Drug product
B Natural Organics, Organic Sunscreen, Broad Spectrum, SPF 30, 25% non-nano Zinc Oxide, a) Nude Tint Mineral Formula for Face and Body, 4 oz. (120 ML) per bottle. NDC: 73369-1002-2; b) Tint Free Mineral Formula for Face and Body, 4 oz. (120 ML) per bottle. NDC: 73369-1001-2; c) Tan Tint Mineral Formula for Face and Body, 4 oz. (120 ML) per bottle. NDC: 73369-1003-2.
D-0512-2025
Product summary
- Firm
- KABANA SKIN CARE
- Event
- Event 96853
- Status
- Ongoing
- Classification
- Class II
- Quantity
- 204 tubes
- Official record key
drug-enforcement:D-0512-2025
Official wording
Reason: cGMP deviations
Code information: Lots: a) 410-001, Exp 10/31/2027 b) 404-003, Exp 04/30/2027 c) 404-001, Exp 04/30/2027
Distribution pattern: NJ, FL, MI
Derived failure modes
-
Manufacturing or process control
cGMP deviations