NDC Code(s) : 76159-004-00
Packager : 3LAB, Inc.

Category : HUMAN OTC DRUG LABEL

DEA Schedule : none

Marketing Status : New Drug Application

INGREDIENTS AND APPEARANCE

3LAB Aqua BB SPF 40 BROAD SPECTRUM 01TITANIUM DIOXIDE CREAM
Product Information
Product Type HUMAN OTC DRUG Item Code (Source) NDC:76159-004
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 DIOXIDE78.6 mg in 1 mL
Inactive Ingredients
Ingredient Name Strength
TRIETHOXYCAPRYLYLSILANE(UNII: LDC331P08E)
POLYSORBATE 20(UNII: 7T1F30V5YH)
1,2-HEXANEDIOL(UNII: TR046Y3K1G)
CYCLOMETHICONE 5(UNII: 0THT5PCI0R)
ROSA CENTIFOLIA FLOWER OIL(UNII: H32V31VMWY)
WATER(UNII: 059QF0KO0R)
BUTYLENE GLYCOL(UNII: 3XUS85K0RA)
BUTYLOCTYL SALICYLATE(UNII: 2EH13UN8D3)
DIMETHICONE(UNII: 92RU3N3Y1O)
SODIUM PYRROLIDONE CARBOXYLATE(UNII: 469OTG57A2)
GLYCERIN(UNII: PDC6A3C0OX)
ALUMINUM OXIDE(UNII: LMI26O6933)
TRISILOXANE(UNII: 9G1ZW13R0G)
GLYCERETH-26(UNII: NNE56F2N14)
HYALURONATE SODIUM(UNII: YSE9PPT4TH)
ADENOSINE(UNII: K72T3FS567)
GLYCYRRHIZINATE DIPOTASSIUM(UNII: CA2Y0FE3FX)
ALLANTOIN(UNII: 344S277G0Z)
PALMITOYL OLIGOPEPTIDE(UNII: HO4ZT5S86C)
PALMITOYL TETRAPEPTIDE-7(UNII: Q41S464P1R)
.ALPHA.-TOCOPHEROL ACETATE(UNII: 9E8X80D2L0)
PEG/PPG-20/15 DIMETHICONE(UNII: 06R6X77P9C)
CAPRYLYL GLYCOL(UNII: 00YIU5438U)
EDETATE DISODIUM(UNII: 7FLD91C86K)
PHENOXYETHANOL(UNII: HIE492ZZ3T)
LAVENDER OIL(UNII: ZBP1YXW0H8)
FERRIC OXIDE RED(UNII: 1K09F3G675)
FERRIC OXIDE YELLOW(UNII: EX438O2MRT)
FERROSOFERRIC OXIDE(UNII: XM0M87F357)
Packaging
# Item Code Package Description Marketing Start Date Marketing End Date
1NDC:76159-004-001 in 1 CARTON 19/12/2017
128 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 11/18/2013

LABELER - 3LAB, Inc.(162333277)

Establishment
Name Address ID/FEI Business Operations
Englewood Lab, Inc 172198223 manufacture(76159-004)

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