SPL v1
SPL
SPL Set ID b1e63aa4-2226-b0e9-e053-2995a90a3c8b
Route
TOPICAL
Published
Effective Date 2020-10-18
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Titanium Dioxide (2.075 g)
Inactive Ingredients
Aluminum Hydroxide Water Glycerin

Identifiers & Packaging

Marketing Status
OTC MONOGRAPH NOT FINAL Active Since 2020-10-18

Description

titanium dioxide


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

Section 50565-1

KEEP OUT OF REACH OF THE CHILDREN

Section 51727-6

Sambucus Nigra Flower Extract

Glycerin

1,2-Hexanediol

Ethylhexylglycerin

Glycerin

Ethylhexyl Methoxycinnamate

Ethylhexyl Salicylate

Cyclopentasiloxane

Cyclohexasiloxane

Centella Asiatica Extract

1,2-Hexanediol

Dicaprylyl Carbonate

Aluminum Hydroxide

Stearic Acid

Niacinamide

Butylene Glycol

Bis-Ethylhexyloxyphenol Methoxyphenyl Triazine

Diethylamino Hydroxybenzoyl Hexyl Benzoate

Cetearyl Alcohol

1,2-Hexanediol

Arachidyl Alcohol

Behenyl Alcohol

Arachidyl Glucoside

Phenyl Trimethicone

Caulerpa Lentillifera Extract

Sea Cucumber Extract

1,2-Hexanediol

Paeonia Suffruticosa Root Extract

Schisandra Chinensis Fruit Extract

Lycium Chinense Fruit Extract

1,2-Hexanediol

Sambucus Nigra Flower Extract

Chamomilla Recutita (Matricaria) Flower Extract

Calendula Officinalis Flower Extract

1,2-Hexanediol

Glyceryl Stearate

Stearic Acid

Potassium Cetyl Phosphate

Polymethyl Methacrylate

Ammonium Acryloyldimethyltaurate/VP Copolymer

Xanthan Gum

Dipropylene glycol

Lavandula hybrida oil

Pelargonium graveolens flower oil

Rosmarinus officinalis (rosemary) leaf oil

Eucalyptus globulus leaf oil

Tromethamine

Carbomer

Adenosine

Dipotassium Glycyrrhizate

Disodium EDTA

Panthenol

rh-Oligopeptide-1

Ceramide NP

(-)-Alpha-Bisabolol

Section 51945-4

Section 55105-1

UV protection

skin whitening

wrinkle care

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 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)

Sambucus Nigra Flower Extract

Glycerin

1,2-Hexanediol

Ethylhexylglycerin

Glycerin

Ethylhexyl Methoxycinnamate

Ethylhexyl Salicylate

Cyclopentasiloxane

Cyclohexasiloxane

Centella Asiatica Extract

1,2-Hexanediol

Dicaprylyl Carbonate

Aluminum Hydroxide

Stearic Acid

Niacinamide

Butylene Glycol

Bis-Ethylhexyloxyphenol Methoxyphenyl Triazine

Diethylamino Hydroxybenzoyl Hexyl Benzoate

Cetearyl Alcohol

1,2-Hexanediol

Arachidyl Alcohol

Behenyl Alcohol

Arachidyl Glucoside

Phenyl Trimethicone

Caulerpa Lentillifera Extract

Sea Cucumber Extract

1,2-Hexanediol

Paeonia Suffruticosa Root Extract

Schisandra Chinensis Fruit Extract

Lycium Chinense Fruit Extract

1,2-Hexanediol

Sambucus Nigra Flower Extract

Chamomilla Recutita (Matricaria) Flower Extract

Calendula Officinalis Flower Extract

1,2-Hexanediol

Glyceryl Stearate

Stearic Acid

Potassium Cetyl Phosphate

Polymethyl Methacrylate

Ammonium Acryloyldimethyltaurate/VP Copolymer

Xanthan Gum

Dipropylene glycol

Lavandula hybrida oil

Pelargonium graveolens flower oil

Rosmarinus officinalis (rosemary) leaf oil

Eucalyptus globulus leaf oil

Tromethamine

Carbomer

Adenosine

Dipotassium Glycyrrhizate

Disodium EDTA

Panthenol

rh-Oligopeptide-1

Ceramide NP

(-)-Alpha-Bisabolol

Section 51945-4 (51945-4)

Section 55105-1 (55105-1)

UV protection

skin whitening

wrinkle care

Section 55106-9 (55106-9)

titanium dioxide


Advanced Ingredient Data


Raw Label Data

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