NDC Code(s) : 76151-261-01
Packager : Boscia LLC

Category : HUMAN OTC DRUG LABEL

DEA Schedule : none

Marketing Status : New Drug Application

INGREDIENTS AND APPEARANCE

Boscia All In One B.B. Eye Brightener Broad Spectrum SPF 20TITANIUM DIOXIDE CREAM
Product Information
Product Type HUMAN OTC DRUG Item Code (Source) NDC:76151-261
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 DIOXIDE6.45 g in 100 g
Inactive Ingredients
Ingredient Name Strength
1,2-HEXANEDIOL(UNII: TR046Y3K1G)
ALLANTOIN(UNII: 344S277G0Z)
ALUMINUM OXIDE(UNII: LMI26O6933)
ARGININE(UNII: 94ZLA3W45F)
BAKUCHIOL(UNII: OT12HJU3AR)
BUTYLENE GLYCOL(UNII: 3XUS85K0RA)
MEDIUM-CHAIN TRIGLYCERIDES(UNII: C9H2L21V7U)
CAPRYLYL GLYCOL(UNII: 00YIU5438U)
CAPRYLYL TRISILOXANE(UNII: Q95M2P1KJL)
CITRUS AURANTIUM FLOWER(UNII: O730ZX2Z83)
CYCLOMETHICONE 5(UNII: 0THT5PCI0R)
DIMETHICONE(UNII: 92RU3N3Y1O)
VALYLTRYPTOPHAN(UNII: 3G64B4AFQN)
GLYCYRRHIZINATE DIPOTASSIUM(UNII: CA2Y0FE3FX)
DISTEARDIMONIUM HECTORITE(UNII: X687XDK09L)
GLYCERETH-26(UNII: NNE56F2N14)
GLYCERIN(UNII: PDC6A3C0OX)
SUNFLOWER OIL(UNII: 3W1JG795YI)
HESPERIDIN METHYLCHALCONE(UNII: 4T2GVA922X)
FERRIC OXIDE RED(UNII: 1K09F3G675)
FERRIC OXIDE YELLOW(UNII: EX438O2MRT)
FERROSOFERRIC OXIDE(UNII: XM0M87F357)
ISOPROPYL TITANIUM TRIISOSTEARATE(UNII: 949E3KBJ1I)
MICA(UNII: V8A1AW0880)
NEOPENTYL GLYCOL DICAPRATE(UNII: 77T908SE82)
PALMITOYL OLIGOPEPTIDE(UNII: HO4ZT5S86C)
PALMITOYL TETRAPEPTIDE-7(UNII: Q41S464P1R)
PANTHENOL(UNII: WV9CM0O67Z)
PEG/PPG-20/15 DIMETHICONE(UNII: 06R6X77P9C)
POLYSORBATE 20(UNII: 7T1F30V5YH)
SALICORNIA EUROPAEA(UNII: 6ADL50JAKW)
SILICON DIOXIDE(UNII: ETJ7Z6XBU4)
SIMMONDSIA CHINENSIS SEED(UNII: D24K2Q1F6H)
SODIUM CHLORIDE(UNII: 451W47IQ8X)
SODIUM PYRROLIDONE CARBOXYLATE(UNII: 469OTG57A2)
STEARETH-20(UNII: L0Q8IK9E08)
.ALPHA.-TOCOPHEROL ACETATE(UNII: 9E8X80D2L0)
TRIETHOXYCAPRYLYLSILANE(UNII: LDC331P08E)
UNDARIA PINNATIFIDA(UNII: ICV1OK7M1S)
WATER(UNII: 059QF0KO0R)
Packaging
# Item Code Package Description Marketing Start Date Marketing End Date
1NDC:76151-261-011 in 1 CARTON 19/12/2017
116 g in 1 BOTTLE Type 0: Not a Combination Product
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
OTC Monograph Drug M020 04/10/2014

LABELER - Boscia LLC(967960951)

Establishment
Name Address ID/FEI Business Operations
Englewood Lab, Inc. 172198223 manufacture(76151-261)

PRINCIPAL DISPLAY PANEL

Bottle LabelBottle Label