SPL v1
SPL
SPL Set ID afdd2516-7411-c93c-e053-2995a90a8646
Route
TOPICAL
Published
Effective Date 2020-09-22
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Titanium Dioxide (10 g) Zinc Oxide (12 g)
Inactive Ingredients
Aluminum Hydroxide Water Glycerin

Identifiers & Packaging

Marketing Status
OTC MONOGRAPH NOT FINAL Active Since 2020-09-22

Description

titanium dioxide, zinc oxide


Medication Information

Warnings and Precautions

■ For external use only.

■ Do not use in eyes.

■ lf swallowed, get medical help promptly.

■ Stop use, ask doctor lf irritation occurs.

■ Keep out of reach of children.

Indications and Usage

apply proper amount to the skin

Dosage and Administration

for external use only

Description

titanium dioxide, zinc oxide

Section 50565-1

KEEP OUT OF REACH OF THE CHILDREN

Section 51727-6

Water

C12-15 Alkyl Benzoate

Cyclopentasiloxane

Glycerin

Methylpropanediol

Cetyl PEG/PPG-10/1 Dimethicone

Aluminum Hydroxide

Polyhydroxystearic Acid

Niacinamide

Cetyl Dimethicone

Sea Water

Cetyl Ethylhexanoate

Sorbitan Trioleate

Stearic Acid

Isostearic Acid

Sorbitan Sesquioleate

Trifluoropropyl Dimethicone

Benzyl Glycol

Disteardimonium Hectorite

Ozokerite

Sodium Chloride

Butylene Glycol

Silica Dimethyl Silylate

Polymethylsilsesquioxane

Fragrance

Silica

Tocopheryl Acetate

Sargassum Fulvellum Extract

Ethylhexylglycerin

Hizikia Fusiforme Extract

1,2-Hexanediol

Adenosine

Disodium EDTA

Ethylhexylglycerin

Section 51945-4

Section 55105-1

UV protection

skin whitening

wrinkle care

Section 55106-9

titanium dioxide, zinc oxide


Structured Label Content

Indications and Usage (34067-9)

apply proper amount to the skin

Dosage and Administration (34068-7)

for external use only

Warnings and Precautions (34071-1)

■ For external use only.

■ Do not use in eyes.

■ lf swallowed, get medical help promptly.

■ Stop use, ask doctor lf irritation occurs.

■ Keep out of reach of children.

Section 50565-1 (50565-1)

KEEP OUT OF REACH OF THE CHILDREN

Section 51727-6 (51727-6)

Water

C12-15 Alkyl Benzoate

Cyclopentasiloxane

Glycerin

Methylpropanediol

Cetyl PEG/PPG-10/1 Dimethicone

Aluminum Hydroxide

Polyhydroxystearic Acid

Niacinamide

Cetyl Dimethicone

Sea Water

Cetyl Ethylhexanoate

Sorbitan Trioleate

Stearic Acid

Isostearic Acid

Sorbitan Sesquioleate

Trifluoropropyl Dimethicone

Benzyl Glycol

Disteardimonium Hectorite

Ozokerite

Sodium Chloride

Butylene Glycol

Silica Dimethyl Silylate

Polymethylsilsesquioxane

Fragrance

Silica

Tocopheryl Acetate

Sargassum Fulvellum Extract

Ethylhexylglycerin

Hizikia Fusiforme Extract

1,2-Hexanediol

Adenosine

Disodium EDTA

Ethylhexylglycerin

Section 51945-4 (51945-4)

Section 55105-1 (55105-1)

UV protection

skin whitening

wrinkle care

Section 55106-9 (55106-9)

titanium dioxide, zinc oxide


Advanced Ingredient Data


Raw Label Data

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