NDC Code(s) : 42508-222-18
Packager : Arbonne International, LLC

Category : HUMAN OTC DRUG LABEL

DEA Schedule : none

Marketing Status : New Drug Application

INGREDIENTS AND APPEARANCE

Arbonne Intelligence Pollution Defense SPF30 CC Cream - Medium ShadeSPF30 CC Cream - Medium Shade CREAM
Product Information
Product Type HUMAN OTC DRUG Item Code (Source) NDC:42508-222
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 DIOXIDE2.5 mg in 100 mg
ZINC OXIDE(UNII: SOI2LOH54Z)
(ZINC OXIDE - UNII:SOI2LOH54Z) 		ZINC OXIDE7.2 mg in 100 mg
Inactive Ingredients
Ingredient Name Strength
ALUMINUM OXIDE(UNII: LMI26O6933)
PHENOXYETHANOL(UNII: HIE492ZZ3T)
SHEA BUTTER(UNII: K49155WL9Y)
MAGNESIUM STEARATE(UNII: 70097M6I30)
ISOPROPYL TITANIUM TRIISOSTEARATE(UNII: 949E3KBJ1I)
ISONONYL ISONONANOATE(UNII: S4V5BS6GCX)
MEDIUM-CHAIN TRIGLYCERIDES(UNII: C9H2L21V7U)
DIISOPROPYL SEBACATE(UNII: J8T3X564IH)
ETHYLHEXYL PALMITATE(UNII: 2865993309)
POLYMETHYLSILSESQUIOXANE (4.5 MICRONS)(UNII: 59Z907ZB69)
GLYCERIN(UNII: PDC6A3C0OX)
ARGAN OIL(UNII: 4V59G5UW9X)
TOCOPHEROL(UNII: R0ZB2556P8)
ISOPROPYL MYRISTATE(UNII: 0RE8K4LNJS)
SILICON DIOXIDE(UNII: ETJ7Z6XBU4)
WATER(UNII: 059QF0KO0R)
DIMETHICONE(UNII: 92RU3N3Y1O)
POLYGLYCERYL-2 MONOISOSTEARATE(UNII: 7B8OE71MQC)
POLYSILICONE-15(UNII: F8DRP5BB29)
POLYHYDROXYSTEARIC ACID (2300 MW)(UNII: YXH47AOU0F)
DISTEARDIMONIUM HECTORITE(UNII: X687XDK09L)
CASTOR OIL(UNII: D5340Y2I9G)
SODIUM CHLORIDE(UNII: 451W47IQ8X)
FERRIC OXIDE RED(UNII: 1K09F3G675)
MICA(UNII: V8A1AW0880)
FERROSOFERRIC OXIDE(UNII: XM0M87F357)
STEARALKONIUM HECTORITE(UNII: OLX698AH5P)
OCTYLDODECYL MYRISTATE(UNII: S013N99GR8)
TARAXACUM OFFICINALE ROOT(UNII: 9DE5YCO0RU)
MEDICAGO SATIVA LEAF(UNII: HY3L927V6M)
CHICORY ROOT(UNII: 090CTY533N)
ETHYLHEXYLGLYCERIN(UNII: 147D247K3P)
FERRIC OXIDE YELLOW(UNII: EX438O2MRT)
LEVOMENOL(UNII: 24WE03BX2T)
ALOE VERA LEAF(UNII: ZY81Z83H0X)
CYCLOMETHICONE 5(UNII: 0THT5PCI0R)
PROPYLENE CARBONATE(UNII: 8D08K3S51E)
FARNESOL(UNII: EB41QIU6JL)
CYCLOMETHICONE 4(UNII: CZ227117JE)
BIOSACCHARIDE GUM-4(UNII: 9XRL057X90)
CAPPARIS SPINOSA WHOLE(UNII: 4UJ92RL9U7)
Packaging
# Item Code Package Description Marketing Start Date Marketing End Date
1NDC:42508-222-181 in 1 CARTON 09/01/2018
134000 mg 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 09/01/2018

LABELER - Arbonne International, LLC(961643454)

REGISTRANT - Autumn Harp, Incorporated(064187883)

PRINCIPAL DISPLAY PANEL

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