PROVENCE AIR SKIN FIT PACT 02 NATURAL BEIGE- zinc oxide, octinoxate, octisalate powder

PROVENCE AIR SKIN FIT PACT 02 NATURAL BEIGE by

Drug Labeling and Warnings

PROVENCE AIR SKIN FIT PACT 02 NATURAL 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 4.80%, ETHYLHEXYL METHOXYCINNAMATE 3.75%, ETHYLHEXYL SALICYLATE 2.50%

INACTIVE INGREDIENT

Inactive ingredients:

Talc, Triethoxycaprylylsilane, Dimethicone, Boron Nitride, Polymethyl Methacrylate, Silica, Zinc Oxide, Methicone, Synthetic Fluorphlogopite, Triethoxycaprylylsilane, Acrylates/Tridecyl Acrylate/Triethoxysilylpropyl Methacrylate/Dimethicone Methacrylate Copolymer, Ethylhexyl Methoxycinnamate, Nylon-12, Ethylhexyl Salicylate, Magnesium Myristate, Dimethicone, Phenyl Trimethicone, Iron Oxides (CI 77492), Mica, Methicone, 1,2-Hexanediol, Iron Oxides (CI 77491), Mica, Methicone, Glyceryl Caprylate, Iron Oxides (CI 77499), Mica, Methicone, Fragrance, Aloe Barbadensis Leaf Extract, Water, Butylene Glycol, 1,2-Hexanediol, Chamomilla Recutita (Matricaria) Flower Water, Camellia Sinensis Leaf Extract, Butylene Glycol, Water, Lippia Citriodora Leaf Extract, Citric Acid, Sodium Benzoate, Water, Calendula Officinalis Flower Extract, Sodium Benzoate, Citric Acid, Water, Butylene Glycol, Rosa Hybrid Flower Extract, 1,2-Hexanediol, Ethyl Hexanediol, Lavandula Angustifolia (Lavender) Flower Water, Phenoxyethanol

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

Indications & Usage:

The powder pact brightens skin complexion for long lasting hours with its lightweight texture.

Directions:

Apply an appropriate amount to the face evenly.

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

INGREDIENTS AND APPEARANCE

PROVENCE AIR SKIN FIT PACT 02 NATURAL BEIGE 
zinc oxide, octinoxate, octisalate powder

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 51346-439
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
ZINC OXIDE (UNII: SOI2LOH54Z) (ZINC CATION - UNII:13S1S8SF37)	ZINC CATION	0.48 g  in 10 g
OCTINOXATE (UNII: 4Y5P7MUD51) (OCTINOXATE - UNII:4Y5P7MUD51)	OCTINOXATE	0.37 g  in 10 g
OCTISALATE (UNII: 4X49Y0596W) (OCTISALATE - UNII:4X49Y0596W)	OCTISALATE	0.25 g  in 10 g

Inactive Ingredients
Ingredient Name	Strength
TALC (UNII: 7SEV7J4R1U)
Dimethicone (UNII: 92RU3N3Y1O)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 51346-439-02	1 in 1 CARTON	12/20/2016
1	NDC: 51346-439-01	10 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	12/20/2016

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

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

Establishment
Name	Address	ID/FEI	Business Operations
Kolmar Korea Co., Ltd.		689049693	manufacture(51346-439)