NDC Code(s) : 43419-601-25, 43419-602-25
Packager : ETUDE HOUSE

Category : HUMAN PRESCRIPTION DRUG LABEL

DEA Schedule : none

Marketing Status : New Drug Application

INGREDIENTS AND APPEARANCE

ETUDE HOUSE Precious Mineral BB Bright Fit TITANIUM DIOXIDE and ZINC OXIDE CREAM
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:43419-601
Route of Administration TOPICAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
TITANIUM DIOXIDE(UNII: 15FIX9V2JP)
(TITANIUM DIOXIDE - UNII:15FIX9V2JP) 		TITANIUM DIOXIDE6.264 g in 60 g
ZINC OXIDE(UNII: SOI2LOH54Z)
(ZINC OXIDE - UNII:SOI2LOH54Z) 		ZINC OXIDE0.864 g in 60 g
Inactive Ingredients
Ingredient Name Strength
WATER(UNII: 059QF0KO0R)
Dipropylene Glycol(UNII: E107L85C40)
Cyclomethicone 5(UNII: 0THT5PCI0R)
Phenyl Trimethicone(UNII: DR0K5NOJ4R)
Butylene Glycol Dicaprylate/Dicaprate(UNII: 75D21FL1PI)
Butylene Glycol(UNII: 3XUS85K0RA)
Arbutin(UNII: C5INA23HXF)
Sodium Chloride(UNII: 451W47IQ8X)
Cyclomethicone 6(UNII: XHK3U310BA)
Talc(UNII: 7SEV7J4R1U)
Hyaluronate Sodium(UNII: YSE9PPT4TH)
Polyglyceryl-4 Isostearate(UNII: 820DPX33S7)
Sorbitan Isostearate(UNII: 01S2G2C1E4)
Hexyl Laurate(UNII: 4CG9F9W01Q)
Disteardimonium Hectorite(UNII: X687XDK09L)
Yellow Wax(UNII: 2ZA36H0S2V)
Sorbitan Olivate(UNII: MDL271E3GR)
Dimethicone(UNII: 92RU3N3Y1O)
Calcium Stearate(UNII: 776XM7047L)
Triethoxycaprylylsilane(UNII: LDC331P08E)
Silicon Dioxide(UNII: ETJ7Z6XBU4)
Adenosine(UNII: K72T3FS567)
.Alpha.-Tocopherol Acetate(UNII: 9E8X80D2L0)
Propylene Carbonate(UNII: 8D08K3S51E)
Aluminum Oxide(UNII: LMI26O6933)
Manganese Dioxide(UNII: TF219GU161)
Lauroyl Lysine(UNII: 113171Q70B)
Coconut Oil(UNII: Q9L0O73W7L)
Aloe Vera Leaf(UNII: ZY81Z83H0X)
Codium Tomentosum(UNII: B8B45BRU87)
Ecklonia Cava(UNII: UXX2N5V39P)
Gelidium Cartilagineum(UNII: 37LBZ0E1UE)
Sargassum Fusiforme(UNII: X436TJ4A11)
Edetate Disodium(UNII: 7FLD91C86K)
Caprylyl Glycol(UNII: 00YIU5438U)
Ethylhexylglycerin(UNII: 147D247K3P)
1,2-Hexanediol(UNII: TR046Y3K1G)
Phenoxyethanol(UNII: HIE492ZZ3T)
Mica(UNII: V8A1AW0880)
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:43419-601-251 in 1 CARTON
160 g in 1 TUBE
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
OTC MONOGRAPH NOT FINAL part352 08/13/2013
ETUDE HOUSE Precious Mineral BB Bright Fit TITANIUM DIOXIDE and ZINC OXIDE CREAM
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:43419-602
Route of Administration TOPICAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
TITANIUM DIOXIDE(UNII: 15FIX9V2JP)
(TITANIUM DIOXIDE - UNII:15FIX9V2JP) 		TITANIUM DIOXIDE6.264 g in 60 g
ZINC OXIDE(UNII: SOI2LOH54Z)
(ZINC OXIDE - UNII:SOI2LOH54Z) 		ZINC OXIDE0.864 g in 60 g
Inactive Ingredients
Ingredient Name Strength
WATER(UNII: 059QF0KO0R)
Dipropylene Glycol(UNII: E107L85C40)
Cyclomethicone 5(UNII: 0THT5PCI0R)
Phenyl Trimethicone(UNII: DR0K5NOJ4R)
Butylene Glycol Dicaprylate/Dicaprate(UNII: 75D21FL1PI)
Butylene Glycol(UNII: 3XUS85K0RA)
Arbutin(UNII: C5INA23HXF)
Sodium Chloride(UNII: 451W47IQ8X)
Cyclomethicone 6(UNII: XHK3U310BA)
Talc(UNII: 7SEV7J4R1U)
Hyaluronate Sodium(UNII: YSE9PPT4TH)
Polyglyceryl-4 Isostearate(UNII: 820DPX33S7)
Sorbitan Isostearate(UNII: 01S2G2C1E4)
Hexyl Laurate(UNII: 4CG9F9W01Q)
Disteardimonium Hectorite(UNII: X687XDK09L)
Yellow Wax(UNII: 2ZA36H0S2V)
Sorbitan Olivate(UNII: MDL271E3GR)
Dimethicone(UNII: 92RU3N3Y1O)
Calcium Stearate(UNII: 776XM7047L)
Triethoxycaprylylsilane(UNII: LDC331P08E)
Silicon Dioxide(UNII: ETJ7Z6XBU4)
Adenosine(UNII: K72T3FS567)
.Alpha.-Tocopherol Acetate(UNII: 9E8X80D2L0)
Propylene Carbonate(UNII: 8D08K3S51E)
Aluminum Oxide(UNII: LMI26O6933)
Manganese Dioxide(UNII: TF219GU161)
Lauroyl Lysine(UNII: 113171Q70B)
Coconut Oil(UNII: Q9L0O73W7L)
Aloe Vera Leaf(UNII: ZY81Z83H0X)
Codium Tomentosum(UNII: B8B45BRU87)
Ecklonia Cava(UNII: UXX2N5V39P)
Gelidium Cartilagineum(UNII: 37LBZ0E1UE)
Sargassum Fusiforme(UNII: X436TJ4A11)
Edetate Disodium(UNII: 7FLD91C86K)
Caprylyl Glycol(UNII: 00YIU5438U)
Ethylhexylglycerin(UNII: 147D247K3P)
1,2-Hexanediol(UNII: TR046Y3K1G)
Phenoxyethanol(UNII: HIE492ZZ3T)
Mica(UNII: V8A1AW0880)
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:43419-602-251 in 1 CARTON
160 g in 1 TUBE
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
OTC MONOGRAPH NOT FINAL part352 08/13/2013

PRINCIPAL DISPLAY PANEL

Precious Mineral
BB
CREAM
Bright Fit

SPF30
•
Brightening

(Sunscreen)

Net wt. 2.11 oz. / 60g

ETUDE HOUSE

Principal Display Panel - 60g Tube Carton - Natural Beige

PRINCIPAL DISPLAY PANEL

Precious Mineral
BB
CREAM
Bright Fit

SPF30
•
Brightening

(Sunscreen)

Net wt. 2.11 oz. / 60g

ETUDE HOUSE

Principal Display Panel - 60g Tube Carton - Honey Beige