Astonea Skin Enshield

Astonea Skin Enshield
SPL v2
SPL
SPL Set ID ef7c1864-336d-c402-e053-2a95a90a8740
Route
TOPICAL
Published
Effective Date 2014-02-17
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Zinc Cation (3.8 g)
Inactive Ingredients
Water Sodium Benzoate Ceteth-20 Aloe Vera Leaf Alpha-tocopherol Cetostearyl Alcohol Cetyl Alcohol Cholecalciferol Glycerin Lanolin Mineral Oil Paraffin Microcrystalline Wax Phenoxyethanol Propylene Glycol Fd&c Yellow No. 5 Ponceau 4r Vitamin A Palmitate Ethylhexylglycerin

Identifiers & Packaging

Marketing Status
OTC MONOGRAPH DRUG Active Since 2019-02-07
Description

Zinc Oxide (3.8%w/w)

Purpose

Skin Protectant

Medication Information

Purpose

Skin Protectant

Description

Zinc Oxide (3.8%w/w)

Uses

■ helps treat and prevent diaper rash ■ temporarily protects minor ■ cuts ■ scrapes ■ burns dries the oozing and weeping of: ■ Poison ivy ■ poison oak ■ poison sumac

Warnings

For external use only

Directions

■ change wet and soiled diapers promptly ■ cleanse the diaper area and allow to dry ■ apply ointment liberally with each diaper change, especially at bedtime or anytime when exposure to wet diapers may be prolonged ■ for poison ivy, oak and sumac ■ apply ointment liberally as needed

Package Label

Active Ingredient

Zinc Oxide (3.8%w/w)

Other Information

■ store at room temperature 15-30C (59-86F) ■ avoid excessive heat

Inactive Ingredients

Aloe Vera Leaf, Alpha-Tocopherol, Ceteth-20, Cetostearyl Alcohol, Cetyl Alcohol, Cholecalciferol, Ethylhexylglycerin,FD&C Yellow No. 5, Fragrance, Glycerin, Lanolin, Microcrystalline Wax, Mineral Oil, Paraffin, Phenoxyethanol, Ponceau 4R, Propylene Glycol, Sodium Benzoate, Vitamin A Palmitate, Water

When Using This Product

■ do not get into eyes

Stop Use and Ask A Doctor If

conditions worsen symptoms last more than 7 days or clear up and occur again in a few days, consult a physician

Keep Out of Reach of Children

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

Structured Label Content

Uses

■ helps treat and prevent diaper rash ■ temporarily protects minor ■ cuts ■ scrapes ■ burns dries the oozing and weeping of: ■ Poison ivy ■ poison oak ■ poison sumac

Purpose

Skin Protectant

Warnings

For external use only

Directions

■ change wet and soiled diapers promptly ■ cleanse the diaper area and allow to dry ■ apply ointment liberally with each diaper change, especially at bedtime or anytime when exposure to wet diapers may be prolonged ■ for poison ivy, oak and sumac ■ apply ointment liberally as needed

Package Label

Active Ingredient

Zinc Oxide (3.8%w/w)

Other Information

■ store at room temperature 15-30C (59-86F) ■ avoid excessive heat

Inactive Ingredients (Inactive ingredients)

Aloe Vera Leaf, Alpha-Tocopherol, Ceteth-20, Cetostearyl Alcohol, Cetyl Alcohol, Cholecalciferol, Ethylhexylglycerin,FD&C Yellow No. 5, Fragrance, Glycerin, Lanolin, Microcrystalline Wax, Mineral Oil, Paraffin, Phenoxyethanol, Ponceau 4R, Propylene Glycol, Sodium Benzoate, Vitamin A Palmitate, Water

When Using This Product (When using this product)

■ do not get into eyes

Stop Use and Ask A Doctor If (Stop Use and ask a doctor if)

conditions worsen symptoms last more than 7 days or clear up and occur again in a few days, consult a physician

Keep Out of Reach of Children (Keep out of reach of children)

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

Advanced Ingredient Data

Raw Label Data

All Sections (JSON)

Additional Information

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Source: dailymed · Ingested: 2026-02-15T12:03:13.015474 · Updated: 2026-03-14T23:03:09.210552