HIGH

Elixir by Coco March Mineral Sunscreen SPF 50 Recalled for CGMP Deviations, HIGH Hazard (2025)

Elixir by Coco March Mineral Sunscreen SPF 50 was recalled on 2025-10-10 and remains active. Manufactured or distributed by CA Botana International and distributed in several states. The FDA recall cites CGMP deviations as the hazard. Consumers and healthcare providers should stop using the product immediately and consult a healthcare provider for guidance.

Quick Facts at a Glance

Recall Date
October 10, 2025
Hazard Level
HIGH
Brands
Elixir, CA Botana International, VitaTienda Co USA
Category
Health & Personal Care
Sold At
Unknown
Geographic Scope
5 states
At-Risk Groups
GENERAL, PREGNANT

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

Mineral-based sunscreen marketed as SPF 50 with 21% zinc oxide. Intended for skin protection in sun exposure. Sold through VitaTienda distribution in multiple states.

Why This Is Dangerous

CGMP deviations indicate manufacturing quality-control issues that could affect product safety and efficacy.

Industry Context

This recall is not part of a broader industry pattern.

Real-World Impact

Consumers face potential safety concerns due to manufacturing deviations; immediate cessation is advised to avoid uncertain quality.

Practical Guidance

How to identify if yours is affected

  1. Check NDC 35192-048-17 and UPC 8 10145 82007 0 on the label.
  2. Look for Lot D53682 and EXP 3/31/2027 on the bottle.
  3. Verify distributor VitaTienda Co USA and CA Botana International contact info.

Where to find product info

FDA recall page linked in the notice and the recall letter from CA Botana International.

What timeline to expect

Refunds or replacements typically processed within 4-8 weeks after claim submission.

If the manufacturer is unresponsive

  • Escalate to FDA recall office
  • File a consumer complaint with CPSC if necessary
  • Consult healthcare provider for guidance on safety

How to prevent similar issues

  • Purchase from reputable retailers with return policies
  • Check CGMP status and sunscreen ingredient safety
  • Watch for recall updates on FDA site

Documentation advice

Keep recall notice, photos of product, lot number, UPC, receipts, and correspondence with the manufacturer

Product Details

Product: Elixir by Coco March Mineral Sunscreen SPF 50. Size: 2.1 oz (62 g) per bottle. NDC: 35192-048-17. UPC: 8 10145 82007 0. Lot: D53682. Expiration: 3/31/2027. Quantity: 3295 bottles. Distributor: VitaTienda Co U.S.A., San Juan, PR 00646. Sold in: CA, CO, FL, PR, WA. Status: ACTIVE recall. Recall date: 2025-10-10.

Reported Incidents

No injuries or incidents have been reported in the recall notice.

Key Facts

  • 3295 bottles recalled
  • NDC 35192-048-17
  • UPC 8 10145 82007 0
  • Lot D53682
  • Exp 3/31/2027
  • States affected: 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
GENERALPREGNANT
Injury Types
ELECTRICALLACERATIONPOISONINGOTHER

Product Details

Model Numbers
Lot D53682
exp 3/31/2027
UPC Codes
35192-048
35192-048-17
Affected States
CA, CO, FL, PR, WA
Report Date
December 3, 2025
Source Agency
FDA - Drug Safety
Recall Status
ACTIVE

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