CLASS II Drug recall · Reported 2 Sep 2020 · FDA Enforcement Report
Rocky Mountain Sunscreen SPF30 Kiwi Flavored Lip Balm recalled
Yusef Manufacturing Laboratories is recalling Rocky Mountain Sunscreen SPF30 Kiwi Flavored Lip Balm (Oxybenzone 5%, Meradimate 5%, distributed in Colorado. The recall was initiated on 3 Jun 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-1540-2020
- FDA event ID
- 85814
- Recalling firm
- Yusef Manufacturing Laboratories, Clearfield, UT
- Classification
- Class II
- Status
- Terminated
- Recall initiated
- 3 Jun 2020
- FDA classified
- 24 Aug 2020
- Reported
- 2 Sep 2020
- Type
- Voluntary: Firm initiated
- Customers notified by
- Reason category
- Potency & Assay
- Drug class
- Sunscreen & Personal Care
Timeline
| 3 Jun 2020 | Recall initiated by company | |
| 24 Aug 2020 | Classified by FDA | +82 days |
| 2 Sep 2020 | Published in enforcement report | +9 days |
Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.
Reason for recall
Superpotent Drug: Active Ingredient Octisalate found at 15% above label claim.
Potency and specification recalls happen when a batch tests outside its approved limits for strength, purity or dissolution, which can mean the dose delivered is higher or lower than labelled.
Product as listed by the FDA
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
Where it was distributed
Shipped to one distributer located in Colorado
Questions about this recall
Is Rocky Mountain Sunscreen SPF30 Kiwi Flavored Lip Balm (Oxybenzone 5%, Meradimate 5% recalled?
Yes. Yusef Manufacturing Laboratories recalled Rocky Mountain Sunscreen SPF30 Kiwi Flavored Lip Balm (Oxybenzone 5%, Meradimate 5% on 3 Jun 2020. The recall is Class II and its status is Terminated. Recall number D-1540-2020.
Why was it recalled?
Superpotent Drug: Active Ingredient Octisalate found at 15% above label claim.
Which lots are affected?
Part ID 9PRKY01, Batch #13852
Where was it sold?
Shipped to one distributer located in Colorado
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 Yusef Manufacturing Laboratories
All 3| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| Drug | CLASS II | Tropical Lip Moisturizer, SPF 30, UVA/UVB Lip Protection recalled | Yusef Manufacturing Laboratories | Potency & Assay | Nationwide |
| Drug | CLASS II | Peppermint Lip Moisturizer (oxybenzone (4%) and Octinoxate recalled | Yusef Manufacturing Laboratories | Potency & Assay | Nationwide |