RECALL RECORD — CLASS IIRecall closedD-1242-2020/FDA enforcement

Dermatone (Avobenzone, Homosalate, Octisalate, and Octocrylene) Sunscreen Lotion Fragrance…

What you need to know

Class II
  • What happened

    Microbial contamination of non-sterile products: positive test for yeast and bacteria.

  • Health risk

    The product may cause temporary or medically reversible health consequences, or the probability of serious harm is remote. The product may not deliver the sun protection stated on its label, increasing the risk of sunburn and UV exposure.

  • Action required

    Stop applying or using the product. Check the UPC and lot codes below, then return it to the retailer or contact the manufacturer about a refund or replacement.

Recall closed · classified by the FDANationwide (US)More cosmetics

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Product identification

Source: FDA COSMETICS

Brand nameFilltech USA, LLC
Recalling firmFilltech USA, LLCRockwell, NC, United States
UPC / barcodes
0 87052 72733 8087052727320 87052 72734 5
Lot / date codes
  • Lot #: a) 05J19, Exp 07/21
  • b) 05J19, Exp 07/21, 43L19, Exp 09/21
  • c) 43L19 Exp 09/21, 44L19 Exp 09/21
Distribution area
Nationwide

USA Nationwide

United States

Quantity affected4790 tottles; 20, 403 tubes
Recall initiationFDA report date: April 22, 2020
FDA recall numberD-1242-2020

Beyond the headline

The recall, in context

Filltech USA, LLC initiated this cosmetics recall on March 19, 2020. The FDA enforcement report states: Microbial contamination of non-sterile products: positive test for yeast and bacteria. The FDA report lists distribution as: USA Nationwide.

The FDA enforcement report describes the reason as: Microbial contamination of non-sterile products: positive test for yeast and bacteria.

Dermatone (Avobenzone, Homosalate, Octisalate, and Octocrylene) Sunscreen Lotion Fragrance… was made or distributed by Filltech USA, LLC in Rockwell, NC, United States. This page reflects FDA report D-1242-2020, dated April 22, 2020.

Why this is a Class II recall

Class II means the product may cause temporary or medically reversible health consequences, or the probability of serious harm is remote. In this recall, the product may not deliver the sun protection stated on its label, increasing the risk of sunburn and UV exposure.

FDA definition

The product may cause temporary or medically reversible health consequences, or the probability of serious harm is remote.

What to do now

  1. 1

    Stop using it

    Set the product aside and do not apply it.

  2. 2

    Check the codes

    Compare the UPC and lot code against the table above.

  3. 3

    Return or discard

    Contact the retailer or recalling firm about a refund, and dispose of the product safely.

Consumer safety guide

Product safety recall

Symptoms to watch for

The official enforcement report describes the specific risk. Follow the recall notice, check the product codes and do not use a product that may be affected.

Higher-risk groups

Children, pregnant people, older adults and people with weakened immune systems should take extra care when a product's safety is uncertain.

What to do now

  1. 1Stop using or eating the product and keep it away from children and pets.
  2. 2Check the UPC and lot/date codes on this page and follow the official recall notice for disposal or return.
  3. 3Seek medical advice if anyone develops severe or worrying symptoms after exposure.

Read the official source record for the specific hazard and instructions.

This is general consumer safety information, not medical advice or a diagnosis. Follow the official recall notice and contact a healthcare professional if you have concerns about exposure or symptoms.

Frequently asked

Questions about this recall

What is the Dermatone (Avobenzone, Homosalate, Octisalate, and Octocrylene) Sunscreen Lotion Fragrance… recall?

Filltech USA, LLC recalled Dermatone (Avobenzone, Homosalate, Octisalate, and Octocrylene) Sunscreen Lotion Fragrance… in an FDA Class II enforcement action reported as D-1242-2020. Microbial contamination of non-sterile products: positive test for yeast and bacteria.

What should I do if I bought this product?

Stop applying or using the product. Check the UPC and lot codes below, then return it to the retailer or contact the manufacturer about a refund or replacement. Stop using or eating the product and keep it away from children and pets. Check the UPC and lot/date codes on this page and follow the official recall notice for disposal or return. Seek medical advice if anyone develops severe or worrying symptoms after exposure.

Is the Filltech USA, LLC recall still active?

The FDA lists this recall as recall closed. It remains relevant if you still have the affected product or need to identify a historical recall.

Where can I verify this recall?

This page is normalized from the openFDA enforcement record D-1242-2020. You can verify it directly using the official source link on this page. VerifyRecall updates its index from public FDA enforcement data and does not replace advice from the FDA, the recalling firm or a healthcare professional.

Verify before you act.

VerifyRecall is independent and not affiliated with the FDA. Always confirm the latest status on the official source record.

Official source

Brand history

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Record last synced from official openFDA enforcement data on November 14, 2026. Source record: official FDA notice.