NDC Code(s) : 76151-211-96, 76151-211-02
Packager : Boscia LLC

Category : HUMAN OTC DRUG LABEL

DEA Schedule : none

Marketing Status : New Drug Application

INGREDIENTS AND APPEARANCE

Boscia BB Broad Spectrum SPF 27 PA Self Adjusting ShadeTITANIUM DIOXIDE, ZINC OXIDE CREAM
Product Information
Product Type HUMAN OTC DRUG Item Code (Source) NDC:76151-211
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 DIOXIDE10.02 g in 100 g
ZINC OXIDE(UNII: SOI2LOH54Z)
(ZINC OXIDE - UNII:SOI2LOH54Z) 		ZINC OXIDE0.97 g in 100 g
Inactive Ingredients
Ingredient Name Strength
WATER(UNII: 059QF0KO0R)
CYCLOMETHICONE 5(UNII: 0THT5PCI0R)
DIPROPYLENE GLYCOL(UNII: E107L85C40)
DIMETHICONE(UNII: 92RU3N3Y1O)
GLYCERETH-26(UNII: NNE56F2N14)
SODIUM PYRROLIDONE CARBOXYLATE(UNII: 469OTG57A2)
PEG/PPG-18/18 DIMETHICONE(UNII: 9H0AO7T794)
GLYCYRRHIZINATE DIPOTASSIUM(UNII: CA2Y0FE3FX)
GLYCERIN(UNII: PDC6A3C0OX)
PEG/PPG-20/15 DIMETHICONE(UNII: 06R6X77P9C)
ALLANTOIN(UNII: 344S277G0Z)
CITRIC ACID MONOHYDRATE(UNII: 2968PHW8QP)
HYALURONATE SODIUM(UNII: YSE9PPT4TH)
PHENYL TRIMETHICONE(UNII: DR0K5NOJ4R)
SODIUM ANISATE(UNII: F9WFJ28MV9)
TRIETHOXYCAPRYLYLSILANE(UNII: LDC331P08E)
SORBITOL(UNII: 506T60A25R)
ALUMINUM OXIDE(UNII: LMI26O6933)
STEARIC ACID(UNII: 4ELV7Z65AP)
SODIUM LEVULINATE(UNII: VK44E1MQU8)
PANTHENOL(UNII: WV9CM0O67Z)
MICA(UNII: V8A1AW0880)
CAPRYLYL GLYCOL(UNII: 00YIU5438U)
FERRIC OXIDE YELLOW(UNII: EX438O2MRT)
FERRIC OXIDE RED(UNII: 1K09F3G675)
FERROSOFERRIC OXIDE(UNII: XM0M87F357)
Packaging
# Item Code Package Description Marketing Start Date Marketing End Date
1NDC:76151-211-9625 g in 1 JAR Type 0: Not a Combination Product19/12/2017
2NDC:76151-211-0250 g in 1 TUBE Type 0: Not a Combination Product19/12/2017
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
OTC Monograph Drug M020 11/07/2012

LABELER - Boscia LLC(967960951)

Establishment
Name Address ID/FEI Business Operations
Englewood Lab, Inc. 172198223 manufacture(76151-211)

PRINCIPAL DISPLAY PANEL

boscia B.B. Cream Broad Spectrum SPF 27 PA++ Oil-Free Self-adjusting shade for all skin types 1.75oz/50 g

PRINCIPAL DISPLAY PANEL

Inner LabelInner Label