NDC Code(s) : 11559-055-01
Packager : ESTEE LAUDER INC

Category : HUMAN OTC DRUG LABEL

DEA Schedule : none

Marketing Status : New Drug Application

INGREDIENTS AND APPEARANCE

DAYWEAR ANTI OXIDANT 72H-HYDRATION SORBET CREME BROAD SPECTRUM SPF 15AVOBENZONE, HOMOSALATE, OCTISALATE, and OCTOCRYLENE CREAM
Product Information
Product Type HUMAN OTC DRUG Item Code (Source) NDC:11559-055
Route of Administration TOPICAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
AVOBENZONE(UNII: G63QQF2NOX)
(AVOBENZONE - UNII:G63QQF2NOX) 		AVOBENZONE20 mg in 1 mL
HOMOSALATE(UNII: V06SV4M95S)
(HOMOSALATE - UNII:V06SV4M95S) 		HOMOSALATE40 mg in 1 mL
OCTISALATE(UNII: 4X49Y0596W)
(OCTISALATE - UNII:4X49Y0596W) 		OCTISALATE45 mg in 1 mL
OCTOCRYLENE(UNII: 5A68WGF6WM)
(OCTOCRYLENE - UNII:5A68WGF6WM) 		OCTOCRYLENE20 mg in 1 mL
Inactive Ingredients
Ingredient Name Strength
WATER(UNII: 059QF0KO0R)
GLYCERIN(UNII: PDC6A3C0OX)
PENTYLENE GLYCOL(UNII: 50C1307PZG)
BIOSACCHARIDE GUM-1(UNII: BB4PU4V09H)
AMMONIUM ACRYLOYLDIMETHYLTAURATE/VP COPOLYMER(UNII: W59H9296ZG)
CUCUMBER(UNII: YY7C30VXJT)
HYALURONATE SODIUM(UNII: YSE9PPT4TH)
THERMUS THERMOPHILUS LYSATE(UNII: 775R692494)
ETHYLBISIMINOMETHYLGUAIACOL MANGANESE CHLORIDE(UNII: SM5YJ88LTU)
ERGOTHIONEINE(UNII: BDZ3DQM98W)
TETRAHEXYLDECYL ASCORBATE(UNII: 9LBV3F07AZ)
GUAVA(UNII: 74O70D6VG0)
CAFFEINE(UNII: 3G6A5W338E)
HELIANTHUS ANNUUS SEEDCAKE(UNII: 482WYF7XLC)
GRAPE(UNII: 6X543N684K)
WHEAT(UNII: 4J2I0SN84Y)
BARLEY(UNII: 5PWM7YLI7R)
LINOLEIC ACID(UNII: 9KJL21T0QJ)
CHOLESTEROL(UNII: 97C5T2UQ7J)
ENOXOLONE(UNII: P540XA09DR)
ETHYLHEXYLGLYCERIN(UNII: 147D247K3P)
PROPANEDIOL(UNII: 5965N8W85T)
SQUALANE(UNII: GW89575KF9)
BUTYLENE GLYCOL(UNII: 3XUS85K0RA)
CITRIC ACID MONOHYDRATE(UNII: 2968PHW8QP)
SODIUM HYDROXIDE(UNII: 55X04QC32I)
EDETATE DISODIUM ANHYDROUS(UNII: 8NLQ36F6MM)
BUTYLATED HYDROXYTOLUENE(UNII: 1P9D0Z171K)
PHENOXYETHANOL(UNII: HIE492ZZ3T)
FD&C BLUE NO. 1(UNII: H3R47K3TBD)
SODIUM BENZOATE(UNII: OJ245FE5EU)
LECITHIN, SOYBEAN(UNII: 1DI56QDM62)
CARBOMER INTERPOLYMER TYPE A (ALLYL SUCROSE CROSSLINKED)(UNII: 59TL3WG5CO)
GLUCOSE 1,6-BISPHOSPHATE(UNII: DRX17R6AM2)
TOCOPHEROL(UNII: R0ZB2556P8)
BRINE SHRIMP(UNII: 3ID50N77DH)
TRIMETHYLPENTANEDIOL/ADIPIC ACID/GLYCERIN CROSSPOLYMER (25000 MPA.S)(UNII: 587WKM3S9Q)
SACCHAROMYCES LYSATE(UNII: R85W246Z1C)
GENTIANA LUTEA ROOT(UNII: S72O3284MS)
AGAR, UNSPECIFIED(UNII: 89T13OHQ2B)
REYNOUTRIA JAPONICA ROOT(UNII: 7TRV45YZF7)
NARCISSUS TAZETTA BULB(UNII: K17762966S)
.BETA.-CYCLODEXTRIN SULFOBUTYL ETHER(UNII: H1HJ8WR7WG)
.ALPHA.-TOCOPHEROL ACETATE(UNII: 9E8X80D2L0)
CAPRYLYL TRISILOXANE(UNII: Q95M2P1KJL)
ALCOHOL(UNII: 3K9958V90M)
Packaging
# Item Code Package Description Marketing Start Date Marketing End Date
1NDC:11559-055-011 in 1 CARTON 12/01/2018
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 Drug M020 12/01/2018

LABELER - ESTEE LAUDER INC(005914387)

REGISTRANT - Estee Lauder Companies Inc.(790802086)

Establishment
Name Address ID/FEI Business Operations
Whitman Laboratories Ltd. 216866277 manufacture(11559-055), pack(11559-055), label(11559-055)

PRINCIPAL DISPLAY PANEL

ESTĒE LAUDER

DayWear
Anti-Oxidant 72H-Hydration Sorbet Creme
Broad Spectrum SPF 15

Normal/Combination Skin

POIDS NET WT. 1.7 OZ./50 ml e

PRINCIPAL DISPLAY PANEL - 50 ml Jar Carton