Ultra Umbrella Sunscreen by CA BOTANA Recalled for CGMP Deviations in 874 Tubes (HIGH Hazard)
CA BOTANA International recalled 874 tubes of Sea Enzyme Ultra Umbrella Sunscreen SPF 30. The recall, active as of Dec 3, 2025, covers tubes with lot D53950 and expiration 05/31/2027 distributed in CA, CO, FL, PR, and WA. The agency cites CGMP deviations as the hazard. Consumers should stop using this product immediately and contact CA BOTANA for guidance or consult a healthcare provider.
About This Product
Sunscreen product used for UV protection. Consumers buy for sun safety, outdoor activities, and skin protection.
Why This Is Dangerous
CGMP deviations refer to manufacturing practice deviations and do not imply an acute hazard described in the notice.
Industry Context
This recall is not part of a broader industry pattern.
Real-World Impact
Recall affects consumers who have the product. Action required to stop use and seek guidance from the manufacturer.
Practical Guidance
How to identify if yours is affected
- Locate NDC 35192-011-02 on packaging
- Check Lot D53950 and expiration 05/31/2027
- Confirm product is Sea Enzyme Ultra Umbrella Sunscreen SPF 30
Where to find product info
FDA enforcement page recertified recall details; CA BOTANA contact information on the product label and recall notice
What timeline to expect
Refunds or replacements may take several weeks after contact
If the manufacturer is unresponsive
- Escalate to FDA recall line
- File a consumer complaint with state attorney general’s office
How to prevent similar issues
- Verify CGMP compliance before purchase
- Prefer trusted brands with CGMP audits
- Keep receipts and lot numbers for recalls
Documentation advice
Save packaging, take photos of lot and expiration, maintain correspondence with the manufacturer
Product Details
Product: Sea Enzyme Ultra Umbrella Sunscreen SPF 30. Size: 4 oz (113.4 g) per tube. NDC: 35192-011-02. Brand: Ultra Umbrella. Manufacturer: CA BOTANA International, Inc., San Diego, CA 92121. Quantity: 874 tubes. Distribution: California, Colorado, Florida, Puerto Rico, Washington. Sold as drug/health product in Health & Personal Care category.
Reported Incidents
No injuries or incidents have been reported in the recall notice.