NDC Code(s) : 76151-106-12
Packager : Boscia LLC

Category : HUMAN OTC DRUG LABEL

DEA Schedule : none

Marketing Status : New Drug Application

INGREDIENTS AND APPEARANCE

Boscia Daily Hydration SPF 15 Broad Spectrum For Normal To Oily SkinAVOBENZONE, OCTINOXATE CREAM
Product Information
Product Type HUMAN OTC DRUG Item Code (Source) NDC:76151-106
Route of Administration TOPICAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
AVOBENZONE(UNII: G63QQF2NOX)
(AVOBENZONE - UNII:G63QQF2NOX) 		AVOBENZONE30 mg in 1 mL
OCTINOXATE(UNII: 4Y5P7MUD51)
(OCTINOXATE - UNII:4Y5P7MUD51) 		OCTINOXATE60 mg in 1 mL
Inactive Ingredients
Ingredient Name Strength
1,2-HEXANEDIOL(UNII: TR046Y3K1G)
CAPRYLYL GLYCOL(UNII: 00YIU5438U)
WATER(UNII: 059QF0KO0R)
BUTYLENE GLYCOL(UNII: 3XUS85K0RA)
SILICON DIOXIDE(UNII: ETJ7Z6XBU4)
POLYGLYCERYL-10 STEARATE(UNII: 90TF85HH91)
PENTYLENE GLYCOL(UNII: 50C1307PZG)
POTASSIUM PHOSPHATE, UNSPECIFIED FORM(UNII: B7862WZ632)
ROSEMARY(UNII: IJ67X351P9)
PHELLODENDRON AMURENSE BARK(UNII: PBG27B754G)
SIMMONDSIA CHINENSIS SEED(UNII: D24K2Q1F6H)
EPILOBIUM ANGUSTIFOLIUM FLOWERING TOP(UNII: 08H094218D)
CITRUS AURANTIUM FLOWER(UNII: O730ZX2Z83)
ARCTIUM LAPPA ROOT(UNII: 597E9BI3Z3)
CHAMAEMELUM NOBILE FLOWER(UNII: O2T154T6OG)
PEG-100 STEARATE(UNII: YD01N1999R)
GLYCERIN(UNII: PDC6A3C0OX)
STEARIC ACID(UNII: 4ELV7Z65AP)
GLYCERYL MONOSTEARATE(UNII: 230OU9XXE4)
MICA(UNII: V8A1AW0880)
TITANIUM DIOXIDE(UNII: 15FIX9V2JP)
Packaging
# Item Code Package Description Marketing Start Date Marketing End Date
1NDC:76151-106-121 in 1 CARTON 19/12/2017
140 mL in 1 TUBE 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 11/08/2012

LABELER - Boscia LLC(967960951)

Establishment
Name Address ID/FEI Business Operations
Englewood Lab, Inc. 172198223 manufacture(76151-106)

PRINCIPAL DISPLAY PANEL

boscia   Oil-free Daily Hydration Broad Spectrum SPF 15 1.4 fl oz/40 ml For normal to oily skin

PRINCIPAL DISPLAY PANEL

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