Higher Education Make Out Ready Vegan Lip Balm, SPF 15, Net Wt. 0.15 oz (4.25 g) per tube, Active Ingredients: Oxtinoxat
Summary
The FDA issued a Class III for Higher Education Make Out Ready Vegan Lip Balm, SPF 15, Net Wt. 0.15 oz (4.25 g) by Eco Lips, Inc. Reason: Mislabeling: The active ingredient list on the label does not match the product's actual ingredients Specifically, the label states Octinoxate 7.5% an.
Details
Source
Drug Recall
External ID
D-0890-2022
Action Date
2022-06-01
Status
Terminated
Category
drug
Product Description
Higher Education Make Out Ready Vegan Lip Balm, SPF 15, Net Wt. 0.15 oz (4.25 g) per tube, Active Ingredients: Oxtinoxate (7.5%), Oxybenzone (3%); Distributed by: Higher Education Skincare, 1.833.251.0388
Lot/Code Info: Lot 93400-21200
Quantity Affected: 17,000 units
Reason for Recall
Mislabeling: The active ingredient list on the label does not match the product's actual ingredients Specifically, the label states Octinoxate 7.5% and Oxybenzone 3%, while the product therein is made with Octinoxate 7.5%, Octisalate 5%, Octocrylene 5%, and Avobenzone 3%.
Distribution
CA
Type: Voluntary: Firm initiated
Recall Initiated: 2022-04-29
Company
Cedar Rapids, IA
Context & Analysis
This is a Class III recall. Class III recalls involve products unlikely to cause adverse health consequences, but that violate FDA regulations.
This was one of 101 drug recalls issued in the same week, part of 267 drug-related FDA actions this month.
Eco Lips, Inc has 3 FDA actions in our database, including 3 recalls.
Frequently Asked Questions
What is a Class III recall?
A Class III recall involves products that are unlikely to cause adverse health effects but violate FDA labeling or manufacturing regulations.
What should I do if I have this product?
Stop using the product. Check the product against the specific lot numbers or identifiers listed in the recall. Contact the manufacturer (Eco Lips, Inc) or your retailer for a refund or replacement. If you experienced adverse effects, report them to the FDA via MedWatch.
How often does Eco Lips, Inc have FDA actions?
Eco Lips, Inc has 3 FDA actions in our database, including 3 recalls and 0 device clearances.
Where can I find the official FDA record?
The official record is available on FDA.gov. Search for "D-0890-2022" on FDA.gov for the full record. You can also use the openFDA API to query this record programmatically.
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