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Class IIOngoing

babyganics, Sheer Blend, SPF 50 Mineral Sunscreen Fragrance Free (zinc oxide 20%), a) 1.7… recall

FDA recall D-0298-2025 · initiated Jan 8, 2025

By the pharmaranks editorial teamReviewed against the FDA (openFDA) sourcesUpdated Apr 2, 2025How we research

Johnson, S C and Son, Inc recalled babyganics, Sheer Blend, SPF 50 Mineral Sunscreen Fragrance Free (zinc oxide 20%… in Jan 2025 — an FDA Class II recall (D-0298-2025) because Failed stability specifications: during routine stability monitoring quality concerns were identified. Physical separation for ingredients was observed.

May cause temporary or medically reversible harm; low probability of serious harm.

Why it was recalled

Failed stability specifications: during routine stability monitoring quality concerns were identified. Physical separation for ingredients was observed.

Wrong strength, or it did not keep

The product did not contain what the label promised, or stopped meeting specification before its expiry date. Under-strength medicine can mean an untreated condition.

This is a manufacturing or quality failure, not a finding that the medicine is unsafe to take — across every recall we hold, none was issued for that reason. It does not mean the batch was harmless.

Is your product affected? Check the lot number

A recall covers only specific lots. Find the lot number and expiration date on your package and compare them to the affected codes below — if yours is not listed, it was not part of this recall.

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

Quantity recalled: 57,184 bottles

Details

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.
Recalling company
Johnson, S C and Son, Inc
Classification
Class II
Status
Ongoing
Type
Voluntary: Firm initiated
Distribution
Nationwide in the USA
Initiated
Jan 8, 2025
FDA report date
Apr 2, 2025
What to do.If you have a recalled product, don't throw away questions — check the FDA notice for the affected lot numbers and expiration dates, and ask your pharmacist or doctor before stopping a prescribed medicine. This page reproduces public FDA data and is not medical advice.

Frequently asked

Was babyganics, Sheer Blend, SPF 50 Mineral Sunscreen Fragrance Free (zinc oxide 20%… recalled?
Johnson, S C and Son, Inc recalled babyganics, Sheer Blend, SPF 50 Mineral Sunscreen Fragrance Free (zinc oxide 20%… in Jan 2025 — an FDA Class II recall (D-0298-2025) because Failed stability specifications: during routine stability monitoring quality concerns were identified. Physical separation for ingredients was observed. May cause temporary or medically reversible harm; low probability of serious harm.
Why was babyganics, Sheer Blend, SPF 50 Mineral Sunscreen Fragrance Free (zinc oxide 20%… recalled?
Per the FDA enforcement record, the reason for recall D-0298-2025 was: Failed stability specifications: during routine stability monitoring quality concerns were identified. Physical separation for ingredients was observed.
Is a recalled babyganics, Sheer Blend, SPF 50 Mineral Sunscreen Fragrance Free (zinc oxide 20%… dangerous to take?
An FDA recall removes specific lots from the market for a defined reason and does not by itself mean the medicine is unsafe for everyone — your specific lot may never have been affected. May cause temporary or medically reversible harm; low probability of serious harm. Check the FDA notice for the affected lot numbers and expiration dates, and ask your pharmacist or doctor before stopping a prescribed medicine. This reproduces public FDA data and is not medical advice.
Which lots of babyganics, Sheer Blend, SPF 50 Mineral Sunscreen Fragrance Free (zinc oxide 20%… are affected?
Distributed: Nationwide in the USA. The recall covers these lots — Lot #: a) 097C4/C080316, Exp 03/31/2026; b) 177K3/A303407, Exp 10/31/2025. Check the lot number and expiration date on your package against this list; if yours is not listed, it was not part of recall D-0298-2025.

Source: openFDA Drug Enforcement record D-0298-2025

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