Drug Facts

Drug Facts
SPL v2
SPL
SPL Set ID 9164c7fb-4ec0-1a2e-e053-2a95a90a8683
Route
TOPICAL
Published
Effective Date 2019-08-31
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Titanium Dioxide (0.234 g)
Inactive Ingredients
Water Butylene Glycol Dimethicone

Identifiers & Packaging

Marketing Status
OTC MONOGRAPH FINAL Active Since 2019-08-31

Description

Titanium Dioxide


Medication Information

Warnings and Precautions

1. While using this product , if there

is any abnormal symptoms or side effect such as red spot,

swelling or itching, please consult with dermatologist.

2. Do not use in areas with wounds 3. Instructions for sto

-rage and usage. (i) Keep out of reach of infants and chil

-dren (ii) Store it in a place away from direct sunlight

Indications and Usage

As the last step of skin care, turn the dial on

the bottom of container to raise content about 5 millimeters

and apply on areas that need UV protection (face, body).

Usage/Volume Take an appropriate amount of this pro

-duct and apply it evenly on 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

WATER

POLYETHYLENE

TRIHEPTANOIN

HOMOSALATE

ETHYLHEXYL METHOXYCINNAMATE

BHT

DIMETHICONE

ETHYLHEXYL SALICYLATE

POLYMETHYLSILSESQUIOXANE

METHYL METHACRYLATE CROSSPOLYMER

BUTYLENE GLYCOL

CETYL ETHYLHEXANOATE

SILICA DIMETHYL SILYLATE

POLYMETHYLSILSESQUIOXANE

SILICA

POLYHYDROXYSTEARIC ACID

TOCOPHERYL ACETATE

BIS-ETHYLHEXYLOXYPHENOL METHOXYPHENYL TRIAZINE

DIETHYLAMINO HYDROXYBENZOYL HEXYL BENZOATE

POLYGLYCERYL-4 DIISOSTEARATE/POLYHYDROXYSTEARATE/SEBACATE

OZOKERITE

DIMETHICONE

BISABOLOL

LAURYL POLYGLYCERYL-3 POLYDIMETHYLSILOXYETHYL DIMETHICONE

TOCOPHEROL

FRAGRANCE

CAPRYLYL GLYCOL

STEARIC ACID

ALUMINUM HYDROXIDE

GLYCERYL CAPRYLATE

MELIA AZADIRACHTA LEAF EXTRACT

MELIA AZADIRACHTA FLOWER EXTRACT

COCCINIA INDICA FRUIT EXTRACT

SOLANUM MELONGENA (EGGPLANT) FRUIT EXTRACT

ALOE BARBADENSIS FLOWER EXTRACT

SIMMONDSIA CHINENSIS (JOJOBA) SEED OIL

OCIMUM SANCTUM LEAF EXTRACT

CORALLINA OFFICINALIS EXTRACT

CURCUMA LONGA (TURMERIC) ROOT EXTRACT

ETHYLHEXYLGLYCERIN

TOCOPHEROL

ALLANTOIN

WATER

BUTYLENE GLYCOL

ALOE BARBADENSIS LEAF EXTRACT

PENTYLENE GLYCOL

1,2-HEXANEDIOL

CAPRYLYL GLYCOL

WATER

PENTYLENE GLYCOL

CENTELLA ASIATICA EXTRACT

ETHYLHEXYLGLYCERIN

WATER

1,2-HEXANEDIOL

WATER

DIPROPYLENE GLYCOL

1,2-HEXANEDIOL

MENTHA AQUATICA EXTRACT

Section 51945-4

Section 55105-1

Brightens your skin. Enhances wrinkles Protects the skin against UV rays. (SPF50+,PA++++)

Section 55106-9

Titanium Dioxide


Structured Label Content

Indications and Usage (34067-9)

As the last step of skin care, turn the dial on

the bottom of container to raise content about 5 millimeters

and apply on areas that need UV protection (face, body).

Usage/Volume Take an appropriate amount of this pro

-duct and apply it evenly on the skin.

Dosage and Administration (34068-7)

for external use only

Warnings and Precautions (34071-1)

1. While using this product , if there

is any abnormal symptoms or side effect such as red spot,

swelling or itching, please consult with dermatologist.

2. Do not use in areas with wounds 3. Instructions for sto

-rage and usage. (i) Keep out of reach of infants and chil

-dren (ii) Store it in a place away from direct sunlight

Section 50565-1 (50565-1)

keep out of reach of the children

Section 51727-6 (51727-6)

WATER

POLYETHYLENE

TRIHEPTANOIN

HOMOSALATE

ETHYLHEXYL METHOXYCINNAMATE

BHT

DIMETHICONE

ETHYLHEXYL SALICYLATE

POLYMETHYLSILSESQUIOXANE

METHYL METHACRYLATE CROSSPOLYMER

BUTYLENE GLYCOL

CETYL ETHYLHEXANOATE

SILICA DIMETHYL SILYLATE

POLYMETHYLSILSESQUIOXANE

SILICA

POLYHYDROXYSTEARIC ACID

TOCOPHERYL ACETATE

BIS-ETHYLHEXYLOXYPHENOL METHOXYPHENYL TRIAZINE

DIETHYLAMINO HYDROXYBENZOYL HEXYL BENZOATE

POLYGLYCERYL-4 DIISOSTEARATE/POLYHYDROXYSTEARATE/SEBACATE

OZOKERITE

DIMETHICONE

BISABOLOL

LAURYL POLYGLYCERYL-3 POLYDIMETHYLSILOXYETHYL DIMETHICONE

TOCOPHEROL

FRAGRANCE

CAPRYLYL GLYCOL

STEARIC ACID

ALUMINUM HYDROXIDE

GLYCERYL CAPRYLATE

MELIA AZADIRACHTA LEAF EXTRACT

MELIA AZADIRACHTA FLOWER EXTRACT

COCCINIA INDICA FRUIT EXTRACT

SOLANUM MELONGENA (EGGPLANT) FRUIT EXTRACT

ALOE BARBADENSIS FLOWER EXTRACT

SIMMONDSIA CHINENSIS (JOJOBA) SEED OIL

OCIMUM SANCTUM LEAF EXTRACT

CORALLINA OFFICINALIS EXTRACT

CURCUMA LONGA (TURMERIC) ROOT EXTRACT

ETHYLHEXYLGLYCERIN

TOCOPHEROL

ALLANTOIN

WATER

BUTYLENE GLYCOL

ALOE BARBADENSIS LEAF EXTRACT

PENTYLENE GLYCOL

1,2-HEXANEDIOL

CAPRYLYL GLYCOL

WATER

PENTYLENE GLYCOL

CENTELLA ASIATICA EXTRACT

ETHYLHEXYLGLYCERIN

WATER

1,2-HEXANEDIOL

WATER

DIPROPYLENE GLYCOL

1,2-HEXANEDIOL

MENTHA AQUATICA EXTRACT

Section 51945-4 (51945-4)

Section 55105-1 (55105-1)

Brightens your skin. Enhances wrinkles Protects the skin against UV rays. (SPF50+,PA++++)

Section 55106-9 (55106-9)

Titanium Dioxide


Advanced Ingredient Data


Raw Label Data

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