Drug Facts

Drug Facts
SPL v1
SPL
SPL Set ID 8f328684-d1f5-307d-e053-2a95a90a120f
Route
TOPICAL
Published
Effective Date 2019-08-02
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Titanium Dioxide (11.4072 g)
Inactive Ingredients
Butylene Glycol

Identifiers & Packaging

Marketing Status
OTC MONOGRAPH NOT FINAL Active Since 2019-08-02

Description

titanium dioxide


Medication Information

Warnings and Precautions

discontinue use if irritation or rash appears

avoid using on injured skin

keep out of childres

store out of direct sunlight

Indications and Usage

apply proper amount to the skin

Dosage and Administration

for topical use only

Description

titanium dioxide

Section 50565-1

keep out of reach of the children

Section 51727-6

Water

Phenyl Trimethicone

Ethylhexyl Methoxycinnamate

Diphenyl Dimethicone

Ethylhexyl Salicylate

Cyclopentasiloxane

Dipropylene Glycol

Glycereth-26

Isododecane

Triethylhexanoin

Trimethylsiloxysilicate

Glycerin

Niacinamide

Butyl

Cetyl PEG/PPG-10/1

Dimethicone

CI 77492

Talc

C16-18 Hydroxyalkyl

Hydroxydimerdilinoleyl Ether

Magnesium Sulfate

Sorbitan Sesquioleate

Sorbitan Olivate

Zinc Stearate

Triethanolamine

Polypropylsilsesquioxane

Dimethicone/Vinyl

Dimethicone Crosspolymer

Mica

Disteardimonium Hectorite

CI 77491

Aluminum Hydroxide

Caprylyl Glycol

Triethoxycaprylylsilane

CI 77499

Allantoin

Methicone

Fragrance

Butylene Glycol

Adenosine

Disodium EDTA

Propylene Carbonate

Morus Alba Bark Extract

Glycyrrhiza Glabra (Licorice)

Root Extract

Oryza Sativa (Rice) Bran Extract

Lilium Tigrinum Extract

Centella Asiatica Extract

1,2-hexanediol

Phenoxyethanol

Section 51945-4

Section 55105-1

Whitening, anti-wrinkle, UV protection

Section 55106-9

titanium dioxide


Structured Label Content

Indications and Usage (34067-9)

apply proper amount to the skin

Dosage and Administration (34068-7)

for topical use only

Warnings and Precautions (34071-1)

discontinue use if irritation or rash appears

avoid using on injured skin

keep out of childres

store out of direct sunlight

Section 50565-1 (50565-1)

keep out of reach of the children

Section 51727-6 (51727-6)

Water

Phenyl Trimethicone

Ethylhexyl Methoxycinnamate

Diphenyl Dimethicone

Ethylhexyl Salicylate

Cyclopentasiloxane

Dipropylene Glycol

Glycereth-26

Isododecane

Triethylhexanoin

Trimethylsiloxysilicate

Glycerin

Niacinamide

Butyl

Cetyl PEG/PPG-10/1

Dimethicone

CI 77492

Talc

C16-18 Hydroxyalkyl

Hydroxydimerdilinoleyl Ether

Magnesium Sulfate

Sorbitan Sesquioleate

Sorbitan Olivate

Zinc Stearate

Triethanolamine

Polypropylsilsesquioxane

Dimethicone/Vinyl

Dimethicone Crosspolymer

Mica

Disteardimonium Hectorite

CI 77491

Aluminum Hydroxide

Caprylyl Glycol

Triethoxycaprylylsilane

CI 77499

Allantoin

Methicone

Fragrance

Butylene Glycol

Adenosine

Disodium EDTA

Propylene Carbonate

Morus Alba Bark Extract

Glycyrrhiza Glabra (Licorice)

Root Extract

Oryza Sativa (Rice) Bran Extract

Lilium Tigrinum Extract

Centella Asiatica Extract

1,2-hexanediol

Phenoxyethanol

Section 51945-4 (51945-4)

Section 55105-1 (55105-1)

Whitening, anti-wrinkle, UV protection

Section 55106-9 (55106-9)

titanium dioxide


Advanced Ingredient Data


Raw Label Data

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