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Recall data is sourced from official U.S. government agencies (CPSC, FDA, NHTSA, USDA) and processed using AI to improve readability. This site is not affiliated with or endorsed by any government agency. Always refer to the original agency notice for authoritative information.

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Medium RiskFDA Drug
Medications & Supplements/Topical Products

Babyganics SPF 50 Mineral Sunscreen Recalled for Ingredient Separation

Agency Publication Date: March 25, 2025
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Summary

Johnson, S C and Son, Inc has recalled 57,184 bottles of Babyganics Sheer Blend SPF 50 Mineral Sunscreen Fragrance Free (zinc oxide 20%) because the product ingredients may physically separate. This recall affects both the 1.7 FL OZ and 8 FL OZ bottle sizes distributed nationwide. If you are using this product, you should contact your healthcare provider or pharmacist regarding any skin concerns.

Risk

When ingredients in sunscreen separate, the active sun-protection component (zinc oxide) may not be distributed evenly, which can lead to inadequate skin protection and an increased risk of sunburn. No incidents or injuries have been reported to date.

What You Should Do

  1. This recall affects Babyganics Sheer Blend SPF 50 Mineral Sunscreen Fragrance Free (zinc oxide 20%) sold in 1.7 FL OZ (50 mL) bottles with UPC 810035921658 and 8 FL OZ (236 mL) bottles with UPC 810035921382.
  2. Check your bottle for lot number 097C4/C080316 with expiration date 03/31/2026 (for 1.7 oz bottles) or lot number 177K3/A303407 with expiration date 10/31/2025 (for 8 oz bottles).
  3. If you have health concerns, contact your healthcare provider or pharmacist. Return any unused product to the place of purchase for a refund, throw it away, or contact the manufacturer for further instructions.
  4. Call the FDA Consumer Complaint hotline at 1-888-723-3332 (1-888-SAFEFDA) for additional questions regarding this recall.

Your Remedy Options

You have 2 options:

๐Ÿ’ฐOption 1: Full Refund
How to: Contact your healthcare provider or pharmacist for guidance, or return any unused product to the place of purchase for a refund
๐Ÿ—‘๏ธOption 2: Dispose of Product
How to: Throw the product away. For prescription medications, a DEA take-back location or pharmacy mail-back program is preferred when available.

Affected Products

Product: Babyganics Sheer Blend SPF 50 Mineral Sunscreen Fragrance Free (1.7 FL OZ)by Babyganics
Variants: 1.7 FL OZ (50 mL), SPF 50, Fragrance Free, Zinc Oxide 20%
UPC Codes:
810035921658
Lot Numbers:
097C4/C080316 (Exp 03/31/2026)

Distributed by KAS Direct, LLC

Product: Babyganics Sheer Blend SPF 50 Mineral Sunscreen Fragrance Free (8 FL OZ)by Babyganics
Variants: 8 FL OZ (236 mL), SPF 50, Fragrance Free, Zinc Oxide 20%
UPC Codes:
810035921382
Lot Numbers:
177K3/A303407 (Exp 10/31/2025)

Distributed by KAS Direct, LLC

Additional Information

Agency: Food and Drug Administration (FDA)
Event ID: 96334
Status: Active
Manufacturer: Johnson, S C and Son, Inc
Sold By: Retailers nationwide
Manufactured In: Canada
Units Affected: 57,184 bottles
Distributed To: Nationwide

Were You Affected by This Recall?

If you or a family member were harmed by this recalled product, you may have legal rights. Consider consulting a consumer protection attorney to understand your options for compensation.

Find an Attorney

This is general information, not legal advice. Go Backs is not a law firm and does not provide legal services.

AI-Enhanced Content: The summary, action steps, and risk assessment on this page were generated by AI from official government recall data to improve readability. This is not legal or medical advice. Always refer to the official agency sources below for authoritative information.

Sources: FDA iRES ยท Raw API Response

openFDA Disclaimer: This recall information is sourced from the openFDA API. Do not rely on openFDA to make decisions regarding medical care. While we make every effort to ensure that data is accurate, you should assume all results are unvalidated. Refer to the openFDA terms of service for more information.