Rocky Mountain Sunscreen Lip Balm Recalled for Excess Octisalate
Yusef Manufacturing is recalling Rocky Mountain Sunscreen SPF30 Kiwi Flavored Lip Balm because the active ingredient Octisalate was found at 15% above the label claim.
The agency’s classification
FDA (Drugs): Class II
Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.
This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work
What this means for you
Our assessment, not the agency’s: severity 2/5 (Moderate).
Minor labeling or packaging issue, or a voluntary precautionary recall. Risk of harm is low but real — follow the manufacturer's instructions.
Our severity reasoning: The recall is classified as FDA Class II, and the source text does not report any illnesses or injuries, fitting the criteria for a moderate severity rating involving labeling or potency discrepancies without reported harm.
Plain-English summary
Yusef Manufacturing Laboratories, LLC is recalling Rocky Mountain Sunscreen SPF30 Kiwi Flavored Lip Balm (Oxybenzone 5%, Meradimate 5%, Octinoxate 7.5%, Octisalate 5%) 0.15 Oz Tube. The recall involves 2,558 pieces identified by Part ID 9PRKY01 and Batch #13852.
The product is being recalled because the active ingredient Octisalate was found at 15% above the label claim. This discrepancy classifies the product as a superpotent drug. The FDA has classified this recall as Class II.
The product was shipped to one distributor located in Colorado. Consumers who have this product should stop using it and contact the recalling firm for further instructions.
The recalled product
- 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
- Manufacturer
- Yusef Manufacturing Laboratories, LLC
- Category
- Drug — Topical Sunscreen
- Affected units
- 2,558
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (2)
- Part ID 9PRKY01
- Batch #13852
Distribution
Distributed in 1 state:
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