IOPE CC Cream

IOPE CC Cream

Drug Labeling and Warnings

Drug Details

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IOPE CC NO. 1- octinoxate, titanium dioxide, and zinc oxide cream 
IOPE CC NO. 2- octinoxate, titanium dioxide, and zinc oxide cream 
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 CC Cream

Drug Facts

ACTIVE INGREDIENTS

ETHYLHEXYL METHOXYCINNAMATE 5% / TITANIUM DIOXIDE 2.49% / ZINC OXIDE 1.96 %

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.

INACTIVE INGREDIENTS

SACCHAROMYCES FERMENT FILTRATE, WATER, PHENYL TRIMETHICONE, TITANIUM DIOXIDE (CI 77891), CYCLOPENTASILOXANE, BUTYLENE GLYCOL, DIMETHICONE, CETYL ETHYLHEXANOATE, LAURYL PEG-9 POLYDIMETHYLSILOXYETHYL DIMETHICONE, CYCLOHEXASILOXANE, GLYCERIN, ARBUTIN, PEG-10 DIMETHICONE, DISTEARDIMONIUM HECTORITE, SACCHAROMYCES FERMENT, SORBITAN ISOSTEARATE, AMMONIUM ACRYLOYLDIMETHYLTAURATE/VP COPOLYMER, METHYL METHACRYLATE CROSSPOLYMER, BEESWAX, SODIUM CHLORIDE, POLYHYDROXYSTEARIC ACID, RICINUS COMMUNIS (CASTOR) SEED OIL, TRIMETHYLSILOXYSILICATE, ALUMINUM HYDROXIDE, GLYCERYL BEHENATE/EICOSADIOATE, STEARIC ACID, CAPRYLYL GLYCOL, TRIETHOXYCAPRYLYLSILANE, POLYSORBATE 80, HYDROGENATED LECITHIN, HYDROGENATED CASTOR OIL, DISODIUM EDTA, VINYL DIMETHICONE/METHICONE SILSESQUIOXANE CROSSPOLYMER, COPERNICIA CERIFERA (CARNAUBA) WAX, ADENOSINE, ETHYLHEXYLGLYCERIN, PHENOXYETHANOL, IRON OXIDES (CI 77492), IRON OXIDES (CI 77491), IRON OXIDES (CI 77499), FRAGRANCE

OTHER INFORMATION

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

PRINCIPAL DISPLAY PANEL - 35 mL Tube Carton - 01 Clear Beige

IOPE

CC CREAM

COMPLETE CARE CREAM

SUNSCREEN
BROAD SPECTRUM
[SPF 35]

Bio-redox™

CLEAR AND SMOOTH SKIN
THROUGH THE SKIN CONDITIONING

01 CLEAR BEIGE

35 ml / 1.1 FL.OZ.

PRINCIPAL DISPLAY PANEL - 35 mL Tube Carton - 01 Clear Beige

PRINCIPAL DISPLAY PANEL - 35 mL Tube Carton - 02 Natural Beige

IOPE

CC CREAM

COMPLETE CARE CREAM

SUNSCREEN
BROAD SPECTRUM
[SPF 35]

Bio-redox™

CLEAR AND SMOOTH SKIN
THROUGH THE SKIN CONDITIONING

02 NATURAL BEIGE

35 ml / 1.1 FL.OZ.

PRINCIPAL DISPLAY PANEL - 35 mL Tube Carton - 02 Natural Beige
IOPE CC NO. 1 
octinoxate, titanium dioxide, and zinc oxide cream
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC: 43419-351
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 DIOXIDE0.8715 g  in 35 mL
ZINC OXIDE (UNII: SOI2LOH54Z) (ZINC OXIDE - UNII:SOI2LOH54Z) ZINC OXIDE0.686 g  in 35 mL
Inactive Ingredients
Ingredient NameStrength
WATER (UNII: 059QF0KO0R)  
PHENYL TRIMETHICONE (UNII: DR0K5NOJ4R)  
CYCLOMETHICONE 5 (UNII: 0THT5PCI0R)  
BUTYLENE GLYCOL (UNII: 3XUS85K0RA)  
DIMETHICONE (UNII: 92RU3N3Y1O)  
CETYL ETHYLHEXANOATE (UNII: 134647WMX4)  
LAURYL PEG-9 POLYDIMETHYLSILOXYETHYL DIMETHICONE (UNII: 25G622K2RA)  
CYCLOMETHICONE 6 (UNII: XHK3U310BA)  
GLYCERIN (UNII: PDC6A3C0OX)  
ARBUTIN (UNII: C5INA23HXF)  
PEG-14 DIMETHICONE (UNII: G7DL1Y4G26)  
DISTEARDIMONIUM HECTORITE (UNII: X687XDK09L)  
SORBITAN ISOSTEARATE (UNII: 01S2G2C1E4)  
AMMONIUM ACRYLOYLDIMETHYLTAURATE/VP COPOLYMER (UNII: W59H9296ZG)  
YELLOW WAX (UNII: 2ZA36H0S2V)  
SODIUM CHLORIDE (UNII: 451W47IQ8X)  
CASTOR OIL (UNII: D5340Y2I9G)  
ALUMINUM HYDROXIDE (UNII: 5QB0T2IUN0)  
GLYCERYL BEHENATE/EICOSADIOATE (UNII: 73CJJ317SR)  
STEARIC ACID (UNII: 4ELV7Z65AP)  
CAPRYLYL GLYCOL (UNII: 00YIU5438U)  
TRIETHOXYCAPRYLYLSILANE (UNII: LDC331P08E)  
POLYSORBATE 80 (UNII: 6OZP39ZG8H)  
HYDROGENATED SOYBEAN LECITHIN (UNII: H1109Z9J4N)  
HYDROGENATED CASTOR OIL (UNII: ZF94AP8MEY)  
EDETATE DISODIUM (UNII: 7FLD91C86K)  
CARNAUBA WAX (UNII: R12CBM0EIZ)  
ADENOSINE (UNII: K72T3FS567)  
ETHYLHEXYLGLYCERIN (UNII: 147D247K3P)  
PHENOXYETHANOL (UNII: HIE492ZZ3T)  
FERRIC OXIDE YELLOW (UNII: EX438O2MRT)  
FERRIC OXIDE RED (UNII: 1K09F3G675)  
FERROSOFERRIC OXIDE (UNII: XM0M87F357)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC: 43419-351-271 in 1 CARTON10/20/2014
135 mL in 1 TUBE; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC MONOGRAPH NOT FINALpart35210/20/2014
IOPE CC NO. 2 
octinoxate, titanium dioxide, and zinc oxide cream
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC: 43419-352
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 DIOXIDE0.8715 g  in 35 mL
ZINC OXIDE (UNII: SOI2LOH54Z) (ZINC OXIDE - UNII:SOI2LOH54Z) ZINC OXIDE0.686 g  in 35 mL
Inactive Ingredients
Ingredient NameStrength
WATER (UNII: 059QF0KO0R)  
PHENYL TRIMETHICONE (UNII: DR0K5NOJ4R)  
CYCLOMETHICONE 5 (UNII: 0THT5PCI0R)  
BUTYLENE GLYCOL (UNII: 3XUS85K0RA)  
DIMETHICONE (UNII: 92RU3N3Y1O)  
CETYL ETHYLHEXANOATE (UNII: 134647WMX4)  
LAURYL PEG-9 POLYDIMETHYLSILOXYETHYL DIMETHICONE (UNII: 25G622K2RA)  
CYCLOMETHICONE 6 (UNII: XHK3U310BA)  
ARBUTIN (UNII: C5INA23HXF)  
GLYCERIN (UNII: PDC6A3C0OX)  
DISTEARDIMONIUM HECTORITE (UNII: X687XDK09L)  
PEG-14 DIMETHICONE (UNII: G7DL1Y4G26)  
SORBITAN ISOSTEARATE (UNII: 01S2G2C1E4)  
AMMONIUM ACRYLOYLDIMETHYLTAURATE/VP COPOLYMER (UNII: W59H9296ZG)  
YELLOW WAX (UNII: 2ZA36H0S2V)  
SODIUM CHLORIDE (UNII: 451W47IQ8X)  
CASTOR OIL (UNII: D5340Y2I9G)  
ALUMINUM HYDROXIDE (UNII: 5QB0T2IUN0)  
GLYCERYL BEHENATE/EICOSADIOATE (UNII: 73CJJ317SR)  
STEARIC ACID (UNII: 4ELV7Z65AP)  
CAPRYLYL GLYCOL (UNII: 00YIU5438U)  
TRIETHOXYCAPRYLYLSILANE (UNII: LDC331P08E)  
POLYSORBATE 80 (UNII: 6OZP39ZG8H)  
HYDROGENATED SOYBEAN LECITHIN (UNII: H1109Z9J4N)  
ETHYLHEXYLGLYCERIN (UNII: 147D247K3P)  
HYDROGENATED CASTOR OIL (UNII: ZF94AP8MEY)  
EDETATE DISODIUM (UNII: 7FLD91C86K)  
ADENOSINE (UNII: K72T3FS567)  
CARNAUBA WAX (UNII: R12CBM0EIZ)  
PHENOXYETHANOL (UNII: HIE492ZZ3T)  
FERRIC OXIDE YELLOW (UNII: EX438O2MRT)  
FERRIC OXIDE RED (UNII: 1K09F3G675)  
FERROSOFERRIC OXIDE (UNII: XM0M87F357)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC: 43419-352-271 in 1 CARTON10/20/2014
135 mL in 1 TUBE; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC MONOGRAPH NOT FINALpart35210/20/2014
Labeler - AMOREPACIFIC CORPORATION (631035289)
Establishment
NameAddressID/FEIBusiness Operations
AMOREPACIFIC CORPORATION694894112MANUFACTURE(43419-351, 43419-352)

Revised: 7/2018
 
AMOREPACIFIC CORPORATION


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