Medications & Supplements/Topical Products

CBI Laboratories, Inc.: Sunscreen Recalled for Subpotency and Incorrect Active Ingredient Levels

Agency Publication Date: December 20, 2018

Summary

Approximately 7,418 units of Advanced Protection Sunscreen SPF 30 and Options Rx Anti-Oxidant Oil-Free Sunscreen are being recalled because they are subpotent. Testing revealed that the percentage of active pharmaceutical ingredients (Octinoxate, Octisalate, and Oxybenzone) is out of specification, meaning the products may not provide the level of sun protection promised on the label. These products were sold in 4.5-ounce tubes and distributed across the United States and internationally.

Risk

Because these sunscreens contain lower levels of active ingredients than required, they may fail to protect users from ultraviolet (UV) radiation as intended. This increases the risk of sunburn and long-term skin damage from sun exposure.

What You Should Do

Identify if you have Advanced Protection Sunscreen SPF 30 (4.5 oz tube) by checking for lot numbers 131965 (Exp 12/2018), 127426 (Exp 01/2019), 129045 (Exp 06/2019), 130424 (Exp 06/2019), 130432 (Exp 10/2019), 131870 (Exp 06/2019), 132648 (Exp 03/2020), 133732 (Exp 04/2020), 134400 (Exp 02/2020), or 135345 (Exp 08/2020).
Identify if you have Options Rx Anti-Oxidant Oil-Free Sunscreen (4.5 oz tube) by checking for lot numbers 129114 (Exp 06/2019), 131927 (Exp 03/2020), 133239 (Exp 03/2020), or 126292 (Exp 01/2019).
Contact your healthcare provider or pharmacist for guidance if you have concerns about skin protection or potential sun damage while using these products.
Return any unused product to the place of purchase for a refund and contact CBI Laboratories, Inc. at 4201 Diplomacy Rd, Fort Worth, Texas, 76155-2633 for further instructions.
For additional questions, contact the FDA Consumer Complaint hotline at 1-888-723-3332 (1-888-SAFEFDA).

Your Remedy Options

Full Refund

Drug product refund and consultation

How to: Contact your healthcare provider or pharmacist for guidance. Return any unused product to the pharmacy for a refund

Affected Products

Product: Advanced Protection Sunscreen spf 30 (4.5 Oz/127.5 g)

Model:

Recall #: D-0341-2019

Lot Numbers:

131965 (Exp 12/2018)

127426 (Exp. 01/2019)

129045 (Exp. 06/2019)

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)

Date Ranges: Expiration dates between December 2018 and August 2020

Product: Options Rx Anti-Oxidant Oil-Free Sunscreeen (4.5 oz./128 g)

Model:

Recall #: D-0342-2019

Lot Numbers:

129114 (Exp. 06/2019)

131927 (Exp. 03/2020)

133239 (Exp. 03/2020)

126292 (Exp. 01/2019)

Date Ranges: Expiration dates between January 2019 and March 2020

Additional Information

Agency: Food and Drug Administration (FDA)

Event ID: 81775

Status: Resolved

Manufacturer: CBI Laboratories, Inc.

Sold By: Credentials Skincare

Manufactured In: United States

Units Affected: 2 products (5363 tubes; 2055 tubes)

Distributed To: Nationwide

AI-Enhanced Content: The summary, action steps, and risk assessment on this page were generated by AI from official government recall data to improve readability. This is not legal or medical advice. Always refer to the official agency sources below for authoritative information.

Sources: FDA iRES · Raw API Response

openFDA Disclaimer: This recall information is sourced from the openFDA API. Do not rely on openFDA to make decisions regarding medical care. While we make every effort to ensure that data is accurate, you should assume all results are unvalidated. Refer to the openFDA terms of service for more information.

Summary

What You Should Do

Identify if you have Advanced Protection Sunscreen SPF 30 (4.5 oz tube) by checking for lot numbers 131965 (Exp 12/2018), 127426 (Exp 01/2019), 129045 (Exp 06/2019), 130424 (Exp 06/2019), 130432 (Exp 10/2019), 131870 (Exp 06/2019), 132648 (Exp 03/2020), 133732 (Exp 04/2020), 134400 (Exp 02/2020), or 135345 (Exp 08/2020).

Identify if you have Options Rx Anti-Oxidant Oil-Free Sunscreen (4.5 oz tube) by checking for lot numbers 129114 (Exp 06/2019), 131927 (Exp 03/2020), 133239 (Exp 03/2020), or 126292 (Exp 01/2019).

Contact your healthcare provider or pharmacist for guidance if you have concerns about skin protection or potential sun damage while using these products.

Return any unused product to the place of purchase for a refund and contact CBI Laboratories, Inc. at 4201 Diplomacy Rd, Fort Worth, Texas, 76155-2633 for further instructions.

For additional questions, contact the FDA Consumer Complaint hotline at 1-888-723-3332 (1-888-SAFEFDA).

Affected Products

Product: Advanced Protection Sunscreen spf 30 (4.5 Oz/127.5 g)

Model:

Recall #: D-0341-2019

Lot Numbers:

131965 (Exp 12/2018)

127426 (Exp. 01/2019)

129045 (Exp. 06/2019)

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)

Date Ranges: Expiration dates between December 2018 and August 2020

Product: Options Rx Anti-Oxidant Oil-Free Sunscreeen (4.5 oz./128 g)

Model:

Recall #: D-0342-2019

Lot Numbers:

129114 (Exp. 06/2019)

131927 (Exp. 03/2020)

133239 (Exp. 03/2020)

126292 (Exp. 01/2019)

Date Ranges: Expiration dates between January 2019 and March 2020