Label: DAYWEAR SHEER TINT RELEASE ADVANCED MULTI-PROTECTION ANTI-OXIDANT MOISTURIZER SPF 15- octisalate, avobenzone lotion

  • Category: HUMAN OTC DRUG LABEL

DISCLAIMER: Most OTC drugs are not reviewed and approved by FDA, however they may be marketed if they comply with applicable regulations and policies. FDA has not evaluated whether this product complies.

Drug Label Information

Updated December 17, 2010

If you are a healthcare professional or from the pharmaceutical industry please visit this version.

View All Sections
  • ACTIVE INGREDIENT

    ACTIVE INGREDIENTS: OCTISALATE 5.00% [] AVOBENZONE 3.00%

  • INACTIVE INGREDIENT

    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 [] STEARYL ALCOHOL [] PSIDIUM GUAJAVA (GUAVA) FRUIT EXTRACT [] GENTIANA LUTEA (GENTIAN) ROOT EXTRACT [] POLYGONUM CUSPIDATUM ROOT EXTRACT [] HORDEUM VULGARE (BARLEY) EXTRACT\EXTRAIT D'ORGE [] TRITICUM VULGARE (WHEAT) GERM EXTRACT [] CITRUS MEDICA LIMONUM (LEMON) FRUIT EXTRACT [] LAMINARIA OCHROLEUCA EXTRACT [] HYDROLYZED RICE BRAN EXTRACT [] HYDROLYZED RICE EXTRACT [] FUMARIA OFFICINALIS FLOWER/LEAF/STEM EXTRACT [] ROSMARINUS OFFICINALIS (ROSEMARY) LEAF EXTRACT [] ARTEMIA EXTRACT [] VITIS VINIFERA (GRAPE) SEED EXTRACT [] THERMUS THERMOPHILLUS FERMENT [] CHOLESTEROL [] POLYQUATERNIUM-51 [] HYDROGENATED LECITHIN [] ERGOTHIONEINE [] CAFFEINE [] LINOLEIC ACID [] PENTYLENE GLYCOL [] ISOPROPYL MYRISTATE [] LAURYL PEG-9 POLYDIMETHYLSILOXYETHYL DIMETHICONE [] BEHENYL ALCOHOL [] TRIACONTANYL PVP [] GLYCERIN [] ACRYLIC ACID/VP CROSSPOLYMER [] POLYMETHYL METHACRYLATE [] C12-15 ALKYL BENZOATE [] SQUALANE [] SODIUM PCA [] 1,2-HEXANEDIOL [] UREA [] CAPRYLIC/CAPRIC TRIGLYCERIDE [] PALMITOYL HYDROXYPROPYLTRIMONIUM AMYLOPECTIN/GLYCERIN CROSSPOLYMER [] DIPROPYLENE GLYCOL DIBENZOATE [] TOCOPHERYL ACETATE [] TETRAHEXYLDECYL ASCORBATE [] CITRIC ACID [] SODIUM HYALURONATE [] PPG-15 STEARYL ETHER BENZOATE [] GLYCYRRHETINIC ACID [] CAPRYLYL GLYCOL [] TREHALOSE [] LECITHIN [] SODIUM HYDROXIDE [] FUMARIC ACID [] CYCLODEXTRIN [] NORDIHYDROGUAIARETIC ACID [] ASCORBYL TOCOPHERYL MALEATE [] ETHYLBISIMINOMETHYLGUAIACOL MANGANESE CHLORIDE [] FRAGRANCE (PARFUM) [] DISODIUM EDTA [] BHT [] SODIUM DEHYDROACETATE [] PHENOXYETHANOL [] IRON OXIDES (CI 77491, CI 77492, CI 77499) [] TITANIUM DIOXIDE (CI 77891)

  • WARNINGS


    WARNING: KEEP OUT OF EYES. DISCONTINUE USE IF IRRITATION OCCURS.
  • KEEP OUT OF REACH OF CHILDREN

    KEEP OUT OF REACH OF CHILDREN.

  • PRINCIPAL DISPLAY PANEL

    PRINCIPAL DISPLAY PANEL:



    ESTEE LAUDER
    DAYWEAR

    SHEER TINT RELEASE
    ADVANCED MULTI-PROTECTION
    ANTI-OXIDANT MOISTURIZER
    SPF 15


    1.7 FL OZ. LIQ/ 50ML

    ESTEE LAUDER DISTR

    NEW YORK, NY 10022

    FOLDING CARTON

  • INGREDIENTS AND APPEARANCE
    DAYWEAR  SHEER TINT RELEASE ADVANCED MULTI-PROTECTION ANTI-OXIDANT MOISTURIZER SPF 15
    octisalate, avobenzone lotion
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:11559-008
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    OCTISALATE (UNII: 4X49Y0596W) (OCTISALATE - UNII:4X49Y0596W) OCTISALATE5.0 mL  in 100 mL
    AVOBENZONE (UNII: G63QQF2NOX) (AVOBENZONE - UNII:G63QQF2NOX) AVOBENZONE3.0 mL  in 100 mL
    Inactive Ingredients
    Ingredient NameStrength
    WATER (UNII: 059QF0KO0R)  
    BUTYLENE GLYCOL (UNII: 3XUS85K0RA)  
    DIMETHICONE (UNII: 92RU3N3Y1O)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    CHOLESTEROL (UNII: 97C5T2UQ7J)  
    SQUALANE (UNII: GW89575KF9)  
    CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP)  
    LECITHIN, SOYBEAN (UNII: 1DI56QDM62)  
    BUTYLATED HYDROXYTOLUENE (UNII: 1P9D0Z171K)  
    PHENOXYETHANOL (UNII: HIE492ZZ3T)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:11559-008-011 in 1 TUBE
    1NDC:11559-008-0250 mL in 1 TUBE
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph not finalpart35209/01/2010
    Labeler - ESTEE LAUDER INC (005914387)
    Establishment
    NameAddressID/FEIBusiness Operations
    ESTEE LAUDER COSMETICS, LTD205952385manufacture
    Establishment
    NameAddressID/FEIBusiness Operations
    ESTEE LAUDER N.V.370151326manufacture
    Establishment
    NameAddressID/FEIBusiness Operations
    Len-Ron Manufacturing Division of Aramis Inc.809771152manufacture
    Establishment
    NameAddressID/FEIBusiness Operations
    Aramis Inc.042918826manufacture
    Establishment
    NameAddressID/FEIBusiness Operations
    Northtec Bristol949264774manufacture, relabel, repack
    Establishment
    NameAddressID/FEIBusiness Operations
    Northtec Keystone618107429manufacture, relabel, repack
    Establishment
    NameAddressID/FEIBusiness Operations
    Estee Lauder Pennsylvania Distribution Center 2828534516manufacture, relabel, repack
    Establishment
    NameAddressID/FEIBusiness Operations
    Estee Lauder Cosmetics, Ltd.255175580manufacture
    Establishment
    NameAddressID/FEIBusiness Operations
    Estee Lauder Cosmetics, Ltd253616536manufacture
    Establishment
    NameAddressID/FEIBusiness Operations
    Estee Lauder Cosmetics Distribution Center208579636repack, relabel
    Establishment
    NameAddressID/FEIBusiness Operations
    Estee Lauder Kabushiki Kaisha712808195relabel, repack
    Establishment
    NameAddressID/FEIBusiness Operations
    Whitman Laboratories Ltd.216866277manufacture
    Establishment
    NameAddressID/FEIBusiness Operations
    Aveda Corporation071352058manufacture
View All Sections

Find additional resources

(also available in the left menu)

Safety

Report Adverse Events, FDA Safety Recalls, Presence in Breast Milk

Related Resources

Medline Plus, Clinical Trials

More Info on this Drug

Get Label RSS Feed, View NDC Code(s)NEW!