NDC Code(s) : 68745-2044-1, 68745-2045-1, 68745-2046-1
Packager : CHANEL PARFUMS BEAUTE

Category : HUMAN PRESCRIPTION DRUG LABEL

DEA Schedule : none

Marketing Status : New Drug Application

INGREDIENTS AND APPEARANCE

CC Octinoxate, Titanium dioxide, and Zinc Oxide CREAM
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:68745-2044
Route of Administration TOPICAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
Octinoxate(UNII: 4Y5P7MUD51)
(Octinoxate - UNII:4Y5P7MUD51) 		Octinoxate75 mg in 1 mL
Titanium dioxide(UNII: 15FIX9V2JP)
(Titanium dioxide - UNII:15FIX9V2JP) 		Titanium dioxide32 mg in 1 mL
Zinc Oxide(UNII: SOI2LOH54Z)
(Zinc Oxide - UNII:SOI2LOH54Z) 		Zinc Oxide152 mg in 1 mL
Inactive Ingredients
Ingredient Name Strength
water(UNII: 059QF0KO0R)
caprylyl trisiloxane(UNII: Q95M2P1KJL)
PEG-10 dimethicone (600 CST)(UNII: 8PR7V1SVM0)
dimethicone(UNII: 92RU3N3Y1O)
glycerin(UNII: PDC6A3C0OX)
phenyl trimethicone(UNII: DR0K5NOJ4R)
alcohol(UNII: 3K9958V90M)
methyl trimethicone(UNII: S73ZQI0GXM)
butylene glycol(UNII: 3XUS85K0RA)
prunus persica leaf(UNII: VN3501T41P)
glycyrrhiza glabra(UNII: 2788Z9758H)
peach(UNII: 3OKE88I3QG)
Hydrogenated Polybutene (1300 Mw)(UNII: 7D1YQ9Y5EZ)
triethoxycaprylylsilane(UNII: LDC331P08E)
phenoxyethanol(UNII: HIE492ZZ3T)
sodium chloride(UNII: 451W47IQ8X)
stearic acid(UNII: 4ELV7Z65AP)
potassium sorbate(UNII: 1VPU26JZZ4)
aluminum oxide(UNII: LMI26O6933)
aluminum hydroxide(UNII: 5QB0T2IUN0)
disteardimonium hectorite(UNII: X687XDK09L)
sodium lauroyl glutamate(UNII: NCX1UU2D33)
hyaluronate sodium(UNII: YSE9PPT4TH)
lysine(UNII: K3Z4F929H6)
propylene carbonate(UNII: 8D08K3S51E)
silicon dioxide(UNII: ETJ7Z6XBU4)
propylene glycol(UNII: 6DC9Q167V3)
magnesium chloride(UNII: 02F3473H9O)
dipropylene glycol(UNII: E107L85C40)
butylated hydroxytoluene(UNII: 1P9D0Z171K)
ethylhexylglycerin(UNII: 147D247K3P)
tocopherol(UNII: R0ZB2556P8)
citric acid monohydrate(UNII: 2968PHW8QP)
sorbic acid(UNII: X045WJ989B)
ferric oxide red(UNII: 1K09F3G675)
ferric oxide yellow(UNII: EX438O2MRT)
ferrosoferric oxide(UNII: XM0M87F357)
Packaging
# Item Code Package Description Marketing Start Date Marketing End Date
1NDC:68745-2044-11 in 1 CARTON 04/05/2015
130 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 05/04/2015
CC Octinoxate, Titanium dioxide, and Zinc Oxide CREAM
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:68745-2045
Route of Administration TOPICAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
Octinoxate(UNII: 4Y5P7MUD51)
(Octinoxate - UNII:4Y5P7MUD51) 		Octinoxate75 mg in 1 mL
Titanium dioxide(UNII: 15FIX9V2JP)
(Titanium dioxide - UNII:15FIX9V2JP) 		Titanium dioxide32 mg in 1 mL
Zinc Oxide(UNII: SOI2LOH54Z)
(Zinc Oxide - UNII:SOI2LOH54Z) 		Zinc Oxide152 mg in 1 mL
Inactive Ingredients
Ingredient Name Strength
water(UNII: 059QF0KO0R)
caprylyl trisiloxane(UNII: Q95M2P1KJL)
PEG-10 dimethicone (600 CST)(UNII: 8PR7V1SVM0)
dimethicone(UNII: 92RU3N3Y1O)
glycerin(UNII: PDC6A3C0OX)
phenyl trimethicone(UNII: DR0K5NOJ4R)
alcohol(UNII: 3K9958V90M)
methyl trimethicone(UNII: S73ZQI0GXM)
butylene glycol(UNII: 3XUS85K0RA)
prunus persica leaf(UNII: VN3501T41P)
glycyrrhiza glabra(UNII: 2788Z9758H)
peach(UNII: 3OKE88I3QG)
Hydrogenated Polybutene (1300 Mw)(UNII: 7D1YQ9Y5EZ)
triethoxycaprylylsilane(UNII: LDC331P08E)
phenoxyethanol(UNII: HIE492ZZ3T)
sodium chloride(UNII: 451W47IQ8X)
stearic acid(UNII: 4ELV7Z65AP)
potassium sorbate(UNII: 1VPU26JZZ4)
aluminum oxide(UNII: LMI26O6933)
aluminum hydroxide(UNII: 5QB0T2IUN0)
disteardimonium hectorite(UNII: X687XDK09L)
sodium lauroyl glutamate(UNII: NCX1UU2D33)
hyaluronate sodium(UNII: YSE9PPT4TH)
lysine(UNII: K3Z4F929H6)
propylene carbonate(UNII: 8D08K3S51E)
silicon dioxide(UNII: ETJ7Z6XBU4)
propylene glycol(UNII: 6DC9Q167V3)
magnesium chloride(UNII: 02F3473H9O)
dipropylene glycol(UNII: E107L85C40)
butylated hydroxytoluene(UNII: 1P9D0Z171K)
ethylhexylglycerin(UNII: 147D247K3P)
tocopherol(UNII: R0ZB2556P8)
citric acid monohydrate(UNII: 2968PHW8QP)
sorbic acid(UNII: X045WJ989B)
ferric oxide red(UNII: 1K09F3G675)
ferric oxide yellow(UNII: EX438O2MRT)
ferrosoferric oxide(UNII: XM0M87F357)
Packaging
# Item Code Package Description Marketing Start Date Marketing End Date
1NDC:68745-2045-11 in 1 CARTON 04/05/2015
130 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 05/04/2015
CC Octinoxate, Titanium dioxide, and Zinc Oxide CREAM
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:68745-2046
Route of Administration TOPICAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
Octinoxate(UNII: 4Y5P7MUD51)
(Octinoxate - UNII:4Y5P7MUD51) 		Octinoxate75 mg in 1 mL
Titanium dioxide(UNII: 15FIX9V2JP)
(Titanium dioxide - UNII:15FIX9V2JP) 		Titanium dioxide32 mg in 1 mL
Zinc Oxide(UNII: SOI2LOH54Z)
(Zinc Oxide - UNII:SOI2LOH54Z) 		Zinc Oxide152 mg in 1 mL
Inactive Ingredients
Ingredient Name Strength
water(UNII: 059QF0KO0R)
caprylyl trisiloxane(UNII: Q95M2P1KJL)
PEG-10 dimethicone (600 CST)(UNII: 8PR7V1SVM0)
dimethicone(UNII: 92RU3N3Y1O)
glycerin(UNII: PDC6A3C0OX)
phenyl trimethicone(UNII: DR0K5NOJ4R)
alcohol(UNII: 3K9958V90M)
methyl trimethicone(UNII: S73ZQI0GXM)
butylene glycol(UNII: 3XUS85K0RA)
prunus persica leaf(UNII: VN3501T41P)
glycyrrhiza glabra(UNII: 2788Z9758H)
peach(UNII: 3OKE88I3QG)
Hydrogenated Polybutene (1300 Mw)(UNII: 7D1YQ9Y5EZ)
triethoxycaprylylsilane(UNII: LDC331P08E)
phenoxyethanol(UNII: HIE492ZZ3T)
sodium chloride(UNII: 451W47IQ8X)
stearic acid(UNII: 4ELV7Z65AP)
potassium sorbate(UNII: 1VPU26JZZ4)
aluminum oxide(UNII: LMI26O6933)
aluminum hydroxide(UNII: 5QB0T2IUN0)
disteardimonium hectorite(UNII: X687XDK09L)
sodium lauroyl glutamate(UNII: NCX1UU2D33)
hyaluronate sodium(UNII: YSE9PPT4TH)
lysine(UNII: K3Z4F929H6)
propylene carbonate(UNII: 8D08K3S51E)
silicon dioxide(UNII: ETJ7Z6XBU4)
propylene glycol(UNII: 6DC9Q167V3)
magnesium chloride(UNII: 02F3473H9O)
dipropylene glycol(UNII: E107L85C40)
butylated hydroxytoluene(UNII: 1P9D0Z171K)
ethylhexylglycerin(UNII: 147D247K3P)
tocopherol(UNII: R0ZB2556P8)
citric acid monohydrate(UNII: 2968PHW8QP)
sorbic acid(UNII: X045WJ989B)
ferric oxide red(UNII: 1K09F3G675)
ferric oxide yellow(UNII: EX438O2MRT)
ferrosoferric oxide(UNII: XM0M87F357)
Packaging
# Item Code Package Description Marketing Start Date Marketing End Date
1NDC:68745-2046-11 in 1 CARTON 04/05/2015
130 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 05/04/2015

PRINCIPAL DISPLAY PANEL

CC CREAM

COMPLETE CORRECTION SUNSCREEN

BROAD SPECTRUM SPF 50

20 BEIGE

CHANEL

30 ml
1 FL.OZ.

PRINCIPAL DISPLAY PANEL - 30 mL Tube Carton - 20 Beige

PRINCIPAL DISPLAY PANEL

CC CREAM

COMPLETE CORRECTION SUNSCREEN

BROAD SPECTRUM SPF 50

30 BEIGE

CHANEL

30 ml
1 FL.OZ.

PRINCIPAL DISPLAY PANEL - 30 mL Tube Carton - 30 Beige

PRINCIPAL DISPLAY PANEL

CC CREAM

COMPLETE CORRECTION SUNSCREEN

BROAD SPECTRUM SPF 50

40 BEIGE

CHANEL

30 ml
1 FL.OZ.

PRINCIPAL DISPLAY PANEL - 30 mL Tube Carton - 40 Beige