The Recall Desk
LowFDA (Drugs)·D-0341-2019·Announced 2018-12-26

CBI Laboratories Recalls Advanced Protection Sunscreen SPF 30 for Low Active Ingredients

CBI Laboratories is recalling 5,363 tubes of Advanced Protection Sunscreen SPF 30 because the product contains less active ingredient than required.

What this means for you

Cosmetic or documentation issue. No expected health impact, but the manufacturer is correcting the affected products.

Our severity reasoning: The FDA classified this as a Class III recall, which indicates the product is unlikely to cause adverse health consequences. The defect is a subpotent formulation rather than a dangerous contamination.

Plain-English summary

CBI Laboratories, Inc. is recalling 5,363 tubes of Advanced Protection Sunscreen SPF 30 (4.5 oz/127.5 g). The product contains Octinoxate 7.5%, Octisalate 5%, and Oxybenzone 6%. The recall was initiated because the sunscreen is subpotent, meaning it is out of specification for the percentage of active pharmaceutical ingredients.

The affected product was distributed in the United States, Maldives, Canada, United Arab Emirates, and New Zealand. The recall covers multiple lots with expiration dates ranging from December 2018 to August 2020. Specific lot numbers include 131965, 127426, 129045, 130424, 131870, 132648, 133732, 134400, and 135345.

Consumers should check their inventory for the specific lot numbers and expiration dates listed above. If they possess the recalled product, they should stop using it and contact the manufacturer for instructions on return or disposal.

The recalled product

Product
Advanced Protection Sunscreen spf 30 (Octinoxate 7.5%, Octisalate 5%, Oxybenzone 6%), 4.5 Oz/127.5 g tube.
Manufacturer
CBI Laboratories, Inc.
Category
Drug — Sunscreen
Hazard
Affected units
5,363

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 (12)

  • Lot #: 131965
  • Exp 12/2018
  • 127426 Exp. 01/2019
  • 129045
  • 130424 Exp. 06/2019
  • 130432 Exp. 10/2019
  • 131870 Exp. 06/2019
  • 132648
  • Exp. 03/2020
  • 133732 Exp. 04/2020
  • 134400 Exp. 02/2020
  • 135345 Exp. 08/2020

Distribution

Distribution scope not specified by the agency.

Part of a larger recall action

This product is one of 2 recalled by CBI 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 2 products in this recall →

Related recalls

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Same hazard · subpotent drug

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