PROVENCE AIR SKIN FIT MAKE UP BASE 02 GREEN- octinoxate, titanium dioxide, octisalate cream

PROVENCE AIR SKIN FIT MAKE UP BASE 02 GREEN by

Drug Labeling and Warnings

PROVENCE AIR SKIN FIT MAKE UP BASE 02 GREEN 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: Ethylhexyl Methoxycinnamate 6.7%, Titanium Dioxide 3.6%, Ethylhexyl Salicylate 2.5%

INACTIVE INGREDIENT

Inactive Ingredients: WATER,BUTYLENE GLYCOL,GLYCERIN,CYCLOPENTASILOXANE,CYCLOHEXASILOXANE,CETYL ETHYLHEXANOATE,DICAPRYLYL CARBONATE,NIACINAMIDE,OCTYLDODECANOL,PENTYLENE GLYCOL,DIETHYLAMINO HYDROXYBENZOYL HEXYL BENZOATE,DIPHENYLSILOXY PHENYL TRIMETHICONE,TRICETEARETH-4 PHOSPHATE,GLYCOL STEARATE,PHENOXYETHANOL,GLYCERYL STEARATE,PEG-100 STEARATE,PEG-2 STEARATE,POTASSIUM CETYL PHOSPHATE,CARBOMER,LAURYL PEG-9 POLYDIMETHYLSILOXYETHYL DIMETHICONE,TRIETHANOLAMINE,MICA (CI 77019),CHROMIUM OXIDE GREENS (CI 77288),ALUMINUM HYDROXIDE,STEARIC ACID,HYDROXYETHYL ACRYLATE/SODIUM ACRYLOYLDIMETHYL TAURATE COPOLYMER,FRAGRANCE(PARFUM),SQUALANE,ETHYLHEXYLGLYCERIN,TRIETHOXYCAPRYLYLSILANE,ADENOSINE,IRON OXIDES (CI 77492),DISODIUM EDTA,POLYSORBATE 60,SORBITAN ISOSTEARATE,ALOE BARBADENSIS LEAF EXTRACT,CHAMOMILLA RECUTITA (MATRICARIA) FLOWER WATER,ROSA CENTIFOLIA FLOWER WATER,TOCOPHEROL,CAMELLIA SINENSIS LEAF EXTRACT,ALCOHOL,SACCHAROMYCES FERMENT

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 makeup base with an air-like texture perfectly adheres to the skin.

Dosage & administration: Apply an appropriate amount to the skin evenly.

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

INGREDIENTS AND APPEARANCE

PROVENCE AIR SKIN FIT MAKE UP BASE 02 GREEN 
octinoxate, titanium dioxide, octisalate cream

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 51346-406
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
OCTINOXATE (UNII: 4Y5P7MUD51) (OCTINOXATE - UNII:4Y5P7MUD51)	OCTINOXATE	2.01 g  in 30 mL
TITANIUM DIOXIDE (UNII: 15FIX9V2JP) (TITANIUM DIOXIDE - UNII:15FIX9V2JP)	TITANIUM DIOXIDE	1.08 g  in 30 mL
OCTISALATE (UNII: 4X49Y0596W) (OCTISALATE - UNII:4X49Y0596W)	OCTISALATE	0.75 g  in 30 mL

Inactive Ingredients
Ingredient Name	Strength
WATER (UNII: 059QF0KO0R)
BUTYLENE GLYCOL (UNII: 3XUS85K0RA)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 51346-406-02	1 in 1 CARTON	11/01/2016
1	NDC: 51346-406-01	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(51346-406)

Establishment
Name	Address	ID/FEI	Business Operations
Kolmar Korea Co., Ltd.		688732723	manufacture(51346-406)