Humanrace Suncare, Ozone Body Protection Cream, Broad Spectrum Sunscreen SPF 30, packaged as a 148mL (5 fl oz.) bottle,
Summary
The FDA issued a Class II for Humanrace Suncare, Ozone Body Protection Cream, Broad Spectrum Sunscreen SPF 30, by HUMANRACE. Reason: Subpotent Drug: Product does not contain SPF that is declared on the label..
Details
Source
Drug Recall
External ID
D-1176-2023
Action Date
2023-09-27
Status
Ongoing
Category
drug
Product Description
Humanrace Suncare, Ozone Body Protection Cream, Broad Spectrum Sunscreen SPF 30, packaged as a 148mL (5 fl oz.) bottle, PA ++++, 100% mineral, Active Ingredient: Zinc oxide 15%, Snow Mushroom, Squalene, Aloe, Dist. By: @Humanrace 2022 Beverly Hills, CA 90210, USA, NDC 82779-002
Lot/Code Info: Lot #: 1752A, 1752B, 1782E, 1782G, 1782C, 1752C, 1782B; Exp. 06/2024.
Quantity Affected: 2942 units
Reason for Recall
Subpotent Drug: Product does not contain SPF that is declared on the label.
Distribution
Nationwide in the USA, Spain, Italy, UK, and France.
Type: Voluntary: Firm initiated
Recall Initiated: 2023-08-18
Company
Beverly Hills, CA
Context & Analysis
This is a Class II recall. Class II recalls indicate that use of or exposure to the product may cause temporary or medically reversible health consequences, or that the probability of serious consequences is remote.
This was one of 47 drug recalls issued in the same week, part of 267 drug-related FDA actions this month.
HUMANRACE has 2 FDA actions in our database, including 2 recalls.
Frequently Asked Questions
What is a Class II recall?
A Class II recall means the product may cause temporary or medically reversible adverse health consequences, or the probability of serious adverse consequences is remote. Consumers should discontinue use.
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 (HUMANRACE) or your retailer for a refund or replacement. If you experienced adverse effects, report them to the FDA via MedWatch.
How often does HUMANRACE have FDA actions?
HUMANRACE has 2 FDA actions in our database, including 2 recalls and 0 device clearances.
Where can I find the official FDA record?
The official record is available on FDA.gov. Search for "D-1176-2023" on FDA.gov for the full record. You can also use the openFDA API to query this record programmatically.
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