NDC Code(s) : 76159-001-00
Packager : 3LAB, Inc

Category : HUMAN OTC DRUG LABEL

DEA Schedule : none

Marketing Status : New Drug Application

INGREDIENTS AND APPEARANCE

3LAB PERFECT BB SPF 40 Broad Spectrum 01TITANIUM DIOXIDE CREAM
Product Information
Product Type HUMAN OTC DRUG Item Code (Source) NDC:76159-001
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 DIOXIDE121.6 mg in 1 mL
Inactive Ingredients
Ingredient Name Strength
PANTHENOL(UNII: WV9CM0O67Z)
POTASSIUM HYDROXIDE(UNII: WZH3C48M4T)
GLYCYRRHIZINATE DIPOTASSIUM(UNII: CA2Y0FE3FX)
SODIUM PHOSPHATE(UNII: SE337SVY37)
CAPRYLYL GLYCOL(UNII: 00YIU5438U)
BORON NITRIDE(UNII: 2U4T60A6YD)
ALCOHOL(UNII: 3K9958V90M)
EDETATE DISODIUM(UNII: 7FLD91C86K)
EDETIC ACID(UNII: 9G34HU7RV0)
PHENOXYETHANOL(UNII: HIE492ZZ3T)
ORANGE OIL(UNII: AKN3KSD11B)
FERRIC OXIDE RED(UNII: 1K09F3G675)
FERRIC OXIDE YELLOW(UNII: EX438O2MRT)
FERROSOFERRIC OXIDE(UNII: XM0M87F357)
WATER(UNII: 059QF0KO0R)
CYCLOMETHICONE 5(UNII: 0THT5PCI0R)
BUTYLENE GLYCOL(UNII: 3XUS85K0RA)
ALUMINUM STARCH OCTENYLSUCCINATE(UNII: I9PJ0O6294)
ASCORBYL GLUCOSIDE(UNII: 2V52R0NHXW)
CAPRYLYL TRISILOXANE(UNII: Q95M2P1KJL)
XANTHAN GUM(UNII: TTV12P4NEE)
GLYCERETH-26(UNII: NNE56F2N14)
NEOPENTYL GLYCOL DICAPRATE(UNII: 77T908SE82)
PHENYL TRIMETHICONE(UNII: DR0K5NOJ4R)
DIMETHICONE(UNII: 92RU3N3Y1O)
ALUMINUM OXIDE(UNII: LMI26O6933)
DIPROPYLENE GLYCOL(UNII: E107L85C40)
SODIUM CHLORIDE(UNII: 451W47IQ8X)
SQUALANE(UNII: GW89575KF9)
ACHILLEA MILLEFOLIUM(UNII: 2FXJ6SW4PK)
SHEA BUTTER(UNII: K49155WL9Y)
CHAMOMILE(UNII: FGL3685T2X)
FENNEL SEED(UNII: G3QC02NIE6)
HOPS(UNII: 01G73H6H83)
MELISSA OFFICINALIS LEAF(UNII: 50D2ZE9219)
VISCUM ALBUM FRUITING TOP(UNII: BK9092J5MP)
OLIVE OIL(UNII: 6UYK2W1W1E)
.ALPHA.-TOCOPHEROL ACETATE(UNII: 9E8X80D2L0)
ADENOSINE(UNII: K72T3FS567)
TOCOPHEROL(UNII: R0ZB2556P8)
HYALURONATE SODIUM(UNII: YSE9PPT4TH)
ALLANTOIN(UNII: 344S277G0Z)
CERAMIDE 3(UNII: 4370DF050B)
GLYCERIN(UNII: PDC6A3C0OX)
PEG/PPG-20/15 DIMETHICONE(UNII: 06R6X77P9C)
PEG/PPG-18/18 DIMETHICONE(UNII: 9H0AO7T794)
SILICON DIOXIDE(UNII: ETJ7Z6XBU4)
SODIUM OLEATE(UNII: 399SL044HN)
SODIUM PYRROLIDONE CARBOXYLATE(UNII: 469OTG57A2)
TRIETHOXYCAPRYLYLSILANE(UNII: LDC331P08E)
UREA(UNII: 8W8T17847W)
Packaging
# Item Code Package Description Marketing Start Date Marketing End Date
1NDC:76159-001-001 in 1 CARTON 19/12/2017
145 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 01/10/2013

LABELER - 3LAB, Inc(162333277)

Establishment
Name Address ID/FEI Business Operations
Englewood Lab, Inc. 172198223 manufacture(76159-001)

PRINCIPAL DISPLAY PANEL

3LAB  PERFECT BB SPF 40  BROAD SPECTRUM  #01 NET WT. 1.5 OZ. 45 mL e

PRINCIPAL DISPLAY PANEL

Perfect BB 1