NDC Code(s) : 69049-018-01
Packager : KIKO USA, Inc.

Category : HUMAN PRESCRIPTION DRUG LABEL

DEA Schedule : none

Marketing Status : New Drug Application

INGREDIENTS AND APPEARANCE

KIKO MILANO HYDRA PRO DAYAVOBENZONE, OCTINOXATE, and OCTOCRYLENE CREAM
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:69049-018
Route of Administration TOPICAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
AVOBENZONE(UNII: G63QQF2NOX)
(AVOBENZONE - UNII:G63QQF2NOX) 		AVOBENZONE1.4955 g in 50 mL
OCTINOXATE(UNII: 4Y5P7MUD51)
(OCTINOXATE - UNII:4Y5P7MUD51) 		OCTINOXATE2.991 g in 50 mL
OCTOCRYLENE(UNII: 5A68WGF6WM)
(OCTOCRYLENE - UNII:5A68WGF6WM) 		OCTOCRYLENE1.04685 g in 50 mL
Inactive Ingredients
Ingredient Name Strength
WATER(UNII: 059QF0KO0R)
BUTYLENE GLYCOL(UNII: 3XUS85K0RA)
DIMETHICONE(UNII: 92RU3N3Y1O)
HYDROXYETHYL ACRYLATE/SODIUM ACRYLOYLDIMETHYL TAURATE COPOLYMER (100000 MPA.S AT 1.5%)(UNII: 86FQE96TZ4)
NIACINAMIDE(UNII: 25X51I8RD4)
POTASSIUM CETYL PHOSPHATE(UNII: 03KCY6P7UT)
PHENOXYETHANOL(UNII: HIE492ZZ3T)
SQUALANE(UNII: GW89575KF9)
GLYCERIN(UNII: PDC6A3C0OX)
CARBOMER INTERPOLYMER TYPE A (ALLYL SUCROSE CROSSLINKED)(UNII: 59TL3WG5CO)
ALUMINUM STARCH OCTENYLSUCCINATE(UNII: I9PJ0O6294)
CAPRYLYL GLYCOL(UNII: 00YIU5438U)
ETHYLHEXYLGLYCERIN(UNII: 147D247K3P)
DIMETHICONOL (2000 CST)(UNII: T74O12AN6Y)
.ALPHA.-TOCOPHEROL ACETATE(UNII: 9E8X80D2L0)
POLYSORBATE 60(UNII: CAL22UVI4M)
SODIUM HYDROXIDE(UNII: 55X04QC32I)
EDETATE DISODIUM ANHYDROUS(UNII: 8NLQ36F6MM)
HYALURONATE SODIUM(UNII: YSE9PPT4TH)
DIETHYLHEXYL SYRINGYLIDENEMALONATE(UNII: 3V5U97P248)
SORBITAN ISOSTEARATE(UNII: 01S2G2C1E4)
MICA(UNII: V8A1AW0880)
TITANIUM DIOXIDE(UNII: 15FIX9V2JP)
MEDIUM-CHAIN TRIGLYCERIDES(UNII: C9H2L21V7U)
BUTYLATED HYDROXYTOLUENE(UNII: 1P9D0Z171K)
LIMONENE, (+)-(UNII: GFD7C86Q1W)
PURSLANE(UNII: M6S840WXG5)
D&C RED NO. 33(UNII: 9DBA0SBB0L)
Product Characteristics
Color WHITE Score
Shape Size
Flavor Imprint Code
Contains
Packaging
# Item Code Package Description Marketing Start Date Marketing End Date
1NDC:69049-018-011 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

HYDRA PRO DAY

GLOBAL MOISTURIZING CREAM
SUNSCREEN BROAD SPECTRUM SPF 15

ACTIGLOW

NORMAL TO DRY SKIN

FACE

KIKO
MILANO

e 50 ml / 1.69 FL.OZ.

PRINCIPAL DISPLAY PANEL - 50 ml Jar Carton