IOPE SUPER VITAL EXTRA MOIST TWIN PACT NO. 21 SPF25 PA PLUS PLUS

Dosage form: powder
Ingredients: OCTINOXATE 1.08g in 18g, TITANIUM DIOXIDE 1.11744g in 18g, ZINC OXIDE 0.5292g in 18g
Labeler: AMOREPACIFIC
NDC Code: 43419-373

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 SUPER VITAL EXTRA MOIST TWIN PACT

Drug Facts

ACTIVE INGREDIENTS
ETHYLHEXYL METHOXYCINNAMATE6%
TITANIUM DIOXIDE6.208%
ZINC OXIDE2.94%

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 waterresistant sunscreen if swimming or sweating. Children under 6 months of age: Ask a doctor

Other information

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

INACTIVE INGREDIENTS

TALC, SYNTHETIC FLUORPHLOGOPITE, MAGNESIUM POTASSIUM FLUOROSILICATE, SILICA, ETHYLENE/ACRYLIC ACID COPOLYMER, PHYTOSTERYL/BEHENYL/OCTYLDODECYL LAUROYL GLUTAMATE, POLYMETHYLSILSESQUIOXANE, DIMETHICONE/VINYL DIMETHICONE CROSSPOLYMER, TRIETHOXYCAPRYLYLSILANE, DIMETHICONE, BUTYLENE GLYCOL DICAPRYLATE/DICAPRATE, METHICONE, ETHYLHEXYLGLYCERIN, LAUROYL LYSINE, ALUMINUM HYDROXIDE, HYDROGENATED LECITHIN, GLYCERYL CAPRYLATE, ACRYLATES/TRIDECYL ACRYLATE/TRIETHOXYSILYLPROPYL METHACRYLATE/DIMETHICONE METHACRYLATE COPOLYMER, WATER, CAMELLIA SINENSIS LEAF EXTRACT, RIBES NIGRUM (BLACK CURRANT) SEED OIL, GLYCERIN, COPERNICIA CERIFERA (CARNAUBA) WAX, BUTYLENE GLYCOL, PROPANEDIOL, PENTYLENE GLYCOL, UBIQUINONE, DECYL GLUCOSIDE, CALCIUM PANTETHEINE SULFONATE, AMMONIUM ACRYLOYLDIMETHYLTAURATE/VP COPOLYMER, TOCOPHEROL, PEG-60 HYDROGENATED CASTOR OIL, BETA-GLUCAN, PORTULACA OLERACEA EXTRACT, XANTHAN GUM, METHOXY PEG-114/POLYEPSILON CAPROLACTONE, ASCORBIC ACID, CAFFEIC ACID, ACRYLATES/AMMONIUM METHACRYLATE COPOLYMER, THEOBROMA CACAO (COCOA) EXTRACT, TOCOPHERYL ACETATE,POLYACRYLIC ACID, LECITHIN, ALCOHOL, HYDROLYZED MILLET, BETA-CAROTENE, CAPRYLYL GLYCOL, ZINC DNA, COPPER TRIPEPTIDE-1, CHOLESTERYL HEXYL DICARBAMATE PULLULAN, FRAGRANCE, TITANIUM DIOXIDE (CI 77891), MICA (CI 77019), IRON OXIDES (CI 77492), IRON OXIDES (CI 77491), IRON OXIDES (CI 77499), ULTRAMARINES (CI 77007)

PRINCIPAL DISPLAY PANEL - 18 g Container Carton - #21

IOPE

IOPE

SUPER VITAL
EXTRA MOIST TWIN PACT

SUNSCREEN
[SPF 25]

Net wt. 18 g/0.6 OZ.

PRINCIPAL DISPLAY PANEL - 18 g Container Carton - #23

IOPE

IOPE

SUPER VITAL
EXTRA MOIST TWIN PACT

SUNSCREEN
[SPF 25]

Net wt. 18 g/0.6 OZ.

IOPE SUPER VITAL  EXTRA MOIST TWIN PACT NO. 21 SPF25 PA PLUS PLUS
titanium dioxide, octinoxate, and zinc oxide powder
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:43419-373
Route of AdministrationTOPICALDEA Schedule    
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
OCTINOXATE (OCTINOXATE) OCTINOXATE1.08 g  in 18 g
TITANIUM DIOXIDE (TITANIUM DIOXIDE) TITANIUM DIOXIDE1.11744 g  in 18 g
ZINC OXIDE (ZINC OXIDE) ZINC OXIDE0.5292 g  in 18 g
Inactive Ingredients
Ingredient NameStrength
TALC 
MICA 
SILICON DIOXIDE 
FERRIC OXIDE YELLOW 
DIMETHICONE 
TRIETHOXYCAPRYLYLSILANE 
BUTYLENE GLYCOL DICAPRYLATE/DICAPRATE 
FERRIC OXIDE RED 
ETHYLHEXYLGLYCERIN 
LAUROYL LYSINE 
GLYCERYL CAPRYLATE 
FERROSOFERRIC OXIDE 
ULTRAMARINE BLUE 
WATER 
GREEN TEA LEAF 
RIBES NIGRUM SEED OIL 
GLYCERIN 
CARNAUBA WAX 
BUTYLENE GLYCOL 
PROPANEDIOL 
PENTYLENE GLYCOL 
UBIDECARENONE 
DECYL GLUCOSIDE 
AMMONIUM ACRYLOYLDIMETHYLTAURATE/VP COPOLYMER 
PEG-60 HYDROGENATED CASTOR OIL 
TOCOPHEROL 
XANTHAN GUM 
CAFFEIC ACID 
ASCORBIC ACID 
COCOA 
ALCOHOL 
CAPRYLYL GLYCOL 
PREZATIDE COPPER 
.BETA.-CAROTENE 
.ALPHA.-TOCOPHEROL ACETATE 
ALUMINUM HYDROXIDE 
PURSLANE 
Packaging
#Item CodePackage Description
1NDC:43419-373-441 CONTAINER in 1 CARTON
118 g in 1 CONTAINER
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC MONOGRAPH NOT FINALpart35202/01/2011
IOPE SUPER VITAL   EXTRA MOIST TWIN PACT NO. 23 SPF25 PA PLUS PLUS
titanium dioxide, octinoxate, and zinc oxide powder
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:43419-374
Route of AdministrationTOPICALDEA Schedule    
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
OCTINOXATE (OCTINOXATE) OCTINOXATE1.08 g  in 18 g
TITANIUM DIOXIDE (TITANIUM DIOXIDE) TITANIUM DIOXIDE1.11744 g  in 18 g
ZINC OXIDE (ZINC OXIDE) ZINC OXIDE0.5292 g  in 18 g
Inactive Ingredients
Ingredient NameStrength
TALC 
MICA 
SILICON DIOXIDE 
FERRIC OXIDE YELLOW 
DIMETHICONE 
TRIETHOXYCAPRYLYLSILANE 
BUTYLENE GLYCOL DICAPRYLATE/DICAPRATE 
FERRIC OXIDE RED 
ETHYLHEXYLGLYCERIN 
LAUROYL LYSINE 
GLYCERYL CAPRYLATE 
FERROSOFERRIC OXIDE 
ULTRAMARINE BLUE 
WATER 
GREEN TEA LEAF 
RIBES NIGRUM SEED OIL 
GLYCERIN 
CARNAUBA WAX 
BUTYLENE GLYCOL 
PROPANEDIOL 
PENTYLENE GLYCOL 
UBIDECARENONE 
DECYL GLUCOSIDE 
AMMONIUM ACRYLOYLDIMETHYLTAURATE/VP COPOLYMER 
PEG-60 HYDROGENATED CASTOR OIL 
TOCOPHEROL 
XANTHAN GUM 
CAFFEIC ACID 
ASCORBIC ACID 
COCOA 
ALCOHOL 
CAPRYLYL GLYCOL 
PREZATIDE COPPER 
.BETA.-CAROTENE 
.ALPHA.-TOCOPHEROL ACETATE 
ALUMINUM HYDROXIDE 
PURSLANE 
Packaging
#Item CodePackage Description
1NDC:43419-374-451 CONTAINER in 1 CARTON
118 g in 1 CONTAINER
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC MONOGRAPH NOT FINALpart35202/01/2011
Labeler - AMOREPACIFIC (687995683)
Establishment
NameAddressID/FEIOperations
AMOREPACIFIC687995683MANUFACTURE(43419-373, 43419-374)

Revised: 12/2013
 
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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