Erin's Faces mineral sunscreen recalled over manufacturing practice deviations
Erin's Faces Mineral SPF 32 sunscreen is being recalled because of cGMP deviations. 54 tubes are affected.
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: FDA Class II recall for manufacturing practice deviations with no contamination, potency failure or health consequence stated in the source.
Plain-English summary
Erin's Faces, Mineral SPF 32, UVA/UVB Sunscreen, Broad Spectrum SPF 32, 25% zinc oxide, 3 fl oz (85 mL) per bottle, made in the USA for Erin's Faces of Millburn, New Jersey, NDC 73369-1401-1, is being recalled. The action covers 54 tubes.
The stated reason is cGMP deviations, meaning departures from current good manufacturing practice. The FDA classified the action as Class II. The source does not describe a resulting health consequence.
The affected lot is 410-002. Distribution was in New Jersey, Florida and Michigan.
Consumers who have the affected lot should stop using it and follow the instructions issued by the firm.
The recalled product
- Product
- Erin's Faces, Mineral SPF 32, UVA/UVB Sunscreen, Broad Spectrum SPF 32, 25% Zinc Oxide, 3 FL OZ/ 85 mL per bottle, Made in USA for Erin's Faces, Millburn, NO 07041. NDC: 73369-1401-1
- Manufacturer
- KABANA SKIN CARE
- Category
- Drug — Sunscreen
- Affected units
- 54
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 (1)
- Lot: 410-002
Distribution
Part of a larger recall action
This product is one of 4 recalled by KABANA SKIN CARE under a single FDA (Drugs) recall action. The agency files each product separately, so the size of the action is not visible from this page alone.
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