IOPE SUPER VITAL EXTRA MOIST FOUNDATION NO. 21 SPF12 PA PLUS

Dosage form: lotion
Ingredients: TITANIUM DIOXIDE 0.287g in 35mL, OCTINOXATE 1.75g in 35mL
Labeler: AMOREPACIFIC
NDC Code: 43419-371

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 FOUNDATION

Drug Facts

ACTIVE INGREDIENTS

ETHYLHEXYL METHOXYCINNAMATE 5%
TITANIUM DIOXIDE 0.82%

PURPOSE

Sunscreen

USES

Helps prevent sunburn. If used as directed with other sun protection measures (see Directions), decreases the risk of skin cancer and early skin aging caused by the sun.

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

Other information

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

INACTIVE INGREDIENTS

WATER, TITANIUM DIOXIDE (CI 77891), CYCLOPENTASILOXANE, BUTYLENE GLYCOL DICAPRYLATE/ DICAPRATE, BUTYLENE GLYCOL, PROPYLENE GLYCOL, CYCLOHEXASILOXANE, DIMETHICONE, LAURYL POLYGLYCERYL-3 POLYDIMETHYLSILOXYETHYL DIMETHICONE, POLYMETHYL METHACRYLATE, LAURYL PEG-9 POLYDIMETHYLSILOXYETHYL DIMETHICONE, SODIUM CHLORIDE, TRIBEHENIN, IRON OXIDES (CI 77492), DIMETHICONE/VINYL DIMETHICONE CROSSPOLYMER, LAURYL PEG/ PPG-18/18 METHICONE, TALC, DISTEARDIMONIUM HECTORITE, ASTROCARYUM MURUMURU SEED BUTTER, POLYHYDROXYSTEARIC ACID, ALUMINUM HYDROXIDE, SILICA, IRON OXIDES (CI 77491), TRIETHOXYCAPRYLYLSILANE, FRAGRANCE, LECITHIN, ETHYLHEXYL PALMITATE, ISOSTEARIC ACID, ISOPROPYL PALMITATE, CAPRYLYL GLYCOL, ETHYLHEXYLGLYCERIN, IRON OXIDES (CI 77499), STEARIC ACID, POLYGLYCERYL-3 POLYRICINOLEATE, DISODIUM EDTA, CAMELLIA SINENSIS LEAF EXTRACT, SYNTHETIC FLUORPHLOGOPITE, RIBES NIGRUM (BLACK CURRANT) SEED OIL, GLYCERIN, COPERNICIA CERIFERA (CARNAUBA) WAX, PROPANEDIOL, PENTYLENE GLYCOL, UBIQUINONE, DECYL GLUCOSIDE, CALCIUM PANTETHEINE SULFONATE, AMMONIUM ACRYLOYLDIMETHYLTAURATE/VP COPOLYMER, TOCOPHEROL, PEG-60 HYDROGENATED CASTOR OIL, BETAGLUCAN, 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, ALCOHOL, HYDROLYZED MILLET, BETACAROTENE, ZINC DNA, CHOLESTERYL HEXYL DICARBAMATE PULLULAN, COPPER TRIPEPTIDE-1

PRINCIPAL DISPLAY PANEL - 35 ml Container Carton - #21

IOPE

IOPE

SUPER VITAL
EXTRA MOIST FOUNDATION

SUNSCREEN
BROAD SPECTRUM
[SPF 12]

35 ml / 1.1 FL.OZ.

PRINCIPAL DISPLAY PANEL - 35 ml Container Carton - #23

IOPE

IOPE

SUPER VITAL
EXTRA MOIST FOUNDATION

SUNSCREEN
BROAD SPECTRUM
[SPF 12]

35 ml / 1.1 FL.OZ.

IOPE SUPER VITAL   EXTRA MOIST FOUNDATION NO. 21 SPF12 PA PLUS
titanium dioxide and octinoxate lotion
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:43419-371
Route of AdministrationTOPICALDEA Schedule    
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
TITANIUM DIOXIDE (TITANIUM DIOXIDE) TITANIUM DIOXIDE0.287 g  in 35 mL
OCTINOXATE (OCTINOXATE) OCTINOXATE1.75 g  in 35 mL
Inactive Ingredients
Ingredient NameStrength
WATER 
CYCLOMETHICONE 5 
BUTYLENE GLYCOL 
PROPYLENE GLYCOL 
CYCLOMETHICONE 6 
DIMETHICONE 
SODIUM CHLORIDE 
TRIBEHENIN 
FERRIC OXIDE YELLOW 
TALC 
ASTROCARYUM MURUMURU SEED BUTTER 
ALUMINUM HYDROXIDE 
SILICON DIOXIDE 
FERRIC OXIDE RED 
TRIETHOXYCAPRYLYLSILANE 
ETHYLHEXYL PALMITATE 
ISOPROPYL PALMITATE 
ISOSTEARIC ACID 
CAPRYLYL GLYCOL 
ETHYLHEXYLGLYCERIN 
FERROSOFERRIC OXIDE 
STEARIC ACID 
EDETATE DISODIUM 
GREEN TEA LEAF 
RIBES NIGRUM SEED OIL 
GLYCERIN 
CARNAUBA WAX 
PROPANEDIOL 
PENTYLENE GLYCOL 
WHEAT GERM OIL 
PURSLANE 
.ALPHA.-TOCOPHEROL 
PEG-60 HYDROGENATED CASTOR OIL 
XANTHAN GUM 
CAFFEIC ACID 
ASCORBIC ACID 
COCOA BUTTER 
ALCOHOL 
.BETA.-CAROTENE 
Packaging
#Item CodePackage Description
1NDC:43419-371-4235 mL 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 FOUNDATION NO. 23 SPF12 PA PLUS
titanium dioxide and octinoxate lotion
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:43419-372
Route of AdministrationTOPICALDEA Schedule    
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
TITANIUM DIOXIDE (TITANIUM DIOXIDE) TITANIUM DIOXIDE0.287 g  in 35 mL
OCTINOXATE (OCTINOXATE) OCTINOXATE1.75 g  in 35 mL
Inactive Ingredients
Ingredient NameStrength
WATER 
CYCLOMETHICONE 5 
BUTYLENE GLYCOL 
PROPYLENE GLYCOL 
CYCLOMETHICONE 6 
DIMETHICONE 
SODIUM CHLORIDE 
TRIBEHENIN 
FERRIC OXIDE YELLOW 
TALC 
ASTROCARYUM MURUMURU SEED BUTTER 
ALUMINUM HYDROXIDE 
SILICON DIOXIDE 
FERRIC OXIDE RED 
TRIETHOXYCAPRYLYLSILANE 
ETHYLHEXYL PALMITATE 
ISOPROPYL PALMITATE 
ISOSTEARIC ACID 
CAPRYLYL GLYCOL 
ETHYLHEXYLGLYCERIN 
FERROSOFERRIC OXIDE 
STEARIC ACID 
EDETATE DISODIUM 
GREEN TEA LEAF 
RIBES NIGRUM SEED OIL 
GLYCERIN 
CARNAUBA WAX 
PROPANEDIOL 
PENTYLENE GLYCOL 
WHEAT GERM OIL 
PURSLANE 
.ALPHA.-TOCOPHEROL 
PEG-60 HYDROGENATED CASTOR OIL 
XANTHAN GUM 
CAFFEIC ACID 
ASCORBIC ACID 
COCOA BUTTER 
ALCOHOL 
.BETA.-CAROTENE 
Packaging
#Item CodePackage Description
1NDC:43419-372-4335 mL 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(43419-371, 43419-372)

Revised: 03/2014
 
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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