Rocky Mountain Sunscreen SPF30 Kiwi Flavored Lip Balm — Class II drug recall D-1540-2020
Terminated recall by Yusef Manufacturing Laboratories, LLC, reported 2020-09-02, distributed in CO. Superpotent Drug: Active Ingredient Octisalate found at 15% above label claim.
| Recall number | D-1540-2020 |
|---|---|
| Product type | Drug |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | Yusef Manufacturing Laboratories, LLC, Clearfield, UT, United States |
| Recall initiated | 2020-06-03 |
| Classified | 2020-08-24 |
| Reported by FDA | 2020-09-02 |
| Terminated | 2024-02-13 |
| Distributed | CO |
| Quantity | 2,558 units |
| Reason classes | labeling, potency |
| UPC / GTIN / UDI-DI | 00754018200043 |
| Lot numbers | 13852 |
| Model numbers | 9PRKY01 |
Product
Rocky Mountain Sunscreen SPF30 Kiwi Flavored Lip Balm (Oxybenzone 5%, Meradimate 5%, Octinoxate 7.5%, Octisalate 5%) 0.15 Oz Tube, Rocky Mtn. Sunscreen, UPC 7 54018 20004 3
Reason for recall
Superpotent Drug: Active Ingredient Octisalate found at 15% above label claim.
Machine access
This record, with every extracted code, the verbatim FDA record and provenance, is available from the recall API: GET https://api.data.aroqon.com/v1/recalls/D-1540-2020. Look up any UPC, UDI, NDC or lot with /v1/recalls/lookup?code=…. API docs · free and paid keys.
Source: U.S. Food and Drug Administration enforcement report via openFDA (CC0). Structured by Data Foundry (recall-structuring@2); last changed 2026-09-26. Not affiliated with or endorsed by FDA. Not medical or legal advice.