FDA Drug recall D-0341-2019
Advanced Protection Sunscreen spf 30 (Octinoxate 7.5%, Octisalate 5%, Oxybenzone 6%), 4.5 Oz/127.5 g tube
- FDA Drug
- Class III
- terminated
- Published 2018-12-26
On 2018-12-26 the FDA classified a Class III recall of Advanced Protection Sunscreen spf 30 (Octinoxate 7.5%, Octisalate 5%, Oxybenzone 6%), 4.5 Oz/127.5 g tube by Cbi Laboratories, citing subpotent Drug:Out of specification for percentage of active pharmaceutical ingredients.
Read the official FDA Drug notice
| Agency | FDA Drug |
|---|---|
| Recall number | D-0341-2019 |
| Classification | Class III |
| Status | terminated |
| Initiated | 2018-12-10 |
| Published | 2018-12-26 |
| Last updated | 2026-09-13 11:52 UTC |
| Company | Cbi Laboratories |
| Distribution | n/a |
Product
Advanced Protection Sunscreen spf 30 (Octinoxate 7.5%, Octisalate 5%, Oxybenzone 6%), 4.5 Oz/127.5 g tube.
Reason
Subpotent Drug:Out of specification for percentage of active pharmaceutical ingredients.
Identifiers
| code_info | Lot #: 131965, Exp 12/2018; 127426 Exp. 01/2019; 129045, 130424 Exp. 06/2019; 130432 Exp. 10/2019; 131870 Exp. 06/2019;…Lot #: 131965, Exp 12/2018; 127426 Exp. 01/2019; 129045, 130424 Exp. 06/2019; 130432 Exp. 10/2019; 131870 Exp. 06/2019; 132648, Exp. 03/2020; 133732 Exp. 04/2020; 134400 Exp. 02/2020; 135345 Exp. 08/2020 |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:52 UTC. Current status: terminated.
Source
Official record: https://api.fda.gov/drug/enforcement.json?search=recall_number:%22D-0341-2019%22
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