NDC Code(s) : 49527-060-01
Packager : CLINIQUE LABORATORIES LLC

Category : HUMAN OTC DRUG LABEL

DEA Schedule : none

Marketing Status : New Drug Application

INGREDIENTS AND APPEARANCE

ALMOST powder MAKEUP BROAD SPECTRUM SPF 18OCTINOXATE and TITANIUM DIOXIDE POWDER
Product Information
Product Type HUMAN OTC DRUG Item Code (Source) NDC:49527-060
Route of Administration TOPICAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
OCTINOXATE(UNII: 4Y5P7MUD51)
(OCTINOXATE - UNII:4Y5P7MUD51) 		OCTINOXATE2 g in 100 g
TITANIUM DIOXIDE(UNII: 15FIX9V2JP)
(TITANIUM DIOXIDE - UNII:15FIX9V2JP) 		TITANIUM DIOXIDE1.2 g in 100 g
Inactive Ingredients
Ingredient Name Strength
FERRIC OXIDE YELLOW(UNII: EX438O2MRT)
FERROSOFERRIC OXIDE(UNII: XM0M87F357)
TALC(UNII: 7SEV7J4R1U)
DIMETHICONE(UNII: 92RU3N3Y1O)
NYLON-12(UNII: 446U8J075B)
SILICON DIOXIDE(UNII: ETJ7Z6XBU4)
SQUALANE(UNII: GW89575KF9)
BORON NITRIDE(UNII: 2U4T60A6YD)
VINYL DIMETHICONE/METHICONE SILSESQUIOXANE CROSSPOLYMER(UNII: 9NH1UDD2RR)
FERRIC OXIDE RED(UNII: 1K09F3G675)
CETYL ETHYLHEXANOATE(UNII: 134647WMX4)
DIISOSTEARYL MALATE(UNII: QBS8A3XZGQ)
PHYTOSTERYL/ISOSTEARYL/CETYL/STEARYL/BEHENYL DIMER DILINOLEATE(UNII: 8N725H4EFN)
METHICONE (20 CST)(UNII: 6777U11MKT)
GLYCERIN(UNII: PDC6A3C0OX)
HYALURONATE SODIUM(UNII: YSE9PPT4TH)
MAGNESIUM PALMITOYL GLUTAMATE(UNII: DH37YM1F48)
SODIUM PALMITOYL SARCOSINATE(UNII: 7297LY09YF)
PALMITOYL PROLINE(UNII: I49727TDYF)
ALUMINUM OXIDE(UNII: LMI26O6933)
TOCOPHEROL(UNII: R0ZB2556P8)
PALMITIC ACID(UNII: 2V16EO95H1)
1,2-HEXANEDIOL(UNII: TR046Y3K1G)
HYDRATED SILICA(UNII: Y6O7T4G8P9)
ASCORBYL TETRAISOPALMITATE(UNII: 47143LT58A)
ALUMINUM HYDROXIDE(UNII: 5QB0T2IUN0)
STANNIC OXIDE(UNII: KM7N50LOS6)
SODIUM DEHYDROACETATE(UNII: 8W46YN971G)
MICA(UNII: V8A1AW0880)
Packaging
# Item Code Package Description Marketing Start Date Marketing End Date
1NDC:49527-060-011 in 1 CARTON 03/01/2018
110 g 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 Drug M020 03/01/2018

LABELER - CLINIQUE LABORATORIES LLC(044475127)

REGISTRANT - Estee Lauder Companies Inc.(790802086)

Establishment
Name Address ID/FEI Business Operations
ASANUMA CORPORATION 715464942 manufacture(49527-060)

PRINCIPAL DISPLAY PANEL

02 neutral fair (VF/MF)

CLINIQUE

almost powder makeup
broad spectrum
SPF 18

POIDS NET WT. .35 OZ./10 g e

PRINCIPAL DISPLAY PANEL - 10 g Jar Carton