PROVENCE INTENSIVE AMPOULE FOUNDATION P21 ROSY VANILLA- titanium dioxide, zinc oxide cream

PROVENCE INTENSIVE AMPOULE FOUNDATION P21 ROSY VANILLA by

Drug Labeling and Warnings

PROVENCE INTENSIVE AMPOULE FOUNDATION P21 ROSY VANILLA 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:
Titanium Dioxide 13.36%, Zinc Oxide 1.92%

INACTIVE INGREDIENT

Inactive ingredients:
WATER, DIPHENYLSILOXY PHENYL TRIMETHICONE, CYCLOPENTASILOXANE, METHYL TRIMETHICONE, ISOTRIDECYL ISONONANOATE, ALCOHOL, DIPROPYLENE GLYCOL, PENTAERYTHRITYL TETRAETHYLHEXANOATE, LAURYL PEG-10 TRIS(TRIMETHYLSILOXY)SILYLETHYL DIMETHICONE, DIISOSTEARYL MALATE, NIACINAMIDE, METHYL METHACRYLATE CROSSPOLYMER, CETYL PEG/PPG-10/1 DIMETHICONE, SORBITAN SESQUIOLEATE, IRON OXIDES(CI 77492), DISTEARDIMONIUM HECTORITE, MAGNESIUM SULFATE, BEESWAX, PHENOXYETHANOL, ACRYLATES/DIMETHICONE COPOLYMER,OZOKERITE, IRON OXIDES(CI 77491), TRIETHOXYCAPRYLYLSILANE, FRAGRANCE, ALUMINUM HYDROXIDE, SILICA DIMETHYL SILYLATE, STEARIC ACID, ETHYLHEXYLGLYCERIN, METHICONE, IRON OXIDES(CI 77499), ADENOSINE, SODIUM HYALURONATE, CAMELLIA JAPONICA SEED OIL, ROSA CANINA FRUIT OIL, CALENDULA OFFICINALIS FLOWER EXTRACT, HYDROGENATED POLYISOBUTENE, HYDROLYZED HYALURONIC ACID, LAVANDULA ANGUSTIFOLIA (LAVENDER) FLOWER WATER, LIPPIA CITRIODORA LEAF EXTRACT, CENTAUREA CYANUS FLOWER WATER, BUTYLENE GLYCOL, GLYCERIN, TOCOPHEROL, MORINGA OLEIFERA SEED EXTRACT, 1,2-HEXANEDIOL, RHODODENDRON FERRUGINEUM EXTRACT, PANAX GINSENG ROOT EXTRACT, ETHYL HEXANEDIOL, BENZYL ALCOHOL, SODIUM BENZOATE, CITRIC ACID, SILK AMINO ACIDS, PROPOLIS EXTRACT, ROYAL JELLY EXTRACT, FICUS CARICA (FIG) FRUIT EXTRACT, CORNUS OFFICINALIS FRUIT EXTRACT, MALPIGHIA EMARGINATA (ACEROLA) FRUIT EXTRACT, SALMON EGG EXTRACT, CARICA PAPAYA (PAPAYA) FRUIT EXTRACT, OENOTHERA BIENNIS (EVENING PRIMROSE) OIL, DEHYDROACETIC ACID, SQUALANE, HELIANTHUS ANNUUS (SUNFLOWER) SEED OIL, ANEMARRHENA ASPHODELOIDES ROOT EXTRACT

PURPOSE

Purpose: Sunscreen

WARNINGS

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

DESCRIPTION

Uses:
The foundation makes skin look smooth and provides moisture with its ampoule ingredients.
Helps prevent sunburn

Directions
Fully shake the container. Apply an appropriate amount on the face in the direction of skin texture. Gently pat as a finishing touch.

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

INGREDIENTS AND APPEARANCE

PROVENCE INTENSIVE AMPOULE FOUNDATION P21 ROSY VANILLA 
titanium dioxide, zinc oxide cream

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 51346-511
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
Titanium Dioxide (UNII: 15FIX9V2JP) (TITANIUM DIOXIDE - UNII:15FIX9V2JP)	Titanium Dioxide	4.00 g  in 30 mL
Zinc Oxide (UNII: SOI2LOH54Z) (ZINC CATION - UNII:13S1S8SF37)	ZINC CATION	0.57 g  in 30 mL

Inactive Ingredients
Ingredient Name	Strength
WATER (UNII: 059QF0KO0R)
DIPHENYLSILOXY PHENYL TRIMETHICONE (UNII: I445L28B12)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 51346-511-02	1 in 1 CARTON	12/01/2018
1	NDC: 51346-511-01	30 mL 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	12/01/2018

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

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

Establishment
Name	Address	ID/FEI	Business Operations
Kolmar Korea Co., Ltd.		689512611	manufacture(51346-511)