HIGH

CA Botana Recalls Ultra Umbrella Sunscreen Due to CGMP Violations

CA Botana International, Inc. recalled 874 tubes of Ultra Umbrella Sunscreen SPF 30 on October 10, 2025. The recall stems from CGMP deviations that may affect product safety. Consumers in CA, CO, FL, PR, and WA should stop using the product immediately.

Quick Facts at a Glance

Recall Date
October 10, 2025
Hazard Level
HIGH
Brands
ULTRA UMBRELLA, CA-BOTANA INTERNATIONAL
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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Product Details

The recalled product is Sea Enzyme Ultra Umbrella Sunscreen SPF 30, containing Titanium Dioxide 4% and Octinoxate 4%. Each tube contains 4 oz. (113.4 g) and has the lot number D53950, expiring on May 31, 2027.

The Hazard

The sunscreen has been recalled due to deviations from Current Good Manufacturing Practices (CGMP). These violations could lead to potential safety risks in the product.

Reported Incidents

There have been no reported incidents or injuries associated with the use of this sunscreen. However, the recall is classified as high due to the potential risks.

What to Do

Consumers should stop using the product immediately. Contact CA Botana International, Inc. or your healthcare provider for further guidance.

Contact Information

For more information, contact CA Botana International, Inc. at their website: https://www.accessdata.fda.gov/scripts/enforcement/enforce_rpt-Product-Tabs.cfm?recall_number=D-0187-2026.

Key Facts

  • 874 tubes recalled
  • CGMP deviations
  • Stop using immediately
  • Contact manufacturer for guidance

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Safety Assessment

Risk LevelHIGH
Severity Score
7/ 10
Affected Groups
GENERAL
Injury Types
OTHER

Product Classification

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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