NDC Code(s) : 50184-6800-1
Packager : Philosophy, Inc.

Category : HUMAN PRESCRIPTION DRUG LABEL

DEA Schedule : none

Marketing Status : New Drug Application

INGREDIENTS AND APPEARANCE

Kiss of Hope Octinoxate and Oxybenzone STICK
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:50184-6800
Route of Administration TOPICAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
OCTINOXATE(UNII: 4Y5P7MUD51)
(OCTINOXATE - UNII:4Y5P7MUD51) 		OCTINOXATE0.238 g in 3.4 g
OXYBENZONE(UNII: 95OOS7VE0Y)
(OXYBENZONE - UNII:95OOS7VE0Y) 		OXYBENZONE0.102 g in 3.4 g
Inactive Ingredients
Ingredient Name Strength
SHEA BUTTER(UNII: K49155WL9Y)
WHITE WAX(UNII: 7G1J5DA97F)
GLYCERIN(UNII: PDC6A3C0OX)
SUNFLOWER OIL(UNII: 3W1JG795YI)
OLIVE OIL(UNII: 6UYK2W1W1E)
ALKYL (C12-15) BENZOATE(UNII: A9EJ3J61HQ)
OCTYLDODECANOL(UNII: 461N1O614Y)
DIPALMITOYL HYDROXYPROLINE(UNII: E6AHA53N1H)
COCO-GLYCERIDES(UNII: ISE9I7DNUG)
CANDELILLA WAX(UNII: WL0328HX19)
CARNAUBA WAX(UNII: R12CBM0EIZ)
BEET(UNII: N487KM8COK)
AZADIRACHTA INDICA FLOWER(UNII: 3TE8A92UPM)
VITAMIN A PALMITATE(UNII: 1D1K0N0VVC)
.ALPHA.-TOCOPHEROL ACETATE, D-(UNII: A7E6112E4N)
SORBITAN SESQUIOLEATE(UNII: 0W8RRI5W5A)
HYDROGENATED SOYBEAN LECITHIN(UNII: H1109Z9J4N)
PALMITIC ACID(UNII: 2V16EO95H1)
PHENOXYETHANOL(UNII: HIE492ZZ3T)
MANGIFERA INDICA SEED BUTTER(UNII: 4OXD9M35X2)
C12-16 ALCOHOLS(UNII: S4827SZE3L)
IRVINGIA GABONENSIS SEED(UNII: 0J4W1PR213)
MORINGA OLEIFERA SEED OIL(UNII: REM6A5QMC0)
Packaging
# Item Code Package Description Marketing Start Date Marketing End Date
1NDC:50184-6800-13.4 g in 1 TUBE
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
OTC monograph not final part352 02/07/2011

PRINCIPAL DISPLAY PANEL

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