NDC Code(s) : 76151-241-01
Packager : Boscia LLC

Category : HUMAN OTC DRUG LABEL

DEA Schedule : none

Marketing Status : New Drug Application

INGREDIENTS AND APPEARANCE

Boscia Daily Defense Sunscreen Broad Spectrum SPF 50 PAOCTINOXATE, TITANIUM DIOXIDE, ZINC OXIDE CREAM
Product Information
Product Type HUMAN OTC DRUG Item Code (Source) NDC:76151-241
Route of Administration TOPICAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
OCTINOXATE(UNII: 4Y5P7MUD51)
(OCTINOXATE - UNII:4Y5P7MUD51) 		OCTINOXATE7.25 g in 100 g
TITANIUM DIOXIDE(UNII: 15FIX9V2JP)
(TITANIUM DIOXIDE - UNII:15FIX9V2JP) 		TITANIUM DIOXIDE5.742 g in 100 g
ZINC OXIDE(UNII: SOI2LOH54Z)
(ZINC OXIDE - UNII:SOI2LOH54Z) 		ZINC OXIDE4.75 g in 100 g
Inactive Ingredients
Ingredient Name Strength
CYCLOMETHICONE 5(UNII: 0THT5PCI0R)
WATER(UNII: 059QF0KO0R)
BUTYLENE GLYCOL(UNII: 3XUS85K0RA)
GLYCERIN(UNII: PDC6A3C0OX)
CAPRYLYL TRISILOXANE(UNII: Q95M2P1KJL)
ISODECYL NEOPENTANOATE(UNII: W60VYE24XC)
ALUMINUM STARCH OCTENYLSUCCINATE(UNII: I9PJ0O6294)
SODIUM CHLORIDE(UNII: 451W47IQ8X)
ALUMINUM OXIDE(UNII: LMI26O6933)
DIPROPYLENE GLYCOL(UNII: E107L85C40)
DIMETHICONE(UNII: 92RU3N3Y1O)
CAMELLIA OLEIFERA LEAF(UNII: 5077EL0C60)
EPILOBIUM ANGUSTIFOLIUM FLOWERING TOP(UNII: 08H094218D)
JOJOBA OIL(UNII: 724GKU717M)
GLYCYRRHIZINATE DIPOTASSIUM(UNII: CA2Y0FE3FX)
HYALURONATE SODIUM(UNII: YSE9PPT4TH)
.ALPHA.-TOCOPHEROL ACETATE(UNII: 9E8X80D2L0)
PANTHENOL(UNII: WV9CM0O67Z)
SODIUM LEVULINATE(UNII: VK44E1MQU8)
SODIUM PYRROLIDONE CARBOXYLATE(UNII: 469OTG57A2)
SODIUM ANISATE(UNII: F9WFJ28MV9)
SILICON DIOXIDE(UNII: ETJ7Z6XBU4)
CAPRYLYL GLYCOL(UNII: 00YIU5438U)
Packaging
# Item Code Package Description Marketing Start Date Marketing End Date
1NDC:76151-241-0150 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 11/07/2012

LABELER - Boscia LLC(967960951)

Establishment
Name Address ID/FEI Business Operations
Englewood Lab, Inc. 172198223 manufacture(76151-241)

PRINCIPAL DISPLAY PANEL

boscia   Daily Defense Sunscreen Broad Spectrum SPF 50 PA+++     1.7 oz / 50 g For all skin types

PRINCIPAL DISPLAY PANEL

Inner LabelInner Label