NDC Code(s) : 98132-252-50
Packager : Orveon Global US LLC

Category : HUMAN OTC DRUG LABEL

DEA Schedule : none

Marketing Status : New Drug Application

INGREDIENTS AND APPEARANCE

bareMinerals Skinlongevity Vital Power Moisturizer Broad Spectrum SPF 30TITANIUM DIOXIDE and ZINC OXIDE CREAM
Product Information
Product Type HUMAN OTC DRUG Item Code (Source) NDC:98132-252
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 DIOXIDE1870 mg in 50 mL
ZINC OXIDE(UNII: SOI2LOH54Z)
(ZINC OXIDE - UNII:SOI2LOH54Z) 		ZINC OXIDE7128 mg in 50 mL
Inactive Ingredients
Ingredient Name Strength
CITRIC ACID MONOHYDRATE(UNII: 2968PHW8QP)
VINYLPYRROLIDONE/EICOSENE COPOLYMER(UNII: 035MV9S1C3)
CETYL ALCOHOL(UNII: 936JST6JCN)
CARBOXYMETHYLCELLULOSE SODIUM, UNSPECIFIED FORM(UNII: K679OBS311)
GERANIOL(UNII: L837108USY)
LINALOOL, (+/-)-(UNII: D81QY6I88E)
LIMONENE, (+/-)-(UNII: 9MC3I34447)
CITRAL(UNII: T7EU0O9VPP)
SODIUM BENZOATE(UNII: OJ245FE5EU)
PHENOXYETHANOL(UNII: HIE492ZZ3T)
MICA(UNII: V8A1AW0880)
WATER(UNII: 059QF0KO0R)
DIMETHICONE(UNII: 92RU3N3Y1O)
PROPANEDIOL(UNII: 5965N8W85T)
GLYCERIN(UNII: PDC6A3C0OX)
POLYETHYLENE GLYCOL 1500(UNII: 1212Z7S33A)
POLYETHYLENE GLYCOL 300(UNII: 5655G9Y8AQ)
POLYSORBATE 60(UNII: CAL22UVI4M)
ARABICA COFFEE OIL(UNII: IK55HKE887)
DECYL ISOSTEARATE(UNII: NRB038QC02)
COCO-CAPRYLATE/CAPRATE(UNII: 8D9H4QU99H)
ISOHEXADECANE(UNII: 918X1OUF1E)
ISOSTEARYL ISOSTEARATE(UNII: IV0Z586Z4Y)
CETYL STEARATE(UNII: 06RI5UQA7L)
CAPRYLYL GLYCOL(UNII: 00YIU5438U)
.ALPHA.-TOCOPHEROL(UNII: H4N855PNZ1)
AMMONIUM ACRYLOYLDIMETHYLTAURATE, DIMETHYLACRYLAMIDE, LAURYL METHACRYLATE AND LAURETH-4 METHACRYLATE COPOLYMER, TRIMETHYLOLPROPANE TRIACRYLATE CROSSLINKED (45000 MPA.S)(UNII: Q7UI015FF9)
SODIUM ACRYLATE/SODIUM ACRYLOYLDIMETHYLTAURATE COPOLYMER (4000000 MW)(UNII: 1DXE3F3OZX)
SODIUM METHYL STEAROYL TAURATE(UNII: JFM219LJ55)
SORBITAN SESQUIISOSTEARATE(UNII: VU97D01BF9)
POTASSIUM CETYL PHOSPHATE(UNII: 03KCY6P7UT)
DECYL GLUCOSIDE(UNII: Z17H97EA6Y)
POLYSORBATE 80(UNII: 6OZP39ZG8H)
STEARIC ACID(UNII: 4ELV7Z65AP)
SORBITAN MONOOLEATE(UNII: 06XEA2VD56)
ISOSTEARIC ACID(UNII: X33R8U0062)
HEXYLENE GLYCOL(UNII: KEH0A3F75J)
TERT-BUTYL ALCOHOL(UNII: MD83SFE959)
BUTYLENE GLYCOL(UNII: 3XUS85K0RA)
HYDROGEN DIMETHICONE (13 CST)(UNII: 4QGR4P2YOI)
SILICON DIOXIDE(UNII: ETJ7Z6XBU4)
SODIUM CITRATE, UNSPECIFIED FORM(UNII: 1Q73Q2JULR)
TRIETHOXYCAPRYLYLSILANE(UNII: LDC331P08E)
ALUMINUM HYDROXIDE(UNII: 5QB0T2IUN0)
ALCOHOL(UNII: 3K9958V90M)
EDETATE DISODIUM(UNII: 7FLD91C86K)
TREHALOSE(UNII: B8WCK70T7I)
POTASSIUM SORBATE(UNII: 1VPU26JZZ4)
Packaging
# Item Code Package Description Marketing Start Date Marketing End Date
1NDC:98132-252-501 in 1 CARTON 01/01/2019
150 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 01/01/2019

LABELER - Orveon Global US LLC(118344494)

PRINCIPAL DISPLAY PANEL

bareMinerals ®

SKINLONGEVITY™

VITAL
POWER
MOISTURIZER

POWERED BY
LONG LIFE HERB,
GREEN COFFEE BEAN,
AND PEONY EXTRACT

FOR ALL SKIN TYPES

BROAD SPECTRUM
SPF30

50 ml / 1.7 fl. oz.

PRINCIPAL DISPLAY PANEL - 50 ml Tube Carton