IOPE RETIGEN MOISTURE TWIN CAKE NO.17 SPF 25/PA PLUS PLUS- octinoxate, titanium dioxide and zinc oxide cream 
IOPE RETIGEN MOISTURE TWIN CAKE NO.21 SPF 25/PA PLUS PLUS- octinoxate, titanium dioxide and zinc oxide cream 
IOPE RETIGEN MOISTURE TWIN CAKE NO.23 SPF 25/PA PLUS PLUS- octinoxate, titanium dioxide and zinc oxide cream 
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.

----------

IOPE
RETIGEN
MOISTURE TWIN CAKE

Drug Fact

Active ingredients
ETHYLHEXYL METHOXYCINNAMATE6%
TITANIUM DIOXIDE6.208%
ZINC OXIDE2.94%

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

Lightly apply onto the face with the provided puff.

-
Light and bright skin expression: Using the provided puff, pat onto the face.
-
Spot covered skin expression: Using the optional puff, nudge onto the face, and carefully press it onto the skin.

Inactive ingredients

TALC, SILICA, BORON NITRIDE, POLYMETHYL METHACRYLATE, NYLON-12, TRIETHOXYCAPRYLYLSILANE, DIISOSTEARYL MALATE, METHICONE, PHENYL TRIMETHICONE, ETHYLHEXYLGLYCERIN, DIMETHICONE/VINYL DIMETHICONE CROSSPOLYMER, LAUROYL LYSINE, GLYCERYL CAPRYLATE, DIMETHICONE, WATER, VINYL DIMETHICONE/METHICONE SILSESQUIOXANE CROSSPOLYMER, CAMELLIA SINENSIS LEAF EXTRACT, HYDROLYZED EXTENSIN, ACRYLATES/AMMONIUM METHACRYLATE COPOLYMER, BUTYLENE GLYCOL, POLYACRYLIC ACID, GLYCERIN, PROPANEDIOL, BETA-CAROTENE, CAPRYLYL GLYCOL, BETA-GLUCAN, FRAGRANCE, MICA, TITANIUM DIOXIDE, IRON OXIDE (CI 77492), IRON OXIDE (CI 77491), IRON OXIDE (CI 77499), ULTRAMARINES (CI 77007)

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

PRINCIPAL DISPLAY PANEL - 14 g Container Carton NO. 17

IOPE

IOPE
RETIGEN
MOISTURE TWIN CAKE

PRINCIPAL DISPLAY PANEL - 14 Gram Container Carton

PRINCIPAL DISPLAY PANEL - 14 g Container Carton NO. 21

IOPE

IOPE
RETIGEN
MOISTURE TWIN CAKE

PRINCIPAL DISPLAY PANEL - 14 g Container Carton NO. 21

PRINCIPAL DISPLAY PANEL - 14 g Container Carton NO. 23

IOPE

IOPE
RETIGEN
MOISTURE TWIN CAKE

PRINCIPAL DISPLAY PANEL - 14 g Container Carton NO. 23
IOPE RETIGEN MOISTURE TWIN CAKE  NO.17 SPF 25/PA PLUS PLUS
octinoxate, titanium dioxide, and zinc oxide cream
Product Information
Product TypeHUMAN OTC DRUG LABELItem Code (Source)NDC:43419-313
Route of AdministrationTOPICALDEA Schedule    
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
OCTINOXATE (OCTINOXATE) OCTINOXATE0.84 g  in 14 g
TITANIUM DIOXIDE (TITANIUM DIOXIDE) TITANIUM DIOXIDE0.86912 g  in 14 g
ZINC OXIDE (ZINC OXIDE) ZINC OXIDE0.4116 g  in 14 g
Inactive Ingredients
Ingredient NameStrength
MICA 
TALC 
SILICON DIOXIDE 
BORON NITRIDE 
TRIETHOXYCAPRYLYLSILANE 
FERRIC OXIDE YELLOW 
PHENYL TRIMETHICONE 
FERRIC OXIDE RED 
ETHYLHEXYLGLYCERIN 
LAUROYL LYSINE 
GLYCERYL CAPRYLATE 
DIMETHICONE 
WATER 
GREEN TEA LEAF 
FERROSOFERRIC OXIDE 
ULTRAMARINE BLUE 
BUTYLENE GLYCOL 
GLYCERIN 
PROPANEDIOL 
BETA CAROTENE 
CAPRYLYL GLYCOL 
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:43419-313-0614 g in 1 CONTAINER
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC MONOGRAPH NOT FINALpart35208/01/2011
IOPE RETIGEN MOISTURE TWIN CAKE  NO.21 SPF 25/PA PLUS PLUS
octinoxate, titanium dioxide, and zinc oxide cream
Product Information
Product TypeHUMAN OTC DRUG LABELItem Code (Source)NDC:43419-311
Route of AdministrationTOPICALDEA Schedule    
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
OCTINOXATE (OCTINOXATE) OCTINOXATE0.84 g  in 14 g
TITANIUM DIOXIDE (TITANIUM DIOXIDE) TITANIUM DIOXIDE0.86912 g  in 14 g
ZINC OXIDE (ZINC OXIDE) ZINC OXIDE0.4116 g  in 14 g
Inactive Ingredients
Ingredient NameStrength
MICA 
TALC 
SILICON DIOXIDE 
BORON NITRIDE 
TRIETHOXYCAPRYLYLSILANE 
FERRIC OXIDE YELLOW 
PHENYL TRIMETHICONE 
FERRIC OXIDE RED 
ETHYLHEXYLGLYCERIN 
LAUROYL LYSINE 
GLYCERYL CAPRYLATE 
DIMETHICONE 
WATER 
GREEN TEA LEAF 
FERROSOFERRIC OXIDE 
ULTRAMARINE BLUE 
BUTYLENE GLYCOL 
GLYCERIN 
PROPANEDIOL 
BETA CAROTENE 
CAPRYLYL GLYCOL 
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:43419-311-0614 g in 1 CONTAINER
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC MONOGRAPH NOT FINALpart35208/01/2011
IOPE RETIGEN MOISTURE TWIN CAKE  NO.23 SPF 25/PA PLUS PLUS
octinoxate, titanium dioxide, and zinc oxide cream
Product Information
Product TypeHUMAN OTC DRUG LABELItem Code (Source)NDC:43419-312
Route of AdministrationTOPICALDEA Schedule    
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
OCTINOXATE (OCTINOXATE) OCTINOXATE0.84 g  in 14 g
TITANIUM DIOXIDE (TITANIUM DIOXIDE) TITANIUM DIOXIDE0.86912 g  in 14 g
ZINC OXIDE (ZINC OXIDE) ZINC OXIDE0.4116 g  in 14 g
Inactive Ingredients
Ingredient NameStrength
MICA 
TALC 
SILICON DIOXIDE 
BORON NITRIDE 
TRIETHOXYCAPRYLYLSILANE 
FERRIC OXIDE YELLOW 
PHENYL TRIMETHICONE 
FERRIC OXIDE RED 
ETHYLHEXYLGLYCERIN 
LAUROYL LYSINE 
GLYCERYL CAPRYLATE 
DIMETHICONE 
WATER 
GREEN TEA LEAF 
FERROSOFERRIC OXIDE 
ULTRAMARINE BLUE 
BUTYLENE GLYCOL 
GLYCERIN 
PROPANEDIOL 
BETA CAROTENE 
CAPRYLYL GLYCOL 
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:43419-312-0614 g in 1 CONTAINER
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: 89d6f233-9c8f-4972-aad9-94118c70e8b8
Set id: 29457efc-7425-454a-b690-969493afaec0
Version: 1
Effective Time: 20110804
 
AMOREPACIFIC