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Recall Observatory FDA recall evidence

Drug 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

D-0192-2026

October 10, 2025

Class II

Product summary

Firm
CA BOTANA International, Inc.
Event
Event 97820
Status
Ongoing
Classification
Class II
Quantity
2090 tubes
Official record key
drug-enforcement:D-0192-2026

Official wording

Reason: CGMP Deviations

Code information: Lot D53797, exp 04/30/27

Distribution pattern: CA, CO, FL, PR, WA

Derived failure modes

  • Manufacturing or process control

    reason.manufacturing_process_control · v1.0.0

    CGMP Deviations