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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

Filltech USA, LLC: Dermatone Sunscreen Recalled for Yeast and Bacteria Contamination

Agency Publication Date: April 16, 2020
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Summary

Filltech USA, LLC has recalled 9,709 units of Dermatone Sunscreen Lotion (avobenzone, homosalate, octisalate, and octocrylene) in SPF 30 and SPF 50 varieties due to microbial contamination. Testing confirmed the presence of yeast and bacteria in these non-sterile products, which were distributed nationwide in 1.5 fl. oz. tottles and 2 fl. oz. or 4 fl. oz. tubes. While no specific injuries have been reported, using contaminated topical products can lead to skin infections or other health issues.

Risk

The product tested positive for yeast and bacteria, which can cause skin or eye infections, especially if applied to broken skin or used by individuals with weakened immune systems.

What You Should Do

  1. Check your sunscreen packaging for Dermatone Sunscreen Lotion Fragrance Free SPF 30 (1.5 fl. oz. tottles) with UPC 020908422698 and lot 22J19 (Exp 07/21).
  2. Check your sunscreen packaging for Dermatone Sunscreen Lotion Fragrance Free SPF 50 in 1.5 fl. oz. tottles (UPC 087052727338, lot 05J19, Exp 07/21), 2 fl. oz. tubes (UPC 08705272732, lots 05J19 Exp 07/21 or 43L19 Exp 09/21), or 4 fl. oz. tubes (UPC 087052727345, lots 43L19 Exp 09/21 or 44L19 Exp 09/21).
  3. Immediately stop using the affected sunscreen lotions and set them aside to ensure they are not used by others.
  4. Contact your healthcare provider or pharmacist if you have used this product and are experiencing any unusual skin irritation or signs of infection.
  5. Return any unused product to the place of purchase for a full refund and contact Filltech USA, LLC for further instructions regarding the disposal or return of the contaminated items.
  6. For additional questions, contact the FDA Consumer Complaint hotline at 1-888-723-3332 (1-888-SAFEFDA).

Your Remedy Options

💰Full Refund

Contact your healthcare provider or pharmacist for guidance. Return any unused product to the pharmacy for a refund

How to: Contact your healthcare provider or pharmacist for guidance. Return any unused product to the pharmacy for a refund

Affected Products

Product: Dermatone (avobenzone, homosalate, octisalate, and octocrylene) Sunscreen Lotion Fragrance Free, SPF 30 (1.5 fl. oz.)
UPC Codes:
020908422698
Lot Numbers:
22J19 (Exp 07/21)
Date Ranges: Expiration 07/21
Product: Dermatone (avobenzone, homosalate, octisalate, and octocrylene) Sunscreen Lotion Fragrance Free, SPF 50 (1.5 fl. oz.)
UPC Codes:
087052727338
Lot Numbers:
05J19 (Exp 07/21)
Date Ranges: Expiration 07/21
Product: Dermatone (avobenzone, homosalate, octisalate, and octocrylene) Sunscreen Lotion Fragrance Free, SPF 50 (2 fl. oz.)
UPC Codes:
08705272732
Lot Numbers:
05J19 (Exp 07/21)
43L19 (Exp 09/21)
Date Ranges: Expiration 07/21, Expiration 09/21
Product: Dermatone (avobenzone, homosalate, octisalate, and octocrylene) Sunscreen Lotion Fragrance Free, SPF 50 (4 fl. oz.)
UPC Codes:
087052727345
Lot Numbers:
43L19 (Exp 09/21)
44L19 (Exp 09/21)
Date Ranges: Expiration 09/21

Additional Information

Agency: Food and Drug Administration (FDA)
Event ID: 85274
Status: Resolved
Manufacturer: Filltech USA, LLC
Sold By: Beaumont Products, Inc.
Manufactured In: United States
Units Affected: 2 products (4919 tottles; 4790 tottles; 20,403 tubes)
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 · 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.