Quick Facts at a Glance
- Recall Date
- October 10, 2025
- Hazard Level
- HIGH
- Brands
- Gabriel Mineral Sunscreen, CA-Botana International
- Category
- Health & Personal Care
- Sold At
- Unknown
- Geographic Scope
- 5 states
- At-Risk Groups
- GENERAL
What to Do Now
Use this page like a recall checklist: verify the product first, then act on the official remedy.
Immediate steps
- 1Stop using the product until you confirm whether it is included in the recall.
- 2Compare the product label, model number, UPC, color, size, and purchase location against the identifiers below.
- 3Follow the official remedy from FDA - Drug Safety; save photos, receipts, labels, and correspondence before contacting the company.
- 4If the product could harm a child, older adult, pet, or patient, move it out of reach immediately.
Check these identifiers
- Brand
- Gabriel Mineral Sunscreen, CA-Botana International
- Product type
- Sunscreen
- Model numbers
- Lot D53371, exp 10/31/2026
- UPC codes
- 35192-044, 35192-044-01
- Sizes
- 2.1 oz, 61 g
- Sold at
- Unknown
- Where affected
- CA, CO, FL, PR, WA
Recall Timeline
Key dates and source checks for this recall record.
Recall announced
October 10, 2025
Reported by FDA DRUG
December 3, 2025
RecallRadar source check
April 18, 2026
Consumer action
Use the official remedy and keep documentation.
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
About This Product
Gabriel Mineral Sunscreen SPF 50 is a mineral sunscreen with zinc oxide 21%. It is distributed by Gabriel Cosmetics, Inc. in Redmond, WA.
Why This Is Dangerous
The recall is due to CGMP deviations in manufacturing. There are no reported injuries or illnesses in the notice.
Industry Context
This recall is not described as part of a broader pattern in the notice.
Real-World Impact
No injuries reported. The immediate consumer risk is not defined by the notice, but stop-use guidance is issued.
Practical Guidance
How to identify if yours is affected
- Check the lot number D53371
- Check expiration date 10/31/2026
- Verify UPC 7 07060 9592 1 and NDC 35192-044-01
- Confirm distributor CA-Botana International
Where to find product info
FDA recall notice D-0190-2026, enforcement report online
What timeline to expect
Refunds or replacements typically take several weeks after the recall is acknowledged
If the manufacturer is unresponsive
- Document all communications
- Escalate to FDA or consumer protection authorities if needed
- Consider legal advice if product caused damages
How to prevent similar issues
- Buy from reputable retailers
- Verify CGMP compliance on the label
- Store away from high heat
- Keep batch numbers for recalls
Documentation advice
Keep product, packaging, and all recall notices; save emails and tracking numbers
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Product Details
Product: Gabriel Mineral Sunscreen SPF 50, Zinc Oxide 21%, 2.1 oz / 61 g per tube. Distributor: Gabriel Cosmetics, Inc., Redmond, WA 98052. NDC: 35192-044-01. UPC: 7 07060 9592 1. Lot: D53371. Exp: 10/31/2026. Quantity: 1617 tubes. Distribution: CA, CO, FL, PR, WA.
Reported Incidents
No injuries or incidents have been reported.
Key Facts
- Distributed to CA, CO, FL, PR, WA
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Safety Guide
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