IOPE SUPER VITAL EXTRA MOIST FOUNDATION NO.21- octinoxate and titanium dioxide lotion 
IOPE SUPER VITAL EXTRA MOIST FOUNDATION NO.23- octinoxate and titanium dioxide lotion 
Amorepacific Corporation

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 SUPER VITAL EXTRA MOIST FOUNDATION

Drug Facts

ACTIVE INGREDIENTS

ETHYLHEXYL METHOXYCINNAMATE 5%
TITANIUM DIOXIDE 1%

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, DIMETHICONE/VINYL DIMETHICONE CROSSPOLYMER, TALC, LAURYL PEG/PPG-18/18 METHICONE, DISTEARDIMONIUM HECTORITE, ASTROCARYUM MURUMURU SEED BUTTER, POLYHYDROXYSTEARIC ACID, ALUMINUM HYDROXIDE, SILICA, TRIETHOXYCAPRYLYLSILANE, LECITHIN, ETHYLHEXYL PALMITATE, ISOSTEARIC ACID, ISOPROPYL PALMITATE, CAPRYLYL GLYCOL, ETHYLHEXYLGLYCERIN, 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, PORTULACA OLERACEA EXTRACT, BETA-GLUCAN, XANTHAN GUM, METHOXY PEG-114/POLYEPSILON CAPROLACTONE, ASCORBIC ACID, CAFFEIC ACID, ACRYLATES/AMMONIUM METHACRYLATE COPOLYMER, THEOBROMA CACAO (COCOA) EXTRACT, TOCOPHERYLACETATE, POLYACRYLIC ACID, ALCOHOL, HYDROLYZED MILLET, BETA-CAROTENE, ZINC DNA, CHOLESTERYL HEXYL DICARBAMATE PULLULAN, COPPER TRIPEPTIDE-1, FRAGRANCE, IRON OXIDES (CI 77492), IRON OXIDES (CI 77491), IRON OXIDES (CI 77499)

PRINCIPAL DISPLAY PANEL - 35 ml Bottle Container - No.21

IOPE

IOPE

SUPER VITAL
EXTRA MOIST FOUNDATION

SUNSCREEN
BROAD SPECTRUM
[SPF 12]

35 ml / 1.1 FL.OZ.

PRINCIPAL DISPLAY PANEL - 35 ml Bottle Container - No.21

PRINCIPAL DISPLAY PANEL - 35 ml Bottle Container - No.23

IOPE

IOPE

SUPER VITAL
EXTRA MOIST FOUNDATION

SUNSCREEN
BROAD SPECTRUM
[SPF 12]

35 ml / 1.1 FL.OZ.

PRINCIPAL DISPLAY PANEL - 35 ml Bottle Container - No.23
IOPE SUPER VITAL EXTRA MOIST FOUNDATION NO.21 
octinoxate and titanium dioxide lotion
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:43419-409
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
OCTINOXATE (UNII: 4Y5P7MUD51) (OCTINOXATE - UNII:4Y5P7MUD51) OCTINOXATE1.75 g  in 35 mL
TITANIUM DIOXIDE (UNII: 15FIX9V2JP) (TITANIUM DIOXIDE - UNII:15FIX9V2JP) TITANIUM DIOXIDE0.35 g  in 35 mL
Inactive Ingredients
Ingredient NameStrength
WATER (UNII: 059QF0KO0R)  
CYCLOMETHICONE 5 (UNII: 0THT5PCI0R)  
BUTYLENE GLYCOL DICAPRYLATE/DICAPRATE (UNII: 75D21FL1PI)  
BUTYLENE GLYCOL (UNII: 3XUS85K0RA)  
PROPYLENE GLYCOL (UNII: 6DC9Q167V3)  
CYCLOMETHICONE 6 (UNII: XHK3U310BA)  
DIMETHICONE (UNII: 92RU3N3Y1O)  
POLY(METHYL METHACRYLATE; 450000 MW) (UNII: Z47NNT4J11)  
LAURYL PEG-9 POLYDIMETHYLSILOXYETHYL DIMETHICONE (UNII: 25G622K2RA)  
SODIUM CHLORIDE (UNII: 451W47IQ8X)  
TRIBEHENIN (UNII: 8OC9U7TQZ0)  
FERRIC OXIDE YELLOW (UNII: EX438O2MRT)  
LAURYL PEG/PPG-18/18 METHICONE (UNII: ZJ5S27D9NX)  
TALC (UNII: 7SEV7J4R1U)  
DISTEARDIMONIUM HECTORITE (UNII: X687XDK09L)  
ASTROCARYUM MURUMURU SEED BUTTER (UNII: 12V64UPU6R)  
ALUMINUM HYDROXIDE (UNII: 5QB0T2IUN0)  
SILICON DIOXIDE (UNII: ETJ7Z6XBU4)  
FERRIC OXIDE RED (UNII: 1K09F3G675)  
TRIETHOXYCAPRYLYLSILANE (UNII: LDC331P08E)  
ETHYLHEXYL PALMITATE (UNII: 2865993309)  
ISOSTEARIC ACID (UNII: X33R8U0062)  
ISOPROPYL PALMITATE (UNII: 8CRQ2TH63M)  
CAPRYLYL GLYCOL (UNII: 00YIU5438U)  
ETHYLHEXYLGLYCERIN (UNII: 147D247K3P)  
FERROSOFERRIC OXIDE (UNII: XM0M87F357)  
STEARIC ACID (UNII: 4ELV7Z65AP)  
EDETATE DISODIUM ANHYDROUS (UNII: 8NLQ36F6MM)  
GREEN TEA LEAF (UNII: W2ZU1RY8B0)  
RIBES NIGRUM SEED OIL (UNII: GKE1188837)  
GLYCERIN (UNII: PDC6A3C0OX)  
CARNAUBA WAX (UNII: R12CBM0EIZ)  
PROPANEDIOL (UNII: 5965N8W85T)  
PENTYLENE GLYCOL (UNII: 50C1307PZG)  
UBIDECARENONE (UNII: EJ27X76M46)  
DECYL GLUCOSIDE (UNII: Z17H97EA6Y)  
AMMONIUM ACRYLOYLDIMETHYLTAURATE/VP COPOLYMER (UNII: W59H9296ZG)  
TOCOPHEROL (UNII: R0ZB2556P8)  
PEG-60 HYDROGENATED CASTOR OIL (UNII: 02NG325BQG)  
PURSLANE (UNII: M6S840WXG5)  
XANTHAN GUM (UNII: TTV12P4NEE)  
ASCORBIC ACID (UNII: PQ6CK8PD0R)  
CAFFEIC ACID (UNII: U2S3A33KVM)  
COCOA (UNII: D9108TZ9KG)  
.ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)  
ALCOHOL (UNII: 3K9958V90M)  
.BETA.-CAROTENE (UNII: 01YAE03M7J)  
PREZATIDE COPPER (UNII: 6BJQ43T1I9)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:43419-409-031 in 1 CONTAINER01/02/201810/01/2018
135 mL in 1 BOTTLE, PUMP; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph not finalpart35201/02/201810/01/2018
IOPE SUPER VITAL EXTRA MOIST FOUNDATION NO.23 
octinoxate and titanium dioxide lotion
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:43419-410
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
OCTINOXATE (UNII: 4Y5P7MUD51) (OCTINOXATE - UNII:4Y5P7MUD51) OCTINOXATE1.75 g  in 35 mL
TITANIUM DIOXIDE (UNII: 15FIX9V2JP) (TITANIUM DIOXIDE - UNII:15FIX9V2JP) TITANIUM DIOXIDE0.35 g  in 35 mL
Inactive Ingredients
Ingredient NameStrength
WATER (UNII: 059QF0KO0R)  
CYCLOMETHICONE 5 (UNII: 0THT5PCI0R)  
BUTYLENE GLYCOL DICAPRYLATE/DICAPRATE (UNII: 75D21FL1PI)  
BUTYLENE GLYCOL (UNII: 3XUS85K0RA)  
PROPYLENE GLYCOL (UNII: 6DC9Q167V3)  
CYCLOMETHICONE 6 (UNII: XHK3U310BA)  
DIMETHICONE (UNII: 92RU3N3Y1O)  
LAURYL PEG-9 POLYDIMETHYLSILOXYETHYL DIMETHICONE (UNII: 25G622K2RA)  
POLY(METHYL METHACRYLATE; 450000 MW) (UNII: Z47NNT4J11)  
SODIUM CHLORIDE (UNII: 451W47IQ8X)  
TRIBEHENIN (UNII: 8OC9U7TQZ0)  
FERRIC OXIDE YELLOW (UNII: EX438O2MRT)  
LAURYL PEG/PPG-18/18 METHICONE (UNII: ZJ5S27D9NX)  
TALC (UNII: 7SEV7J4R1U)  
DISTEARDIMONIUM HECTORITE (UNII: X687XDK09L)  
ASTROCARYUM MURUMURU SEED BUTTER (UNII: 12V64UPU6R)  
ALUMINUM HYDROXIDE (UNII: 5QB0T2IUN0)  
SILICON DIOXIDE (UNII: ETJ7Z6XBU4)  
FERRIC OXIDE RED (UNII: 1K09F3G675)  
TRIETHOXYCAPRYLYLSILANE (UNII: LDC331P08E)  
FERROSOFERRIC OXIDE (UNII: XM0M87F357)  
ETHYLHEXYL PALMITATE (UNII: 2865993309)  
ISOSTEARIC ACID (UNII: X33R8U0062)  
ISOPROPYL PALMITATE (UNII: 8CRQ2TH63M)  
CAPRYLYL GLYCOL (UNII: 00YIU5438U)  
ETHYLHEXYLGLYCERIN (UNII: 147D247K3P)  
STEARIC ACID (UNII: 4ELV7Z65AP)  
EDETATE DISODIUM ANHYDROUS (UNII: 8NLQ36F6MM)  
GREEN TEA LEAF (UNII: W2ZU1RY8B0)  
RIBES NIGRUM SEED OIL (UNII: GKE1188837)  
GLYCERIN (UNII: PDC6A3C0OX)  
CARNAUBA WAX (UNII: R12CBM0EIZ)  
PROPANEDIOL (UNII: 5965N8W85T)  
PENTYLENE GLYCOL (UNII: 50C1307PZG)  
UBIDECARENONE (UNII: EJ27X76M46)  
DECYL GLUCOSIDE (UNII: Z17H97EA6Y)  
AMMONIUM ACRYLOYLDIMETHYLTAURATE/VP COPOLYMER (UNII: W59H9296ZG)  
TOCOPHEROL (UNII: R0ZB2556P8)  
PEG-60 HYDROGENATED CASTOR OIL (UNII: 02NG325BQG)  
PURSLANE (UNII: M6S840WXG5)  
XANTHAN GUM (UNII: TTV12P4NEE)  
ASCORBIC ACID (UNII: PQ6CK8PD0R)  
CAFFEIC ACID (UNII: U2S3A33KVM)  
COCOA (UNII: D9108TZ9KG)  
.ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)  
ALCOHOL (UNII: 3K9958V90M)  
.BETA.-CAROTENE (UNII: 01YAE03M7J)  
PREZATIDE COPPER (UNII: 6BJQ43T1I9)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:43419-410-031 in 1 CONTAINER01/02/201810/01/2018
135 mL in 1 BOTTLE, PUMP; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph not finalpart35201/02/201810/01/2018
Labeler - Amorepacific Corporation (631035289)

Revised: 10/2018
Document Id: 53763c81-1450-4d8e-99e5-cef3be42ae88
Set id: 8130afad-8886-4f48-a37e-204b18133c54
Version: 2
Effective Time: 20181023
 
Amorepacific Corporation