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DAYWEAR BB (ESTEE LAUDER INC)

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Dosage Form Package Information Links
CREAM 1 BOTTLE in 1 CARTON (11559-015-01) > 30 mL in 1 BOTTLE Label Information

Complete DAYWEAR BB Information

  • SPL UNCLASSIFIED SECTION

    Drug Facts


  • ACTIVE INGREDIENT

    Active ingredients Purpose
    Octinoxate 7.50% Sunscreen
    Octisalate 4.00% Sunscreen
    Oxybenzone 2.50% Sunscreen
    Titanium dioxide 1.10% 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 dimethicone butylene glycol pentylene glycol phenyl trimethicone glyceryl stearate behenyl alcohol trioctyldodecyl citrate polymethylsilsesquioxane octyldodecyl stearoyl stearate peg-40 stearate polyglyceryl-10 pentastearate gentiana lutea (gentian) root extract polygonum cuspidatum root extract thermus thermophillus ferment hordeum vulgare (barley) extract\extrait d' orge fumaria officinalis flower/leaf/stem extract citrus medica limonum (lemon) fruit extract hydrolyzed rice bran extract laminaria saccharina extract hydrolyzed rice extract rosmarinus officinalis (rosemary) leaf extract artemia extract vitis vinifera (grape) seed extract triticum vulgare (wheat) germ extract cholesterol caffeine propylene glycol stearate octyldodecyl neopentanoate polyglyceryl-6 polyricinoleate tocopheryl acetate sucrose glycerin sodium stearoyl lactylate linoleic acid lecithin squalane sodium pca urea isopropyl titanium triisostearate ergothioneine sodium dehydroacetate tetrahexyldecyl ascorbate polysorbate 20 sorbitan laurate sodium hyaluronate citric acid propylene glycol laurate glycyrrhetinic acid trehalose polyquaternium-51 hydrogenated lecithin fumaric acid alumina palmitoyl hydroxypropyltrimonium amylopectin/glycerin crosspolymer ammonium acryloyldimethyltaurate/vp copolymer cyclodextrin nordihydroguaiaretic acid ascorbyl tocopheryl maleate xanthan gum stearic acid silica fragrance (parfum) ethylbisiminomethylguaiacol manganese chloride pentaerythrityl tetra-di-t-butyl hydroxyhydrocinnamate disodium edta phenoxyethanol chlorphenesin [+/- titanium dioxide (ci 77891) zinc oxide (ci 77947) iron oxides (ci 77491, ci 77492, ci 77499) yellow 5 lake (ci 19140) chromium oxide greens (ci 77288) mica ferric ferrocyanide (ci 77510) chromium hydroxide green (ci 77289) carmine (ci 75470) bismuth oxychloride (ci 77163) blue 1 lake (ci 42090)] [iln38365]


  • Other information

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


  • SPL UNCLASSIFIED SECTION

    © ESTÄ’E LAUDER, DIST.
    NEW YORK, N.Y. 10022


  • PRINCIPAL DISPLAY PANEL - 30 ml Carton

    ESTÄ’E LAUDER

    DayWear

    BB

    Anti-Oxidant
    Beauty Benefit Creme
    Broad Spectrum
    SPF 35

    All Skintypes

    1 FL. OZ. LIQ./30 ml e

    Principal Display Panel - 30 ml Carton

  • INGREDIENTS AND APPEARANCE
    DAYWEAR BB   ANTI OXIDANT BEAUTY BENEFIT BROAD SPECTRUM SPF 35
    octinoxate, octisalate, oxybenzone, and titanium dioxide cream
    Product Information
    Product Type HUMAN OTC DRUG Item Code (Source) NDC:11559-015
    Route of Administration TOPICAL
    Active Ingredient/Active Moiety
    Ingredient Name Basis of Strength Strength
    OCTINOXATE (UNII: 4Y5P7MUD51) (OCTINOXATE - UNII:4Y5P7MUD51) OCTINOXATE 7.5 mL  in 100 mL
    OCTISALATE (UNII: 4X49Y0596W) (OCTISALATE - UNII:4X49Y0596W) OCTISALATE 4 mL  in 100 mL
    OXYBENZONE (UNII: 95OOS7VE0Y) (OXYBENZONE - UNII:95OOS7VE0Y) OXYBENZONE 2.5 mL  in 100 mL
    TITANIUM DIOXIDE (UNII: 15FIX9V2JP) (TITANIUM DIOXIDE - UNII:15FIX9V2JP) TITANIUM DIOXIDE 1.1 mL  in 100 mL
    Inactive Ingredients
    Ingredient Name Strength
    WATER (UNII: 059QF0KO0R)  
    DIMETHICONE (UNII: 92RU3N3Y1O)  
    BUTYLENE GLYCOL (UNII: 3XUS85K0RA)  
    PENTYLENE GLYCOL (UNII: 50C1307PZG)  
    PHENYL TRIMETHICONE (UNII: DR0K5NOJ4R)  
    GLYCERYL MONOSTEARATE (UNII: 230OU9XXE4)  
    DOCOSANOL (UNII: 9G1OE216XY)  
    OCTYLDODECYL STEAROYL STEARATE (UNII: 3D47Q6D93C)  
    PEG-40 STEARATE (UNII: ECU18C66Q7)  
    GENTIANA LUTEA ROOT (UNII: S72O3284MS)  
    POLYGONUM CUSPIDATUM ROOT (UNII: 7TRV45YZF7)  
    HORDEUM VULGARE ROOT (UNII: 790S39483Z)  
    FUMARIA OFFICINALIS FLOWERING TOP (UNII: VH659J61ZL)  
    LEMON (UNII: 24RS0A988O)  
    SACCHARINA LATISSIMA THALLUS (UNII: 68CMP2MB55)  
    ROSEMARY (UNII: IJ67X351P9)  
    VITIS VINIFERA SEED (UNII: C34U15ICXA)  
    WHEAT GERM (UNII: YR3G369F5A)  
    CHOLESTEROL (UNII: 97C5T2UQ7J)  
    CAFFEINE (UNII: 3G6A5W338E)  
    PROPYLENE GLYCOL STEARATE (UNII: MZM1I680W0)  
    OCTYLDODECYL NEOPENTANOATE (UNII: X8725R883T)  
    ALPHA-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)  
    SUCROSE (UNII: C151H8M554)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    SODIUM STEAROYL LACTYLATE (UNII: IN99IT31LN)  
    LINOLEIC ACID (UNII: 9KJL21T0QJ)  
    SQUALANE (UNII: GW89575KF9)  
    SODIUM PYRROLIDONE CARBOXYLATE (UNII: 469OTG57A2)  
    UREA (UNII: 8W8T17847W)  
    ERGOTHIONEINE (UNII: BDZ3DQM98W)  
    SODIUM DEHYDROACETATE (UNII: 8W46YN971G)  
    TETRAHEXYLDECYL ASCORBATE (UNII: 9LBV3F07AZ)  
    POLYSORBATE 20 (UNII: 7T1F30V5YH)  
    SORBITAN MONOLAURATE (UNII: 6W9PS8B71J)  
    HYALURONATE SODIUM (UNII: YSE9PPT4TH)  
    CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP)  
    PROPYLENE GLYCOL LAURATES (UNII: 40KT317HGP)  
    ENOXOLONE (UNII: P540XA09DR)  
    TREHALOSE (UNII: B8WCK70T7I)  
    FUMARIC ACID (UNII: 88XHZ13131)  
    ALUMINUM OXIDE (UNII: LMI26O6933)  
    MASOPROCOL (UNII: 7BO8G1BYQU)  
    XANTHAN GUM (UNII: TTV12P4NEE)  
    STEARIC ACID (UNII: 4ELV7Z65AP)  
    SILICON DIOXIDE (UNII: ETJ7Z6XBU4)  
    EDETATE DISODIUM (UNII: 7FLD91C86K)  
    PHENOXYETHANOL (UNII: HIE492ZZ3T)  
    CHLORPHENESIN (UNII: I670DAL4SZ)  
    ZINC OXIDE (UNII: SOI2LOH54Z)  
    FERRIC OXIDE RED (UNII: 1K09F3G675)  
    FERRIC OXIDE YELLOW (UNII: EX438O2MRT)  
    FERROSOFERRIC OXIDE (UNII: XM0M87F357)  
    FD&C YELLOW NO. 5 (UNII: I753WB2F1M)  
    CHROMIC OXIDE (UNII: X5Z09SU859)  
    MICA (UNII: V8A1AW0880)  
    FERRIC FERROCYANIDE (UNII: TLE294X33A)  
    COCHINEAL (UNII: TZ8Z31B35M)  
    BISMUTH OXYCHLORIDE (UNII: 4ZR792I587)  
    FD&C BLUE NO. 1 (UNII: H3R47K3TBD)  
    Packaging
    # Item Code Package Description Marketing Start Date Marketing End Date
    1 NDC:11559-015-01 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 09/01/2011
    Labeler - ESTEE LAUDER INC (005914387)
    Establishment
    Name Address ID/FEI Business Operations
    ELGC K.K. 712808195 RELABEL(11559-015) , REPACK(11559-015)
    Establishment
    Name Address ID/FEI Business Operations
    Estee Lauder Pennsylvania Distribution Center 2 (PADC 2) 828534516 MANUFACTURE(11559-015) , RELABEL(11559-015) , REPACK(11559-015)
    Establishment
    Name Address ID/FEI Business Operations
    Estee Lauder Inc. 042918826 MANUFACTURE(11559-015)
    Establishment
    Name Address ID/FEI Business Operations
    ESTEE LAUDER COSMETICS DISTRIBUTION CENTER 208579636 REPACK(11559-015) , RELABEL(11559-015)
    Establishment
    Name Address ID/FEI Business Operations
    ESTEE LAUDER COSMETICS, LTD 253616536 MANUFACTURE(11559-015)
    Establishment
    Name Address ID/FEI Business Operations
    ESTEE LAUDER COSMETICS, LTD 244669714 MANUFACTURE(11559-015)
    Establishment
    Name Address ID/FEI Business Operations
    ESTEE LAUDER COSMETICS, LTD. 205952385 MANUFACTURE(11559-015)
    Establishment
    Name Address ID/FEI Business Operations
    ESTEE LAUDER N.V. 370151326 MANUFACTURE(11559-015)
    Establishment
    Name Address ID/FEI Business Operations
    LEN-RON MANUFACTURING DIVISION OF ARAMIS INC 809771152 MANUFACTURE(11559-015)
    Establishment
    Name Address ID/FEI Business Operations
    NORTEC KEYSTONE 943871157 MANUFACTURE(11559-015) , RELABEL(11559-015) , REPACK(11559-015)
    Establishment
    Name Address ID/FEI Business Operations
    NORTHTEC BRISTOL 959338336 MANUFACTURE(11559-015) , RELABEL(11559-015) , REPACK(11559-015)
    Establishment
    Name Address ID/FEI Business Operations
    NORTHTEC KEYSTONE 949264774 MANUFACTURE(11559-015) , RELABEL(11559-015) , REPACK(11559-015)
    Establishment
    Name Address ID/FEI Business Operations
    WHITMAN LABORATORIES, LTD. 216866277 MANUFACTURE(11559-015)
    Establishment
    Name Address ID/FEI Business Operations
    Aveda Corporation 071352058 MANUFACTURE(11559-015)
    Establishment
    Name Address ID/FEI Business Operations
    Pennsylvania Logistics Center 078364654 REPACK(11559-015) , RELABEL(11559-015)