IOPE PERFECT SKIN COVER CAKE  21 LIGHT BEIGE- octinoxate, titanium dioxide, and zinc oxide cream 
IOPE PERFECT SKIN COVER CAKE  23 NATURAL BEIGE- 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 PERFECT SKIN COVER CAKE

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

TITANIUM DIOXIDE (CI 77891), WATER, CYCLOPENTASILOXANE, BUTYLENE GLYCOL DICAPRYLATE/DICAPRATE, HYDROGENATED POLYDECENE, CAPRYLIC/CAPRIC TRIGLYCERIDE, CYCLOHEXASILOXANE, GLYCERIN, BUTYLENE GLYCOL, BARIUM SULFATE, OZOKERITE, POLYETHYLENE, IRON OXIDES (CI 77492), SORBITAN ISOSTEARATE, CETYL PEG/PPG-10/1 DIMETHICONE, POLYMETHYL METHACRYLATE, HDI/ TRIMETHYLOL HEXYLLACTONE CROSSPOLYMER, SORBITAN SESQUIOLEATE, VP/HEXADECENE COPOLYMER, ALUMINUM HYDROXIDE, CERESIN, SODIUM CHLORIDE, LAURYL PEG-9 POLYDIMETHYLSILOXYETHYL DIMETHICONE, POLYPROPYLSILSESQUIOXANE, DISTEARDIMONIUM HECTORITE, STEARIC ACID, POLYHYDROXYSTEARIC ACID, BORON NITRIDE, GLYCERYL CAPRYLATE, DISODIUM EDTA, TRIETHOXYCAPRYLYLSILANE, ADENOSINE, ISOSTEARIC ACID, LECITHIN, ISOPROPYL PALMITATE, ETHYLHEXYL PALMITATE, ALCOHOL, SILICA, POLYGLYCERYL-3 POLYRICINOLEATE, MAGNESIUM MYRISTATE, SODIUM HYALURONATE, SODIUM ACRYLATE/ VINYL ALCOHOL COPOLYMER, SODIUM ACRYLIC ACID/MA COPOLYMER, HEXANEDIOL, CAPRYLYL GLYCOL, ZINC OXIDE (CI 77947), 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 - 14 g Container Carton - 21 Light Beige

IOPE

PERFECT SKIN
COVER CAKE

SUNSCREEN
BROAD SPECTRUM
SPF 32
HYALURONIC FORMULA

Net wt. 14 g/0.4 OZ.

PRINCIPAL DISPLAY PANEL - 14 g Container Carton - 21 Light Beige

PRINCIPAL DISPLAY PANEL - 14 g Container Carton - 23 Natural Beige

IOPE

PERFECT SKIN
COVER CAKE

SUNSCREEN
BROAD SPECTRUM
SPF 32
HYALURONIC FORMULA

Net wt. 14 g/0.4 OZ.

PRINCIPAL DISPLAY PANEL - 14 g Container Carton - 23 Natural Beige
IOPE PERFECT SKIN COVER CAKE   21 LIGHT BEIGE
octinoxate, titanium dioxide, and zinc oxide cream
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:43419-388
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
OCTINOXATE (UNII: 4Y5P7MUD51) (OCTINOXATE - UNII:4Y5P7MUD51) OCTINOXATE0.7 g  in 14 g
TITANIUM DIOXIDE (UNII: 15FIX9V2JP) (TITANIUM DIOXIDE - UNII:15FIX9V2JP) TITANIUM DIOXIDE0.3486 g  in 14 g
ZINC OXIDE (UNII: SOI2LOH54Z) (ZINC OXIDE - UNII:SOI2LOH54Z) ZINC OXIDE0.2744 g  in 14 g
Inactive Ingredients
Ingredient NameStrength
WATER (UNII: 059QF0KO0R)  
CYCLOMETHICONE 5 (UNII: 0THT5PCI0R)  
BUTYLENE GLYCOL DICAPRYLATE/DICAPRATE (UNII: 75D21FL1PI)  
MEDIUM-CHAIN TRIGLYCERIDES (UNII: C9H2L21V7U)  
CYCLOMETHICONE 6 (UNII: XHK3U310BA)  
GLYCERIN (UNII: PDC6A3C0OX)  
BUTYLENE GLYCOL (UNII: 3XUS85K0RA)  
BARIUM SULFATE (UNII: 25BB7EKE2E)  
HIGH DENSITY POLYETHYLENE (UNII: UG00KM4WR7)  
FERRIC OXIDE YELLOW (UNII: EX438O2MRT)  
SORBITAN ISOSTEARATE (UNII: 01S2G2C1E4)  
HEXAMETHYLENE DIISOCYANATE/TRIMETHYLOL HEXYLLACTONE CROSSPOLYMER (UNII: WB5K9Y35Y9)  
SORBITAN SESQUIOLEATE (UNII: 0W8RRI5W5A)  
VINYLPYRROLIDONE/HEXADECENE COPOLYMER (UNII: KFR5QEN0N9)  
ALUMINUM HYDROXIDE (UNII: 5QB0T2IUN0)  
CERESIN (UNII: Q1LS2UJO3A)  
SODIUM CHLORIDE (UNII: 451W47IQ8X)  
LAURYL PEG-9 POLYDIMETHYLSILOXYETHYL DIMETHICONE (UNII: 25G622K2RA)  
DISTEARDIMONIUM HECTORITE (UNII: X687XDK09L)  
STEARIC ACID (UNII: 4ELV7Z65AP)  
BORON NITRIDE (UNII: 2U4T60A6YD)  
GLYCERYL MONOCAPRYLATE (UNII: TM2TZD4G4A)  
EDETATE DISODIUM (UNII: 7FLD91C86K)  
TRIETHOXYCAPRYLYLSILANE (UNII: LDC331P08E)  
ADENOSINE (UNII: K72T3FS567)  
ISOSTEARIC ACID (UNII: X33R8U0062)  
ISOPROPYL PALMITATE (UNII: 8CRQ2TH63M)  
ETHYLHEXYL PALMITATE (UNII: 2865993309)  
ALCOHOL (UNII: 3K9958V90M)  
SILICON DIOXIDE (UNII: ETJ7Z6XBU4)  
MAGNESIUM MYRISTATE (UNII: Z1917F0578)  
HYALURONATE SODIUM (UNII: YSE9PPT4TH)  
HEXANEDIOL (UNII: ZIA319275I)  
CAPRYLYL GLYCOL (UNII: 00YIU5438U)  
FERRIC OXIDE RED (UNII: 1K09F3G675)  
FERROSOFERRIC OXIDE (UNII: XM0M87F357)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:43419-388-061 in 1 CARTON05/12/201510/01/2018
114 g in 1 CONTAINER; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC MONOGRAPH NOT FINALpart35205/12/201510/01/2018
IOPE PERFECT SKIN COVER CAKE   23 NATURAL BEIGE
octinoxate, titanium dioxide, and zinc oxide cream
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:43419-387
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
OCTINOXATE (UNII: 4Y5P7MUD51) (OCTINOXATE - UNII:4Y5P7MUD51) OCTINOXATE0.7 g  in 14 g
TITANIUM DIOXIDE (UNII: 15FIX9V2JP) (TITANIUM DIOXIDE - UNII:15FIX9V2JP) TITANIUM DIOXIDE0.3486 g  in 14 g
ZINC OXIDE (UNII: SOI2LOH54Z) (ZINC OXIDE - UNII:SOI2LOH54Z) ZINC OXIDE0.2744 g  in 14 g
Inactive Ingredients
Ingredient NameStrength
WATER (UNII: 059QF0KO0R)  
CYCLOMETHICONE 5 (UNII: 0THT5PCI0R)  
BUTYLENE GLYCOL DICAPRYLATE/DICAPRATE (UNII: 75D21FL1PI)  
MEDIUM-CHAIN TRIGLYCERIDES (UNII: C9H2L21V7U)  
CYCLOMETHICONE 6 (UNII: XHK3U310BA)  
GLYCERIN (UNII: PDC6A3C0OX)  
BUTYLENE GLYCOL (UNII: 3XUS85K0RA)  
BARIUM SULFATE (UNII: 25BB7EKE2E)  
HIGH DENSITY POLYETHYLENE (UNII: UG00KM4WR7)  
FERRIC OXIDE YELLOW (UNII: EX438O2MRT)  
SORBITAN ISOSTEARATE (UNII: 01S2G2C1E4)  
HEXAMETHYLENE DIISOCYANATE/TRIMETHYLOL HEXYLLACTONE CROSSPOLYMER (UNII: WB5K9Y35Y9)  
SORBITAN SESQUIOLEATE (UNII: 0W8RRI5W5A)  
VINYLPYRROLIDONE/HEXADECENE COPOLYMER (UNII: KFR5QEN0N9)  
ALUMINUM HYDROXIDE (UNII: 5QB0T2IUN0)  
CERESIN (UNII: Q1LS2UJO3A)  
SODIUM CHLORIDE (UNII: 451W47IQ8X)  
LAURYL PEG-9 POLYDIMETHYLSILOXYETHYL DIMETHICONE (UNII: 25G622K2RA)  
DISTEARDIMONIUM HECTORITE (UNII: X687XDK09L)  
STEARIC ACID (UNII: 4ELV7Z65AP)  
BORON NITRIDE (UNII: 2U4T60A6YD)  
GLYCERYL MONOCAPRYLATE (UNII: TM2TZD4G4A)  
EDETATE DISODIUM (UNII: 7FLD91C86K)  
TRIETHOXYCAPRYLYLSILANE (UNII: LDC331P08E)  
ADENOSINE (UNII: K72T3FS567)  
ISOSTEARIC ACID (UNII: X33R8U0062)  
ISOPROPYL PALMITATE (UNII: 8CRQ2TH63M)  
ETHYLHEXYL PALMITATE (UNII: 2865993309)  
ALCOHOL (UNII: 3K9958V90M)  
SILICON DIOXIDE (UNII: ETJ7Z6XBU4)  
MAGNESIUM MYRISTATE (UNII: Z1917F0578)  
HYALURONATE SODIUM (UNII: YSE9PPT4TH)  
HEXANEDIOL (UNII: ZIA319275I)  
CAPRYLYL GLYCOL (UNII: 00YIU5438U)  
FERRIC OXIDE RED (UNII: 1K09F3G675)  
FERROSOFERRIC OXIDE (UNII: XM0M87F357)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:43419-387-061 in 1 CARTON05/12/201510/01/2018
114 g in 1 CONTAINER; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC MONOGRAPH NOT FINALpart35205/12/201510/01/2018
Labeler - Amorepacific Corporation (631035289)

Revised: 10/2018
 
Amorepacific Corporation