SPL v1
SPL
SPL Set ID 382b2771-99a4-5863-e054-00144ff8d46c
Route
TOPICAL
Published
Effective Date 2015-08-26
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Zinc Oxide (12 g)
Inactive Ingredients
Jojoba Oil Chamomile Potassium Sorbate Medium-chain Triglycerides Water Yellow Wax Glycerin Cetostearyl Alcohol Sodium Stearoyl Glutamate Glyceryl Stearate Se Coco-caprylate Almond Oil Sunflower Oil Shea Butter Xanthan Gum Calendula Arvensis Leaf .alpha.-tocopherol Acetate, D- Glyceryl Caprylate Sodium Levulinate

Identifiers & Packaging

Marketing Status
OTC MONOGRAPH FINAL Active Since 2016-07-21
Description

ACTIVE INGREDIENT Zinc Oxide 12%

Medication Information

Warnings and Precautions

Warnings 

For external use only

Avoider contact with eyes. If any adverse reaction develops, stop use, and contact a physician.

Indications and Usage

Uses and Indications

For the relief of diaper rash, minor cuts and burns

Dosage and Administration

Directions

Apply cream, liberally, and as often as necessary to dry skin, with each diaper change, especially at bedtime or anytime when exposure to wet diapers may be prolonged.

Description

ACTIVE INGREDIENT Zinc Oxide 12%

Section 50565-1

Keep out of reach of children

Section 51727-6

Inactive Ingredients

Purified Water, Betaine,

Glycerin, Cetearyl Alcohol, Glyceryl Stearate SE, Coco-

Caprylate, Prunus Amygdalus Dulcis (Sweet Almond) Oil),

Helianthus Annuus (Sunflower) Seed Oil, Butyrospermum

Parkii (Shea Butter), Beeswax, Caprylic/Capric

Triglyceride, Sodium Stearoyl Glutamate, Jojoba Oil,

Xanthan Gum, Chamomile Extract, Calendula Extract,

Tocopherol Acetate, Phenoxyethanol, Capryl Glycol

Section 51945-4

Section 53413-1



Questions 

www.itchy.net.au

Made in Australia

Grahams Natural Alternatives Pty Ltd

7 Palings Crt, Nerang, QLD 4211 Australia

Section 55105-1

PURPOSE

Skin Protectant

Section 55106-9

ACTIVE INGREDIENT

Zinc Oxide 12%

Structured Label Content

Indications and Usage (34067-9)

Uses and Indications

For the relief of diaper rash, minor cuts and burns

Dosage and Administration (34068-7)

Directions

Apply cream, liberally, and as often as necessary to dry skin, with each diaper change, especially at bedtime or anytime when exposure to wet diapers may be prolonged.

Warnings and Precautions (34071-1)

Warnings 

For external use only

Avoider contact with eyes. If any adverse reaction develops, stop use, and contact a physician.

Section 50565-1 (50565-1)

Keep out of reach of children

Section 51727-6 (51727-6)

Inactive Ingredients

Purified Water, Betaine,

Glycerin, Cetearyl Alcohol, Glyceryl Stearate SE, Coco-

Caprylate, Prunus Amygdalus Dulcis (Sweet Almond) Oil),

Helianthus Annuus (Sunflower) Seed Oil, Butyrospermum

Parkii (Shea Butter), Beeswax, Caprylic/Capric

Triglyceride, Sodium Stearoyl Glutamate, Jojoba Oil,

Xanthan Gum, Chamomile Extract, Calendula Extract,

Tocopherol Acetate, Phenoxyethanol, Capryl Glycol

Section 51945-4 (51945-4)

Section 53413-1 (53413-1)



Questions 

www.itchy.net.au

Made in Australia

Grahams Natural Alternatives Pty Ltd

7 Palings Crt, Nerang, QLD 4211 Australia

Section 55105-1 (55105-1)

PURPOSE

Skin Protectant

Section 55106-9 (55106-9)

ACTIVE INGREDIENT

Zinc Oxide 12%

Advanced Ingredient Data

Raw Label Data

All Sections (JSON)

Additional Information

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Source: dailymed · Ingested: 2026-02-15T11:56:09.932454 · Updated: 2026-03-14T22:54:24.786834