Agency classClass IIOur severity:High FDA (Drugs)·D-1176-2023·Announced 2023-09-27

Sunscreen Recall: Humanrace Ozone Body Protection Cream Lacks Declared SPF

Humanrace Suncare Ozone Body Protection Cream SPF 30 does not contain the sun protection factor declared on the label. Approximately 2,942 units have been recalled.

The agency’s classification

FDA (Drugs): Class II

Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.

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 3/5 (High).

Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.

Our severity reasoning: FDA Class II subpotency recall where the product does not contain the declared SPF sun protection factor. No illnesses or injuries have been reported, but this represents a risk-of-harm product where consumers may receive inadequate UV protection.

Plain-English summary

Humanrace is recalling Humanrace Suncare Ozone Body Protection Cream, Broad Spectrum Sunscreen SPF 30, a mineral sunscreen packaged in 148mL (5 fl oz.) bottles. The product contains Zinc oxide 15% as the active ingredient along with Snow Mushroom, Squalene, and Aloe. Approximately 2,942 units are affected by this recall.

The product has been determined to be subpotent because it does not contain the sun protection factor (SPF) that is declared on the label. The label indicates SPF 30 broad spectrum protection, but the product does not contain sufficient active ingredients to provide this level of sun protection.

The affected product was distributed nationwide in the United States, as well as in Spain, Italy, the United Kingdom, and France. The recall includes all units with lot numbers 1752A, 1752B, 1782E, 1782G, 1782C, 1752C, and 1782B with an expiration date of June 2024. The product's National Drug Code (NDC) number is 82779-002.

Consumers who have obtained this product should be aware that the sunscreen does not provide the advertised level of protection.

The recalled product

Product: 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
Manufacturer: HUMANRACE
Category: Drug — Sunscreen
Hazard: subpotency
mis-labeling
Affected units: 2,942

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 (8)

Lot #: 1752A
1752B
1782E
1782G
1782C
1752C
1782B
Exp. 06/2024.

Distribution

Distributed nationwide across the United States.

Part of a larger recall action

This product is one of 2 recalled by HUMANRACE 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 →

Same manufacturer · HUMANRACE

See all →

High
Humanrace Suncare SPF 30 Sunscreen Recalled for Subpotent Protection
FDA (Drugs) · 2023-09-27

Same hazard · subpotency