FDA Drug recall D-0100-2018
Vertra Elemental Resistance (Octyl Methoxycinnamate 6%, Oxybenzone 5%, Titanium Dioxide 6.3%, Zinc Oxide 9.9%) Sun Protection Cream, SPF 50…
- FDA Drug
- Class II
- terminated
- Published 2017-12-06
On 2017-12-06 the FDA classified a Class II recall of Vertra Elemental Resistance (Octyl Methoxycinnamate 6%, Oxybenzone 5%, Titanium Dioxide 6.3%, Zinc Oxide 9.9%) Sun Protection Cream, SPF 50… by Eai Jr286, citing CGMP Deviations: products manufactured in a manner that may impact product quality that includes but is not limited to failed viscosity.
Read the official FDA Drug notice
| Agency | FDA Drug |
|---|---|
| Recall number | D-0100-2018 |
| Classification | Class II |
| Status | terminated |
| Initiated | 2017-11-28 |
| Published | 2017-12-06 |
| Last updated | 2026-09-13 11:51 UTC |
| Company | Eai Jr286 |
| Distribution | US |
Product
Vertra Elemental Resistance (Octyl Methoxycinnamate 6%, Oxybenzone 5%, Titanium Dioxide 6.3%, Zinc Oxide 9.9%) Sun Protection Cream, SPF 50+, Net. Wt. 2.8 oz (80 g) tube in a carton, Distributed by Vertra/EAI-JR286, 20100 S Vermont Ave, Torrance, CA 90502, Made In Australia, UPC 8 94140 00103 0.
Reason
CGMP Deviations: products manufactured in a manner that may impact product quality that includes but is not limited to failed viscosity.
Identifiers
| upc | 894140001030 |
|---|---|
| code_info | Lot #: 609124, Exp 03/18 Manufacturing batches were mfg at Delta Laboratories under Batch Number 511103 11/16/2015 Batch Number 609124 09/21/2016 |
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:51 UTC. Current status: terminated.
Source
Official record: https://api.fda.gov/drug/enforcement.json?search=recall_number:%22D-0100-2018%22
RecallRadar indexes public recall notices from the FDA, USDA FSIS, and CPSC. The official agency notice is the authoritative source. Always confirm details at the linked source before acting.