NDC Code(s) : 76151-251-01
Packager : Boscia LLC

Category : HUMAN OTC DRUG LABEL

DEA Schedule : none

Marketing Status : New Drug Application

INGREDIENTS AND APPEARANCE

Boscia Self-Defense Vital Antioxidant Moisture Broad Spectrum SPF 30 AVOBENZONE, OCTINOXATE CREAM
Product Information
Product Type HUMAN OTC DRUG Item Code (Source) NDC:76151-251
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) 		OCTINOXATE75 mg in 1 mL
Inactive Ingredients
Ingredient Name Strength
WATER(UNII: 059QF0KO0R)
BUTYLENE GLYCOL(UNII: 3XUS85K0RA)
KAOLIN(UNII: 24H4NWX5CO)
BUTYLOCTYL SALICYLATE(UNII: 2EH13UN8D3)
ISODECYL NEOPENTANOATE(UNII: W60VYE24XC)
CAPRYLYL TRISILOXANE(UNII: Q95M2P1KJL)
DIMETHICONE(UNII: 92RU3N3Y1O)
PENTYLENE GLYCOL(UNII: 50C1307PZG)
GLYCERYL MONOSTEARATE(UNII: 230OU9XXE4)
DIETHYLHEXYL SYRINGYLIDENEMALONATE(UNII: 3V5U97P248)
GLYCERETH-26(UNII: NNE56F2N14)
OLIVE OIL(UNII: 6UYK2W1W1E)
CARROT(UNII: L56Z1JK48B)
MARITIME PINE(UNII: 50JZ5Z98QY)
EPILOBIUM ANGUSTIFOLIUM LEAF(UNII: 7NV86426N2)
ALTHAEA OFFICINALIS LEAF(UNII: E2QQV92338)
ROSEMARY(UNII: IJ67X351P9)
SIMMONDSIA CHINENSIS SEED(UNII: D24K2Q1F6H)
JASMINUM OFFICINALE FLOWER(UNII: 0Q8K841432)
JOJOBA OIL(UNII: 724GKU717M)
RICE BRAN OIL(UNII: LZO6K1506A)
DECYLENE GLYCOL(UNII: S57M60MI88)
MEDIUM-CHAIN TRIGLYCERIDES(UNII: C9H2L21V7U)
TRISODIUM ETHYLENEDIAMINE DISUCCINATE(UNII: YA22H34H9Q)
POLYSORBATE 80(UNII: 6OZP39ZG8H)
DIGLYCERIN(UNII: 3YC120743U)
CYCLOMETHICONE 5(UNII: 0THT5PCI0R)
STEARIC ACID(UNII: 4ELV7Z65AP)
DOCOSANOL(UNII: 9G1OE216XY)
TRIETHOXYCAPRYLYLSILANE(UNII: LDC331P08E)
XANTHAN GUM(UNII: TTV12P4NEE)
CITRIC ACID MONOHYDRATE(UNII: 2968PHW8QP)
POTASSIUM HYDROXIDE(UNII: WZH3C48M4T)
CAPRYLYL GLYCOL(UNII: 00YIU5438U)
1,2-HEXANEDIOL(UNII: TR046Y3K1G)
Packaging
# Item Code Package Description Marketing Start Date Marketing End Date
1NDC:76151-251-011 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 11/03/2012

LABELER - Boscia LLC(967960951)

Establishment
Name Address ID/FEI Business Operations
Englewood Lab, Inc. 172198223 manufacture(76151-251)

PRINCIPAL DISPLAY PANEL

boscia  Self-Defense Vital Antioxidant Moisture Broad Spectrum SPF 30   1.4 fl oz / 40 ml      www.boscia.net  B104-15   Distributed by boscia, LLC.  Irvine, CA 92614   Made in USA For normal to dry skin types

PRINCIPAL DISPLAY PANEL

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