NDC Code(s) : 43419-412-34, 43419-413-34
Packager : AMOREPACIFIC CORPORATION

Category : HUMAN PRESCRIPTION DRUG LABEL

DEA Schedule : none

Marketing Status : New Drug Application

INGREDIENTS AND APPEARANCE

IOPE Air Cushion Intense Cover 21ZINC OXIDE, OCTINOXATE, and TITANIUM DIOXIDE LOTION
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:43419-412
Route of Administration TOPICAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
ZINC OXIDE(UNII: SOI2LOH54Z)
(ZINC OXIDE - UNII:SOI2LOH54Z) 		ZINC OXIDE1.47 g in 15 g
OCTINOXATE(UNII: 4Y5P7MUD51)
(OCTINOXATE - UNII:4Y5P7MUD51) 		OCTINOXATE1.05 g in 15 g
TITANIUM DIOXIDE(UNII: 15FIX9V2JP)
(TITANIUM DIOXIDE - UNII:15FIX9V2JP) 		TITANIUM DIOXIDE0.6225 g in 15 g
Inactive Ingredients
Ingredient Name Strength
WATER(UNII: 059QF0KO0R)
CYCLOMETHICONE 5(UNII: 0THT5PCI0R)
BUTYLENE GLYCOL DICAPRYLATE/DICAPRATE(UNII: 75D21FL1PI)
PROPANEDIOL(UNII: 5965N8W85T)
CYCLOMETHICONE 6(UNII: XHK3U310BA)
LAURYL PEG-9 POLYDIMETHYLSILOXYETHYL DIMETHICONE(UNII: 25G622K2RA)
NIACINAMIDE(UNII: 25X51I8RD4)
FERRIC OXIDE YELLOW(UNII: EX438O2MRT)
SODIUM CHLORIDE(UNII: 451W47IQ8X)
ALUMINUM HYDROXIDE(UNII: 5QB0T2IUN0)
STEARIC ACID(UNII: 4ELV7Z65AP)
TRIETHOXYCAPRYLYLSILANE(UNII: LDC331P08E)
DIMETHICONE(UNII: 92RU3N3Y1O)
ETHYLHEXYL PALMITATE(UNII: 2865993309)
ISOSTEARIC ACID(UNII: X33R8U0062)
ISOPROPYL PALMITATE(UNII: 8CRQ2TH63M)
FERRIC OXIDE RED(UNII: 1K09F3G675)
CAPRYLYL GLYCOL(UNII: 00YIU5438U)
DISTEARDIMONIUM HECTORITE(UNII: X687XDK09L)
FERROSOFERRIC OXIDE(UNII: XM0M87F357)
ETHYLHEXYLGLYCERIN(UNII: 147D247K3P)
EDETATE DISODIUM ANHYDROUS(UNII: 8NLQ36F6MM)
ADENOSINE(UNII: K72T3FS567)
BUTYLENE GLYCOL(UNII: 3XUS85K0RA)
PIDOLIC ACID(UNII: SZB83O1W42)
LACTIC ACID, UNSPECIFIED FORM(UNII: 33X04XA5AT)
DEXTROSE, UNSPECIFIED FORM(UNII: IY9XDZ35W2)
GLYCINE(UNII: TE7660XO1C)
SILICON DIOXIDE(UNII: ETJ7Z6XBU4)
UREA(UNII: 8W8T17847W)
SODIUM GLYCEROPHOSPHATE(UNII: RCS9EQ01V4)
SERINE(UNII: 452VLY9402)
GLUTAMIC ACID(UNII: 3KX376GY7L)
POTASSIUM MAGNESIUM ASPARTATE(UNII: 55TUI7Q42I)
ASPARTIC ACID(UNII: 30KYC7MIAI)
LEUCINE(UNII: GMW67QNF9C)
ALANINE(UNII: OF5P57N2ZX)
LYSINE(UNII: K3Z4F929H6)
ARGININE(UNII: 94ZLA3W45F)
CALCIUM GLUCONATE(UNII: SQE6VB453K)
MAGNESIUM GLUCONATE(UNII: T42NAD2KHC)
TYROSINE(UNII: 42HK56048U)
PHENYLALANINE(UNII: 47E5O17Y3R)
PROLINE(UNII: 9DLQ4CIU6V)
THREONINE(UNII: 2ZD004190S)
VALINE(UNII: HG18B9YRS7)
ISOLEUCINE(UNII: 04Y7590D77)
CITRIC ACID MONOHYDRATE(UNII: 2968PHW8QP)
HISTIDINE(UNII: 4QD397987E)
N-ACETYLGLUCOSAMINE(UNII: V956696549)
CREATINE(UNII: MU72812GK0)
URIC ACID(UNII: 268B43MJ25)
CYSTEINE(UNII: K848JZ4886)
METHIONINE(UNII: AE28F7PNPL)
PANCRELIPASE LIPASE(UNII: 8MYC33932O)
Packaging
# Item Code Package Description Marketing Start Date Marketing End Date
1NDC:43419-412-341 in 1 POUCH 01/05/2018
115 g in 1 CONTAINER 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 01/02/2018
IOPE Air Cushion Intense Cover 23ZINC OXIDE, OCTINOXATE, and TITANIUM DIOXIDE LOTION
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:43419-413
Route of Administration TOPICAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
ZINC OXIDE(UNII: SOI2LOH54Z)
(ZINC OXIDE - UNII:SOI2LOH54Z) 		ZINC OXIDE1.47 g in 15 g
OCTINOXATE(UNII: 4Y5P7MUD51)
(OCTINOXATE - UNII:4Y5P7MUD51) 		OCTINOXATE1.05 g in 15 g
TITANIUM DIOXIDE(UNII: 15FIX9V2JP)
(TITANIUM DIOXIDE - UNII:15FIX9V2JP) 		TITANIUM DIOXIDE0.6225 g in 15 g
Inactive Ingredients
Ingredient Name Strength
WATER(UNII: 059QF0KO0R)
CYCLOMETHICONE 5(UNII: 0THT5PCI0R)
BUTYLENE GLYCOL DICAPRYLATE/DICAPRATE(UNII: 75D21FL1PI)
PROPANEDIOL(UNII: 5965N8W85T)
CYCLOMETHICONE 6(UNII: XHK3U310BA)
LAURYL PEG-9 POLYDIMETHYLSILOXYETHYL DIMETHICONE(UNII: 25G622K2RA)
NIACINAMIDE(UNII: 25X51I8RD4)
FERRIC OXIDE YELLOW(UNII: EX438O2MRT)
SODIUM CHLORIDE(UNII: 451W47IQ8X)
ALUMINUM HYDROXIDE(UNII: 5QB0T2IUN0)
STEARIC ACID(UNII: 4ELV7Z65AP)
TRIETHOXYCAPRYLYLSILANE(UNII: LDC331P08E)
DIMETHICONE(UNII: 92RU3N3Y1O)
ETHYLHEXYL PALMITATE(UNII: 2865993309)
ISOSTEARIC ACID(UNII: X33R8U0062)
ISOPROPYL PALMITATE(UNII: 8CRQ2TH63M)
FERRIC OXIDE RED(UNII: 1K09F3G675)
CAPRYLYL GLYCOL(UNII: 00YIU5438U)
DISTEARDIMONIUM HECTORITE(UNII: X687XDK09L)
FERROSOFERRIC OXIDE(UNII: XM0M87F357)
ETHYLHEXYLGLYCERIN(UNII: 147D247K3P)
EDETATE DISODIUM ANHYDROUS(UNII: 8NLQ36F6MM)
ADENOSINE(UNII: K72T3FS567)
BUTYLENE GLYCOL(UNII: 3XUS85K0RA)
PIDOLIC ACID(UNII: SZB83O1W42)
LACTIC ACID, UNSPECIFIED FORM(UNII: 33X04XA5AT)
DEXTROSE, UNSPECIFIED FORM(UNII: IY9XDZ35W2)
GLYCINE(UNII: TE7660XO1C)
SILICON DIOXIDE(UNII: ETJ7Z6XBU4)
UREA(UNII: 8W8T17847W)
SODIUM GLYCEROPHOSPHATE(UNII: RCS9EQ01V4)
SERINE(UNII: 452VLY9402)
GLUTAMIC ACID(UNII: 3KX376GY7L)
POTASSIUM MAGNESIUM ASPARTATE(UNII: 55TUI7Q42I)
ASPARTIC ACID(UNII: 30KYC7MIAI)
LEUCINE(UNII: GMW67QNF9C)
ALANINE(UNII: OF5P57N2ZX)
LYSINE(UNII: K3Z4F929H6)
ARGININE(UNII: 94ZLA3W45F)
CALCIUM GLUCONATE(UNII: SQE6VB453K)
MAGNESIUM GLUCONATE(UNII: T42NAD2KHC)
TYROSINE(UNII: 42HK56048U)
PHENYLALANINE(UNII: 47E5O17Y3R)
PROLINE(UNII: 9DLQ4CIU6V)
THREONINE(UNII: 2ZD004190S)
VALINE(UNII: HG18B9YRS7)
ISOLEUCINE(UNII: 04Y7590D77)
CITRIC ACID MONOHYDRATE(UNII: 2968PHW8QP)
HISTIDINE(UNII: 4QD397987E)
N-ACETYLGLUCOSAMINE(UNII: V956696549)
CREATINE(UNII: MU72812GK0)
URIC ACID(UNII: 268B43MJ25)
CYSTEINE(UNII: K848JZ4886)
METHIONINE(UNII: AE28F7PNPL)
PANCRELIPASE LIPASE(UNII: 8MYC33932O)
Packaging
# Item Code Package Description Marketing Start Date Marketing End Date
1NDC:43419-413-341 in 1 POUCH 01/05/2018
115 g in 1 CONTAINER 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 01/02/2018

PRINCIPAL DISPLAY PANEL

REFILL

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AIR CUSHION®

INTENSE COVER

21 VANILLA

BROAD SPECTRUM
SPF 50+ SUNSCREEN

Net wt. 0.52 OZ. / 15 g

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PRINCIPAL DISPLAY PANEL - 15 g Container Pouch - 21 Vanilla

PRINCIPAL DISPLAY PANEL

REFILL

IOPE

AIR CUSHION®

INTENSE COVER

23 BEIGE

BROAD SPECTRUM
SPF 50+ SUNSCREEN

Net wt. 0.52 OZ. / 15 g

Cut here

PRINCIPAL DISPLAY PANEL - 15 g Container Pouch - 23 Beige