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

IOPE CC no. 2 by

Drug Labeling and Warnings

IOPE CC no. 2 by is a Otc medication manufactured, distributed, or labeled by AMOREPACIFIC CORPORATION. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

SPL UNCLASSIFIED SECTION

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 - 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.

INGREDIENTS AND APPEARANCE

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

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 43419-351
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
OCTINOXATE (UNII: 4Y5P7MUD51) (OCTINOXATE - UNII:4Y5P7MUD51)	OCTINOXATE	1.75 g  in 35 mL
TITANIUM DIOXIDE (UNII: 15FIX9V2JP) (TITANIUM DIOXIDE - UNII:15FIX9V2JP)	TITANIUM DIOXIDE	0.8715 g  in 35 mL
ZINC OXIDE (UNII: SOI2LOH54Z) (ZINC OXIDE - UNII:SOI2LOH54Z)	ZINC OXIDE	0.686 g  in 35 mL

Inactive Ingredients
Ingredient Name	Strength
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 Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 43419-351-27	1 in 1 CARTON	10/20/2014	12/01/2020
1		35 mL in 1 TUBE; Type 0: Not a Combination Product

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph not final	part352	10/20/2014	12/31/2020

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

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 43419-352
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
OCTINOXATE (UNII: 4Y5P7MUD51) (OCTINOXATE - UNII:4Y5P7MUD51)	OCTINOXATE	1.75 g  in 35 mL
TITANIUM DIOXIDE (UNII: 15FIX9V2JP) (TITANIUM DIOXIDE - UNII:15FIX9V2JP)	TITANIUM DIOXIDE	0.8715 g  in 35 mL
ZINC OXIDE (UNII: SOI2LOH54Z) (ZINC OXIDE - UNII:SOI2LOH54Z)	ZINC OXIDE	0.686 g  in 35 mL

Inactive Ingredients
Ingredient Name	Strength
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 Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 43419-352-27	1 in 1 CARTON	10/20/2014	12/31/2020
1		35 mL in 1 TUBE; Type 0: Not a Combination Product

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph not final	part352	10/20/2014	12/31/2020

Labeler - AMOREPACIFIC CORPORATION (631035289)

Establishment
Name	Address	ID/FEI	Business Operations
AMOREPACIFIC CORPORATION		694894112	manufacture(43419-351, 43419-352)