Recalls / Class II

Class IID-0187-2026

Product

Sea Enzyme Ultra Umbrella Sunscreen SPF 30, Titanium Dioxide 4%, Octinoxate 4%, 4 oz./113.4 g per tube, Manufactured by CA BOTANA, San Diego, CA 92121. NDC: 35192-011-02

Affected lot / code info

Lot D53950, exp 5/31/2027

Why it was recalled

CGMP Deviations

Recalling firm

Firm

CA BOTANA International, Inc.

Notification channel

Letter

Type

Voluntary: Firm initiated

Address

9505 Chesapeake Dr, N/A, San Diego, California 92123-1304

Distribution

Quantity

874 tubes

Distribution pattern

CA, CO, FL, PR, WA

Timeline

Recall initiated

2025-10-10

FDA classified

2025-11-26

Posted by FDA

2025-12-03

Status

Ongoing

Source: openFDA Drug Enforcement endpoint. Recall record D-0187-2026. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.