NDC Code(s) : 68745-2080-1, 68745-2080-2, 68745-2081-1, 68745-2081-2, 68745-2082-1, 68745-2082-2, 68745-2083-1, 68745-2083-2, 68745-2084-1, 68745-2084-2, 68745-2085-1, 68745-2085-2, 68745-2086-1, 68745-2086-2, 68745-2087-1, 68745-2087-2, 68745-2088-1, 68745-2088-2, 68745-2089-1, 68745-2089-2
Packager : CHANEL PARFUMS BEAUTE

Category : HUMAN PRESCRIPTION DRUG LABEL

DEA Schedule : none

Marketing Status : New Drug Application

INGREDIENTS AND APPEARANCE

Les Beiges Octinoxate and Titanium Dioxide GEL
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:68745-2080
Route of Administration TOPICAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
Octinoxate(UNII: 4Y5P7MUD51)
(Octinoxate - UNII:4Y5P7MUD51) 		Octinoxate0.748 g in 11 g
Titanium Dioxide(UNII: 15FIX9V2JP)
(TITANIUM DIOXIDE - UNII:15FIX9V2JP) 		Titanium Dioxide0.264 g in 11 g
Inactive Ingredients
Ingredient Name Strength
water(UNII: 059QF0KO0R)
polysorbate 85(UNII: A7F3N56197)
silicon dioxide(UNII: ETJ7Z6XBU4)
glycerin(UNII: PDC6A3C0OX)
alcohol(UNII: 3K9958V90M)
isononyl isononanoate(UNII: S4V5BS6GCX)
butylene glycol(UNII: 3XUS85K0RA)
cetyl ethylhexanoate(UNII: 134647WMX4)
hydrogenated soybean lecithin(UNII: H1109Z9J4N)
kalanchoe pinnata leaf(UNII: 3R963LO08T)
phenoxyethanol(UNII: HIE492ZZ3T)
dicaprylyl carbonate(UNII: 609A3V1SUA)
sorbitan monolaurate(UNII: 6W9PS8B71J)
dimethicone(UNII: 92RU3N3Y1O)
potassium sorbate(UNII: 1VPU26JZZ4)
caprylyl glycol(UNII: 00YIU5438U)
stearic acid(UNII: 4ELV7Z65AP)
aluminum oxide(UNII: LMI26O6933)
.alpha.-tocopherol acetate(UNII: 9E8X80D2L0)
hydroxyethyl acrylate/sodium acryloyldimethyl taurate copolymer (100000 MPA.S AT 1.5%)(UNII: 86FQE96TZ4)
disodium stearoyl glutamate(UNII: 45ASM2L11M)
xanthan gum(UNII: TTV12P4NEE)
aluminum hydroxide(UNII: 5QB0T2IUN0)
citric acid monohydrate(UNII: 2968PHW8QP)
hyaluronate sodium(UNII: YSE9PPT4TH)
biosaccharide gum-1(UNII: BB4PU4V09H)
polysorbate 60(UNII: CAL22UVI4M)
sorbitan isostearate(UNII: 01S2G2C1E4)
butylated hydroxytoluene(UNII: 1P9D0Z171K)
maltodextrin(UNII: 7CVR7L4A2D)
potassium laurate(UNII: V4361R8N4Z)
tocopherol(UNII: R0ZB2556P8)
ferric oxide red(UNII: 1K09F3G675)
ferric oxide yellow(UNII: EX438O2MRT)
ferrosoferric oxide(UNII: XM0M87F357)
mica(UNII: V8A1AW0880)
Packaging
# Item Code Package Description Marketing Start Date Marketing End Date
1NDC:68745-2080-11 in 1 CARTON 04/08/2017
111 g in 1 CASE Type 0: Not a Combination Product
2NDC:68745-2080-21 in 1 CARTON 04/08/2017
29 g in 1 CASE 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 08/04/2017
Les Beiges Octinoxate and Titanium dioxide GEL
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:68745-2081
Route of Administration TOPICAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
Octinoxate(UNII: 4Y5P7MUD51)
(Octinoxate - UNII:4Y5P7MUD51) 		Octinoxate0.748 g in 11 g
Titanium dioxide(UNII: 15FIX9V2JP)
(TITANIUM DIOXIDE - UNII:15FIX9V2JP) 		Titanium dioxide0.264 g in 11 g
Inactive Ingredients
Ingredient Name Strength
water(UNII: 059QF0KO0R)
polysorbate 85(UNII: A7F3N56197)
silicon dioxide(UNII: ETJ7Z6XBU4)
glycerin(UNII: PDC6A3C0OX)
alcohol(UNII: 3K9958V90M)
isononyl isononanoate(UNII: S4V5BS6GCX)
butylene glycol(UNII: 3XUS85K0RA)
cetyl ethylhexanoate(UNII: 134647WMX4)
hydrogenated soybean lecithin(UNII: H1109Z9J4N)
kalanchoe pinnata leaf(UNII: 3R963LO08T)
phenoxyethanol(UNII: HIE492ZZ3T)
dicaprylyl carbonate(UNII: 609A3V1SUA)
sorbitan monolaurate(UNII: 6W9PS8B71J)
dimethicone(UNII: 92RU3N3Y1O)
potassium sorbate(UNII: 1VPU26JZZ4)
caprylyl glycol(UNII: 00YIU5438U)
stearic acid(UNII: 4ELV7Z65AP)
aluminum oxide(UNII: LMI26O6933)
.alpha.-tocopherol acetate(UNII: 9E8X80D2L0)
hydroxyethyl acrylate/sodium acryloyldimethyl taurate copolymer (100000 MPA.S AT 1.5%)(UNII: 86FQE96TZ4)
disodium stearoyl glutamate(UNII: 45ASM2L11M)
xanthan gum(UNII: TTV12P4NEE)
aluminum hydroxide(UNII: 5QB0T2IUN0)
citric acid monohydrate(UNII: 2968PHW8QP)
hyaluronate sodium(UNII: YSE9PPT4TH)
biosaccharide gum-1(UNII: BB4PU4V09H)
polysorbate 60(UNII: CAL22UVI4M)
sorbitan isostearate(UNII: 01S2G2C1E4)
butylated hydroxytoluene(UNII: 1P9D0Z171K)
maltodextrin(UNII: 7CVR7L4A2D)
potassium laurate(UNII: V4361R8N4Z)
tocopherol(UNII: R0ZB2556P8)
ferric oxide red(UNII: 1K09F3G675)
ferric oxide yellow(UNII: EX438O2MRT)
ferrosoferric oxide(UNII: XM0M87F357)
mica(UNII: V8A1AW0880)
Packaging
# Item Code Package Description Marketing Start Date Marketing End Date
1NDC:68745-2081-11 in 1 CARTON 04/08/2017
111 g in 1 CASE Type 0: Not a Combination Product
2NDC:68745-2081-21 in 1 CARTON 04/08/2017
29 g in 1 CASE 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 08/04/2017
Les Beiges Octinoxate and Titanium dioxide GEL
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:68745-2082
Route of Administration TOPICAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
Octinoxate(UNII: 4Y5P7MUD51)
(Octinoxate - UNII:4Y5P7MUD51) 		Octinoxate0.748 g in 11 g
Titanium dioxide(UNII: 15FIX9V2JP)
(TITANIUM DIOXIDE - UNII:15FIX9V2JP) 		Titanium dioxide0.264 g in 11 g
Inactive Ingredients
Ingredient Name Strength
water(UNII: 059QF0KO0R)
polysorbate 85(UNII: A7F3N56197)
silicon dioxide(UNII: ETJ7Z6XBU4)
glycerin(UNII: PDC6A3C0OX)
alcohol(UNII: 3K9958V90M)
isononyl isononanoate(UNII: S4V5BS6GCX)
butylene glycol(UNII: 3XUS85K0RA)
cetyl ethylhexanoate(UNII: 134647WMX4)
hydrogenated soybean lecithin(UNII: H1109Z9J4N)
kalanchoe pinnata leaf(UNII: 3R963LO08T)
phenoxyethanol(UNII: HIE492ZZ3T)
dicaprylyl carbonate(UNII: 609A3V1SUA)
sorbitan monolaurate(UNII: 6W9PS8B71J)
dimethicone(UNII: 92RU3N3Y1O)
potassium sorbate(UNII: 1VPU26JZZ4)
caprylyl glycol(UNII: 00YIU5438U)
stearic acid(UNII: 4ELV7Z65AP)
aluminum oxide(UNII: LMI26O6933)
.alpha.-tocopherol acetate(UNII: 9E8X80D2L0)
hydroxyethyl acrylate/sodium acryloyldimethyl taurate copolymer (100000 MPA.S AT 1.5%)(UNII: 86FQE96TZ4)
disodium stearoyl glutamate(UNII: 45ASM2L11M)
xanthan gum(UNII: TTV12P4NEE)
aluminum hydroxide(UNII: 5QB0T2IUN0)
citric acid monohydrate(UNII: 2968PHW8QP)
hyaluronate sodium(UNII: YSE9PPT4TH)
biosaccharide gum-1(UNII: BB4PU4V09H)
polysorbate 60(UNII: CAL22UVI4M)
sorbitan isostearate(UNII: 01S2G2C1E4)
butylated hydroxytoluene(UNII: 1P9D0Z171K)
maltodextrin(UNII: 7CVR7L4A2D)
potassium laurate(UNII: V4361R8N4Z)
tocopherol(UNII: R0ZB2556P8)
ferric oxide red(UNII: 1K09F3G675)
ferric oxide yellow(UNII: EX438O2MRT)
ferrosoferric oxide(UNII: XM0M87F357)
mica(UNII: V8A1AW0880)
Packaging
# Item Code Package Description Marketing Start Date Marketing End Date
1NDC:68745-2082-11 in 1 CARTON 04/08/2017
111 g in 1 CASE Type 0: Not a Combination Product
2NDC:68745-2082-21 in 1 CARTON 04/08/2017
29 g in 1 CASE 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 08/04/2017
Les Beiges Octinoxate and Titanium dioxide GEL
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:68745-2083
Route of Administration TOPICAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
Octinoxate(UNII: 4Y5P7MUD51)
(Octinoxate - UNII:4Y5P7MUD51) 		Octinoxate0.748 g in 11 g
Titanium dioxide(UNII: 15FIX9V2JP)
(TITANIUM DIOXIDE - UNII:15FIX9V2JP) 		Titanium dioxide0.264 g in 11 g
Inactive Ingredients
Ingredient Name Strength
water(UNII: 059QF0KO0R)
polysorbate 85(UNII: A7F3N56197)
silicon dioxide(UNII: ETJ7Z6XBU4)
glycerin(UNII: PDC6A3C0OX)
alcohol(UNII: 3K9958V90M)
isononyl isononanoate(UNII: S4V5BS6GCX)
butylene glycol(UNII: 3XUS85K0RA)
cetyl ethylhexanoate(UNII: 134647WMX4)
hydrogenated soybean lecithin(UNII: H1109Z9J4N)
kalanchoe pinnata leaf(UNII: 3R963LO08T)
phenoxyethanol(UNII: HIE492ZZ3T)
dicaprylyl carbonate(UNII: 609A3V1SUA)
sorbitan monolaurate(UNII: 6W9PS8B71J)
dimethicone(UNII: 92RU3N3Y1O)
potassium sorbate(UNII: 1VPU26JZZ4)
caprylyl glycol(UNII: 00YIU5438U)
stearic acid(UNII: 4ELV7Z65AP)
aluminum oxide(UNII: LMI26O6933)
.alpha.-tocopherol acetate(UNII: 9E8X80D2L0)
hydroxyethyl acrylate/sodium acryloyldimethyl taurate copolymer (100000 MPA.S AT 1.5%)(UNII: 86FQE96TZ4)
disodium stearoyl glutamate(UNII: 45ASM2L11M)
xanthan gum(UNII: TTV12P4NEE)
aluminum hydroxide(UNII: 5QB0T2IUN0)
citric acid monohydrate(UNII: 2968PHW8QP)
hyaluronate sodium(UNII: YSE9PPT4TH)
biosaccharide gum-1(UNII: BB4PU4V09H)
polysorbate 60(UNII: CAL22UVI4M)
sorbitan isostearate(UNII: 01S2G2C1E4)
butylated hydroxytoluene(UNII: 1P9D0Z171K)
maltodextrin(UNII: 7CVR7L4A2D)
potassium laurate(UNII: V4361R8N4Z)
tocopherol(UNII: R0ZB2556P8)
ferric oxide red(UNII: 1K09F3G675)
ferric oxide yellow(UNII: EX438O2MRT)
ferrosoferric oxide(UNII: XM0M87F357)
mica(UNII: V8A1AW0880)
Packaging
# Item Code Package Description Marketing Start Date Marketing End Date
1NDC:68745-2083-11 in 1 CARTON 04/08/2017
111 g in 1 CASE Type 0: Not a Combination Product
2NDC:68745-2083-21 in 1 CARTON 04/08/2017
29 g in 1 CASE 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 08/04/2017
Les Beiges Octinoxate and Titanium dioxide GEL
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:68745-2084
Route of Administration TOPICAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
Octinoxate(UNII: 4Y5P7MUD51)
(Octinoxate - UNII:4Y5P7MUD51) 		Octinoxate0.748 g in 11 g
Titanium dioxide(UNII: 15FIX9V2JP)
(TITANIUM DIOXIDE - UNII:15FIX9V2JP) 		Titanium dioxide0.264 g in 11 g
Inactive Ingredients
Ingredient Name Strength
water(UNII: 059QF0KO0R)
polysorbate 85(UNII: A7F3N56197)
silicon dioxide(UNII: ETJ7Z6XBU4)
glycerin(UNII: PDC6A3C0OX)
alcohol(UNII: 3K9958V90M)
isononyl isononanoate(UNII: S4V5BS6GCX)
butylene glycol(UNII: 3XUS85K0RA)
cetyl ethylhexanoate(UNII: 134647WMX4)
hydrogenated soybean lecithin(UNII: H1109Z9J4N)
kalanchoe pinnata leaf(UNII: 3R963LO08T)
phenoxyethanol(UNII: HIE492ZZ3T)
dicaprylyl carbonate(UNII: 609A3V1SUA)
sorbitan monolaurate(UNII: 6W9PS8B71J)
dimethicone(UNII: 92RU3N3Y1O)
potassium sorbate(UNII: 1VPU26JZZ4)
caprylyl glycol(UNII: 00YIU5438U)
stearic acid(UNII: 4ELV7Z65AP)
aluminum oxide(UNII: LMI26O6933)
.alpha.-tocopherol acetate(UNII: 9E8X80D2L0)
hydroxyethyl acrylate/sodium acryloyldimethyl taurate copolymer (100000 MPA.S AT 1.5%)(UNII: 86FQE96TZ4)
disodium stearoyl glutamate(UNII: 45ASM2L11M)
xanthan gum(UNII: TTV12P4NEE)
aluminum hydroxide(UNII: 5QB0T2IUN0)
citric acid monohydrate(UNII: 2968PHW8QP)
hyaluronate sodium(UNII: YSE9PPT4TH)
biosaccharide gum-1(UNII: BB4PU4V09H)
polysorbate 60(UNII: CAL22UVI4M)
sorbitan isostearate(UNII: 01S2G2C1E4)
butylated hydroxytoluene(UNII: 1P9D0Z171K)
maltodextrin(UNII: 7CVR7L4A2D)
potassium laurate(UNII: V4361R8N4Z)
tocopherol(UNII: R0ZB2556P8)
ferric oxide red(UNII: 1K09F3G675)
ferric oxide yellow(UNII: EX438O2MRT)
ferrosoferric oxide(UNII: XM0M87F357)
mica(UNII: V8A1AW0880)
Packaging
# Item Code Package Description Marketing Start Date Marketing End Date
1NDC:68745-2084-11 in 1 CARTON 04/08/2017
111 g in 1 CASE Type 0: Not a Combination Product
2NDC:68745-2084-21 in 1 CARTON 04/08/2017
29 g in 1 CASE 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 08/04/2017
Les Beiges Octinoxate and Titanium dioxide GEL
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:68745-2085
Route of Administration TOPICAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
Octinoxate(UNII: 4Y5P7MUD51)
(Octinoxate - UNII:4Y5P7MUD51) 		Octinoxate0.748 g in 11 g
Titanium dioxide(UNII: 15FIX9V2JP)
(TITANIUM DIOXIDE - UNII:15FIX9V2JP) 		Titanium dioxide0.264 g in 11 g
Inactive Ingredients
Ingredient Name Strength
water(UNII: 059QF0KO0R)
polysorbate 85(UNII: A7F3N56197)
silicon dioxide(UNII: ETJ7Z6XBU4)
glycerin(UNII: PDC6A3C0OX)
alcohol(UNII: 3K9958V90M)
isononyl isononanoate(UNII: S4V5BS6GCX)
butylene glycol(UNII: 3XUS85K0RA)
cetyl ethylhexanoate(UNII: 134647WMX4)
hydrogenated soybean lecithin(UNII: H1109Z9J4N)
kalanchoe pinnata leaf(UNII: 3R963LO08T)
phenoxyethanol(UNII: HIE492ZZ3T)
dicaprylyl carbonate(UNII: 609A3V1SUA)
sorbitan monolaurate(UNII: 6W9PS8B71J)
dimethicone(UNII: 92RU3N3Y1O)
potassium sorbate(UNII: 1VPU26JZZ4)
caprylyl glycol(UNII: 00YIU5438U)
stearic acid(UNII: 4ELV7Z65AP)
aluminum oxide(UNII: LMI26O6933)
.alpha.-tocopherol acetate(UNII: 9E8X80D2L0)
hydroxyethyl acrylate/sodium acryloyldimethyl taurate copolymer (100000 MPA.S AT 1.5%)(UNII: 86FQE96TZ4)
disodium stearoyl glutamate(UNII: 45ASM2L11M)
xanthan gum(UNII: TTV12P4NEE)
aluminum hydroxide(UNII: 5QB0T2IUN0)
citric acid monohydrate(UNII: 2968PHW8QP)
hyaluronate sodium(UNII: YSE9PPT4TH)
biosaccharide gum-1(UNII: BB4PU4V09H)
polysorbate 60(UNII: CAL22UVI4M)
sorbitan isostearate(UNII: 01S2G2C1E4)
butylated hydroxytoluene(UNII: 1P9D0Z171K)
maltodextrin(UNII: 7CVR7L4A2D)
potassium laurate(UNII: V4361R8N4Z)
tocopherol(UNII: R0ZB2556P8)
ferric oxide red(UNII: 1K09F3G675)
ferric oxide yellow(UNII: EX438O2MRT)
ferrosoferric oxide(UNII: XM0M87F357)
mica(UNII: V8A1AW0880)
Packaging
# Item Code Package Description Marketing Start Date Marketing End Date
1NDC:68745-2085-11 in 1 CARTON 04/08/2017
111 g in 1 CASE Type 0: Not a Combination Product
2NDC:68745-2085-21 in 1 CARTON 04/08/2017
29 g in 1 CASE 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 08/04/2017
Les Beiges Octinoxate and Titanium dioxide GEL
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:68745-2086
Route of Administration TOPICAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
Octinoxate(UNII: 4Y5P7MUD51)
(Octinoxate - UNII:4Y5P7MUD51) 		Octinoxate0.748 g in 11 g
Titanium dioxide(UNII: 15FIX9V2JP)
(TITANIUM DIOXIDE - UNII:15FIX9V2JP) 		Titanium dioxide0.264 g in 11 g
Inactive Ingredients
Ingredient Name Strength
water(UNII: 059QF0KO0R)
polysorbate 85(UNII: A7F3N56197)
silicon dioxide(UNII: ETJ7Z6XBU4)
glycerin(UNII: PDC6A3C0OX)
alcohol(UNII: 3K9958V90M)
isononyl isononanoate(UNII: S4V5BS6GCX)
butylene glycol(UNII: 3XUS85K0RA)
cetyl ethylhexanoate(UNII: 134647WMX4)
hydrogenated soybean lecithin(UNII: H1109Z9J4N)
kalanchoe pinnata leaf(UNII: 3R963LO08T)
phenoxyethanol(UNII: HIE492ZZ3T)
dicaprylyl carbonate(UNII: 609A3V1SUA)
sorbitan monolaurate(UNII: 6W9PS8B71J)
dimethicone(UNII: 92RU3N3Y1O)
potassium sorbate(UNII: 1VPU26JZZ4)
caprylyl glycol(UNII: 00YIU5438U)
stearic acid(UNII: 4ELV7Z65AP)
aluminum oxide(UNII: LMI26O6933)
.alpha.-tocopherol acetate(UNII: 9E8X80D2L0)
hydroxyethyl acrylate/sodium acryloyldimethyl taurate copolymer (100000 MPA.S AT 1.5%)(UNII: 86FQE96TZ4)
disodium stearoyl glutamate(UNII: 45ASM2L11M)
xanthan gum(UNII: TTV12P4NEE)
aluminum hydroxide(UNII: 5QB0T2IUN0)
citric acid monohydrate(UNII: 2968PHW8QP)
hyaluronate sodium(UNII: YSE9PPT4TH)
biosaccharide gum-1(UNII: BB4PU4V09H)
polysorbate 60(UNII: CAL22UVI4M)
sorbitan isostearate(UNII: 01S2G2C1E4)
butylated hydroxytoluene(UNII: 1P9D0Z171K)
maltodextrin(UNII: 7CVR7L4A2D)
potassium laurate(UNII: V4361R8N4Z)
tocopherol(UNII: R0ZB2556P8)
ferric oxide red(UNII: 1K09F3G675)
ferric oxide yellow(UNII: EX438O2MRT)
ferrosoferric oxide(UNII: XM0M87F357)
mica(UNII: V8A1AW0880)
Packaging
# Item Code Package Description Marketing Start Date Marketing End Date
1NDC:68745-2086-11 in 1 CARTON 04/08/2017
111 g in 1 CASE Type 0: Not a Combination Product
2NDC:68745-2086-21 in 1 CARTON 04/08/2017
29 g in 1 CASE 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 08/04/2017
Les Beiges Octinoxate and Titanium dioxide GEL
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:68745-2087
Route of Administration TOPICAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
Octinoxate(UNII: 4Y5P7MUD51)
(Octinoxate - UNII:4Y5P7MUD51) 		Octinoxate0.748 g in 11 g
Titanium dioxide(UNII: 15FIX9V2JP)
(TITANIUM DIOXIDE - UNII:15FIX9V2JP) 		Titanium dioxide0.264 g in 11 g
Inactive Ingredients
Ingredient Name Strength
water(UNII: 059QF0KO0R)
polysorbate 85(UNII: A7F3N56197)
silicon dioxide(UNII: ETJ7Z6XBU4)
glycerin(UNII: PDC6A3C0OX)
alcohol(UNII: 3K9958V90M)
isononyl isononanoate(UNII: S4V5BS6GCX)
butylene glycol(UNII: 3XUS85K0RA)
cetyl ethylhexanoate(UNII: 134647WMX4)
hydrogenated soybean lecithin(UNII: H1109Z9J4N)
kalanchoe pinnata leaf(UNII: 3R963LO08T)
phenoxyethanol(UNII: HIE492ZZ3T)
dicaprylyl carbonate(UNII: 609A3V1SUA)
sorbitan monolaurate(UNII: 6W9PS8B71J)
dimethicone(UNII: 92RU3N3Y1O)
potassium sorbate(UNII: 1VPU26JZZ4)
caprylyl glycol(UNII: 00YIU5438U)
stearic acid(UNII: 4ELV7Z65AP)
aluminum oxide(UNII: LMI26O6933)
.alpha.-tocopherol acetate(UNII: 9E8X80D2L0)
hydroxyethyl acrylate/sodium acryloyldimethyl taurate copolymer (100000 MPA.S AT 1.5%)(UNII: 86FQE96TZ4)
disodium stearoyl glutamate(UNII: 45ASM2L11M)
xanthan gum(UNII: TTV12P4NEE)
aluminum hydroxide(UNII: 5QB0T2IUN0)
citric acid monohydrate(UNII: 2968PHW8QP)
hyaluronate sodium(UNII: YSE9PPT4TH)
biosaccharide gum-1(UNII: BB4PU4V09H)
polysorbate 60(UNII: CAL22UVI4M)
sorbitan isostearate(UNII: 01S2G2C1E4)
butylated hydroxytoluene(UNII: 1P9D0Z171K)
maltodextrin(UNII: 7CVR7L4A2D)
potassium laurate(UNII: V4361R8N4Z)
tocopherol(UNII: R0ZB2556P8)
ferric oxide red(UNII: 1K09F3G675)
ferric oxide yellow(UNII: EX438O2MRT)
ferrosoferric oxide(UNII: XM0M87F357)
mica(UNII: V8A1AW0880)
Packaging
# Item Code Package Description Marketing Start Date Marketing End Date
1NDC:68745-2087-11 in 1 CARTON 04/08/2017
111 g in 1 CASE Type 0: Not a Combination Product
2NDC:68745-2087-21 in 1 CARTON 04/08/2017
29 g in 1 CASE 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 08/04/2017
Les Beiges Octinoxate and Titanium dioxide GEL
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:68745-2088
Route of Administration TOPICAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
Octinoxate(UNII: 4Y5P7MUD51)
(Octinoxate - UNII:4Y5P7MUD51) 		Octinoxate0.748 g in 11 g
Titanium dioxide(UNII: 15FIX9V2JP)
(TITANIUM DIOXIDE - UNII:15FIX9V2JP) 		Titanium dioxide0.264 g in 11 g
Inactive Ingredients
Ingredient Name Strength
water(UNII: 059QF0KO0R)
polysorbate 85(UNII: A7F3N56197)
silicon dioxide(UNII: ETJ7Z6XBU4)
glycerin(UNII: PDC6A3C0OX)
alcohol(UNII: 3K9958V90M)
isononyl isononanoate(UNII: S4V5BS6GCX)
butylene glycol(UNII: 3XUS85K0RA)
cetyl ethylhexanoate(UNII: 134647WMX4)
hydrogenated soybean lecithin(UNII: H1109Z9J4N)
kalanchoe pinnata leaf(UNII: 3R963LO08T)
phenoxyethanol(UNII: HIE492ZZ3T)
dicaprylyl carbonate(UNII: 609A3V1SUA)
sorbitan monolaurate(UNII: 6W9PS8B71J)
dimethicone(UNII: 92RU3N3Y1O)
potassium sorbate(UNII: 1VPU26JZZ4)
caprylyl glycol(UNII: 00YIU5438U)
stearic acid(UNII: 4ELV7Z65AP)
aluminum oxide(UNII: LMI26O6933)
.alpha.-tocopherol acetate(UNII: 9E8X80D2L0)
hydroxyethyl acrylate/sodium acryloyldimethyl taurate copolymer (100000 MPA.S AT 1.5%)(UNII: 86FQE96TZ4)
disodium stearoyl glutamate(UNII: 45ASM2L11M)
xanthan gum(UNII: TTV12P4NEE)
aluminum hydroxide(UNII: 5QB0T2IUN0)
citric acid monohydrate(UNII: 2968PHW8QP)
hyaluronate sodium(UNII: YSE9PPT4TH)
biosaccharide gum-1(UNII: BB4PU4V09H)
polysorbate 60(UNII: CAL22UVI4M)
sorbitan isostearate(UNII: 01S2G2C1E4)
butylated hydroxytoluene(UNII: 1P9D0Z171K)
maltodextrin(UNII: 7CVR7L4A2D)
potassium laurate(UNII: V4361R8N4Z)
tocopherol(UNII: R0ZB2556P8)
ferric oxide red(UNII: 1K09F3G675)
ferric oxide yellow(UNII: EX438O2MRT)
ferrosoferric oxide(UNII: XM0M87F357)
mica(UNII: V8A1AW0880)
Packaging
# Item Code Package Description Marketing Start Date Marketing End Date
1NDC:68745-2088-11 in 1 CARTON 04/08/2017
111 g in 1 CASE Type 0: Not a Combination Product
2NDC:68745-2088-21 in 1 CARTON 04/08/2017
29 g in 1 CASE 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 08/04/2017
Les Beiges Octinoxate and Titanium dioxide GEL
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:68745-2089
Route of Administration TOPICAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
Octinoxate(UNII: 4Y5P7MUD51)
(Octinoxate - UNII:4Y5P7MUD51) 		Octinoxate0.748 g in 11 g
Titanium dioxide(UNII: 15FIX9V2JP)
(TITANIUM DIOXIDE - UNII:15FIX9V2JP) 		Titanium dioxide0.264 g in 11 g
Inactive Ingredients
Ingredient Name Strength
water(UNII: 059QF0KO0R)
polysorbate 85(UNII: A7F3N56197)
silicon dioxide(UNII: ETJ7Z6XBU4)
glycerin(UNII: PDC6A3C0OX)
alcohol(UNII: 3K9958V90M)
isononyl isononanoate(UNII: S4V5BS6GCX)
butylene glycol(UNII: 3XUS85K0RA)
cetyl ethylhexanoate(UNII: 134647WMX4)
hydrogenated soybean lecithin(UNII: H1109Z9J4N)
kalanchoe pinnata leaf(UNII: 3R963LO08T)
phenoxyethanol(UNII: HIE492ZZ3T)
dicaprylyl carbonate(UNII: 609A3V1SUA)
sorbitan monolaurate(UNII: 6W9PS8B71J)
dimethicone(UNII: 92RU3N3Y1O)
potassium sorbate(UNII: 1VPU26JZZ4)
caprylyl glycol(UNII: 00YIU5438U)
stearic acid(UNII: 4ELV7Z65AP)
aluminum oxide(UNII: LMI26O6933)
.alpha.-tocopherol acetate(UNII: 9E8X80D2L0)
hydroxyethyl acrylate/sodium acryloyldimethyl taurate copolymer (100000 MPA.S AT 1.5%)(UNII: 86FQE96TZ4)
disodium stearoyl glutamate(UNII: 45ASM2L11M)
xanthan gum(UNII: TTV12P4NEE)
aluminum hydroxide(UNII: 5QB0T2IUN0)
citric acid monohydrate(UNII: 2968PHW8QP)
hyaluronate sodium(UNII: YSE9PPT4TH)
biosaccharide gum-1(UNII: BB4PU4V09H)
polysorbate 60(UNII: CAL22UVI4M)
sorbitan isostearate(UNII: 01S2G2C1E4)
butylated hydroxytoluene(UNII: 1P9D0Z171K)
maltodextrin(UNII: 7CVR7L4A2D)
potassium laurate(UNII: V4361R8N4Z)
tocopherol(UNII: R0ZB2556P8)
ferric oxide red(UNII: 1K09F3G675)
ferric oxide yellow(UNII: EX438O2MRT)
ferrosoferric oxide(UNII: XM0M87F357)
mica(UNII: V8A1AW0880)
Packaging
# Item Code Package Description Marketing Start Date Marketing End Date
1NDC:68745-2089-11 in 1 CARTON 04/08/2017
111 g in 1 CASE Type 0: Not a Combination Product
2NDC:68745-2089-21 in 1 CARTON 04/08/2017
29 g in 1 CASE 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 08/04/2017

PRINCIPAL DISPLAY PANEL

LES BEIGES

GEL TOUCH HEALTHY GLOW TINT

BROAD SPECTRUM SPF 15 SUNSCREEN

N° 10

CHANEL

POIDS NET 11 g
NET WT. 0.38 OZ.

PRINCIPAL DISPLAY PANEL - 11 g Case Carton - N° 10

PRINCIPAL DISPLAY PANEL

LES BEIGES

GEL TOUCH HEALTHY GLOW TINT

BROAD SPECTRUM SPF 15 SUNSCREEN

N° 12 ROSÉ

CHANEL

POIDS NET 11 g
NET WT. 0.38 OZ.

PRINCIPAL DISPLAY PANEL - 11 g Case Carton - N° 12 ROSÉ

PRINCIPAL DISPLAY PANEL

LES BEIGES

GEL TOUCH HEALTHY GLOW TINT

BROAD SPECTRUM SPF 15 SUNSCREEN

N° 20

CHANEL

POIDS NET 11 g
NET WT. 0.38 OZ.

PRINCIPAL DISPLAY PANEL - 11 g Case Carton - N° 20

PRINCIPAL DISPLAY PANEL

LES BEIGES

GEL TOUCH HEALTHY GLOW TINT

BROAD SPECTRUM SPF 15 SUNSCREEN

N° 21

CHANEL

POIDS NET 11 g
NET WT. 0.38 OZ.

PRINCIPAL DISPLAY PANEL - 11 g Case Carton - N° 21

PRINCIPAL DISPLAY PANEL

LES BEIGES

GEL TOUCH HEALTHY GLOW TINT

BROAD SPECTRUM SPF 15 SUNSCREEN

N° 22 ROSÉ

CHANEL

POIDS NET 11 g
NET WT. 0.38 OZ.

PRINCIPAL DISPLAY PANEL - 11 g Case Carton - N° 22 ROSÉ

PRINCIPAL DISPLAY PANEL

LES BEIGES

GEL TOUCH HEALTHY GLOW TINT

BROAD SPECTRUM SPF 15 SUNSCREEN

N° 30

CHANEL

POIDS NET 11 g
NET WT. 0.38 OZ.

PRINCIPAL DISPLAY PANEL - 11 g Case Carton - N° 30

PRINCIPAL DISPLAY PANEL

LES BEIGES

GEL TOUCH HEALTHY GLOW TINT

BROAD SPECTRUM SPF 15 SUNSCREEN

N° 40

CHANEL

POIDS NET 11 g
NET WT. 0.38 OZ.

PRINCIPAL DISPLAY PANEL - 11 g Case Carton - N° 40

PRINCIPAL DISPLAY PANEL

LES BEIGES

GEL TOUCH HEALTHY GLOW TINT

BROAD SPECTRUM SPF 15 SUNSCREEN

N° 50

CHANEL

POIDS NET 11 g
NET WT. 0.38 OZ.

PRINCIPAL DISPLAY PANEL - 11 g Case Carton - N° 50

PRINCIPAL DISPLAY PANEL

LES BEIGES

GEL TOUCH HEALTHY GLOW TINT

BROAD SPECTRUM SPF 15 SUNSCREEN

N° 60

CHANEL

POIDS NET 11 g
NET WT. 0.38 OZ.

PRINCIPAL DISPLAY PANEL - 11 g Case Carton - N° 60

PRINCIPAL DISPLAY PANEL

LES BEIGES

GEL TOUCH HEALTHY GLOW TINT

BROAD SPECTRUM SPF 15 SUNSCREEN

N° 91 CARAMEL

CHANEL

POIDS NET 11 g
NET WT. 0.38 OZ.

PRINCIPAL DISPLAY PANEL - 11 g Case Carton - N° 91 CARAMEL