen SPF 50, Zinc Oxide 21%, Net WT 3.3 OZ (93 G) per tube, Dist. By: Sugared+Bronzed, 929 Montana Ave, Santa Monica, CA 90403. NDC: 35192-055-18, UPC 8 50047 92223 6
- Manufacturer
- CA BOTANA International, Inc.
- Category
- Drug — Topical Sunscreen
- Hazard
- cgmp-deviation
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (2)
- Lot D53797
- exp 04/30/27
Distribution
Distributed in 5 states:
- CA
- CO
- FL
- PR
- WA
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