The Recall Desk
ModerateFDA (Drugs)·D-0839-2021·Announced 2021-10-06

Neutrogena Ultra Sheer Sunscreen Recalled for cGMP Deviations

Johnson & Johnson Consumer is voluntarily recalling Neutrogena Ultra Sheer body mist sunscreen SPF 100+ nationwide due to manufacturing deviations. Approximately 3.98 million cans are affected.

What this means for you

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 voluntary recall based on manufacturing deviations rather than a known safety hazard, contamination event, or reported injuries. cGMP deviations are procedural/control issues that warrant a Class II classification but do not indicate actual harm has occurred.

Plain-English summary

Johnson & Johnson Consumer, Inc. is recalling Neutrogena Ultra Sheer body mist sunscreen BROAD SPECTRUM SPF 100+ (5.0 oz aerosol cans, UPC 0 86800 10041 6) distributed nationwide in the United States. The product contains Avobenzone (3%), Homosalate (15%), Octisalate (5%), Octocrylene (10%), and Oxybenzone (15%).

The recall was initiated due to current Good Manufacturing Practice (cGMP) deviations identified in the manufacturing process. The recall is voluntary and firm-initiated, with the company notifying distributors through email, fax, letter, press release, telephone, and direct visits.

Approximately 3,985,392 cans are subject to this recall. All affected lots remain within their expiration dates. Consumers in possession of this product should stop using it and contact the manufacturer for instructions on return or disposal.

The recalled product

Product
Neutrogena Ultra Sheer body mist sunscreen BROAD SPECTRUM SPF 100+, Avobenzone (3%), Homosalate (15%), Octisalate (5%), Octocrylene (10%), Oxybenzone (15%), NET WT. 5.0 OZ (141 g) aerosol can, Distributed by: JOHNSON & JOHNSON CONSUMER INC. Skillman, NJ 08858, UPC 0 86800 10041 6
Manufacturer
Johnson & Johnson Consumer, Inc.
Category
Drug — Sunscreen / Topical
Hazard
  • manufacturing-deviation
  • cgmp-non-compliance

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.

Related recalls

Same category