Drug Labeling and Warnings

Drug Details [pdf]

PROVENCE INTENSIVE AMPOULE MAKE UP BASE 01 MINT- octinoxate, zinc oxide, titanium dioxide 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.

----------

ACTIVE INGREDIENT

Active ingredients: Ethylhexyl Methoxycinnamate 5.0%, Zinc Oxide 4.9%, Titanium Dioxide 4.1%

INACTIVE INGREDIENT

Inactive ingredients: Water,Cyclopentasiloxane,Dicaprylyl Carbonate,Glycerin,Cyclohexasiloxane,Dimethicone,Dipropylene Glycol,Butylene Glycol Dicaprylate/Dicaprate,Cetyl PEG/PPG-10/1 Dimethicone,Diphenylsiloxy Phenyl Trimethicone,Niacinamide,Sorbitan Isostearate,Tribehenin,Disteardimonium Hectorite,Magnesium Sulfate,Ultramarines (CI 77007),Phenoxyethanol,Dimethicone/Vinyl Dimethicone Crosspolymer,Ceresin,Aluminum Hydroxide,Stearic Acid,Fragrance(Parfum),Dimethicone Crosspolymer,Mica (CI 77019),Ethylhexylglycerin,Triethoxycaprylylsilane,Adenosine,Disodium EDTA,Silk Amino Acids,Panax Ginseng Root Extract,Royal Jelly Extract,Butylene Glycol,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: - After your daily skin care routine, apply a pea sized amount on to the entire face. Mint color will improve skin complexion and cover any redness.

Dosage & Administration: - After your daily skin care routine, apply a pea sized amount on to the entire face. Mint color will improve skin complexion and cover any redness.

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

PROVENCE INTENSIVE AMPOULE MAKE UP BASE 01 MINT 
octinoxate, zinc oxide, titanium dioxide cream

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 51346-464
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
Octinoxate (UNII: 4Y5P7MUD51) (OCTINOXATE - UNII:4Y5P7MUD51)	Octinoxate	1.5 g  in 30 mL
Zinc Oxide (UNII: SOI2LOH54Z) (ZINC CATION - UNII:13S1S8SF37)	ZINC CATION	1.47 g  in 30 mL
Titanium Dioxide (UNII: 15FIX9V2JP) (TITANIUM DIOXIDE - UNII:15FIX9V2JP)	Titanium Dioxide	1.23 g  in 30 mL

Inactive Ingredients
Ingredient Name	Strength
Water (UNII: 059QF0KO0R)
Dimethicone (UNII: 92RU3N3Y1O)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 51346-464-02	1 in 1 CARTON	03/01/2017	12/01/2018
1	NDC: 51346-464-01	30 mL in 1 BOTTLE; 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	03/01/2017	12/01/2018

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

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

Establishment
Name	Address	ID/FEI	Business Operations
Cosmax, Inc.		689049693	manufacture(51346-464)

Revised: 9/2019

Document Id: 602058b9-a726-471f-be87-9679025c87e2

34390-5

Set id: dd3afea4-fcf7-444b-b5aa-bb0d89b373f3

Version: 2

Effective Time: 20190917