IOPE RETIGEN LUMINOUS BASE  SPF34 PA PLUS PLUS- octinoxate, titanium dioxide and zinc oxide lotion 
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 LUMINOUS BASE
[SPF 34/PA++]

Drug Fact

Active ingredients

ETHYLHEXYL METHOXYCINNAMATE7%
TITANIUM DIOXIDE1.66%
ZINC OXIDE1.96%

Purpose

Sunscreen

Use

Helps prevent sunburn

Warnings

For external use only.

When using this product, Keep out of eyes. Rinse with water to remove.

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

Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center right away.

Directions

- After basic care, pump 0.5~1 time on the back of the hand, apply on the face with fingers or a puff in the order of cheeks → forehead → nose → chin, and gently dab on the face.

Inactive ingredients

WATER, METHYL TRIMETHICONE, CYCLOPENTASILOXANE, CYCLOHEXASILOXANE, BUTYLENE GLYCOL, NEOPENTYL GLYCOL DIHEPTANOATE, BUTYLENE GLYCOL DICAPRYLATE/DICAPRATE, LAURYL PEG-9 POLYDIMETHYLSILOXYETHYL DIMETHICONE, ARBUTIN, SODIUM CHLORIDE, POLYMETHYL METHACRYLATE, DISTEARDIMONIUM HECTORITE, HYDROXYPROPYL BISPALMITAMIDE MEA, LAVANDULA STOECHAS EXTRACT, CAMELLIA SINENSIS LEAF EXTRACT, HYDROLYZED EXTENSIN, BETA-CAROTENE, GLYCERIN, PROPANEDIOL, BETA-GLUCAN, SORBITAN ISOSTEARATE, BISISOBUTYL PEG/PPG-10/7/DIMETHICONE COPOLYMER, DIMETHICONE/VINYL DIMETHICONE CROSSPOLYMER, NYLON-12, ALUMINUM HYDROXIDE, CAPRYLYL GLYCOL, BORON NITRIDE, STEARIC ACID, ETHYLHEXYLGLYCERIN, POLYQUATERNIUM-51, ACRYLATES/AMMONIUM METHACRYLATE COPOLYMER, TRIETHOXYCAPRYLYLSILANE, DISODIUM EDTA, ADENOSINE, POLYACRYLIC ACID, PHENOXYETHANOL, VINYL DIMETHICONE/METHICONE SILSESQUIOXANE CROSSPOLYMER, TIN OXIDE, FRAGRANCE, TITANIUM DIOXIDE, MICA, IRON OXIDE (CI 77492), IRON OXIDE (CI 77491)

AMOREPACIFIC US INC.
270 Sylvan Ave. #255
Englewood Cliffs, NJ07632 (4021)

PRINCIPAL DISPLAY PANEL - 35 ml Bottle Carton

IOPE

IOPE
RETIGEN
LUMINOUS BASE

Principal Display Panel - 35 ml Bottle Carton
IOPE RETIGEN LUMINOUS BASE   SPF34 PA PLUS PLUS
octinoxate, titanium dioxide, and zinc oxide lotion
Product Information
Product TypeHUMAN OTC DRUG LABELItem Code (Source)NDC:43419-306
Route of AdministrationTOPICALDEA Schedule    
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
OCTINOXATE (OCTINOXATE) OCTINOXATE2.45 g  in 35 mL
TITANIUM DIOXIDE (TITANIUM DIOXIDE) TITANIUM DIOXIDE0.581 g  in 35 mL
ZINC OXIDE (ZINC OXIDE) ZINC OXIDE0.686 g  in 35 mL
Inactive Ingredients
Ingredient NameStrength
WATER 
METHYL TRIMETHICONE 
CYCLOMETHICONE 5 
CYCLOMETHICONE 6 
BUTYLENE GLYCOL 
NEOPENTYL GLYCOL DIHEPTANOATE 
MICA 
ARBUTIN 
SODIUM CHLORIDE 
ALUMINUM HYDROXIDE 
CAPRYLYL GLYCOL 
BORON NITRIDE 
STEARIC ACID 
ETHYLHEXYLGLYCERIN 
TRIETHOXYCAPRYLYLSILANE 
EDETATE DISODIUM 
ADENOSINE 
FERRIC OXIDE YELLOW 
FERRIC OXIDE RED 
STANNIC OXIDE 
GREEN TEA LEAF 
LAVANDULA STOECHAS FLOWERING TOP 
BETA CAROTENE 
GLYCERIN 
PROPANEDIOL 
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:43419-306-031 in 1 CARTON
135 mL in 1 BOTTLE, PUMP
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: 8/2011
Document Id: 8b6e55da-0270-4366-8f3f-bb49796e84b6
Set id: c911fffa-bc48-4bc7-ab42-1762bf7d091c
Version: 1
Effective Time: 20110804
 
AMOREPACIFIC