HIGH

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.

Quick Facts at a Glance

Recall Date
October 10, 2025
Hazard Level
HIGH
Brands
CA BOTANA, ULTRA UMBRELLA
Category
Health & Personal Care
Sold At
Multiple Retailers
Geographic Scope
5 states
At-Risk Groups
GENERAL

Hazard Information

CGMP Deviations

What You Should Do

Consumers and healthcare providers should stop using this product immediately. Contact CA BOTANA International, Inc. or your healthcare provider for guidance. Notification method: Letter

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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

  1. Locate NDC 35192-011-02 on packaging
  2. Check Lot D53950 and expiration 05/31/2027
  3. 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.

Key Facts

  • 874 tubes recalled
  • Lot D53950
  • Expiration date 05/31/2027
  • NDC 35192-011-02
  • Distributed to CA, CO, FL, PR, WA

Safety Guide

Not sure what to do next? Our guide walks you through the process step by step.

Read: What to Do When You Find a Recalled Product

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Safety Assessment

Risk LevelHIGH
Severity Score
8/ 10
Affected Groups
GENERAL
Injury Types
OTHER

Product Details

Model Numbers
Lot D53950
exp 5/31/2027
UPC Codes
35192-011
35192-011-02
Affected States
CA, CO, FL, PR, WA
Report Date
December 3, 2025
Source Agency
FDA - Drug Safety
Recall Status
ACTIVE

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