HIGH

Gabriel Mineral Sunscreen Recalled Due to CGMP Deviations

Gabriel Cosmetics, Inc. recalled 1,617 tubes of Mineral Sunscreen SPF 50 on October 10, 2025, due to CGMP deviations. The affected product contains 21% zinc oxide and is distributed in California, Colorado, Florida, Puerto Rico, and Washington.

Quick Facts at a Glance

Recall Date
October 10, 2025
Hazard Level
HIGH
Brands
MINERAL SUNSCREEN, 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 Gabriel Mineral Sunscreen SPF 50, 2.1 oz per tube. It has a National Drug Code (NDC) of 35192-044-01 and a UPC of 7 07060 9592 1. The product was distributed in various states including CA, CO, FL, PR, and WA.

The Hazard

The recall was initiated due to deviations from Current Good Manufacturing Practices (CGMP). This classification indicates a potential high risk to consumer safety.

Reported Incidents

There have been no reported incidents or injuries associated with the recall as of the report date. The recall is primarily precautionary due to manufacturing deviations.

What to Do

Consumers should stop using the recalled sunscreen immediately. Contact CA BOTANA International, Inc. or consult a healthcare provider for further guidance.

Contact Information

For more information, visit the FDA recall page or contact CA BOTANA International, Inc. directly. The FDA maintains a comprehensive recall database for consumer safety.

Key Facts

  • Recall date: October 10, 2025
  • Quantity recalled: 1,617 tubes
  • Hazard classification: Class II
  • Distribution includes CA, CO, FL, PR, WA
  • Stop using the product immediately

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Safety Assessment

Risk LevelHIGH
Severity Score
5/ 10
Affected Groups
GENERAL
Injury Types
OTHER

Product Classification

Product TypeMineral Sunscreen
Sold At
Multiple Retailers

Product Details

Model Numbers
Lot D53371
exp 10/31/2026
UPC Codes
35192-044
35192-044-01
Affected States
CA, CO, FL, PR, WA
Report Date
December 3, 2025
Source Agency
FDA - Drug Safety
Recall Status
ACTIVE

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