Drug Labeling and Warnings

Drug Details [pdf]

PROVENCE INTENSIVE AMPOULE MAKE UP BASE 02 LAVENDER- 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.

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ACTIVE INGREDIENT

Active Ingredient: 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: The makeup base improves complexion, preparing skin for the next step.

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

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Image of carton

PROVENCE INTENSIVE AMPOULE MAKE UP BASE 02 LAVENDER 
octinoxate, zinc oxide, titanium dioxide cream
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC: 51346-420
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
Octinoxate (UNII: 4Y5P7MUD51) (OCTINOXATE - UNII:4Y5P7MUD51) Octinoxate1.50 g  in 30 mL
Zinc Oxide (UNII: SOI2LOH54Z) (ZINC CATION - UNII:13S1S8SF37) ZINC CATION1.47 g  in 30 mL
Titanium Dioxide (UNII: 15FIX9V2JP) (TITANIUM DIOXIDE - UNII:15FIX9V2JP) Titanium Dioxide1.23 g  in 30 mL
Inactive Ingredients
Ingredient NameStrength
Water (UNII: 059QF0KO0R)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC: 51346-420-021 in 1 CARTON12/20/201612/01/2018
1NDC: 51346-420-0130 mL in 1 BOTTLE, PUMP; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph not finalpart35212/20/201612/01/2018
Labeler - NATURE REPUBLIC CO., LTD. (631172020)
Registrant - NATURE REPUBLIC CO., LTD. (631172020)
Establishment
NameAddressID/FEIBusiness Operations
Cosmax, Inc.689049693manufacture(51346-420)

Revised: 9/2019