baby specialty cream

SPL v1

SPL

SPL Set ID 1923d661-9395-655b-e054-00144ff8d46c

Route

topical

Published

Effective Date 2015-06-18

Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients

zinc oxide (12 g)

Inactive Ingredients

water glycerin calendula officinalis flower chamomile evening primrose oil rosa canina fruit oil carrot seed oil yellow wax .alpha.-tocopherol citrus paradisi seed

Identifiers & Packaging

Marketing Status

otc monograph final active Since 2015-06-18

Purpose

Skin Protectant

Description

Zinc Oxide 12%

Medication Information

Warnings

For external use only.

Uses

Brings temporary, quick and effective relief for minor skin irritations due to diaper rash. Protects from dampness.

Purpose

Skin Protectant

Directions

Adults and children 2 years of age and older: Apply to affected area not more than 3 to 4 times daily. Children under 2 years of age: consult a doctor.

Other Information

Store at room temperature.

Inactive Ingredients

Purified Water, Glycerin, Calendula, Camomille, Evening Primrose Oil, Rose Hips Extract, Carrot Seed Oil, Beeswax, Vitamin E, Grapefruit Seed Extract.

Description

Zinc Oxide 12%

Principal Display Panel

Questions?

Call toll-free for US & Canada 844-881-2882 or visit www.deserving-health.com

Section 50565-1

Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center right away.

Section 50569-3

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.

Active Ingredient

Zinc Oxide 12%

When Using This Product

do not get into eyes.

Structured Label Content

Warnings

For external use only.

Uses

Brings temporary, quick and effective relief for minor skin irritations due to diaper rash. Protects from dampness.

Purpose

Skin Protectant

Directions

Adults and children 2 years of age and older: Apply to affected area not more than 3 to 4 times daily. Children under 2 years of age: consult a doctor.

Other Information

Store at room temperature.

Inactive Ingredients

Purified Water, Glycerin, Calendula, Camomille, Evening Primrose Oil, Rose Hips Extract, Carrot Seed Oil, Beeswax, Vitamin E, Grapefruit Seed Extract.

Principal Display Panel (PRINCIPAL DISPLAY PANEL)

Questions?

Call toll-free for US & Canada 844-881-2882 or visit www.deserving-health.com

Section 50565-1 (50565-1)

Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center right away.

Section 50569-3 (50569-3)

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.

Active Ingredient

Zinc Oxide 12%

When Using This Product (When using this product)

do not get into eyes.

Advanced Ingredient Data

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Raw Label Data

All Sections (JSON)

{"Uses": "Brings temporary, quick and effective relief for minor skin irritations due to diaper rash. Protects from dampness.", "50565-1": "Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center right away.", "50569-3": "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.", "Purpose": "Skin Protectant", "Warnings": "For external use only.", "Directions": "Adults and children 2 years of age and older: Apply to affected area not more than 3 to 4 times daily. Children under 2 years of age: consult a doctor.", "Questions?": "Call toll-free for US & Canada 844-881-2882 or visit www.deserving-health.com", "Active Ingredient": "Zinc Oxide 12%", "Other Information": "Store at room temperature.", "Inactive Ingredients": "Purified Water, Glycerin, Calendula, Camomille, Evening Primrose Oil, Rose Hips Extract, Carrot Seed Oil, Beeswax, Vitamin E, Grapefruit Seed Extract.", "When using this product": "do not get into eyes."}

Additional Information

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Source: dailymed · Ingested: 2026-02-15T11:55:57.422547 · Updated: 2026-03-14T22:54:02.195419