The Recall Desk
Agency classClass IIOur severity:ModerateFDA (Drugs)·D-0837-2021·Announced 2021-10-06

Neutrogena Ultra Sheer Sunscreen Body Mist Recalled for cGMP Deviations

Johnson & Johnson Consumer is recalling Neutrogena Ultra Sheer body mist sunscreen in 5 oz and 8 oz aerosol cans nationwide due to current good manufacturing practice (cGMP) deviations. The recall is voluntary and initiated by the firm.

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 for cGMP deviations without any reported illnesses, injuries, or deaths. The hazard is regulatory non-compliance rather than an identified safety threat, making it a voluntary precautionary recall characteristic of Moderate severity.

Plain-English summary

Johnson & Johnson Consumer, Inc. is voluntarily recalling Neutrogena Ultra Sheer body mist sunscreen (Broad Spectrum SPF 45) in two package sizes: 5 oz (141 g) cans with UPC 0 86800 10039 3 and 8.0 oz (226 g) cans with UPC 0 86800 11134 4. The product contains Avobenzone (3%), Homosalate (10%), Octisalate (5%), and Octocrylene (10%) as active ingredients.

The recall was initiated due to current good manufacturing practice (cGMP) deviations. The firm reported the issue voluntarily and initiated the recall on July 14, 2021, with the FDA classifying it as a Class II recall on September 24, 2021.

Approximately 1,282,488 cans of the 5 oz size and 475,476 cans of the 8 oz size are affected. These products were distributed nationwide in the United States and all affected lots are within their expiration dates.

Consumers who have purchased this product should stop using it. For additional information, contact Johnson & Johnson Consumer, Inc. at their Skillman, New Jersey location (199 Grandview Rd, Skillman, NJ 08558-1311).

The recalled product

Product
Neutrogena Ultra Sheer body mist sunscreen BROAD SPECTRUM SPF 45, Avobenzone (3%), Homosalate (10%), Octisalate (5%), Octocrylene (10%), a) Net Wt. 5 OZ (141 g) (UPC 0 86800 10039 3) and b) Net Wt. 8.0 oz. (226 g) (UPC 0 86800 11134 4) aerosol can, Distributed by: JOHNSON &…
Manufacturer
Johnson & Johnson Consumer, Inc.
Category
Drug — Sunscreen / Over-the-Counter 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 →

Related recalls

Same manufacturer · Johnson & Johnson Consumer, Inc.

See all →

Same hazard · cgmp deviation

See all →

Similar recalls