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SPL v1

SPL

SPL Set ID f0d5f671-ccec-7a0b-e053-2a95a90a9e01

Route

TOPICAL

Published

Effective Date 2022-12-27

Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients

Zinc Oxide (0.16 g)

Inactive Ingredients

Phenoxyethanol Bentonite Edetate Disodium Anhydrous Cetostearyl Alcohol Glyceryl Monostearate White Petrolatum Sorbitan Olivate Sorbitan Monopalmitate Ceramide 1 Oatmeal Xanthan Gum Ceramide 2 Hydrogenated Soybean Lecithin Sucrose Distearate Ceramide Ap Dipropylene Glycol Polyoxyl 20 Cetostearyl Ether Ceramide Np Ceramide 4 Aloe Vera Leaf Water Cetearyl Olivate Alpha-tocopherol Acetate Cetyl Palmitate Cholesterol

Identifiers & Packaging

Pill Appearance

Color: white

Marketing Status

OTC MONOGRAPH FINAL Active Since 2022-12-27

Medication Information

Warnings and Precautions

Indications and Usage

Dosage and Administration

Section 50565-1

Section 51727-6

Section 51945-4

Section 55105-1

Section 55106-9

Structured Label Content

Indications and Usage (34067-9)

Dosage and Administration (34068-7)

Warnings and Precautions (34071-1)

Section 50565-1 (50565-1)

Section 51727-6 (51727-6)

Section 51945-4 (51945-4)

Section 55105-1 (55105-1)

Section 55106-9 (55106-9)

Advanced Ingredient Data

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Raw Label Data

All Sections (JSON)

Additional Information

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Source: dailymed · Ingested: 2026-02-15T12:00:27.065308 · Updated: 2026-03-14T23:00:53.570671