IOPE RETIGEN MOISTURE BASE  NATURAL YELLOW SPF34 PA PLUS PLUS- octinoxate, titanium dioxide and zinc oxide lotion 
IOPE RETIGEN MOISTURE BASE  NATURAL GREEN 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 MOISTURE 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, CYCLOPENTASILOXANE, CYCLOHEXASILOXANE, PHENYL TRIMETHICONE, LAURYL PEG-9 POLYDIMETHYLSILOXYETHYL DIMETHICONE, BUTYLENE GLYCOL, ARBUTIN, TRIETHYLHEXANOIN, NEOPENTYL GLYCOL DIHEPTANOATE, HDI/TRIMETHYLOL HEXYLLACTONE CROSSPOLYMER, DISTEARDIMONIUM HECTORITE, DIMETHICONE, POLYMETHYL METHACRYLATE, SQUALANE, CAMELLIA SINENSIS LEAF EXTRACT, HYDROLYZED EXTENSIN, SODIUM HYALURONATE, BETA-CAROTENE, BETA-GLUCAN, SODIUM CHLORIDE, VINYL DIMETHICONE/METHICONE SILSESQUIOXANE CROSSPOLYMER, SORBITAN ISOSTEARATE, DIMETHICONE/VINYL DIMETHICONE CROSSPOLYMER, ALUMINUM HYDROXIDE, CALCIUM STEARATE, CAPRYLYL GLYCOL, STEARIC ACID, SORBITAN SESQUIOLEATE, GLYCERIN, TRIETHOXYCAPRYLYLSILANE, ACRYLATES/AMMONIUM METHACRYLATE COPOLYMER, ETHYLHEXYLGLYCERIN, DISODIUM EDTA, SILICA, ADENOSINE, POLYACRYLIC ACID, PROPANEDIOL, PHENOXYETHANOL, ALCOHOL, FRAGRANCE, TITANIUM DIOXIDE, CHROMIUM OXIDE GREENS (CI 77288), ULTRAMARINES (CI 77007) , IRON OXIDE (CI 77492)

AMOREPACIFIC US INC.
270 Sylvan Ave. #255
Englewood Cliffs, NJ07632 (4020)

PRINCIPAL DISPLAY PANEL - 35 ml Carton (natural yellow)

IOPE

IOPE
RETIGEN
MOISTURE BASE

PRINCIPAL DISPLAY PANEL - 35 ml Carton (natural yellow)

PRINCIPAL DISPLAY PANEL - 35 ml Carton (natural green)

IOPE

IOPE
RETIGEN
MOISTURE BASE

PRINCIPAL DISPLAY PANEL - 35 ml Carton (natural green)
IOPE RETIGEN MOISTURE BASE   NATURAL YELLOW SPF34 PA PLUS PLUS
octinoxate, titanium dioxide, and zinc oxide lotion
Product Information
Product TypeHUMAN OTC DRUG LABELItem Code (Source)NDC:43419-304
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 
CYCLOMETHICONE 5 
CYCLOMETHICONE 6 
PHENYL TRIMETHICONE 
BUTYLENE GLYCOL 
TRIETHYLHEXANOIN 
NEOPENTYL GLYCOL DIHEPTANOATE 
ARBUTIN 
DIMETHICONE 
SQUALANE 
SODIUM CHLORIDE 
PHENOXYETHANOL 
ALUMINUM HYDROXIDE 
CALCIUM STEARATE 
CAPRYLYL GLYCOL 
STEARIC ACID 
SORBITAN SESQUIOLEATE 
GLYCERIN 
TRIETHOXYCAPRYLYLSILANE 
FERRIC OXIDE YELLOW 
ETHYLHEXYLGLYCERIN 
EDETATE DISODIUM 
SILICON DIOXIDE 
ADENOSINE 
ALCOHOL 
GREEN TEA LEAF 
HYALURONATE SODIUM 
BETA CAROTENE 
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:43419-304-0335 mL in 1 BOTTLE, PUMP
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC MONOGRAPH NOT FINALpart35208/01/2011
IOPE RETIGEN MOISTURE BASE   NATURAL GREEN SPF34 PA PLUS PLUS
octinoxate, titanium dioxide, and zinc oxide lotion
Product Information
Product TypeHUMAN OTC DRUG LABELItem Code (Source)NDC:43419-305
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 
CYCLOMETHICONE 5 
CYCLOMETHICONE 6 
PHENYL TRIMETHICONE 
BUTYLENE GLYCOL 
TRIETHYLHEXANOIN 
NEOPENTYL GLYCOL DIHEPTANOATE 
ARBUTIN 
DIMETHICONE 
SQUALANE 
SODIUM CHLORIDE 
PHENOXYETHANOL 
ALUMINUM HYDROXIDE 
CALCIUM STEARATE 
CAPRYLYL GLYCOL 
STEARIC ACID 
SORBITAN SESQUIOLEATE 
GLYCERIN 
TRIETHOXYCAPRYLYLSILANE 
FERRIC OXIDE YELLOW 
ETHYLHEXYLGLYCERIN 
EDETATE DISODIUM 
SILICON DIOXIDE 
ADENOSINE 
ALCOHOL 
GREEN TEA LEAF 
HYALURONATE SODIUM 
BETA CAROTENE 
CHROMIC OXIDE 
ULTRAMARINE BLUE 
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:43419-305-0335 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: 697919a0-8b80-4af2-bf69-617ed1650b96
Set id: 300f094c-f6d6-4de8-9210-5c3b6cf728da
Version: 1
Effective Time: 20110804
 
AMOREPACIFIC