Ina Labs Barrier Balm

Ina Labs Barrier Balm
SPL v2
SPL
SPL Set ID ea608b09-a043-7457-e053-2995a90a48af
Route
TOPICAL
Published
Effective Date 2023-10-28
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Zinc Oxide (15 g)
Inactive Ingredients
Moringa Oleifera Seed Oil Centella Asiatica Leaf Coco-caprylate/caprate C15-23 Alkane Asiaticoside Hippophae Rhamnoides Seed Oil Menthol Hydrogenated Soybean Oil Coconut Alkanes Silicon Dioxide Madecassoside .alpha.-tocopherol Acetate

Identifiers & Packaging

Marketing Status
OTC MONOGRAPH DRUG Active Since 2022-10-19
Description

Zinc Oxide 15%

Medication Information

Warnings and Precautions

Warnings:

For external use only.

Indications and Usage

To help prevent and relieve skin irritation from wetness.

Dosage and Administration

Directions:

Apply a thin layer as needed to clean, dry skin.

Description

Zinc Oxide 15%

Section 50565-1

Keep out of reach of children. In case of accidental ingestion, contact a physician or poison control center immediately.

Section 50566-9

Stop use and ask a doctor if condition worsens or doesn't improve

Section 50567-7

When using this product, avoid wounds and contact with eyes.

Section 51727-6

Inactive Ingredients Hydrogenated Soybean Oil, Coconut Alkanes, Silica, Hydrogenated Soy Polyglycerides, C15-23 Alkane, Madecassoside, Asiaticoside, Centella Asiatica Leaf Extract, Hippophae Rhamnoides Seed Oil, Moringa Oleifera Seed Oil, Coco-Caprylate, Tocopheryl Acetate, Menthol.

Section 51945-4

Section 55105-1

Skin Protectant

Section 55106-9

Zinc Oxide 15%

Structured Label Content

Indications and Usage (34067-9)

To help prevent and relieve skin irritation from wetness.

Dosage and Administration (34068-7)

Directions:

Apply a thin layer as needed to clean, dry skin.

Warnings and Precautions (34071-1)

Warnings:

For external use only.

Section 50565-1 (50565-1)

Keep out of reach of children. In case of accidental ingestion, contact a physician or poison control center immediately.

Section 50566-9 (50566-9)

Stop use and ask a doctor if condition worsens or doesn't improve

Section 50567-7 (50567-7)

When using this product, avoid wounds and contact with eyes.

Section 51727-6 (51727-6)

Inactive Ingredients Hydrogenated Soybean Oil, Coconut Alkanes, Silica, Hydrogenated Soy Polyglycerides, C15-23 Alkane, Madecassoside, Asiaticoside, Centella Asiatica Leaf Extract, Hippophae Rhamnoides Seed Oil, Moringa Oleifera Seed Oil, Coco-Caprylate, Tocopheryl Acetate, Menthol.

Section 51945-4 (51945-4)

Section 55105-1 (55105-1)

Skin Protectant

Section 55106-9 (55106-9)

Zinc Oxide 15%

Advanced Ingredient Data

Raw Label Data

All Sections (JSON)

Additional Information

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Source: dailymed · Ingested: 2026-02-15T12:02:10.641362 · Updated: 2026-03-14T23:01:35.007581