CLASS II Drug recall · Reported 22 Apr 2020 · FDA Enforcement Report
Dermatone (avobenzone, homosalate, octisalate recalled by Filltech USA
Filltech USA is recalling Dermatone (avobenzone, homosalate, octisalate, and octocrylene) Sunscreen Lotion, distributed nationwide in the US. The recall was initiated on 19 Mar 2020 and the FDA has classified it as Class II.
Check your package
Check the lot number on your package against the affected lots. If it matches, contact the pharmacy that dispensed it or your prescriber before stopping any medication.
Recall details
- Recall number
- D-1242-2020
- FDA event ID
- 85274
- Recalling firm
- Filltech USA, Rockwell, NC
- Classification
- Class II
- Status
- Terminated
- Recall initiated
- 19 Mar 2020
- FDA classified
- 16 Apr 2020
- Reported
- 22 Apr 2020
- Type
- Voluntary: Firm initiated
- Customers notified by
- Letter
- Reason category
- Mold
- Drug class
- Creams, Ointments & Gels
Timeline
| 19 Mar 2020 | Recall initiated by company | |
| 16 Apr 2020 | Classified by FDA | +28 days |
| 22 Apr 2020 | Published in enforcement report | +6 days |
Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.
Reason for recall
Microbial contamination of non-sterile products: positive test for yeast and bacteria.
Product as listed by the FDA
Dermatone (avobenzone, homosalate, octisalate, and octocrylene) Sunscreen Lotion Fragrance Free, SPF 50, packaged in a) 1.5 fl. oz. (44 mL) tottles, UPC: 087052727338; b) 2 Fl. OZ. (59 mL) tubes, UPC: 08705272732; c) 4 FL. OZ. (118 mL) tubes, UPC: 087052727345, Distributed By: Beaumont Products, Inc. Kennesaw, GA 30144
Where it was distributed
USA Nationwide
Questions about this recall
Is Dermatone (avobenzone, homosalate, octisalate, and octocrylene) Sunscreen Lotion recalled?
Yes. Filltech USA recalled Dermatone (avobenzone, homosalate, octisalate, and octocrylene) Sunscreen Lotion on 19 Mar 2020. The recall is Class II and its status is Terminated. Recall number D-1242-2020.
Why was it recalled?
Microbial contamination of non-sterile products: positive test for yeast and bacteria.
Which lots are affected?
Lot #: a) 05J19, Exp 07/21; b) 05J19, Exp 07/21, 43L19, Exp 09/21; c) 43L19 Exp 09/21, 44L19 Exp 09/21
Where was it sold?
USA Nationwide
What should I do if I have it?
Check the lot number on your package against the affected lots. If it matches, contact the pharmacy that dispensed it or your prescriber before stopping any medication.
What does Class II mean?
Class II means the product may cause temporary or medically reversible health problems, or the probability of serious harm is remote.
Read the official FDA notice · Source record retrieved 21 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.
More recalls from Filltech USA
All 2| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| Drug | CLASS II | Dermatone (avobenzone, homosalate, octisalate recalled by Filltech USA | Filltech USA | Mold | Nationwide |