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DAYWEAR

ESTEE LAUDER INC




FULL PRESCRIBING INFORMATION

Active ingredient

ACTIVE INGREDIENTS: OCTISALATE 5.00% [] AVOBENZONE 3.00%

INACTIVE INGREDIENTS: WATER\AQUA\EAU [] DIMETHICONE [] BUTYLOCTYL SALICYLATE [] BUTYLENE GLYCOL [] POLYESTER-8 [] CETYL RICINOLEATE [] STEARETH-21 [] STEARETH-2 [] DI-C12-15 ALKYL FUMARATE [] CAPRYLIC/CAPRIC/MYRISTIC/STEARIC TRIGLYCERIDE [] POLYSILICONE-11 [] PSIDIUM GUAJAVA (GUAVA) FRUIT EXTRACT [] GENTIANA LUTEA (GENTIAN) ROOT EXTRACT [] POLYGONUM CUSPIDATUM ROOT EXTRACT [] STEARYL ALCOHOL [] HORDEUM VULGARE (BARLEY) EXTRACT\EXTRAIT D'ORGE [] LAMINARIA OCHROLEUCA EXTRACT [] ROSMARINUS OFFICINALIS (ROSEMARY) LEAF EXTRACT [] TRITICUM VULGARE (WHEAT) GERM EXTRACT [] ARTEMIA EXTRACT [] FUMARIA OFFICINALIS FLOWER/LEAF/STEM EXTRACT [] CAFFEINE [] PENTYLENE GLYCOL [] CITRUS MEDICA LIMONUM (LEMON) FRUIT EXTRACT [] HYDROLYZED RICE EXTRACT [] VITIS VINIFERA (GRAPE) SEED EXTRACT [] HYDROLYZED RICE BRAN EXTRACT [] LAURYL PEG-9 POLYDIMETHYLSILOXYETHYL DIMETHICONE [] THERMUS THERMOPHILLUS FERMENT [] BEHENYL ALCOHOL [] ACRYLIC ACID/VP CROSSPOLYMER [] TRIACONTANYL PVP [] GLYCERIN [] C12-15 ALKYL BENZOATE [] LINOLEIC ACID [] CHOLESTEROL [] SQUALANE [] SODIUM PCA [] 1,2-HEXANEDIOL [] UREA [] CAPRYLIC/CAPRIC TRIGLYCERIDE [] DIPROPYLENE GLYCOL DIBENZOATE [] TOCOPHERYL ACETATE [] TETRAHEXYLDECYL ASCORBATE [] SODIUM HYALURONATE [] ERGOTHIONEINE [] PPG-15 STEARYL ETHER BENZOATE [] GLYCYRRHETINIC ACID [] TREHALOSE [] POLYQUATERNIUM-51 [] LECITHIN [] HYDROGENATED LECITHIN [] FUMARIC ACID [] PALMITOYL HYDROXYPROPYLTRIMONIUM AMYLOPECTIN/GLYCERIN CROSSPOLYMER [] CAPRYLYL GLYCOL [] CYCLODEXTRIN [] SODIUM HYDROXIDE [] NORDIHYDROGUAIARETIC ACID [] SODIUM CHLORIDE [] ASCORBYL TOCOPHERYL MALEATE [] FRAGRANCE (PARFUM) [] CITRIC ACID [] ETHYLBISIMINOMETHYLGUAIACOL MANGANESE CHLORIDE [] PENTAERYTHRITYL TETRA-DI-T-BUTYL HYDROXYHYDROCINNAMATE [] DISODIUM EDTA [] SODIUM DEHYDROACETATE [] PHENOXYETHANOL [] BUTYLPHENYL METHYLPROPIONAL [] HYDROXYISOHEXYL 3-CYCLOHEXENE CARBOXALDEHYDE [] BENZYL SALICYLATE [] LINALOOL [] BLUE 1 (CI 42090) [] YELLOW 5 (CI 19140) [] CHROMIUM HYDROXIDE GREEN (CI 77289)



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PRINCIPAL DISPLAY PANEL



















DAYWEAR



DAYWEAR

OCTISALATE, AVOBENZONE CREAM

Product Information

Product Type Human otc drug label Item Code (Source) NDC:11559-009
Route of Administration TOPICAL DEA Schedule

Active Ingredient/Active Moiety

Ingredient Name Basis of Strength Strength
OCTISALATE OCTISALATE 5.0 mL
AVOBENZONE AVOBENZONE 3.0 mL

Inactive Ingredients

Ingredient Name Strength
water
BUTYLENE GLYCOL
DIMETHICONE
GLYCERIN
CHOLESTEROL
SQUALANE
CITRIC ACID MONOHYDRATE
LECITHIN, SOYBEAN
BUTYLATED HYDROXYTOLUENE
PHENOXYETHANOL

Packaging

# Item Code Package Description Marketing Start Date Marketing End Date
1 NDC:11559-009-02 50 in 1 JAR
2 NDC:11559-009-01 1 in 1 CARTON

Marketing Information

Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
part part352 2010-09-01


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