NDC Code(s) : 42508-263-25
Packager : Arbonne International, LLC

Category : HUMAN PRESCRIPTION DRUG LABEL

DEA Schedule : none

Marketing Status : New Drug Application

INGREDIENTS AND APPEARANCE

Arbonne Baby Care OCTINOXATE, OCTISALATE, OXYBENZONE, and ZINC OXIDE CREAM
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:42508-263
Route of Administration TOPICAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
OCTINOXATE(UNII: 4Y5P7MUD51)
(OCTINOXATE - UNII:4Y5P7MUD51) 		OCTINOXATE75 mg in 1 mL
OCTISALATE(UNII: 4X49Y0596W)
(OCTISALATE - UNII:4X49Y0596W) 		OCTISALATE50 mg in 1 mL
OXYBENZONE(UNII: 95OOS7VE0Y)
(OXYBENZONE - UNII:95OOS7VE0Y) 		OXYBENZONE25 mg in 1 mL
ZINC OXIDE(UNII: SOI2LOH54Z)
(ZINC OXIDE - UNII:SOI2LOH54Z) 		ZINC OXIDE100 mg in 1 mL
Inactive Ingredients
Ingredient Name Strength
WATER(UNII: 059QF0KO0R)
NEOPENTYL GLYCOL DIETHYLHEXANOATE(UNII: U68ZV6W62C)
POLYGLYCERYL-4 ISOSTEARATE(UNII: 820DPX33S7)
CYCLOMETHICONE 5(UNII: 0THT5PCI0R)
GLYCERIN(UNII: PDC6A3C0OX)
BUTYLENE GLYCOL(UNII: 3XUS85K0RA)
CYCLOMETHICONE 6(UNII: XHK3U310BA)
HEXYL LAURATE(UNII: 4CG9F9W01Q)
CERESIN(UNII: Q1LS2UJO3A)
MAGNESIUM SULFATE, UNSPECIFIED(UNII: DE08037SAB)
HYDROGENATED CASTOR OIL(UNII: ZF94AP8MEY)
APRICOT SEED OIL(UNII: 54JB35T06A)
SOYBEAN OIL(UNII: 241ATL177A)
SAFFLOWER OIL(UNII: 65UEH262IS)
PEACH(UNII: 3OKE88I3QG)
PLANTAGO MAJOR(UNII: W2469WNO6U)
CHAMOMILE(UNII: FGL3685T2X)
OAT(UNII: Z6J799EAJK)
ALOE VERA LEAF(UNII: ZY81Z83H0X)
SHEA BUTTER(UNII: K49155WL9Y)
OCTYLTRIETHOXYSILANE(UNII: LDC331P08E)
.ALPHA.-TOCOPHEROL ACETATE, D-(UNII: A7E6112E4N)
VITAMIN A PALMITATE(UNII: 1D1K0N0VVC)
ASCORBYL PALMITATE(UNII: QN83US2B0N)
PANTHENOL(UNII: WV9CM0O67Z)
HYDROGENATED SOYBEAN LECITHIN(UNII: H1109Z9J4N)
SODIUM CHLORIDE(UNII: 451W47IQ8X)
CAPRYLYL GLYCOL(UNII: 00YIU5438U)
CAPRYLHYDROXAMIC ACID(UNII: UPY805K99W)
CASTOR OIL(UNII: D5340Y2I9G)
CEDRUS ATLANTICA BARK OIL(UNII: ZX5QRE4U60)
BERGAMOT OIL(UNII: 39W1PKE3JI)
ORANGE OIL(UNII: AKN3KSD11B)
CITRUS RETICULATA LEAF OIL(UNII: 1515UE78IH)
LEMON OIL(UNII: I9GRO824LL)
JASMINUM OFFICINALE FLOWER(UNII: 0Q8K841432)
Packaging
# Item Code Package Description Marketing Start Date Marketing End Date
1NDC:42508-263-251 in 1 CARTON
1177 mL in 1 BOTTLE
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
OTC MONOGRAPH NOT FINAL part352 08/01/2010

PRINCIPAL DISPLAY PANEL

ARBONNE ®

ABC

ARBONNE BABY CARE®

SUNSCREEN
SPF 30

6 fl. oz./177 mL

Principal Display Panel - 177 mL Carton