CBI Laboratories Recalls Subpotent Options Rx Sunscreen Tubes
CBI Laboratories is recalling 2,055 tubes of Options Rx Anti-Oxidant Oil-Free Sunscreen because the product failed to meet specifications for active ingredient percentages.
The agency’s classification
FDA (Drugs): Class III
Class III is a situation in which use of or exposure to a violative product is not likely to cause adverse health consequences.
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 1/5 (Low).
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 is defined as unlikely to cause adverse health consequences. The hazard is a subpotent drug, which is a documentation/specification issue rather than a direct safety threat like contamination or injury.
Plain-English summary
CBI Laboratories, Inc. is recalling 2,055 tubes of Options Rx Anti-Oxidant Oil-Free Sunscreeen (Octinoxate 7.5%, Octisalate 5%, Oxybenzone 6%), 4.5 oz./128 g tube. The product was manufactured for Credentials Skincare in Fort Worth, Texas.
The recall was initiated because the product is subpotent, meaning it is out of specification for the percentage of active pharmaceutical ingredients. The affected lots include 129114 (Exp. 06/2019), 131927 and 133239 (Exp. 03/2020), and 126292 (Exp. 01/2019).
The product was distributed in the United States, Maldives, Canada, United Arab Emirates, and New Zealand. Consumers should stop using the product and return it to the point of purchase or contact the recalling firm for instructions.
The recalled product
- Product
- Options Rx Anti-Oxidant Oil-Free Sunscreeen (Octinoxate 7.5%, Octisalate 5%, Oxybenzone 6%), 4.5 oz./128 g tube, Mfg. For Credentials Skincare Fort Worth, TX 76155
- Manufacturer
- CBI Laboratories, Inc.
- Category
- Drug — Sunscreen
- Hazard
- Affected units
- 2,055
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 (5)
- Lot #: 129114 Exp. 06/2019
- 131927
- 133239 Exp. 03/2020
- 126292
- Exp.01/2019.
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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