PROVENCE INTENSIVE AMPOULE FOUNDATION 01 LIGHT BEIGE- titanium dioxide, octinoxate, zinc oxide cream

PROVENCE INTENSIVE AMPOULE FOUNDATION 01 LIGHT BEIGE by

Drug Labeling and Warnings

PROVENCE INTENSIVE AMPOULE FOUNDATION 01 LIGHT BEIGE by is a Otc medication manufactured, distributed, or labeled by NATURE REPUBLIC CO., LTD., Cosmax, Inc. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

ACTIVE INGREDIENT

Active Ingredient: Titanium Dioxide 9.4%, Ethylhexyl Methoxycinnamate 4.0%, Zinc Oxide 0.9%

INACTIVE INGREDIENT

Inactive Ingredients: Water, Cyclopentasiloxane, Cyclohexasiloxane, Butylene Glycol, Diphenylsiloxy Phenyl Trimethicone, PEG-10 Dimethicone, Butylene Glycol Dicaprylate/Dicaprate, Glycerin, Neopentyl Glycol Diheptanoate, Niacinamide, Pentylene Glycol, Mica (CI 77019), Sodium Chloride, Trimethylsiloxysilicate, Disteardimonium Hectorite, Iron Oxides (CI 77492), Tribehenin, Phenoxyethanol, Sorbitan Isostearate, Lauryl PEG-9 Polydimethylsiloxyethyl Dimethicone, Triethoxycaprylylsilane,Iron Oxides (CI 77491),Polysilicone-11,Aluminum Hydroxide,Fragrance(Parfum),Stearic Acid,Dimethiconol,Iron Oxides (CI 77499),Ethylhexylglycerin,Dimethicone Crosspolymer,Disodium EDTA,Adenosine,Copernicia Cerifera (Carnauba) Wax,Dimethicone,Tocopherol,Silk Amino Acids,Panax Ginseng Root Extract,Royal Jelly Extract,Hyaluronic Acid,Hydrolyzed Hyaluronic Acid,Sodium Hyaluronate,1,2-Hexanediol,Ethyl Hexanediol,Propolis 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

Indications & usage: The foundation provides natural coverage with UV protection.

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

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

INGREDIENTS AND APPEARANCE

PROVENCE INTENSIVE AMPOULE FOUNDATION 01 LIGHT BEIGE 
titanium dioxide, octinoxate, zinc oxide cream

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 51346-421
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
Titanium Dioxide (UNII: 15FIX9V2JP) (TITANIUM DIOXIDE - UNII:15FIX9V2JP)	Titanium Dioxide	2.82 g  in 30 mL
Octinoxate (UNII: 4Y5P7MUD51) (OCTINOXATE - UNII:4Y5P7MUD51)	Octinoxate	1.20 g  in 30 mL
Zinc Oxide (UNII: SOI2LOH54Z) (ZINC CATION - UNII:13S1S8SF37)	ZINC CATION	0.27 g  in 30 mL

Inactive Ingredients
Ingredient Name	Strength
Water (UNII: 059QF0KO0R)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 51346-421-02	1 in 1 CARTON	12/20/2016
1	NDC: 51346-421-01	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	12/20/2016

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

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

Establishment
Name	Address	ID/FEI	Business Operations
NATURE REPUBLIC CO., LTD.		631172020	relabel(51346-421)

Establishment
Name	Address	ID/FEI	Business Operations
Cosmax, Inc		689049693	manufacture(51346-421)