PROVENCE AIR SKIN FIT FOUNDATION W01 LIGHT BEIGE- titanium dioxide, octinoxate, zinc oxide cream

PROVENCE AIR SKIN FIT FOUNDATION W01 LIGHT BEIGE by

Drug Labeling and Warnings

PROVENCE AIR SKIN FIT FOUNDATION W01 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 Ingredient: TITANIUM DIOXIDE 10.8%, ETHYLHEXYL METHOXYCINNAMATE 3.0%, ZINC OXIDE 1.9%

INACTIVE INGREDIENT

Inactive Ingredients: WATER,CYCLOPENTASILOXANE,PENTAERYTHRITYL TETRAISOSTEARATE,ISODODECANE,BUTYLENE GLYCOL,COCO-CAPRYLATE/CAPRATE,TALC,DIPROPYLENE GLYCOL,ALCOHOL,LAURYL PEG-10 TRIS (TRIMETHYLSILOXY)SILYLETHYL DIMETHICONE,DICAPRYLYL CARBONATE,NIACINAMIDE,IRON OXIDES(CI 77492),DISTEARDIMONIUM HECTORITE,MAGNESIUM SULFATE,ACRYLATES/ETHYLHEXYL ACRYLATE/DIMETHICONE METHACRYLATE COPOLYMER,DIMETHICONE/VINYL DIMETHICONE CROSSPOLYMER,DIMETHICONE,POLYGLYCERYL-4 ISOSTEARATE,PHENOXYETHANOL,IRON OXIDES(CI 77491),METHICONE,POLYGLYCERYL-6 POLYRICINOLEATE,FRAGRANCE,IRON OXIDES(CI 77499),ETHYLHEXYLGLYCERIN,TRIETHOXYCAPRYLYLSILANE,ALUMINUM HYDROXIDE,ALUMINUM STEARATE,ADENOSINE,ALOE BARBADENSIS LEAF JUICE,SILICA,1,2-HEXANEDIOL,CAMELLIA SINENSIS LEAF EXTRACT,ALTHAEA OFFICINALIS LEAF/ROOT EXTRACT,OCIMUM BASILICUM (BASIL) FLOWER/LEAF EXTRACT,CENTELLA ASIATICA EXTRACT,HOUTTUYNIA CORDATA EXTRACT,ANTHEMIS NOBILIS FLOWER EXTRACT,FOENICULUM VULGARE (FENNEL) LEAF EXTRACT,CHRYSANTHEMUM MORIFOLIUM FLOWER EXTRACT,LAVANDULA ANGUSTIFOLIA (LAVENDER) FLOWER EXTRACT,SYRINGA VULGARIS (LILAC) EXTRACT,LILIUM CANDIDUM FLOWER EXTRACT,SODIUM BENZOATE,NELUMBO NUCIFERA FLOWER EXTRACT,ROSA HYBRID FLOWER EXTRACT,POTASSIUM SORBATE

PURPOSE

Purpose: Sunscreen

WARNINGS

Warnings: 1. For external use only 2. Avoid contact with eyes and mouth 3. Discontinue use if signs of irritation or rashes appear 4. Keep out of reach of children 5. Replace the cap after use

DESCRIPTION

Indications & usage: The foundation with an air-like texture perfectly adheres to the skin.

Dosage & administration: Apply an appropriate amount to the entire face.

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

INGREDIENTS AND APPEARANCE

PROVENCE AIR SKIN FIT FOUNDATION W01 LIGHT BEIGE 
titanium dioxide, octinoxate, zinc oxide cream

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 51346-401
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
TITANIUM DIOXIDE (UNII: 15FIX9V2JP) (TITANIUM DIOXIDE - UNII:15FIX9V2JP)	TITANIUM DIOXIDE	3.24 g  in 30 mL
OCTINOXATE (UNII: 4Y5P7MUD51) (OCTINOXATE - UNII:4Y5P7MUD51)	OCTINOXATE	0.90 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)
PENTAERYTHRITYL TETRAISOSTEARATE (UNII: 9D7IK5483F)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 51346-401-02	1 in 1 CARTON	11/01/2016
1	NDC: 51346-401-01	30 mL in 1 BOTTLE, PUMP; 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	11/01/2016

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

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

Establishment
Name	Address	ID/FEI	Business Operations
NATURE REPUBLIC CO., LTD.		631172020	repack(51346-401)

Establishment
Name	Address	ID/FEI	Business Operations
Kolmar Korea Co., Ltd.		688732723	manufacture(51346-401)