The Recall Desk
Agency classClass IIOur severity:ModerateFDA (Drugs)·D-0832-2021·Announced 2021-10-06

Neutrogena COOLDRY SPORT Sunscreen Spray Recalled for cGMP Deviations

Johnson & Johnson is recalling Neutrogena COOLDRY SPORT sunscreen spray SPF 30 in two sizes nationwide due to cGMP (current Good Manufacturing Practice) deviations. The recall affects approximately 469,764 cans.

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 2/5 (Moderate).

Minor labeling or packaging issue, or a voluntary precautionary recall. Risk of harm is low but real — follow the manufacturer's instructions.

Our severity reasoning: This is an FDA Class II recall initiated voluntarily for cGMP deviations (a manufacturing/quality control issue). The source text does not report any illnesses, injuries, or safety incidents; the hazard is manufacturing non-compliance. Per the rubric, voluntary precautionary recalls without reported harm and Class II recalls without hospitalization reports score at the Moderate level.

Plain-English summary

Johnson & Johnson Consumer, Inc. is recalling Neutrogena COOLDRY SPORT sunscreen spray SPF 30 in two sizes: 5.0 oz (141g) cans with UPC 0 86800 10035 5 and 8 oz (226g) cans with UPC 0 86800 10031 7. The product contains Avobenzone (3%), Homosalate (8%), Octisalate (5%), and Octocrylene (8%) as active ingredients.

The recall was initiated due to cGMP (current Good Manufacturing Practice) deviations identified by the manufacturer. Johnson & Johnson voluntarily initiated this recall. The FDA classified it as a Class II recall on September 24, 2021, with the recall initiation date of July 14, 2021.

The recalled product was distributed nationwide in the United States. Approximately 223,884 cans of the 5.0 oz size and 245,880 cans of the 8 oz size are affected. All affected lots are within their expiration dates.

Consumers should stop using the recalled product. Johnson & Johnson notified customers through email, fax, letter, press release, telephone, and direct visits.

The recalled product

Product
Neutrogena COOLDRY SPORT sunscreen spray SPF 30, Avobenzone (3%), Homosalate (8%), Octisalate (5%), Octocrylene (8%), a) Net Wt 5.0 oz (141g) (UPC 0 86800 10035 5) and b) Net Wt. 8 oz. (226 g) UPC 0 86800 10031 7 aerosol can, Distributed by: JOHNSON & JOHNSON CONSUMER INC.…
Manufacturer
Johnson & Johnson Consumer, Inc.
Category
Drug — Sunscreen / Topical
Hazard

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 (1)

  • All lots within expiry.

Distribution

Distributed nationwide across the United States.

Part of a larger recall action

This product is one of 20 recalled by Johnson & Johnson Consumer, Inc. 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 20 products in this recall →

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