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TIME ZONE

ESTEE LAUDER INC




FULL PRESCRIBING INFORMATION

Active ingredient

ACTIVE INGREDIENTS: OCTINOXATE 7.50% [] OCTISALATE 5.00% [] AVOBENZONE 3.00%

INACTIVE INGREDIENTS: WATER [] BUTYLENE GLYCOL [] OCTYLDODECYL MYRISTATE [] GLYCERIN [] NEOPENTYL GLYCOL DIHEPTANOATE [] DIMETHICONE [] CETYL ALCOHOL [] PENTYLENE GLYCOL [] GLYCERYL STEARATE [] BEHENYL ALCOHOL [] YEAST EXTRACT\FAEX\EXTRAIT DE LEVURE [] PUNICA GRANATUM (POMEGRANATE) JUICE EXTRACT [] CUCUMIS SATIVUS (CUCUMBER) FRUIT EXTRACT [] HUMULUS LUPULUS (HOPS) EXTRACT [] SELAGINELLA TAMARISCINA (SPIKE MOSS) EXTRACT [] POLYGONUM CUSPIDATUM ROOT EXTRACT [] VITIS VINIFERA (GRAPE) SEED EXTRACT [] ROSMARINUS OFFICINALIS (ROSEMARY) EXTRACT [] CITRUS RETICULATA (TANGERINE) PEEL EXTRACT [] OLEA EUROPAEA (OLIVE) FRUIT EXTRACT [] TRITICUM VULGARE (WHEAT BRAN) EXTRACT [] HORDEUM VULGARE (BARLEY) EXTRACT\EXTRAIT D'ORGE [] TAMARINDUS INDICA SEED EXTRACT [] ARGANIA SPINOSA LEAF EXTRACT [] LAMINARIA SACCHARINA EXTRACT [] LARIX SIBIRICA WOOD EXTRACT [] CENTAURIUM ERYTHRAEA (CENTAURY) EXTRACT [] PADINA PAVONICA THALLUS EXTRACT [] HYDROLYZED RICE EXTRACT [] CAPRYLIC/CAPRIC/MYRISTIC/STEARIC TRIGLYCERIDE [] SIGESBECKIA ORIENTALIS EXTRACT [] CHOLESTEROL [] POLYETHYLENE [] PENTAERYTHRITYL TETRAETHYLHEXANOATE [] CAFFEINE [] LINOLEIC ACID [] HYDROGENATED LECITHIN [] LINOLENIC ACID [] PEG-100 STEARATE [] PHYTANTRIOL [] TREHALOSE [] PVP/HEXADECENE COPOLYMER [] ACETYL GLUCOSAMINE [] CREATINE [] HDI/PPG/POLYCAPROLACTONE CROSSPOLYMER [] CAPRYLYL GLYCOL [] ACRYLAMIDE/SODIUM ACRYLOYLDIMETHYLTAURATE COPOLYMER [] POLYSILICONE-11 [] HYALURONIC ACID [] ISOHEXADECANE [] ACETYL HEXAPEPTIDE-8 [] PROPYLENE GLYCOL DICAPRATE [] SODIUM PCA [] ADENOSINE PHOSPHATE [] HELIANTHUS ANNUUS (SUNFLOWER) SEEDCAKE [] POLYSORBATE 80 [] SODIUM HYALURONATE [] SILICA [] HEXYLENE GLYCOL [] NORDIHYDROGUAIARETIC ACID [] CYCLODEXTRIN [] POTASSIUM CARBOMER [] CARBOMER [] FRAGRANCE (PARFUM) [] ETHYLBISIMINOMETHYLGUAIACOL MANGANESE CHLORIDE [] DISODIUM EDTA [] PHENOXYETHANOL

WARNING: KEEP OUT OF EYES. STOP USE IF IRRITATION OCCURS.



























TIME ZONE

TIME ZONE

OCTINOXATE, OCTSALATE, AVOBENZONE CREAM

Product Information

Product Type Human otc drug label Item Code (Source) NDC:11559-737
Route of Administration TOPICAL DEA Schedule

Active Ingredient/Active Moiety

Ingredient Name Basis of Strength Strength
OCTINOXATE OCTINOXATE 7.5 mL
OCTISALATE OCTISALATE 5.0 mL
AVOBENZONE AVOBENZONE 3.0 mL

Inactive Ingredients

Ingredient Name Strength
water
BUTYLENE GLYCOL
GLYCERIN
DIMETHICONE
CETYL ALCOHOL
GLYCERYL MONOSTEARATE
SACCHAROMYCES LYSATE
CUCUMBER
olive oil
BARLEY
TAMARIND SEED
SACCHARINA LATISSIMA WHOLE
CHOLESTEROL
HIGH DENSITY POLYETHYLENE
LINOLEIC ACID
TREHALOSE
CREATINE
CAPRYLYL GLYCOL
POLYSORBATE 60
HYALURONATE SODIUM
SILICON DIOXIDE
CARBOMER HOMOPOLYMER TYPE C
EDETATE DISODIUM
PHENOXYETHANOL

Packaging

# Item Code Package Description Marketing Start Date Marketing End Date
1 NDC:11559-737-02 50 in 1 JAR
2 NDC:11559-737-01 1 in 1 CARTON

Marketing Information

Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
part part352 2009-11-01


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