NDC Code(s) : 76151-231-01
Packager : Boscia LLC

Category : HUMAN OTC DRUG LABEL

DEA Schedule : none

Marketing Status : New Drug Application

INGREDIENTS AND APPEARANCE

Boscia B.B. LIGHT Broad Spectrum SPF 27 PA Self-Adjusting ShadeTITANIUM DIOXIDE, ZINC OXIDE CREAM
Product Information
Product Type HUMAN OTC DRUG Item Code (Source) NDC:76151-231
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 DIOXIDE11.25 g in 100 g
ZINC OXIDE(UNII: SOI2LOH54Z)
(ZINC OXIDE - UNII:SOI2LOH54Z) 		ZINC OXIDE0.98 g in 100 g
Inactive Ingredients
Ingredient Name Strength
FERRIC OXIDE RED(UNII: 1K09F3G675)
WATER(UNII: 059QF0KO0R)
CYCLOMETHICONE 5(UNII: 0THT5PCI0R)
DIPROPYLENE GLYCOL(UNII: E107L85C40)
GLYCERETH-26(UNII: NNE56F2N14)
SODIUM PYRROLIDONE CARBOXYLATE(UNII: 469OTG57A2)
BUTYLENE GLYCOL(UNII: 3XUS85K0RA)
GLYCERIN(UNII: PDC6A3C0OX)
ARBUTIN(UNII: C5INA23HXF)
SIMMONDSIA CHINENSIS SEED(UNII: D24K2Q1F6H)
EPILOBIUM ANGUSTIFOLIUM FLOWERING TOP(UNII: 08H094218D)
YEAST(UNII: 3NY3SM6B8U)
ALLANTOIN(UNII: 344S277G0Z)
ADENOSINE(UNII: K72T3FS567)
PANTHENOL(UNII: WV9CM0O67Z)
STEARIC ACID(UNII: 4ELV7Z65AP)
PEG/PPG-20/15 DIMETHICONE(UNII: 06R6X77P9C)
TRIETHOXYCAPRYLYLSILANE(UNII: LDC331P08E)
PHENYL TRIMETHICONE(UNII: DR0K5NOJ4R)
SORBITOL(UNII: 506T60A25R)
ALUMINUM OXIDE(UNII: LMI26O6933)
MICA(UNII: V8A1AW0880)
CAPRYLYL GLYCOL(UNII: 00YIU5438U)
Packaging
# Item Code Package Description Marketing Start Date Marketing End Date
1NDC:76151-231-0150 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 11/06/2012

LABELER - Boscia LLC(967960951)

Establishment
Name Address ID/FEI Business Operations
Englewood Lab, Inc. 172198223 manufacture(76151-231)

PRINCIPAL DISPLAY PANEL

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

PRINCIPAL DISPLAY PANEL

Inner LabelInner Label