CA BOTANA International, Inc.

FDA Regulatory Profile

Summary

Total Recalls
14
510(k) Clearances
0
Inspections
4
Compliance Actions
0

Recent Recalls

NumberClassProductDate
D-0193-2026Class IIElixir by Coco March Mineral Sunscreen SPF 50, Zinc Oxide 21%, 2.1 oz (62g) per bottle, Distributed October 10, 2025
D-0194-2026Class IIElixir by Coco March Tinted Mineral Sunscreen SPF 50, Zinc Oxide 21%, 2.1 oz (62g) per bottle, DistrOctober 10, 2025
D-0185-2026Class IIDoctor D. Schwab Controlling Balm with Tea Tree Oil, Salicyclic Acid 0.8%, 1 FL OZ/ 30 ML per tube, October 10, 2025
D-0192-2026Class IISugared+Bronzed Tinted Mineral Sunscreen SPF 50, Zinc Oxide 21%, Net WT 3.3 OZ (93 G) per tube, DistOctober 10, 2025
D-0184-2026Class IIDoctor D. Schwab Flawless Skin Fluid Tinted Moisturizer SPF 50, Zinc Oxide 21%, 2.1 oz/61 g per tubeOctober 10, 2025
D-0190-2026Class IIGabriel Mineral Sunscreen SPF 50, Zinc Oxide 21%, 2.1 oz, Net 61 g per tube, Dist. By: Gabriel CosmeOctober 10, 2025
D-0186-2026Class IIDoctor D. Schwab Controlling Cream, Benzoyl Peroxide 2.7%, 1 FL OZ/ 30 ML per tube, Doctor D. SchwabOctober 10, 2025
D-0196-2026Class IIDr. Bump Natural Pain Relief Gel, Menthol 5%, NET WT 4 FL OZ/118 ML per bottle, Distr. by 1Beauty USOctober 10, 2025
D-0188-2026Class IIDoctor D. Schwab Clinical Weh Weh Natural Pain Relief Gel with Menthol and Arnica, Menthol 5%, 4.2 oOctober 10, 2025
D-0187-2026Class IISea Enzyme Ultra Umbrella Sunscreen SPF 30, Titanium Dioxide 4%, Octinoxate 4%, 4 oz./113.4 g per tOctober 10, 2025
D-0183-2026Class IIDoctor. D. Schwab Mineral Sunscreen SPF 50, Zinc Oxide 21%, 4 oz./ 113.4 g per tube, Manufactured byOctober 10, 2025
D-0189-2026Class IIDoctor D. Schwab Shimmery Sun Lotion Sunscreen SPF 30, Titanium Dioxide 5% and Octinoxate 4%, 4 oz./October 10, 2025
D-0195-2026Class IICLEARSTEM YOU ARE SUNSHINE SPF 50, Zinc Oxide 21%, 2.1 oz/61g per bottle, Distributed by: CLEARSTEM October 10, 2025
D-0191-2026Class IIKarina Daily Moisturizer SPF 25, Octinoxate 7.5% and Zinc Oxide 7.0%, Net WT. 5 oz/ 141.7 g per tubeOctober 10, 2025