CLASS II ONGOING Drug recall · Reported 27 Sep 2023 · FDA Enforcement Report
Suncare, Ozone Body Protection Cream recalled by Humanrace
Humanrace is recalling Suncare, Ozone Body Protection Cream, Broad Spectrum Sunscreen SPF 30, packaged as a, PA, distributed nationwide in the US. The recall was initiated on 18 Aug 2023 and the FDA has classified it as Class II.
Check your package
Check the lot number on your package against the affected lots. If it matches, contact the pharmacy that dispensed it or your prescriber before stopping any medication.
Recall details
- Recall number
- D-1176-2023
- FDA event ID
- 92954
- Recalling firm
- Humanrace, Beverly Hills, CA
- Classification
- Class II
- Status
- Ongoing
- Recall initiated
- 18 Aug 2023
- FDA classified
- 21 Sep 2023
- Reported
- 27 Sep 2023
- Type
- Voluntary: Firm initiated
- Customers notified by
- Letter
- Reason category
- Potency & Assay
- Drug class
- Creams, Ointments & Gels
Timeline
| 18 Aug 2023 | Recall initiated by company | |
| 21 Sep 2023 | Classified by FDA | +34 days |
| 27 Sep 2023 | Published in enforcement report | +6 days |
Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.
Reason for recall
Subpotent Drug: Product does not contain SPF that is declared on the label.
Potency and specification recalls happen when a batch tests outside its approved limits for strength, purity or dissolution, which can mean the dose delivered is higher or lower than labelled.
Product as listed by the FDA
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
Where it was distributed
Nationwide in the USA, Spain, Italy, UK, and France.
Questions about this recall
Why was it recalled?
Subpotent Drug: Product does not contain SPF that is declared on the label.
Which lots are affected?
Lot #: 1752A, 1752B, 1782E, 1782G, 1782C, 1752C, 1782B; Exp. 06/2024.
Where was it sold?
Nationwide in the USA, Spain, Italy, UK, and France.
What should I do if I have it?
Check the lot number on your package against the affected lots. If it matches, contact the pharmacy that dispensed it or your prescriber before stopping any medication.
What does Class II mean?
Class II means the product may cause temporary or medically reversible health problems, or the probability of serious harm is remote.
Read the official FDA notice · Source record retrieved 26 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.
Other products in this recall event
1 other product · FDA event 92954This product is part of a recall event; the main page for the event is Suncare, Ozone Face Protection Daily Moisturizer recalled by Humanrace.
| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| CLASS II | Suncare, Ozone Face Protection Daily Moisturizer recalled by Humanrace | Humanrace | Potency & Assay | Nationwide |
More recalls from Humanrace
All 2| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| Drug | CLASS II | Suncare, Ozone Face Protection Daily Moisturizer recalled by Humanrace | Humanrace | Potency & Assay | Nationwide |