Label: DOUBLE WEAR NUDE WATER FRESH MAKEUP BROAD SPECTRUM SPF 30- octinoxate, titanium dioxide, and zinc oxide liquid

  • NDC Code(s): 11559-048-01, 11559-048-02
  • Packager: ESTEE LAUDER INC
  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None

Drug Label Information

Updated December 20, 2023

If you are a consumer or patient please visit this version.

  • SPL UNCLASSIFIED SECTION

    Drug Facts

  • ACTIVE INGREDIENT

    Active ingredientsPurpose
    Octinoxate 5.0%Sunscreen
    Titanium Dioxide 3.1%Sunscreen
    Zinc Oxide 2.2%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 • methyl trimethicone • phenyl trimethicone • silica • butyloctyl salicylate • dimethicone • neopentyl glycol diheptanoate • c12-15 alkyl benzoate • butylene glycol • dimethicone silylate • lauryl peg-9 polydimethylsiloxyethyl dimethicone • ethylhexyl palmitate • glycerin • polysilicone-11 • litchi chinensis seed extract • peg-10 dimethicone • laminaria saccharina extract • polyglutamic acid • lens esculenta (lentil) fruit extract • pyrus malus (apple) fruit extract • thermus thermophillus ferment • citrullus vulgaris (watermelon) fruit extract • sodium hyaluronate • sodium lactate • sodium chloride • glycine soja (soybean) protein • tocopheryl acetate • zinc stearate • caprylyl glycol • sodium pca • lecithin • dimethicone/peg-10/15 crosspolymer • trimethylsiloxysilicate • laureth-7 • triethyl citrate • triethoxycaprylylsilane • hexylene glycol • silica dimethyl silylate • disteardimonium hectorite • calcium chloride • sodium dehydroacetate • potassium sorbate • magnesium aluminum silicate • xanthan gum • dextrin • disodium edta • bht • phenoxyethanol • [+/- titanium dioxide (ci 77891) • iron oxides (ci 77492) • iron oxides (ci 77491) • iron oxides (ci 77499)] <iln43610>

  • Other information

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

  • PRINCIPAL DISPLAY PANEL - 30 ml Bottle Carton

    ESTĒE LAUDER

    Double Wear
    Nude

    Water Fresh Makeup

    Broad Spectrum SPF 30

    1 FL. OZ. LIQ./30ml e

    PRINCIPAL DISPLAY PANEL - 30 ml Bottle Carton
  • INGREDIENTS AND APPEARANCE
    DOUBLE WEAR NUDE WATER FRESH MAKEUP BROAD SPECTRUM SPF 30 
    octinoxate, titanium dioxide, and zinc oxide liquid
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:11559-048
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    OCTINOXATE (UNII: 4Y5P7MUD51) (OCTINOXATE - UNII:4Y5P7MUD51) OCTINOXATE50 mg  in 1 mL
    TITANIUM DIOXIDE (UNII: 15FIX9V2JP) (TITANIUM DIOXIDE - UNII:15FIX9V2JP) TITANIUM DIOXIDE31 mg  in 1 mL
    ZINC OXIDE (UNII: SOI2LOH54Z) (ZINC OXIDE - UNII:SOI2LOH54Z) ZINC OXIDE22 mg  in 1 mL
    Inactive Ingredients
    Ingredient NameStrength
    WATER (UNII: 059QF0KO0R)  
    METHYL TRIMETHICONE (UNII: S73ZQI0GXM)  
    PHENYL TRIMETHICONE (UNII: DR0K5NOJ4R)  
    SILICON DIOXIDE (UNII: ETJ7Z6XBU4)  
    BUTYLOCTYL SALICYLATE (UNII: 2EH13UN8D3)  
    DIMETHICONE (UNII: 92RU3N3Y1O)  
    NEOPENTYL GLYCOL DIHEPTANOATE (UNII: 5LKW3C543X)  
    ALKYL (C12-15) BENZOATE (UNII: A9EJ3J61HQ)  
    BUTYLENE GLYCOL (UNII: 3XUS85K0RA)  
    LAURYL PEG-9 POLYDIMETHYLSILOXYETHYL DIMETHICONE (UNII: 25G622K2RA)  
    ETHYLHEXYL PALMITATE (UNII: 2865993309)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    DIMETHICONE/VINYL DIMETHICONE CROSSPOLYMER (SOFT PARTICLE) (UNII: 9E4CO0W6C5)  
    LITCHI CHINENSIS SEED (UNII: 9294024N9Q)  
    PEG-10 DIMETHICONE (600 CST) (UNII: 8PR7V1SVM0)  
    SACCHARINA LATISSIMA (UNII: 68CMP2MB55)  
    LENS CULINARIS FRUIT (UNII: ZYZ076G9JH)  
    APPLE (UNII: B423VGH5S9)  
    THERMUS THERMOPHILUS LYSATE (UNII: 775R692494)  
    WATERMELON (UNII: 231473QB6R)  
    HYALURONATE SODIUM (UNII: YSE9PPT4TH)  
    SODIUM LACTATE (UNII: TU7HW0W0QT)  
    SODIUM CHLORIDE (UNII: 451W47IQ8X)  
    .ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)  
    ZINC STEARATE (UNII: H92E6QA4FV)  
    CAPRYLYL GLYCOL (UNII: 00YIU5438U)  
    SODIUM PYRROLIDONE CARBOXYLATE (UNII: 469OTG57A2)  
    LAURETH-7 (UNII: Z95S6G8201)  
    TRIETHYL CITRATE (UNII: 8Z96QXD6UM)  
    TRIETHOXYCAPRYLYLSILANE (UNII: LDC331P08E)  
    HEXYLENE GLYCOL (UNII: KEH0A3F75J)  
    SILICA DIMETHYL SILYLATE (UNII: EU2PSP0G0W)  
    DISTEARDIMONIUM HECTORITE (UNII: X687XDK09L)  
    CALCIUM CHLORIDE (UNII: M4I0D6VV5M)  
    SODIUM DEHYDROACETATE (UNII: 8W46YN971G)  
    POTASSIUM SORBATE (UNII: 1VPU26JZZ4)  
    MAGNESIUM ALUMINUM SILICATE (UNII: 6M3P64V0NC)  
    XANTHAN GUM (UNII: TTV12P4NEE)  
    EDETATE DISODIUM ANHYDROUS (UNII: 8NLQ36F6MM)  
    BUTYLATED HYDROXYTOLUENE (UNII: 1P9D0Z171K)  
    PHENOXYETHANOL (UNII: HIE492ZZ3T)  
    FERRIC OXIDE YELLOW (UNII: EX438O2MRT)  
    FERRIC OXIDE RED (UNII: 1K09F3G675)  
    FERROSOFERRIC OXIDE (UNII: XM0M87F357)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:11559-048-011 in 1 CARTON05/01/201707/15/2025
    130 mL in 1 BOTTLE; Type 0: Not a Combination Product
    2NDC:11559-048-021 in 1 CARTON03/02/202212/31/2023
    215 mL in 1 BOTTLE; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC Monograph DrugM02005/01/201707/15/2025
    Labeler - ESTEE LAUDER INC (005914387)
    Registrant - Estee Lauder Companies Inc. (790802086)
    Establishment
    NameAddressID/FEIBusiness Operations
    Estee Lauder N.V.370151326manufacture(11559-048) , pack(11559-048) , label(11559-048)