SPL v2
SPL
SPL Set ID 0411f5e3-03d2-c512-e063-6394a90a37d3
Route
TOPICAL
Published
Effective Date 2023-08-29
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Zinc Oxide (15 g)
Inactive Ingredients
Shea Butter Caprylyl Glycol Glycerin Glyceryl Oleate Olea Europaea (olive) Oil Unsaponifiables Propanediol Bentonite Olive Oil Caprylhydroxamic Acid Carboxymethylcellulose Sodium Glyceryl Rosinate Water Cetostearyl Alcohol Coco Glucoside Aloe Vera Leaf Calendula Officinalis Flower Chamomile Sunflower Oil Castor Oil Microcrystalline Cellulose

Identifiers & Packaging

Marketing Status
OTC MONOGRAPH DRUG Active Since 2023-03-09
Description

Zinc Oxide 15%

Medication Information

Warnings and Precautions

For external use only.

When using this product do not get into eyes.

Stop use and ask a doctor if condition worsens, symptoms last more than 7 days or clear up and occur again within a few days.

Indications and Usage

Helps treat and prevent diaper rash, protects chafed skin due to diaper rash.

Dosage and Administration

Change wet and soiled diapers promptly. Cleanse the diaper area. Allow to dry. Shake well before each use. Spray liberally onto affected area with each diaper change, especially at bedtime or anytime when exposure to wet diaper may be prolonged. Apply as needed.

Description

Zinc Oxide 15%

Section 50565-1

If swallowed, get medical help or contact a Poison Control Center right away.

Section 51727-6

Aloe Barbadensis Leaf Juice, Bentonite, Butyrospermum Parkii (Shea) Butter, Calendula Officinalis flower Extract, Caprylhydroxamic Acid, Caprylyl Glycol, Cellulose Gum, Cetearyl Alcohol, chamomilla Recutita (Matricaria) Flower Extract, Coco-Glucoside, Glycerin, Glyceryl Oleate, Glyceryl Rosinate, Helianthus Annuus (Sunflower) Seed Oil, Microcrystalline Cellulose, Olea Europaea (Olive) Fruit Oil, Olea Europaes 9Olive) Oil Unsaponifiables, Propanediol, Ricinus Communis (Castor) Seed Oil, Water.

Section 51945-4

Section 55105-1

Skin Protectant

Section 55106-9

Zinc Oxide 15%

Structured Label Content

Indications and Usage (34067-9)

Helps treat and prevent diaper rash, protects chafed skin due to diaper rash.

Dosage and Administration (34068-7)

Change wet and soiled diapers promptly. Cleanse the diaper area. Allow to dry. Shake well before each use. Spray liberally onto affected area with each diaper change, especially at bedtime or anytime when exposure to wet diaper may be prolonged. Apply as needed.

Warnings and Precautions (34071-1)

For external use only.

When using this product do not get into eyes.

Stop use and ask a doctor if condition worsens, symptoms last more than 7 days or clear up and occur again within a few days.

Section 50565-1 (50565-1)

If swallowed, get medical help or contact a Poison Control Center right away.

Section 51727-6 (51727-6)

Aloe Barbadensis Leaf Juice, Bentonite, Butyrospermum Parkii (Shea) Butter, Calendula Officinalis flower Extract, Caprylhydroxamic Acid, Caprylyl Glycol, Cellulose Gum, Cetearyl Alcohol, chamomilla Recutita (Matricaria) Flower Extract, Coco-Glucoside, Glycerin, Glyceryl Oleate, Glyceryl Rosinate, Helianthus Annuus (Sunflower) Seed Oil, Microcrystalline Cellulose, Olea Europaea (Olive) Fruit Oil, Olea Europaes 9Olive) Oil Unsaponifiables, Propanediol, Ricinus Communis (Castor) Seed Oil, Water.

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: 2026-02-15T12:04:55.804719 · Updated: 2026-03-14T23:06:06.305155