HIGHFDA DRUG

Elixir by Coco March Tinted Mineral Sunscreen SPF 50 Recalled for CGMP Deviations

A recall is active for Elixir by Coco March Tinted Mineral Sunscreen SPF 50 amid CGMP deviations. The product is distributed by CA Botana International, Inc. The recall cites CGMP deviations as the hazard and class II designation. Consumers should stop using the product and follow guidance from healthcare providers.

Official notice

Source-backed recall notice

No product image was available from the source feed.

Official source
FDA DRUG
Recall date
October 10, 2025
Status
ACTIVE
Severity
8/10

Quick Facts at a Glance

Recall Date
October 10, 2025
Hazard Level
HIGH
Brands
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

  1. 1Stop using the product until you confirm whether it is included in the recall.
  2. 2Compare the product label, model number, UPC, color, size, and purchase location against the identifiers below.
  3. 3Follow the official remedy from FDA - Drug Safety; save photos, receipts, labels, and correspondence before contacting the company.
  4. 4If the product could harm a child, older adult, pet, or patient, move it out of reach immediately.

Check these identifiers

Brand
SUNSCREEN, CA-Botana International
Product type
Sunscreen
Model numbers
Lot D53681, exp 03/31/2027
UPC codes
35192-050, 35192-050-17
Sizes
2.1 oz (62 g) per bottle
Sold at
Unknown
Where affected
CA, CO, FL, PR, WA

Recall Timeline

Key dates and source checks for this recall record.

  1. Recall announced

    October 10, 2025

  2. Reported by FDA DRUG

    December 3, 2025

  3. RecallRadar source check

    April 18, 2026

  4. 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

Tinted mineral sunscreen for SPF 50 with 21% zinc oxide. Used for sun protection with tint for cosmetic coverage.

Why This Is Dangerous

CGMP deviations indicate potential quality control issues in manufacturing. The exact safety impact is not specified in the notice.

Industry Context

This recall is not described as part of a larger industry pattern in the provided data.

Real-World Impact

Consumers may face compromised product quality or inconsistent sunscreen protection. Immediate cessation of use is advised.

Practical Guidance

How to identify if yours is affected

  1. Examine bottle for Lot D53681
  2. Check expiration date 03/31/2027
  3. Verify NDC 35192-050-17 and UPC 6 7229 99913 8

Where to find product info

NDC and UPC printed on the bottle; Lot number on bottle; expiration date on cap or label

What timeline to expect

Refunds or replacements typically 4-8 weeks after claim processing

If the manufacturer is unresponsive

  • Document all communications
  • Escalate to consumer protection agencies if needed
  • Consider credit card dispute if policy allows

How to prevent similar issues

  • Check CGMP compliance when buying cosmetics/health products
  • Verify lot numbers during recalls
  • Prefer products with clear manufacturing information and reputable distributors

Documentation advice

Keep photos of bottle, lot, expiration, purchase receipt, and all recall communications

Get instant alerts for Health & Personal Care recalls

Be the first to know. Free instant alerts to your inbox.

No spamUnsubscribe anytime

Product Details

Brand: SUNSCREEN; Actual brand variants: SUNSCREEN, CA-Botana International. Product: Elixir by Coco March Tinted Mineral Sunscreen SPF 50. Size: 2.1 oz (62 g) per bottle. NDC: 35192-050-17. UPC: 6 7229 99913 8. Lot: D53681. Expiration: 03/31/2027. Distribution: CA, CO, FL, PR, WA. Sold/distributed by: VitaTienda Co U.S.A., San Juan, PR 00646. Recall date: 2025-10-10. Status: Active.

Reported Incidents

No injuries or incidents have been reported in the provided data.

Key Facts

  • 1) SPF 50 tinted mineral sunscreen
  • 2) 2.1 oz (62 g) bottles
  • 3) Lot D53681, exp 03/31/2027
  • 5) Distributed by VitaTienda Co U.S.A., San Juan, PR 00646

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

Get Alerts for Health & Personal Care Recalls

Get instant alerts for recalls that affect you. Free forever.

Safety Assessment

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

Product Details

Model Numbers
Lot D53681
exp 03/31/2027
UPC Codes
35192-050
35192-050-17
Affected States
CA, CO, FL, PR, WA
Report Date
December 3, 2025
Source Agency
FDA - Drug Safety
Recall Status
ACTIVE

Related Recalls