PROVENCE INTENSIVE AMPOULE BB CUSHION 01 LIGHT BEIGE- zinc oxide, titanium dioxide, octinoxate, octisalate powder

PROVENCE INTENSIVE AMPOULE BB CUSHION 01 LIGHT BEIGE by

Drug Labeling and Warnings

PROVENCE INTENSIVE AMPOULE BB CUSHION 01 LIGHT BEIGE by is a Otc medication manufactured, distributed, or labeled by NATURE REPUBLIC CO., LTD., Kolmar Korea Co., Ltd.. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

ACTIVE INGREDIENT

Active ingredients: ZINC OXIDE 9.60%, TITANIUM DIOXIDE 9.58%, ETHYLHEXYL METHOXYCINNAMATE 7.00%, ETHYLHEXYL SALICYLATE 4.50%

INACTIVE INGREDIENT

Inactive ingredients: WATER, CYCLOPENTASILOXANE, PHENYL TRIMETHICONE, GLYCERIN, LAURYL PEG-10 TRIS(TRIMETHYLSILOXY)SILYLETHYL DIMETHICONE, METHYLPROPANEDIOL, CAPRYLYL METHICONE, TRIDECYL TRIMELLITATE, C12-15 ALKYL BENZOATE, NIACINAMIDE, DIMETHICONE, TALC, DISTEARDIMONIUM HECTORITE, MAGNESIUM SULFATE, PORTULACA OLERACEA EXTRACT, ROSA CANINA SEED EXTRACT, PROPOLIS EXTRACT, PANAX GINSENG ROOT EXTRACT, LAVANDULA ANGUSTIFOLIA (LAVENDER) FLOWER WATER, ROYAL JELLY, FICUS CARICA (FIG) FRUIT EXTRACT, MALPIGHIA EMARGINATA (ACEROLA) FRUIT EXTRACT, SALMON EGG EXTRACT, CARICA PAPAYA FRUIT, CORNUS OFFICINALIS FRUIT EXTRACT, LIPPIA CITRIODORA LEAF EXTRACT, CALENDULA OFFICINALIS FLOWER EXTRACT, OENOTHERA BIENNIS (EVENING PRIMROSE) OIL, SQUALANE, HELIANTHUS ANNUUS (SUNFLOWER) SEED OIL, LAURYL PEG-9 POLYDIMETHYLSILOXYETHYL DIMETHICONE, ALUMINUM HYDROXIDE, STEARIC ACID, TRIETHOXYCAPRYLYLSILANE, DIMETHICONE/VINYL DIMETHICONE CROSSPOLYMER, PALMITIC ACID, POLYGLYCERYL-6 POLYRICINOLEATE, ACRYLATES/DIMETHICONE COPOLYMER, ETHYLHEXYLGLYCERIN, TOCOPHERYL ACETATE, TRIHYDROXYSTEARIN, AMINOPROPYL DIMETHICONE, POLYMETHYLSILSESQUIOXANE, ADENOSINE, ALUMINA, SILICA, BHT, SODIUM HYALURONATE, SILK AMINO ACIDS, HYDROLYZED HYALURONIC ACID, BUTYLENE GLYCOL, SODIUM BENZOATE, CITRIC ACID, FRAGRANCE, PHENOXYETHANOL, IRON OXIDES(CI 77492), IRON OXIDES(CI 77491), IRON OXIDES(CI 77499)

PURPOSE

Purpose: Sunscreen

WARNINGS

Warnings: For external use only. Avoid contact with eyes. Discontinue use if signs of irritation or rashes appear. Keep out of reach of children. Replace the cap after use.

DESCRIPTION

Indications & Usage: - The cushion of the intensive ampoule line provides skincare effect and high coverage.

Dosage & Administration: - Take an adequate amount by gently pressing the sponge with the puff, and apply gently to the face.

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

INGREDIENTS AND APPEARANCE

PROVENCE INTENSIVE AMPOULE BB CUSHION 01 LIGHT BEIGE 
zinc oxide, titanium dioxide, octinoxate, octisalate powder

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 51346-467
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
ZINC OXIDE (UNII: SOI2LOH54Z) (ZINC CATION - UNII:13S1S8SF37)	ZINC CATION	1.24 g  in 13 g
TITANIUM DIOXIDE (UNII: 15FIX9V2JP) (TITANIUM DIOXIDE - UNII:15FIX9V2JP)	TITANIUM DIOXIDE	1.24 g  in 13 g
OCTINOXATE (UNII: 4Y5P7MUD51) (OCTINOXATE - UNII:4Y5P7MUD51)	OCTINOXATE	0.91 g  in 13 g
OCTISALATE (UNII: 4X49Y0596W) (OCTISALATE - UNII:4X49Y0596W)	OCTISALATE	0.58 g  in 13 g

Inactive Ingredients
Ingredient Name	Strength
WATER (UNII: 059QF0KO0R)
PHENYL TRIMETHICONE (UNII: DR0K5NOJ4R)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 51346-467-02	1 in 1 CARTON	04/01/2017
1	NDC: 51346-467-01	13 g in 1 CONTAINER; Type 0: Not a Combination Product

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph not final	part352	04/01/2017

Labeler - NATURE REPUBLIC CO., LTD. (631172020)

Registrant - NATURE REPUBLIC CO., LTD. (631172020)

Establishment
Name	Address	ID/FEI	Business Operations
NATURE REPUBLIC CO., LTD.		631172020	relabel(51346-467)

Establishment
Name	Address	ID/FEI	Business Operations
Kolmar Korea Co., Ltd.		689512611	manufacture(51346-467)