IOPE RETIGEN MOISTURE TWIN CAKE NO.17

Dosage form: cream
Ingredients: OCTINOXATE 0.84g in 14g, TITANIUM DIOXIDE 0.868g in 14g, ZINC OXIDE 0.4116g in 14g
Labeler: AMOREPACIFIC
NDC Code: 43419-313

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 Facts

ACTIVE INGREDIENTS

ETHYLHEXYL METHOXYCINNAMATE 6%
TITANIUM DIOXIDE 6.20%
ZINC OXIDE 2.94%

PURPOSE

Sunscreen

USE

Helps prevent sunburn

WARNINGS

Skin Cancer/Skin Aging Alert

Spending time in the sun increases your risk of skin cancer and early skin aging. This product has been shown only to prevent sunburn, not skin cancer or early skin aging.

For external use only.

Do not use on damaged or broken skin.

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

Stop use and ask a doctor if rash occurs.

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

DIRECTIONS

Apply liberally 15 minutes before sun exposure. Reapply at least every 2 hours. Use a water-resistant sunscreen if swimming or sweating. Children under 6 months of age: Ask a doctor

INACTIVE INGREDIENTS

MICA (CI 77019), TALC, TITANIUM DIOXIDE (CI 77891), SILICA, BORON NITRIDE, POLYMETHYL METHACRYLATE, NYLON-12, DIISOSTEARYL MALATE, TRIETHOXYCAPRYLYLSILANE, PHENYL TRIMETHICONE, METHICONE, ETHYLHEXYLGLYCERIN, LAUROYL LYSINE, ALUMINUM HYDROXIDE, GLYCERYL CAPRYLATE, DIMETHICONE/VINYL DIMETHICONE CROSSPOLYMER, DIMETHICONE, WATER, VINYL DIMETHICONE/METHICONE SILSESQUIOXANE CROSSPOLYMER, CAMELLIA SINENSIS LEAF EXTRACT, HYDROLYZED EXTENSIN, ACRYLATES/AMMONIUM METHACRYLATE COPOLYMER, BUTYLENE GLYCOL, POLYACRYLIC ACID, GLYCERIN, PROPANEDIOL, BETACAROTENE, CAPRYLYL GLYCOL, PHENOXYETHANOL, BETA-GLUCAN, POTASSIUM SORBATE, SODIUM BENZOATE, FRAGRANCE, IRON OXIDES (CI 77492), IRON OXIDES (CI 77491), IRON OXIDES (CI 77499), ULTRAMARINES (CI 77007)

Other information

Protect the product in this container from excessive heat and direct sun

PRINCIPAL DISPLAY PANEL - 12 g Container Carton - No.17

IOPE

IOPE

RETIGEN
MOISTURE TWIN CAKE

SUNSCREEN
[SPF 25]

Net wt. 12 g/0.4 OZ.

PRINCIPAL DISPLAY PANEL - 12 g Container Carton - No.21

IOPE

IOPE

RETIGEN
MOISTURE TWIN CAKE

SUNSCREEN
[SPF 25]

Net wt. 12 g/0.4 OZ.

PRINCIPAL DISPLAY PANEL - 12 g Container Carton - No.23

IOPE

IOPE

RETIGEN
MOISTURE TWIN CAKE

SUNSCREEN
[SPF 25]

Net wt. 12 g/0.4 OZ.

IOPE RETIGEN MOISTURE TWIN CAKE NO.17 
octinoxate, titanium dioxide, and zinc oxide cream
Product Information
Product TypeHUMAN OTC DRUGItem 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 DIOXIDE0.868 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 
NYLON-12 
TRIETHOXYCAPRYLYLSILANE 
DIISOSTEARYL MALATE 
FERRIC OXIDE YELLOW 
PHENYL TRIMETHICONE 
FERRIC OXIDE RED 
ETHYLHEXYLGLYCERIN 
LAUROYL LYSINE 
ALUMINUM HYDROXIDE 
GLYCERYL CAPRYLATE 
DIMETHICONE 
WATER 
GREEN TEA LEAF 
FERROSOFERRIC OXIDE 
ULTRAMARINE BLUE 
BUTYLENE GLYCOL 
GLYCERIN 
PROPANEDIOL 
.BETA.-CAROTENE 
CAPRYLYL GLYCOL 
PHENOXYETHANOL 
SODIUM BENZOATE 
POTASSIUM SORBATE 
Packaging
#Item CodePackage Description
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 
octinoxate, titanium dioxide, and zinc oxide cream
Product Information
Product TypeHUMAN OTC DRUGItem 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 DIOXIDE0.868 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 
NYLON-12 
TRIETHOXYCAPRYLYLSILANE 
DIISOSTEARYL MALATE 
FERRIC OXIDE YELLOW 
PHENYL TRIMETHICONE 
FERRIC OXIDE RED 
ETHYLHEXYLGLYCERIN 
LAUROYL LYSINE 
ALUMINUM HYDROXIDE 
GLYCERYL CAPRYLATE 
DIMETHICONE 
WATER 
GREEN TEA LEAF 
FERROSOFERRIC OXIDE 
ULTRAMARINE BLUE 
BUTYLENE GLYCOL 
GLYCERIN 
PROPANEDIOL 
.BETA.-CAROTENE 
CAPRYLYL GLYCOL 
PHENOXYETHANOL 
SODIUM BENZOATE 
POTASSIUM SORBATE 
Packaging
#Item CodePackage Description
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 
octinoxate, titanium dioxide, and zinc oxide cream
Product Information
Product TypeHUMAN OTC DRUGItem 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 DIOXIDE0.868 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 
NYLON-12 
TRIETHOXYCAPRYLYLSILANE 
DIISOSTEARYL MALATE 
FERRIC OXIDE YELLOW 
PHENYL TRIMETHICONE 
FERRIC OXIDE RED 
ETHYLHEXYLGLYCERIN 
LAUROYL LYSINE 
ALUMINUM HYDROXIDE 
GLYCERYL CAPRYLATE 
DIMETHICONE 
WATER 
GREEN TEA LEAF 
FERROSOFERRIC OXIDE 
ULTRAMARINE BLUE 
BUTYLENE GLYCOL 
GLYCERIN 
PROPANEDIOL 
.BETA.-CAROTENE 
CAPRYLYL GLYCOL 
PHENOXYETHANOL 
SODIUM BENZOATE 
POTASSIUM SORBATE 
Packaging
#Item CodePackage Description
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/FEIOperations
AMOREPACIFIC687995683MANUFACTURE(43419-313, 43419-311, 43419-312)

Revised: 01/2014
 
AMOREPACIFIC

Disclaimer: Every effort has been made to ensure that the information provided here is accurate, up-to-date and complete, but no guarantee is made to that effect. Drug information contained herein may be time sensitive. This information has been compiled for use by healthcare practitioners and consumers in the United States. The absence of a warning for a given drug or combination thereof in no way should be construed to indicate that the drug or combination is safe, effective or appropriate for any given patient. If you have questions about the substances you are taking, check with your doctor, nurse or pharmacist.

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