The Recall Desk
Agency classClass IIOur severity:ModerateFDA (Drugs)·D-0812-2018·Announced 2018-05-23

Milbar Recalls Solar Defense Sunscreen Due to GMP Deviations

Milbar Laboratories is recalling 2,156 tubes of Solar Defense Sheer Sunscreen SPF50 due to Good Manufacturing Practice (GMP) deviations.

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 is voluntary, initiated due to GMP deviations without reported illnesses or injuries, fitting the criteria for a moderate severity score.

Plain-English summary

Milbar Laboratories, Inc. is voluntarily recalling 2,156 tubes of Solar Defense Sheer Sunscreen Broad Spectrum SPF50. The product is distributed by BeautyRx LLC and contains Octinoxate 7.5% and Zinc Oxide 10.5%. The recall was initiated on May 4, 2018, and was classified as Class II by the FDA.

The reason for the recall is Good Manufacturing Practice (GMP) deviations. The affected product includes lot numbers KU455-2 (expiration date 11/09/2020) and KU455-6 (expiration date 11/26/2020). The product was distributed within the United States and Puerto Rico.

Consumers who have this product should stop using it and follow the instructions provided by the recalling firm. The recall status is currently terminated.

The recalled product

Product
Solar Defense Sheer Sunscreen Broad Spectrum SPF50 (Octinoxate 7.5%, Zinc Oxide 10.5%), 2.5 FL OZ. 74 mL, Distributed by: BeautyRx LLC, NY, NY 10128
Manufacturer
Milbar Laboratories, Inc.
Category
Drug — Sunscreen
Hazard
Affected units
2,156

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 (4)

  • Lot #: KU455-2
  • Exp. 11/09/2020
  • KU455-6
  • Exp.11/26/2020

Distribution

Distributed in 1 state:

Part of a larger recall action

This product is one of 4 recalled by Milbar Laboratories, Inc. 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.

See all 4 products in this recall →

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