IOPE RETIGEN ESSENCE DUAL CONCEALER- octinoxate and titanium dioxide stick 
AMOREPACIFIC

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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IOPE
RETIGEN ESSENCE
DUAL CONCEALER
[SPF 25/PA+]
CONCEALER

Drug Fact

Active ingredients

ETHYLHEXYL METHOXYCINNAMATE2%
TITANIUM DIOXIDE20%

Purpose

Sunscreen

Use

Helps prevent sunburn

Warnings

For external use only.

Stop use and ask a doctor if rash and irritation develops and lasts.

Directions

Thinly spread the essence onto the face using the tip, and thinly spread the concealer onto the face.

Inactive ingredients

C12-15 ALKYL ETHYLHEXANOATE, DIMETHICONE, POLYGLYCERYL-2 TRIISOSTEARATE, POLYMETHYL METHACRYLATE, POLYETHYLENE, OZOKERITE, POLYBUTENE, TALC, SILICA, VINYL DIMETHICONE/METHICONE SILSESQUIOXANE CROSSPOLYMER, LAURYL PEG/PPG-18/18 METHICONE, VP/HEXADECENE COPOLYMER, SORBITANISOSTEARATE, SORBITAN SESQUIOLEATE, CAMELLIA SINENSIS LEAF EXTRACT, HYDROGENATED VEGETABLE OIL, HYDROLYZED EXTENSIN, BETACAROTENE, BETA-GLUCAN, CAPRYLYL GLYCOL, 1,2-HEXANEDIOL, ETHYLHEXYLGLYCERIN, WATER, ACRYLATES/AMMONIUM METHACRYLATE COPOLYMER, BUTYLENE GLYCOL, POLYACRYLIC ACID, GLYCERIN, PROPANEDIOL, FRAGRANCE, TITANIUM DIOXIDE, IRON OXIDES (CI 77491, CI 77492, CI 77499)

AMOREPACIFIC US INC.
270 Sylvan Ave. #255
Englewood Cliffs,
NJ07632

PRINCIPAL DISPLAY PANEL - 4.1 g Carton

IOPE

PRINCIPAL DISPLAY PANEL - 4.1 g Carton
IOPE RETIGEN ESSENCE DUAL CONCEALER 
octinoxate and titanium dioxide stick
Product Information
Product TypeHUMAN OTC DRUG LABELItem Code (Source)NDC:43419-301
Route of AdministrationTOPICALDEA Schedule    
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
OCTINOXATE (OCTINOXATE) OCTINOXATE0.082 g  in 4.1 g
TITANIUM DIOXIDE (TITANIUM DIOXIDE) TITANIUM DIOXIDE0.82 g  in 4.1 g
Inactive Ingredients
Ingredient NameStrength
DIMETHICONE 
TALC 
SILICON DIOXIDE 
FERRIC OXIDE YELLOW 
SORBITAN SESQUIOLEATE 
FERRIC OXIDE RED 
CAPRYLYL GLYCOL 
1,2-HEXANEDIOL 
FERROSOFERRIC OXIDE 
ETHYLHEXYLGLYCERIN 
WATER 
GREEN TEA LEAF 
BUTYLENE GLYCOL 
GLYCERIN 
PROPANEDIOL 
BETA CAROTENE 
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:43419-301-054.1 g in 1 CYLINDER
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC MONOGRAPH NOT FINALpart35208/01/2011
Labeler - AMOREPACIFIC (687995683)
Establishment
NameAddressID/FEIBusiness Operations
AMOREPACIFIC687995683MANUFACTURE

Revised: 7/2011
Document Id: 134166e7-ffca-4b9b-9053-a9b7a09217d9
Set id: e3a30fa6-287d-4d32-9b84-cf1bbd1fce48
Version: 1
Effective Time: 20110722
 
AMOREPACIFIC