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IOPE SUPER VITAL EXTRA MOIST BASE

Dosage form: lotion
Ingredients: TITANIUM DIOXIDE 0.8715g in 35mL, OCTINOXATE 1.75g in 35mL, ZINC OXIDE 0.343g in 35mL
Labeler: AMOREPACIFIC
NDC Code: 43419-370

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 BASE

Drug Facts

ACTIVE INGREDIENTS
ETHYLHEXYL METHOXYCINNAMATE5%
TITANIUM DIOXIDE2.49%
ZINC OXIDE0.98%

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

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. Sun Protection Measures. Spending time in the sun increases your risk of skin cancer and early skin aging. To decrease this risk, regularly use a sunscreen with a Broad Spectrum SPF value of 15 or higher and other sun protection measures including: Limit time in the sun, especially from 10 a.m. - 2 p.m. wear long-sleeved shirts, pants, hats, and sunglasses. 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, CYCLOPENTASILOXANE, BUTYLENE GLYCOL, CYCLOHEXASILOXANE, ASTROCARYUM MURUMURU SEED BUTTER, GLYCERIN, DICAPRYLYL CARBONATE, TRIETHYLHEXANOIN, SQUALANE, CETYL PEG/PPG-10/1 DIMETHICONE, DISTEARDIMONIUM HECTORITE, VEGETABLE OIL, SILICA, SORBITAN ISOSTEARATE, SODIUM CHLORIDE, HYDROGENATED CASTOR OIL ISOSTEARATE, CALCIUM STEARATE, POLYGLYCERYL-8 STEARATE, ALUMINUM HYDROXIDE, SORBITAN SESQUIOLEATE, DIMETHICONE, ACETYL GLUCOSAMINE, POLYMETHYL METHACRYLATE, SOY STEROL ACETATE, STEARIC ACID, CAPRYLYL GLYCOL, CERAMIDE 3, NIACINAMIDE, PHYTOSPHINGOSINE, TRIETHOXYCAPRYLYLSILANE, ETHYLHEXYLGLYCERIN, DISODIUM EDTA, 1,2-HEXANEDIOL, PHENOXYETHANOL, SYNTHETIC FLUORPHLOGOPITE, RIBES NIGRUM (BLACK CURRANT) SEED OIL, COPERNICIA CERIFERA (CARNAUBA) WAX, HYALURONIC ACID, PENTYLENE GLYCOL, UBIQUINONE, DECYL GLUCOSIDE, CALCIUM PANTETHEINE SULFONATE, AMMONIUM ACRYLOYLDIMETHYLTAURATE/VP COPOLYMER, TOCOPHEROL, PEG-60 HYDROGENATED CASTOR OIL, 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, ZINC DNA, CHOLESTERYL HEXYL DICARBAMATE PULLULAN, COPPER TRIPEPTIDE-1, FRAGRANCE, TITANIUM DIOXIDE (CI 77891), CHROMIUM HYDROXIDE GREEN (CI 77289), ULTRAMARINES (CI 77007), CHROMIUM OXIDE GREENS (CI 77288), IRON OXIDES (CI 77492)

PRINCIPAL DISPLAY PANEL - 35 ml Container Carton

IOPE

IOPE

SUPER VITAL
EXTRA MOIST BASE

SUNSCREEN
BROAD SPECTRUM
[SPF 22]

35 ml/1.1 FL.OZ.

IOPE SUPER VITAL EXTRA MOIST BASE 
titanium dioxide, octinoxate, and zinc oxide lotion
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:43419-370
Route of AdministrationTOPICALDEA Schedule    
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
TITANIUM DIOXIDE (TITANIUM DIOXIDE) TITANIUM DIOXIDE0.8715 g  in 35 mL
OCTINOXATE (OCTINOXATE) OCTINOXATE1.75 g  in 35 mL
ZINC OXIDE (ZINC OXIDE) ZINC OXIDE0.343 g  in 35 mL
Inactive Ingredients
Ingredient NameStrength
WATER 
CYCLOMETHICONE 5 
BUTYLENE GLYCOL 
CYCLOMETHICONE 6 
ASTROCARYUM MURUMURU SEED BUTTER 
GLYCERIN 
DICAPRYLYL CARBONATE 
TRIETHYLHEXANOIN 
SQUALANE 
SILICON DIOXIDE 
SODIUM CHLORIDE 
DISTEARDIMONIUM HECTORITE 
SORBITAN ISOSTEARATE 
CALCIUM STEARATE 
ALUMINUM HYDROXIDE 
SORBITAN SESQUIOLEATE 
N-ACETYLGLUCOSAMINE 
DIMETHICONE 
STEARIC ACID 
CAPRYLYL GLYCOL 
CERAMIDE 3 
NIACINAMIDE 
CHROMIUM HYDROXIDE GREEN 
PHYTOSPHINGOSINE 
TRIETHOXYCAPRYLYLSILANE 
EDETATE DISODIUM 
ETHYLHEXYLGLYCERIN 
ULTRAMARINE BLUE 
1,2-HEXANEDIOL 
CHROMIC OXIDE 
FERRIC OXIDE YELLOW 
RIBES NIGRUM SEED OIL 
CARNAUBA WAX 
HYALURONIC ACID 
PENTYLENE GLYCOL 
UBIDECARENONE 
DECYL GLUCOSIDE 
AMMONIUM ACRYLOYLDIMETHYLTAURATE/VP COPOLYMER 
PEG-60 HYDROGENATED CASTOR OIL 
TOCOPHEROL 
XANTHAN GUM 
ASCORBIC ACID 
COCOA 
ALCOHOL 
.BETA.-CAROTENE 
.ALPHA.-TOCOPHEROL ACETATE 
PREZATIDE COPPER 
PURSLANE 
PHENOXYETHANOL 
CAFFEIC ACID 
Packaging
#Item CodePackage Description
1NDC:43419-370-411 CONTAINER in 1 CARTON
135 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(43419-370)

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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