The Recall Desk
Agency classClass IIOur severity:HighFDA (Drugs)·D-0298-2025·Announced 2025-04-02

Babyganics Mineral Sunscreen Recalled for Failed Stability Specifications

Babyganics Sheer Blend SPF 50 Mineral Sunscreen is being recalled nationwide because ingredients separated during stability testing, prompting an FDA Class II recall.

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 an FDA Class II recall involving a product whose formulation failed stability specifications, with physical separation of ingredients observed. No illnesses or injuries have been reported; however, the defect in a sun-protective product represents a risk-of-harm situation where injury has not yet manifested.

Plain-English summary

Johnson, S.C. and Son, Inc., the manufacturer of Babyganics Sheer Blend SPF 50 Mineral Sunscreen Fragrance Free, has recalled 57,184 bottles distributed nationwide. The product comes in two sizes: 1.7 fl oz (50 mL) and 8 fl oz (236 mL) bottles.

The FDA classified this as a Class II recall after quality concerns were identified during routine stability monitoring. Testing revealed physical separation of ingredients, indicating the product failed stability specifications.

Consumers who have purchased this sunscreen should stop using it. Affected lot numbers include Lot #097C4/C080316 (expires 3/31/2026) for the 1.7 oz bottles and Lot #177K3/A303407 (expires 10/31/2025) for the 8 oz bottles. Contact the manufacturer or retailer for refund information.

The recalled product

Product
babyganics, Sheer Blend, SPF 50 Mineral Sunscreen Fragrance Free (zinc oxide 20%), a) 1.7 FL OZ (50 mL) bottle, UPC 810035921658, b) 8 FL OZ (236 mL) bottle, UPC 810035921382, Dist. by KAS Direct, LLC, 1525 Howe St., Racine, WI 53403, Made in Canada.
Manufacturer
Johnson, S C and Son, Inc
Category
Drug — Sunscreen
Hazard
Affected units
57,184

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 (4)

  • Lot #: a) 097C4/C080316
  • Exp 03/31/2026
  • b) 177K3/A303407
  • Exp 10/31/2025

Distribution

Distributed nationwide across the United States.

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