NDC Code(s) : 59427-010-01
Packager : ORIGINS NATURAL RESOURCES INC.

Category : HUMAN OTC DRUG LABEL

DEA Schedule : none

Marketing Status : New Drug Application

INGREDIENTS AND APPEARANCE

A PERFECT WORLD SPF 40 AGE DEFENSE BROAD SPECTRUM MOISTURIZER WITH WHITE TEAAVOBENZONE, HOMOSALATE, OCTINOXATE, OCTISALATE, and OCTOCRYLENE CREAM
Product Information
Product Type HUMAN OTC DRUG Item Code (Source) NDC:59427-010
Route of Administration TOPICAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
AVOBENZONE(UNII: G63QQF2NOX)
(AVOBENZONE - UNII:G63QQF2NOX) 		AVOBENZONE30 mg in 1 mL
HOMOSALATE(UNII: V06SV4M95S)
(HOMOSALATE - UNII:V06SV4M95S) 		HOMOSALATE80 mg in 1 mL
OCTINOXATE(UNII: 4Y5P7MUD51)
(OCTINOXATE - UNII:4Y5P7MUD51) 		OCTINOXATE75 mg in 1 mL
OCTISALATE(UNII: 4X49Y0596W)
(OCTISALATE - UNII:4X49Y0596W) 		OCTISALATE45 mg in 1 mL
OCTOCRYLENE(UNII: 5A68WGF6WM)
(OCTOCRYLENE - UNII:5A68WGF6WM) 		OCTOCRYLENE50 mg in 1 mL
Inactive Ingredients
Ingredient Name Strength
WATER(UNII: 059QF0KO0R)
BUTYLENE GLYCOL(UNII: 3XUS85K0RA)
GLYCERIN(UNII: PDC6A3C0OX)
AMMONIUM ACRYLOYLDIMETHYLTAURATE/VP COPOLYMER(UNII: W59H9296ZG)
HIGH DENSITY POLYETHYLENE(UNII: UG00KM4WR7)
BERGAMOT OIL(UNII: 39W1PKE3JI)
LEMON OIL, COLD PRESSED(UNII: I9GRO824LL)
ORANGE OIL, COLD PRESSED(UNII: AKN3KSD11B)
CAMPHOR OIL(UNII: 75IZZ8Y727)
SPEARMINT OIL(UNII: C3M81465G5)
MAGNOLIA ACUMINATA FLOWER(UNII: 8LCB7ZW9UL)
IRIS PALLIDA ROOT(UNII: LVV57EM5OG)
CITRAL(UNII: T7EU0O9VPP)
LINALOOL, (+/-)-(UNII: D81QY6I88E)
LIMONENE, (+)-(UNII: GFD7C86Q1W)
CETYL ALCOHOL(UNII: 936JST6JCN)
GLYCERYL MONOSTEARATE(UNII: 230OU9XXE4)
PEG-100 STEARATE(UNII: YD01N1999R)
POLYETHYLENE GLYCOL 300(UNII: 5655G9Y8AQ)
LOWBUSH BLUEBERRY(UNII: G90PX41VP0)
CRANBERRY(UNII: 0MVO31Q3QS)
POTATO PULP(UNII: 844I2DX0IS)
LYCIUM CHINENSE FRUIT(UNII: TG711Q7A1Q)
ERIOBOTRYA JAPONICA LEAF(UNII: Z02066SV11)
PASSIFLORA INCARNATA FLOWER(UNII: K8F3G29S6Z)
BETULA PUBESCENS BARK(UNII: 3R504894L9)
WHITE TEA(UNII: O0M3396E09)
INDIAN FRANKINCENSE(UNII: 4PW41QCO2M)
THERMUS THERMOPHILUS LYSATE(UNII: 775R692494)
HORDEUM VULGARE WHOLE(UNII: 8JBE478M5Q)
WHEAT GERM(UNII: YR3G369F5A)
SACCHAROMYCES LYSATE(UNII: R85W246Z1C)
YEAST, UNSPECIFIED(UNII: 3NY3SM6B8U)
ORYZANOL(UNII: SST9XCL51M)
SQUALANE(UNII: GW89575KF9)
ETHYLHEXYLGLYCERIN(UNII: 147D247K3P)
TREHALOSE(UNII: B8WCK70T7I)
STEARETH-21(UNII: 53J3F32P58)
ERGOTHIONEINE(UNII: BDZ3DQM98W)
HYALURONATE SODIUM(UNII: YSE9PPT4TH)
NYLON-12(UNII: 446U8J075B)
CAPRYLYL GLYCOL(UNII: 00YIU5438U)
SODIUM PYRROLIDONE CARBOXYLATE(UNII: 469OTG57A2)
SODIUM DEHYDROACETATE(UNII: 8W46YN971G)
.ALPHA.-TOCOPHEROL ACETATE(UNII: 9E8X80D2L0)
UREA(UNII: 8W8T17847W)
ASCORBYL TOCOPHERYL MALEATE(UNII: D2G6259XR5)
CITRIC ACID MONOHYDRATE(UNII: 2968PHW8QP)
HEXYLENE GLYCOL(UNII: KEH0A3F75J)
PHYTATE SODIUM(UNII: 88496G1ERL)
BUTYLATED HYDROXYTOLUENE(UNII: 1P9D0Z171K)
MICA(UNII: V8A1AW0880)
PHENOXYETHANOL(UNII: HIE492ZZ3T)
Packaging
# Item Code Package Description Marketing Start Date Marketing End Date
1NDC:59427-010-011 in 1 CARTON 06/01/2017
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 06/01/2017

LABELER - ORIGINS NATURAL RESOURCES INC.(611716283)

REGISTRANT - Estee Lauder Companies Inc.(790802086)

Establishment
Name Address ID/FEI Business Operations
The Estee Lauder Inc 802599436 manufacture(59427-010), pack(59427-010), label(59427-010)

PRINCIPAL DISPLAY PANEL

ORIGINS

A PERFECT
WORLD™ SPF 40

Age-Defense Moisturizer
with White Tea
Broad Spectrum SPF 40

net wt. 1.7 oz./50 ml e

Principal Display Panel - 50 ml Jar Carton