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DAY WEAR ADVANCED MULTI-PROTECTION ANTI-OXIDANT AND UV DEFENSE (ESTEE LAUDER INC)

Available Formats

Dosage Form Package Information Links
LOTION 1 BOTTLE in 1 CARTON (11559-026-01) > 30 mL in 1 BOTTLE Label Information

Complete DAY WEAR ADVANCED MULTI-PROTECTION ANTI-OXIDANT AND UV DEFENSE Information

  • SPL UNCLASSIFIED SECTION

    Drug Facts


  • ACTIVE INGREDIENT

    Active ingredients Purpose
    Avobenzone 3.00% Sunscreen
    Homosalate 5.00% Sunscreen
    Octisalate 5.00% Sunscreen
    Octocrylene 2.70% Sunscreen
    Oxybenzone 3.00% Sunscreen

  • Use

    helps prevent sunburn


  • Warnings

    For external use only

    Do not use on damaged or broken skin

    When using this product keep out of eyes. Rinse with water to remove.

    Stop use and ask a doctor if rash occurs

    Keep out of reach of children. If product is swallowed, get medical help or contact a Poison Control Center right away.


  • Directions

    For sunscreen use:

    • apply liberally 15 minutes before sun exposure
    • reapply at least every two hours
    • use a water resistant sunscreen if swimming or sweating
    • Sun Protection Measures. Spending time in the sun increases your risk of skin cancer and early skin aging. To decrease this risk, regularly use a sunscreen with a Broad Spectrum SPF value of 15 or higher and other sun protection measures including:
      • limit time in the sun, especially from 10 a.m. – 2 p.m.
      • wear long-sleeved shirts, pants, hats and sunglasses
    • children under 6 months of age: ask a doctor

  • Inactive ingredients

    water\aqua\eau butyloctyl salicylate methyl trimethicone neopentyl glycol diheptanoate aleurites moluccana (kukui) seed oil lauryl peg-9 polydimethylsiloxyethyl dimethicone peg-100 stearate butylene glycol glyceryl stearate dipentaerythrityl tri-polyhydroxystearate potassium cetyl phosphate gentiana lutea (gentian) root extract polygonum cuspidatum root extract hordeum vulgare (barley) extract\extrait d'orge triticum vulgare (wheat) germ extract fumaria officinalis flower/leaf/stem extract citrus medica limonum (lemon) fruit extract hydrolyzed rice bran extract hydrolyzed rice extract rosmarinus officinalis (rosemary) leaf extract vitis vinifera (grape) seed extract artemia extract laminaria ochroleuca extract algae extract hydrogenated lecithin thermus thermophillus ferment squalane glycerin sorbitol linoleic acid caffeine cholesterol ethylhexylglycerin lecithin ergothioneine sodium hyaluronate polyquaternium-51 cetyl alcohol trehalose palmitoyl hydroxypropyltrimonium amylopectin/glycerin crosspolymer ammonium acryloyldimethyltaurate/vp copolymer vp/eicosene copolymer tetrahexyldecyl ascorbate saccharide isomerate caprylyl glycol caprylic/capric triglyceride sodium pca cyclodextrin urea dehydroxanthan gum tocopheryl acetate glycyrrhetinic acid nordihydroguaiaretic acid ascorbyl tocopheryl maleate citric acid stearic acid sodium dehydroacetate fumaric acid ethylbisiminomethylguaiacol manganese chloride silica phenoxyethanol disodium edta bht fragrance (parfum) mica titanium dioxide (ci 77891) blue 1 (ci 42090) yellow 5 (ci 19140) <iln39694>


  • Other information

    protect the product in this container from excessive heat and direct sun


  • SPL UNCLASSIFIED SECTION

    DIST.
    NEW YORK, N.Y. 10022


  • PRINCIPAL DISPLAY PANEL - 30 mL Bottle Carton

    EL

    ESTÄ’E LAUDER

    DayWear

    Advanced Multi-Protection
    Anti-Oxidant & UV Defense

    Broad Spectrum
    SPF 50

    All Skintypes

    1 FL. OZ. LIQ./30 ml e

    Principal Display Panel - 30 mL Bottle Carton

  • INGREDIENTS AND APPEARANCE
    DAY WEAR ADVANCED MULTI-PROTECTION ANTI-OXIDANT AND UV DEFENSE   BROAD SPECTRUM SPF 30
    avobenzone, homosalate, octisalate, octocrylene, and oxybenzone lotion
    Product Information
    Product Type HUMAN OTC DRUG Item Code (Source) NDC:11559-026
    Route of Administration TOPICAL
    Active Ingredient/Active Moiety
    Ingredient Name Basis of Strength Strength
    AVOBENZONE (UNII: G63QQF2NOX) (AVOBENZONE - UNII:G63QQF2NOX) AVOBENZONE 0.0312 g  in 1 mL
    HOMOSALATE (UNII: V06SV4M95S) (HOMOSALATE - UNII:V06SV4M95S) HOMOSALATE 0.052 g  in 1 mL
    OCTISALATE (UNII: 4X49Y0596W) (OCTISALATE - UNII:4X49Y0596W) OCTISALATE 0.052 g  in 1 mL
    OCTOCRYLENE (UNII: 5A68WGF6WM) (OCTOCRYLENE - UNII:5A68WGF6WM) OCTOCRYLENE 0.02808 g  in 1 mL
    OXYBENZONE (UNII: 95OOS7VE0Y) (OXYBENZONE - UNII:95OOS7VE0Y) OXYBENZONE 0.0312 g  in 1 mL
    Inactive Ingredients
    Ingredient Name Strength
    water (UNII: 059QF0KO0R)  
    butyloctyl salicylate (UNII: 2EH13UN8D3)  
    methyl trimethicone (UNII: S73ZQI0GXM)  
    neopentyl glycol diheptanoate (UNII: 5LKW3C543X)  
    kukui nut oil (UNII: TP11QR7B8R)  
    peg-100 stearate (UNII: YD01N1999R)  
    butylene glycol (UNII: 3XUS85K0RA)  
    glyceryl monostearate (UNII: 230OU9XXE4)  
    potassium cetyl phosphate (UNII: 03KCY6P7UT)  
    gentiana lutea root (UNII: S72O3284MS)  
    polygonum cuspidatum root (UNII: 7TRV45YZF7)  
    wheat germ (UNII: YR3G369F5A)  
    fumaria officinalis flowering top (UNII: VH659J61ZL)  
    lemon (UNII: 24RS0A988O)  
    rosemary (UNII: IJ67X351P9)  
    vitis vinifera seed (UNII: C34U15ICXA)  
    laminaria ochroleuca (UNII: 4R2124HE76)  
    squalene (UNII: 7QWM220FJH)  
    glycerin (UNII: PDC6A3C0OX)  
    sorbitol (UNII: 506T60A25R)  
    linoleic acid (UNII: 9KJL21T0QJ)  
    caffeine (UNII: 3G6A5W338E)  
    cholesterol (UNII: 97C5T2UQ7J)  
    ethylhexylglycerin (UNII: 147D247K3P)  
    ergothioneine (UNII: BDZ3DQM98W)  
    hyaluronate sodium (UNII: YSE9PPT4TH)  
    cetyl alcohol (UNII: 936JST6JCN)  
    trehalose (UNII: B8WCK70T7I)  
    ammonium acryloyldimethyltaurate/vp copolymer (UNII: W59H9296ZG)  
    tetrahexyldecyl ascorbate (UNII: 9LBV3F07AZ)  
    saccharide isomerate (UNII: W8K377W98I)  
    caprylyl glycol (UNII: 00YIU5438U)  
    medium-chain triglycerides (UNII: C9H2L21V7U)  
    sodium pyrrolidone carboxylate (UNII: 469OTG57A2)  
    urea (UNII: 8W8T17847W)  
    .alpha.-tocopherol acetate (UNII: 9E8X80D2L0)  
    enoxolone (UNII: P540XA09DR)  
    masoprocol (UNII: 7BO8G1BYQU)  
    ascorbyl tocopheryl maleate (UNII: D2G6259XR5)  
    citric acid monohydrate (UNII: 2968PHW8QP)  
    stearic acid (UNII: 4ELV7Z65AP)  
    sodium dehydroacetate (UNII: 8W46YN971G)  
    fumaric acid (UNII: 88XHZ13131)  
    silicon dioxide (UNII: ETJ7Z6XBU4)  
    phenoxyethanol (UNII: HIE492ZZ3T)  
    edetate disodium (UNII: 7FLD91C86K)  
    butylated hydroxytoluene (UNII: 1P9D0Z171K)  
    mica (UNII: V8A1AW0880)  
    titanium dioxide (UNII: 15FIX9V2JP)  
    FD&C blue no. 1 (UNII: H3R47K3TBD)  
    FD&C yellow no. 5 (UNII: I753WB2F1M)  
    Packaging
    # Item Code Package Description Marketing Start Date Marketing End Date
    1 NDC:11559-026-01 1 in 1 CARTON
    1 30 mL in 1 BOTTLE
    Marketing Information
    Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
    OTC MONOGRAPH NOT FINAL part352 11/07/2012
    Labeler - ESTEE LAUDER INC (005914387)
    Establishment
    Name Address ID/FEI Business Operations
    ELGC K.K. 712808195 RELABEL(11559-026) , REPACK(11559-026)
    Establishment
    Name Address ID/FEI Business Operations
    Estee Lauder Pennsylvania Distribution Center 2 (PADC 2) 828534516 MANUFACTURE(11559-026) , RELABEL(11559-026) , REPACK(11559-026)
    Establishment
    Name Address ID/FEI Business Operations
    Estee Lauder Inc. 042918826 MANUFACTURE(11559-026)
    Establishment
    Name Address ID/FEI Business Operations
    ESTEE LAUDER COSMETICS DISTRIBUTION CENTER 208579636 REPACK(11559-026) , RELABEL(11559-026)
    Establishment
    Name Address ID/FEI Business Operations
    ESTEE LAUDER COSMETICS, LTD 253616536 MANUFACTURE(11559-026)
    Establishment
    Name Address ID/FEI Business Operations
    ESTEE LAUDER COSMETICS, LTD 244669714 MANUFACTURE(11559-026)
    Establishment
    Name Address ID/FEI Business Operations
    ESTEE LAUDER COSMETICS, LTD. 205952385 MANUFACTURE(11559-026)
    Establishment
    Name Address ID/FEI Business Operations
    ESTEE LAUDER N.V. 370151326 MANUFACTURE(11559-026)
    Establishment
    Name Address ID/FEI Business Operations
    LEN-RON MANUFACTURING DIVISION OF ARAMIS INC 809771152 MANUFACTURE(11559-026)
    Establishment
    Name Address ID/FEI Business Operations
    NORTEC KEYSTONE 943871157 MANUFACTURE(11559-026) , RELABEL(11559-026) , REPACK(11559-026)
    Establishment
    Name Address ID/FEI Business Operations
    NORTHTEC BRISTOL 959338336 MANUFACTURE(11559-026) , RELABEL(11559-026) , REPACK(11559-026)
    Establishment
    Name Address ID/FEI Business Operations
    NORTHTEC KEYSTONE 949264774 MANUFACTURE(11559-026) , RELABEL(11559-026) , REPACK(11559-026)
    Establishment
    Name Address ID/FEI Business Operations
    WHITMAN LABORATORIES, LTD. 216866277 MANUFACTURE(11559-026)
    Establishment
    Name Address ID/FEI Business Operations
    Aveda Corporation 071352058 MANUFACTURE(11559-026)
    Establishment
    Name Address ID/FEI Business Operations
    Pennsylvania Logistics Center 078364654 REPACK(11559-026) , RELABEL(11559-026)