PROVENCE INTENSIVE AMPOULE FOUNDATION 02 NATURAL BEIGE- titanium dioxide, octinoxate, zinc oxide cream
NATURE REPUBLIC CO., LTD.

Disclaimer: Most OTC drugs are not reviewed and approved by FDA, however they may be marketed if they comply with applicable regulations and policies. FDA has not evaluated whether this product complies.

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ACTIVE INGREDIENT

Active ingredients: 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, Iron Oxides (CI 77492), Sodium Chloride, Trimethylsiloxysilicate, Disteardimonium Hectorite, Mica (CI 77019),Tribehenin,Phenoxyethanol,Sorbitan Isostearate,Lauryl PEG-9 Polydimethylsiloxyethyl Dimethicone,Iron Oxides (CI 77491),Triethoxycaprylylsilane,Polysilicone-11,Aluminum Hydroxide,Fragrance(Parfum),Stearic Acid,Iron Oxides (CI 77499),Dimethiconol,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. Keep out of reach of children. Replace the cap after use.

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

Image of carton

PROVENCE INTENSIVE AMPOULE FOUNDATION 02 NATURAL BEIGE
titanium dioxide, octinoxate, zinc oxide cream

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC:51346-463
Route of Administration	TOPICAL

Ingredient Name	Basis of Strength	Strength
Active Ingredient/Active Moiety
TITANIUM DIOXIDE (UNII: 15FIX9V2JP) (TITANIUM DIOXIDE - UNII:15FIX9V2JP)	TITANIUM DIOXIDE	2.82 g in 30 mL
OCTINOXATE (UNII: 4Y5P7MUD51) (OCTINOXATE - UNII:4Y5P7MUD51)	OCTINOXATE	1.2 g in 30 mL
ZINC OXIDE (UNII: SOI2LOH54Z) (ZINC CATION - UNII:13S1S8SF37)	ZINC CATION	0.27 g in 30 mL

Ingredient Name	Strength
Inactive Ingredients
Water (UNII: 059QF0KO0R)
Butylene Glycol (UNII: 3XUS85K0RA)

#	Item Code	Package Description	Marketing Start Date	Marketing End Date
Packaging
1	NDC:51346-463-02	1 in 1 CARTON	03/01/2017	12/30/2019
1	NDC:51346-463-01	30 mL in 1 BOTTLE; Type 0: Not a Combination Product

Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
OTC monograph not final	part352	03/01/2017	12/30/2019

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

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

Name	Address	ID/FEI	Business Operations
Establishment
Cosmax, Inc.		689049693	manufacture(51346-463)

Revised: 6/2021

Document Id: f43d6e65-f7fd-4a73-bd84-bd5f510d2f54

Set id: 88372ec9-a01a-4824-8599-fdc3c234b12f

Version: 3

Effective Time: 20210623

NATURE REPUBLIC CO., LTD.