Agency classClass IIOur severity:High FDA (Drugs)·D-1175-2023·Announced 2023-09-27

Humanrace Suncare SPF 30 Sunscreen Recalled for Subpotent Protection

HUMANRACE is recalling Humanrace Suncare Ozone Face Protection Daily Moisturizer SPF 30 because the product does not contain the declared SPF level. Affected consumers should discontinue use immediately.

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: This is a risk-of-harm product where consumers may receive inadequate UV protection while believing they have SPF 30 protection. Although classified as FDA Class II, the source reports no illnesses, injuries, or hospitalizations, so the score does not exceed 3 per the rubric.

Plain-English summary

HUMANRACE is recalling Humanrace Suncare Ozone Face Protection Daily Moisturizer, Broad Spectrum Sunscreen SPF 30 (53mL/1.8 fl oz. bottles, NDC 82779-01) because the product does not contain the sun protection factor (SPF) level declared on the label. This is a subpotent drug recall.

The recalled product was distributed nationwide in the United States, Spain, Italy, United Kingdom, and France. Affected lot numbers are 1732A, 1732B, 1742A, 1742B, 1742C, and 1742D, with expiration date 06/2024. Approximately 5046 units are affected.

Consumers who have purchased this product should discontinue use immediately. The product does not provide the sun protection factor claimed on the label, which may result in inadequate protection from ultraviolet (UV) radiation. Consumers with questions should contact HUMANRACE at 2022 Beverly Hills, CA 90210, USA, or the FDA.

The recalled product

Product: Humanrace Suncare, Ozone Face Protection Daily Moisturizer, Broad Spectrum Sunscreen SPF 30, packaged as a 53mL (1.8 fl oz.) bottle, 100% mineral, Active Ingredient: Zinc oxide 15%, Snow Mushroom, Dist. By: @Humanrace 2022 Beverly Hills, CA 90210, USA, NDC 82779-01
Manufacturer: HUMANRACE
Category: Drug — Topical Sunscreen
Hazard: mis-labeling
subpotent-spf
Affected units: 5,046

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 (7)

Lot #: 1732A
1732B
1742A
1742B
1742C
1742D
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
Sunscreen Recall: Humanrace Ozone Body Protection Cream Lacks Declared SPF
FDA (Drugs) · 2023-09-27

Same hazard · mis labeling