Drug Facts

Drug Facts
SPL v1
SPL
SPL Set ID df05b82f-7266-4989-e053-2995a90afa30
Route
TOPICAL
Published
Effective Date 2013-06-28
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Zinc Oxide (0.01248 g)
Inactive Ingredients
Water Cyclomethicone 5 Dicaprylyl Carbonate Dipropylene Glycol Peg-10 Dimethicone (600 Cst) Titanium Dioxide Portulaca Oleracea Whole .alpha.-tocopherol Acetate Lavandula Angustifolia Flower Ocimum Basilicum Flowering Top Carboxymethylcellulose Sodium Rosemary Althaea Officinalis Whole Apple Hyaluronate Sodium Houttuynia Cordata Flowering Top Matricaria Chamomilla Flowering Top Oil

Identifiers & Packaging

Marketing Status
OTC MONOGRAPH FINAL Active Since 2022-05-15
Description

zinc oxide

Medication Information

Warnings and Precautions

■ For external use only.

■ Avoid contact with eyes.

■ Do not swallow. If swallowed, get medical help.

■ Keep out of reach of children.

■ Stop use and ask doctor if rash and irritation develops.



Indications and Usage


■ Apply Proper Amount of the cream on skin before sun exposure.

■ Reapply Frequently, every 2 hours for best result.



Dosage and Administration

for topical use only



Description

zinc oxide

Section 50565-1

keep out of reach of the children



Section 51727-6

Water, Cyclopentasiloxane, Dicaprylyl Carbonate, Dipropylene Glycol, PEG-10 Dimethicone, Disteardimonium Hectorite, Portulaca Oleracea Extract, Tocopheryl Acetate, Lavendula Angustifolia (Lavender) Extract, Ocimum Basilicum (Basil) Flower/Leaf Extract, Cellulose Gum, Rosmarinus Officinalis (Rosmary) Leaf Extract, Althea Officinalis Leaf/Root Extract, Pyrus Malus (Apple) Fruit Water, Sodium Hyaluronate, Houttuynia Cordata Extract, Chamomilla Recutita (Matricaria) Flower Extract, Foeniculum Vulgare (Fennel) Fruit Extract, Magnesium Sulfate, Methicone, Methyl Methacrylate Crosspolymer, Aluminum Hydroxide, Caprylyl Glycol, Stearic Acid, Dimethicone, Glyceryl Caprylate, Polyglyceryl-6 Polycinoleate, Microcrystalline Cellulose, Phenoxy Ethanol



Section 51945-4
Section 55105-1

helps to protect from UV-Rays



Section 55106-9

zinc oxide



Structured Label Content

Indications and Usage (34067-9)


■ Apply Proper Amount of the cream on skin before sun exposure.

■ Reapply Frequently, every 2 hours for best result.



Dosage and Administration (34068-7)

for topical use only



Warnings and Precautions (34071-1)

■ For external use only.

■ Avoid contact with eyes.

■ Do not swallow. If swallowed, get medical help.

■ Keep out of reach of children.

■ Stop use and ask doctor if rash and irritation develops.



Section 50565-1 (50565-1)

keep out of reach of the children



Section 51727-6 (51727-6)

Water, Cyclopentasiloxane, Dicaprylyl Carbonate, Dipropylene Glycol, PEG-10 Dimethicone, Disteardimonium Hectorite, Portulaca Oleracea Extract, Tocopheryl Acetate, Lavendula Angustifolia (Lavender) Extract, Ocimum Basilicum (Basil) Flower/Leaf Extract, Cellulose Gum, Rosmarinus Officinalis (Rosmary) Leaf Extract, Althea Officinalis Leaf/Root Extract, Pyrus Malus (Apple) Fruit Water, Sodium Hyaluronate, Houttuynia Cordata Extract, Chamomilla Recutita (Matricaria) Flower Extract, Foeniculum Vulgare (Fennel) Fruit Extract, Magnesium Sulfate, Methicone, Methyl Methacrylate Crosspolymer, Aluminum Hydroxide, Caprylyl Glycol, Stearic Acid, Dimethicone, Glyceryl Caprylate, Polyglyceryl-6 Polycinoleate, Microcrystalline Cellulose, Phenoxy Ethanol



Section 51945-4 (51945-4)
Section 55105-1 (55105-1)

helps to protect from UV-Rays



Section 55106-9 (55106-9)

zinc oxide



Advanced Ingredient Data

Raw Label Data

All Sections (JSON)

Additional Information

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Source: dailymed · Ingested: 2026-02-15T12:00:13.700966 · Updated: 2026-03-14T23:00:34.965652