NDC Code(s) : 69049-017-01
Packager : KIKO USA, Inc.

Category : HUMAN PRESCRIPTION DRUG LABEL

DEA Schedule : none

Marketing Status : New Drug Application

INGREDIENTS AND APPEARANCE

KIKO MILANO SUBLIME YOUTH DAYAVOBENZONE, OCTINOXATE, and OCTOCRYLENE CREAM
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:69049-017
Route of Administration TOPICAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
AVOBENZONE(UNII: G63QQF2NOX)
(AVOBENZONE - UNII:G63QQF2NOX) 		AVOBENZONE1.5075 g in 50 mL
OCTINOXATE(UNII: 4Y5P7MUD51)
(OCTINOXATE - UNII:4Y5P7MUD51) 		OCTINOXATE3.015 g in 50 mL
OCTOCRYLENE(UNII: 5A68WGF6WM)
(OCTOCRYLENE - UNII:5A68WGF6WM) 		OCTOCRYLENE1.05525 g in 50 mL
Inactive Ingredients
Ingredient Name Strength
WATER(UNII: 059QF0KO0R)
C12-20 ACID PEG-8 ESTER(UNII: 9M7A3K4339)
BUTYLENE GLYCOL(UNII: 3XUS85K0RA)
CAPRYLYL TRISILOXANE(UNII: Q95M2P1KJL)
CETOSTEARYL ALCOHOL(UNII: 2DMT128M1S)
DIMETHICONE(UNII: 92RU3N3Y1O)
ETHYLHEXYL PALMITATE(UNII: 2865993309)
GALACTOARABINAN(UNII: SL4SX1O487)
MEDIUM-CHAIN TRIGLYCERIDES(UNII: C9H2L21V7U)
NIACINAMIDE(UNII: 25X51I8RD4)
POTASSIUM CETYL PHOSPHATE(UNII: 03KCY6P7UT)
GLYCERIN(UNII: PDC6A3C0OX)
PHENOXYETHANOL(UNII: HIE492ZZ3T)
ARGAN OIL(UNII: 4V59G5UW9X)
CAPRYLYL GLYCOL(UNII: 00YIU5438U)
CARBOXYPOLYMETHYLENE(UNII: 0A5MM307FC)
ETHYLHEXYLGLYCERIN(UNII: 147D247K3P)
PALM OIL(UNII: 5QUO05548Z)
LEVANT COTTONSEED OIL(UNII: N5CFT140R8)
ALLANTOIN(UNII: 344S277G0Z)
.ALPHA.-TOCOPHEROL ACETATE(UNII: 9E8X80D2L0)
SODIUM HYDROXIDE(UNII: 55X04QC32I)
LINSEED OIL(UNII: 84XB4DV00W)
EDETATE DISODIUM ANHYDROUS(UNII: 8NLQ36F6MM)
PENTADECALACTONE(UNII: OK17S3S98K)
VITAMIN A PALMITATE(UNII: 1D1K0N0VVC)
MICA(UNII: V8A1AW0880)
DIETHYLHEXYL SYRINGYLIDENEMALONATE(UNII: 3V5U97P248)
TITANIUM DIOXIDE(UNII: 15FIX9V2JP)
SUNFLOWER OIL(UNII: 3W1JG795YI)
SODIUM ACRYLATE/SODIUM ACRYLOYLDIMETHYLTAURATE COPOLYMER (4000000 MW)(UNII: 1DXE3F3OZX)
POLYSORBATE 20(UNII: 7T1F30V5YH)
ISOHEXADECANE(UNII: 918X1OUF1E)
HYDROXYPROPYL BETADEX(UNII: 1I96OHX6EK)
POLYSORBATE 80(UNII: 6OZP39ZG8H)
BUTYLATED HYDROXYTOLUENE(UNII: 1P9D0Z171K)
ISOMETHYL-.ALPHA.-IONONE(UNII: 9XP4LC555B)
PURSLANE(UNII: M6S840WXG5)
LINALOOL, (+/-)-(UNII: D81QY6I88E)
RETINOL(UNII: G2SH0XKK91)
.BETA.-CITRONELLOL, (R)-(UNII: P01OUT964K)
LIMONENE, (+)-(UNII: GFD7C86Q1W)
DIACETYL BOLDINE(UNII: 37727Z7M0I)
TOCOPHEROL(UNII: R0ZB2556P8)
Product Characteristics
Color WHITE Score
Shape Size
Flavor Imprint Code
Contains
Packaging
# Item Code Package Description Marketing Start Date Marketing End Date
1NDC:69049-017-011 in 1 CARTON 20/12/2016
150 mL in 1 JAR Type 0: Not a Combination Product
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
OTC MONOGRAPH NOT FINAL part352 12/20/2016

PRINCIPAL DISPLAY PANEL

SUBLIME YOUTH
DAY

WRINKLE CORRECTING NOURISHING DAY CREAM
SUNSCREEN BROAD SPECTRUM SPF 15

ACTIGLOW

ALL SKIN TYPES

FACE

KIKO
MILANO

e 50 ml / 1.69 FL.OZ.

PRINCIPAL DISPLAY PANEL - 50 ml Jar Carton