NDC Code(s) : 63903-0110-1, 63903-0120-1, 63903-0130-1, 63903-0140-1
Packager : KOSÉ CORPORATION

Category : HUMAN PRESCRIPTION DRUG LABEL

DEA Schedule : none

Marketing Status : New Drug Application

INGREDIENTS AND APPEARANCE

DECORTE SHEER BRILLIANCE 10Octinoxate, Zinc Oxide LOTION
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:63903-0110
Route of Administration TOPICAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
OCTINOXATE(UNII: 4Y5P7MUD51)
(OCTINOXATE - UNII:4Y5P7MUD51) 		OCTINOXATE3.9 g in 50 mL
ZINC OXIDE(UNII: SOI2LOH54Z)
(ZINC OXIDE - UNII:SOI2LOH54Z) 		ZINC OXIDE3.8 g in 50 mL
Inactive Ingredients
Ingredient Name Strength
WATER(UNII: 059QF0KO0R)
CYCLOMETHICONE(UNII: NMQ347994Z)
ALCOHOL(UNII: 3K9958V90M)
LAURYL PEG-9 POLYDIMETHYLSILOXYETHYL DIMETHICONE(UNII: 25G622K2RA)
ISOTRIDECYL ISONONANOATE(UNII: WEF51750MT)
TRIMETHYLSILOXYSILICATE (M/Q 0.6-0.8)(UNII: 5041RX63GN)
PEG-9 POLYDIMETHYLSILOXYETHYL DIMETHICONE(UNII: TYP81E471F)
TRIETHYLHEXANOIN(UNII: 7K3W1BIU6K)
ACORUS CALAMUS ROOT(UNII: XY1K7KIQ0F)
ASTAXANTHIN(UNII: 8XPW32PR7I)
CLOVE(UNII: K48IKT5321)
HAEMATOCOCCUS PLUVIALIS(UNII: 31T0FF0472)
PALMITOYL PENTAPEPTIDE-4(UNII: KK181SM5JG)
RHODIOLA SACRA ROOT(UNII: 11R149C3CY)
MARINE COLLAGEN, SOLUBLE(UNII: 8JC99XGU4W)
TOCOPHEROL(UNII: R0ZB2556P8)
JUJUBE FRUIT(UNII: G55HNL2C70)
SODIUM ALGINATE(UNII: C269C4G2ZQ)
ALUMINUM HYDROXIDE(UNII: 5QB0T2IUN0)
BUTYLATED HYDROXYTOLUENE(UNII: 1P9D0Z171K)
BUTYLENE GLYCOL(UNII: 3XUS85K0RA)
MEDIUM-CHAIN TRIGLYCERIDES(UNII: C9H2L21V7U)
CARBOXYPOLYMETHYLENE(UNII: 0A5MM307FC)
POWDERED CELLULOSE(UNII: SMD1X3XO9M)
DIMETHICONE/VINYL DIMETHICONE CROSSPOLYMER (SOFT PARTICLE)(UNII: 9E4CO0W6C5)
DISTEARDIMONIUM HECTORITE(UNII: X687XDK09L)
GLYCERIN(UNII: PDC6A3C0OX)
HYDROGEN DIMETHICONE (20 CST)(UNII: 12Z59IF64N)
HYDROGENATED SOYBEAN LECITHIN(UNII: H1109Z9J4N)
ISOPROPYL TITANIUM TRIISOSTEARATE(UNII: 949E3KBJ1I)
POLYSORBATE 20(UNII: 7T1F30V5YH)
SODIUM CHLORIDE(UNII: 451W47IQ8X)
SODIUM LACTATE(UNII: TU7HW0W0QT)
SQUALANE(UNII: GW89575KF9)
TRIETHOXYCAPRYLYLSILANE(UNII: LDC331P08E)
PHENOXYETHANOL(UNII: HIE492ZZ3T)
FERRIC OXIDE RED(UNII: 1K09F3G675)
FERRIC OXIDE YELLOW(UNII: EX438O2MRT)
FERROSOFERRIC OXIDE(UNII: XM0M87F357)
MICA(UNII: V8A1AW0880)
TITANIUM DIOXIDE(UNII: 15FIX9V2JP)
Packaging
# Item Code Package Description Marketing Start Date Marketing End Date
1NDC:63903-0110-11 in 1 CARTON 01/09/2017
150 mL in 1 BOTTLE, PLASTIC Type 0: Not a Combination Product
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
OTC monograph final part352 09/01/2017
DECORTE SHEER BRILLIANCE 20Octinoxate, Zinc Oxide LOTION
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:63903-0120
Route of Administration TOPICAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
OCTINOXATE(UNII: 4Y5P7MUD51)
(OCTINOXATE - UNII:4Y5P7MUD51) 		OCTINOXATE3.9 g in 50 mL
ZINC OXIDE(UNII: SOI2LOH54Z)
(ZINC OXIDE - UNII:SOI2LOH54Z) 		ZINC OXIDE3.8 g in 50 mL
Inactive Ingredients
Ingredient Name Strength
WATER(UNII: 059QF0KO0R)
CYCLOMETHICONE(UNII: NMQ347994Z)
ALCOHOL(UNII: 3K9958V90M)
LAURYL PEG-9 POLYDIMETHYLSILOXYETHYL DIMETHICONE(UNII: 25G622K2RA)
ISOTRIDECYL ISONONANOATE(UNII: WEF51750MT)
TRIMETHYLSILOXYSILICATE (M/Q 0.6-0.8)(UNII: 5041RX63GN)
PEG-9 POLYDIMETHYLSILOXYETHYL DIMETHICONE(UNII: TYP81E471F)
TRIETHYLHEXANOIN(UNII: 7K3W1BIU6K)
ACORUS CALAMUS ROOT(UNII: XY1K7KIQ0F)
ASTAXANTHIN(UNII: 8XPW32PR7I)
CLOVE(UNII: K48IKT5321)
HAEMATOCOCCUS PLUVIALIS(UNII: 31T0FF0472)
PALMITOYL PENTAPEPTIDE-4(UNII: KK181SM5JG)
RHODIOLA SACRA ROOT(UNII: 11R149C3CY)
MARINE COLLAGEN, SOLUBLE(UNII: 8JC99XGU4W)
TOCOPHEROL(UNII: R0ZB2556P8)
JUJUBE FRUIT(UNII: G55HNL2C70)
SODIUM ALGINATE(UNII: C269C4G2ZQ)
ALUMINUM HYDROXIDE(UNII: 5QB0T2IUN0)
BUTYLATED HYDROXYTOLUENE(UNII: 1P9D0Z171K)
BUTYLENE GLYCOL(UNII: 3XUS85K0RA)
MEDIUM-CHAIN TRIGLYCERIDES(UNII: C9H2L21V7U)
CARBOXYPOLYMETHYLENE(UNII: 0A5MM307FC)
POWDERED CELLULOSE(UNII: SMD1X3XO9M)
DIMETHICONE/VINYL DIMETHICONE CROSSPOLYMER (SOFT PARTICLE)(UNII: 9E4CO0W6C5)
DISTEARDIMONIUM HECTORITE(UNII: X687XDK09L)
GLYCERIN(UNII: PDC6A3C0OX)
HYDROGEN DIMETHICONE (20 CST)(UNII: 12Z59IF64N)
HYDROGENATED SOYBEAN LECITHIN(UNII: H1109Z9J4N)
ISOPROPYL TITANIUM TRIISOSTEARATE(UNII: 949E3KBJ1I)
POLYSORBATE 20(UNII: 7T1F30V5YH)
SODIUM CHLORIDE(UNII: 451W47IQ8X)
SODIUM LACTATE(UNII: TU7HW0W0QT)
SQUALANE(UNII: GW89575KF9)
TRIETHOXYCAPRYLYLSILANE(UNII: LDC331P08E)
PHENOXYETHANOL(UNII: HIE492ZZ3T)
FERRIC OXIDE RED(UNII: 1K09F3G675)
FERRIC OXIDE YELLOW(UNII: EX438O2MRT)
FERROSOFERRIC OXIDE(UNII: XM0M87F357)
MICA(UNII: V8A1AW0880)
TITANIUM DIOXIDE(UNII: 15FIX9V2JP)
Packaging
# Item Code Package Description Marketing Start Date Marketing End Date
1NDC:63903-0120-11 in 1 CARTON 01/09/2017
150 mL in 1 BOTTLE, PLASTIC Type 0: Not a Combination Product
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
OTC monograph final part352 09/01/2017
DECORTE SHEER BRILLIANCE 30Octinoxate, Zinc Oxide LOTION
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:63903-0130
Route of Administration TOPICAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
OCTINOXATE(UNII: 4Y5P7MUD51)
(OCTINOXATE - UNII:4Y5P7MUD51) 		OCTINOXATE3.9 g in 50 mL
ZINC OXIDE(UNII: SOI2LOH54Z)
(ZINC OXIDE - UNII:SOI2LOH54Z) 		ZINC OXIDE3.8 g in 50 mL
Inactive Ingredients
Ingredient Name Strength
WATER(UNII: 059QF0KO0R)
CYCLOMETHICONE(UNII: NMQ347994Z)
ALCOHOL(UNII: 3K9958V90M)
LAURYL PEG-9 POLYDIMETHYLSILOXYETHYL DIMETHICONE(UNII: 25G622K2RA)
ISOTRIDECYL ISONONANOATE(UNII: WEF51750MT)
TRIMETHYLSILOXYSILICATE (M/Q 0.6-0.8)(UNII: 5041RX63GN)
PEG-9 POLYDIMETHYLSILOXYETHYL DIMETHICONE(UNII: TYP81E471F)
TRIETHYLHEXANOIN(UNII: 7K3W1BIU6K)
ACORUS CALAMUS ROOT(UNII: XY1K7KIQ0F)
ASTAXANTHIN(UNII: 8XPW32PR7I)
CLOVE(UNII: K48IKT5321)
HAEMATOCOCCUS PLUVIALIS(UNII: 31T0FF0472)
PALMITOYL PENTAPEPTIDE-4(UNII: KK181SM5JG)
RHODIOLA SACRA ROOT(UNII: 11R149C3CY)
MARINE COLLAGEN, SOLUBLE(UNII: 8JC99XGU4W)
TOCOPHEROL(UNII: R0ZB2556P8)
JUJUBE FRUIT(UNII: G55HNL2C70)
SODIUM ALGINATE(UNII: C269C4G2ZQ)
ALUMINUM HYDROXIDE(UNII: 5QB0T2IUN0)
BUTYLATED HYDROXYTOLUENE(UNII: 1P9D0Z171K)
BUTYLENE GLYCOL(UNII: 3XUS85K0RA)
MEDIUM-CHAIN TRIGLYCERIDES(UNII: C9H2L21V7U)
CARBOXYPOLYMETHYLENE(UNII: 0A5MM307FC)
POWDERED CELLULOSE(UNII: SMD1X3XO9M)
DIMETHICONE/VINYL DIMETHICONE CROSSPOLYMER (SOFT PARTICLE)(UNII: 9E4CO0W6C5)
DISTEARDIMONIUM HECTORITE(UNII: X687XDK09L)
GLYCERIN(UNII: PDC6A3C0OX)
HYDROGEN DIMETHICONE (20 CST)(UNII: 12Z59IF64N)
HYDROGENATED SOYBEAN LECITHIN(UNII: H1109Z9J4N)
ISOPROPYL TITANIUM TRIISOSTEARATE(UNII: 949E3KBJ1I)
POLYSORBATE 20(UNII: 7T1F30V5YH)
SODIUM CHLORIDE(UNII: 451W47IQ8X)
SODIUM LACTATE(UNII: TU7HW0W0QT)
SQUALANE(UNII: GW89575KF9)
TRIETHOXYCAPRYLYLSILANE(UNII: LDC331P08E)
PHENOXYETHANOL(UNII: HIE492ZZ3T)
FERRIC OXIDE RED(UNII: 1K09F3G675)
FERRIC OXIDE YELLOW(UNII: EX438O2MRT)
FERROSOFERRIC OXIDE(UNII: XM0M87F357)
MICA(UNII: V8A1AW0880)
TITANIUM DIOXIDE(UNII: 15FIX9V2JP)
Packaging
# Item Code Package Description Marketing Start Date Marketing End Date
1NDC:63903-0130-11 in 1 CARTON 01/09/2017
150 mL in 1 BOTTLE, PLASTIC Type 0: Not a Combination Product
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
OTC monograph final part352 09/01/2017
DECORTE SHEER BRILLIANCE 40Octinoxate, Zinc Oxide LOTION
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:63903-0140
Route of Administration TOPICAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
OCTINOXATE(UNII: 4Y5P7MUD51)
(OCTINOXATE - UNII:4Y5P7MUD51) 		OCTINOXATE4.0 g in 50 mL
ZINC OXIDE(UNII: SOI2LOH54Z)
(ZINC OXIDE - UNII:SOI2LOH54Z) 		ZINC OXIDE3.9 g in 50 mL
Inactive Ingredients
Ingredient Name Strength
WATER(UNII: 059QF0KO0R)
CYCLOMETHICONE(UNII: NMQ347994Z)
ALCOHOL(UNII: 3K9958V90M)
LAURYL PEG-9 POLYDIMETHYLSILOXYETHYL DIMETHICONE(UNII: 25G622K2RA)
ISOTRIDECYL ISONONANOATE(UNII: WEF51750MT)
TRIMETHYLSILOXYSILICATE (M/Q 0.6-0.8)(UNII: 5041RX63GN)
PEG-9 POLYDIMETHYLSILOXYETHYL DIMETHICONE(UNII: TYP81E471F)
TRIETHYLHEXANOIN(UNII: 7K3W1BIU6K)
ACORUS CALAMUS ROOT(UNII: XY1K7KIQ0F)
ASTAXANTHIN(UNII: 8XPW32PR7I)
CLOVE(UNII: K48IKT5321)
HAEMATOCOCCUS PLUVIALIS(UNII: 31T0FF0472)
PALMITOYL PENTAPEPTIDE-4(UNII: KK181SM5JG)
RHODIOLA SACRA ROOT(UNII: 11R149C3CY)
MARINE COLLAGEN, SOLUBLE(UNII: 8JC99XGU4W)
TOCOPHEROL(UNII: R0ZB2556P8)
JUJUBE FRUIT(UNII: G55HNL2C70)
SODIUM ALGINATE(UNII: C269C4G2ZQ)
ALUMINUM HYDROXIDE(UNII: 5QB0T2IUN0)
BUTYLATED HYDROXYTOLUENE(UNII: 1P9D0Z171K)
BUTYLENE GLYCOL(UNII: 3XUS85K0RA)
MEDIUM-CHAIN TRIGLYCERIDES(UNII: C9H2L21V7U)
CARBOXYPOLYMETHYLENE(UNII: 0A5MM307FC)
POWDERED CELLULOSE(UNII: SMD1X3XO9M)
DIMETHICONE/VINYL DIMETHICONE CROSSPOLYMER (SOFT PARTICLE)(UNII: 9E4CO0W6C5)
DISTEARDIMONIUM HECTORITE(UNII: X687XDK09L)
GLYCERIN(UNII: PDC6A3C0OX)
HYDROGEN DIMETHICONE (20 CST)(UNII: 12Z59IF64N)
HYDROGENATED SOYBEAN LECITHIN(UNII: H1109Z9J4N)
ISOPROPYL TITANIUM TRIISOSTEARATE(UNII: 949E3KBJ1I)
POLYSORBATE 20(UNII: 7T1F30V5YH)
SODIUM CHLORIDE(UNII: 451W47IQ8X)
SODIUM LACTATE(UNII: TU7HW0W0QT)
SQUALANE(UNII: GW89575KF9)
TRIETHOXYCAPRYLYLSILANE(UNII: LDC331P08E)
PHENOXYETHANOL(UNII: HIE492ZZ3T)
FERRIC OXIDE RED(UNII: 1K09F3G675)
FERRIC OXIDE YELLOW(UNII: EX438O2MRT)
FERROSOFERRIC OXIDE(UNII: XM0M87F357)
MICA(UNII: V8A1AW0880)
TITANIUM DIOXIDE(UNII: 15FIX9V2JP)
Packaging
# Item Code Package Description Marketing Start Date Marketing End Date
1NDC:63903-0140-11 in 1 CARTON 01/09/2017
150 mL in 1 BOTTLE, PLASTIC Type 0: Not a Combination Product
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
OTC monograph final part352 09/01/2017

PRINCIPAL DISPLAY PANEL

DECORTÉ

SHEER BRILLIANCE

Soft Lifting Tint

Broad Spectrum SPF 32

Sunscreen

Principal Display Panel - Decorte Sheet Brilliance 10 Level 50 ml Bottle Label

PRINCIPAL DISPLAY PANEL

DECORTÉ

SHEER BRILLIANCE

Soft Lifting Tint

Broad Spectrum SPF 32

Sunscreen

NET WT. 1.7 FL. OZ. / 50 ml e

Principal Display Panel - Decorte Sheet Brilliance 10 Level 50 ml Carton Label

PRINCIPAL DISPLAY PANEL

DECORTÉ

SHEER BRILLIANCE

Soft Lifting Tint

Broad Spectrum SPF 32

Sunscreen

Principal Display Panel - Decorte Sheet Brilliance 20 Level 50 ml Bottle Label

PRINCIPAL DISPLAY PANEL

DECORTÉ

SHEER BRILLIANCE

Soft Lifting Tint

Broad Spectrum SPF 32

Sunscreen

NET WT. 1.7 FL. OZ. / 50 ml e

Principal Display Panel - Decorte Sheet Brilliance 20 Level 50 ml Carton Label

PRINCIPAL DISPLAY PANEL

DECORTÉ

SHEER BRILLIANCE

Soft Lifting Tint

Broad Spectrum SPF 32

Sunscreen

Principal Display Panel - Decorte Sheet Brilliance 30 Level 50 ml Bottle Label

PRINCIPAL DISPLAY PANEL

DECORTÉ

SHEER BRILLIANCE

Soft Lifting Tint

Broad Spectrum SPF 32

Sunscreen

NET WT. 1.7 FL. OZ. / 50 ml e

Principal Display Panel - Decorte Sheet Brilliance 30 Level 50 ml Carton Label

PRINCIPAL DISPLAY PANEL

DECORTÉ

SHEER BRILLIANCE

Soft Lifting Tint

Broad Spectrum SPF 32

Sunscreen

Principal Display Panel - Decorte Sheet Brilliance 40 Level 50 ml Bottle Label

PRINCIPAL DISPLAY PANEL

DECORTÉ

SHEER BRILLIANCE

Soft Lifting Tint

Broad Spectrum SPF 32

Sunscreen

NET WT. 1.7 FL. OZ. / 50 ml e

Principal Display Panel - Decorte Sheet Brilliance 40 Level 50 ml Carton Label