NDC Code(s) : 76151-217-01
Packager : Boscia LLC

Category : HUMAN OTC DRUG LABEL

DEA Schedule : none

Marketing Status : New Drug Application

INGREDIENTS AND APPEARANCE

Boscia Restorative Day Moisture Broad Spectrum SPF 15 For Dry SkinAVOBENZONE, OCTINOXATE CREAM
Product Information
Product Type HUMAN OTC DRUG Item Code (Source) NDC:76151-217
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) 		OCTINOXATE65 mg in 1 mL
Inactive Ingredients
Ingredient Name Strength
WATER(UNII: 059QF0KO0R)
GLYCERIN(UNII: PDC6A3C0OX)
BUTYLENE GLYCOL(UNII: 3XUS85K0RA)
C12-15 ALKYL LACTATE(UNII: GC844VRD7E)
PROPYLENE GLYCOL DICAPRATE(UNII: U783H9JHWY)
CETYL RICINOLEATE(UNII: 1P677500YD)
RICE BRAN OIL(UNII: LZO6K1506A)
ROSA CENTIFOLIA FLOWER OIL(UNII: H32V31VMWY)
CYCLOMETHICONE 5(UNII: 0THT5PCI0R)
GLYCERYL MONOSTEARATE(UNII: 230OU9XXE4)
METHYL GLUCETH-20(UNII: J3QD0LD11P)
PENTYLENE GLYCOL(UNII: 50C1307PZG)
DIMETHICONE(UNII: 92RU3N3Y1O)
STEARETH-2(UNII: V56DFE46J5)
SQUALANE(UNII: GW89575KF9)
STEARETH-21(UNII: 53J3F32P58)
STEARIC ACID(UNII: 4ELV7Z65AP)
SILICON DIOXIDE(UNII: ETJ7Z6XBU4)
ALOE VERA LEAF(UNII: ZY81Z83H0X)
MALVA SYLVESTRIS FLOWER(UNII: 12X9JI52BS)
MAGNOLIA OBOVATA BARK(UNII: SM9Z2LD5TK)
SIMMONDSIA CHINENSIS SEED(UNII: D24K2Q1F6H)
EPILOBIUM ANGUSTIFOLIUM FLOWERING TOP(UNII: 08H094218D)
PALMITOYL OLIGOPEPTIDE(UNII: HO4ZT5S86C)
PALMITOYL TETRAPEPTIDE-7(UNII: Q41S464P1R)
CASTOR OIL(UNII: D5340Y2I9G)
SIMMONDSIA CHINENSIS SEED WAX(UNII: 47X6Y9FJJ2)
LONICERA JAPONICA FLOWER(UNII: 4465L2WS4Y)
POTASSIUM HYDROXIDE(UNII: WZH3C48M4T)
BENTONITE(UNII: A3N5ZCN45C)
ALANYL GLUTAMINE(UNII: U5JDO2770Z)
XANTHAN GUM(UNII: TTV12P4NEE)
POLYSORBATE 20(UNII: 7T1F30V5YH)
POLYSORBATE 60(UNII: CAL22UVI4M)
CARBON DIOXIDE(UNII: 142M471B3J)
Packaging
# Item Code Package Description Marketing Start Date Marketing End Date
1NDC:76151-217-011 in 1 CARTON 19/12/2017
130 mL in 1 JAR 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 11/16/2012

LABELER - Boscia LLC(967960951)

Establishment
Name Address ID/FEI Business Operations
Englewood Lab, Inc. 172198223 manufacture(76151-217)

PRINCIPAL DISPLAY PANEL

boscia  Restorative Day Moisture Cream Broad Spectrum SPF 15     1 fl oz / 30 ml For dry skin

PRINCIPAL DISPLAY PANEL

Boscia Restorative 1