Label: ESTEE LAUDER DOUBLE WEAR SOFT GLOW MATTE CUSHION MAKEUP BROAD SPECTRUM SPF 36- octinoxate, titanium dioxide and zinc oxide gel

  • NDC Code(s): 11559-062-01, 11559-062-02
  • Packager: ESTEE LAUDER INC
  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None

Drug Label Information

Updated December 21, 2023

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

  • SPL UNCLASSIFIED SECTION

    Drug Facts

  • ACTIVE INGREDIENT

    Active ingredientsPurpose
    Octinoxate 6.8%Sunscreen
    Titanium Dioxide 7.6%Sunscreen
    Zinc Oxide 3.6%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∙phenyl trimethicone∙dimethicone∙pentaerythrityl tetraisostearate∙methyl trimethicone∙glycerin∙propanediol∙lauryl peg-9 polydimethylsiloxyethyl dimethicone∙silica∙isohexadecane∙cetyl peg/ppg-10/1 dimethicone∙hydroxyethyl urea∙sapindus mukorossi fruit extract∙sodium hyaluronate∙tremella fuciformis sporocarp extract∙glycine soja (soybean) seed extract∙laminaria saccharina extract∙lactobacillus ferment∙trehalose∙dimethicone/vinyl dimethicone crosspolymer∙caprylyl glycol∙diisostearyl malate∙caffeine∙linoleic acid∙phospholipids∙polyglyceryl-2 triisostearate∙caprylic/capric triglyceride∙phytosteryl canola glycerides∙triolein∙tocopheryl acetate∙hydrogenated coco-glycerides∙methicone∙caesalpinia spinosa gum∙jojoba esters∙acetyl hexapeptide-8∙peg-75∙triethoxycaprylylsilane∙alumina∙disteardimonium hectorite∙propylene carbonate∙betaine∙dimethicone silylate∙tocopherol∙dimethicone/peg-10/15 crosspolymer∙magnesium sulfate∙palmitic acid∙oleic acid∙polymethylsilsesquioxane∙butylene glycol∙dipropylene glycol∙stearic acid∙polysilicone-11∙sodium citrate∙glyceryl stearate∙stearyl alcohol∙cetearyl alcohol∙ammonium polyacryloyldimethyl taurate∙polysorbate 80∙trimethylsiloxysilicate∙polysorbate 20∙behenyl alcohol∙dimethicone/divinyldimethicone silsesquioxane crosspolymer∙fragrance (parfum)∙linalool∙limonene∙alpha-isomethyl ionone∙disodium edta∙bht∙phenoxyethanol∙potassium sorbate∙[+/- titanium dioxide (ci 77891)∙iron oxides (ci 77492)∙iron oxides (ci 77491)∙iron oxides (ci 77499)∙mica] <iln49800>

  • Other information

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

  • PRINCIPAL DISPLAY PANEL - 28 g Cartridge Carton

    ESTĒE LAUDER

    Double Wear
    Soft Glow Matte
    Cushion Makeup
    Broad Spectrum SPF 36

    Plus 1 Refill

    TOTAL POIDS NET WT. .98 OZ./28g ℮ (14g X2)

    Principal Display Panel - 28 g Cartridge Carton
  • INGREDIENTS AND APPEARANCE
    ESTEE LAUDER DOUBLE WEAR SOFT GLOW MATTE CUSHION MAKEUP BROAD SPECTRUM SPF 36 
    octinoxate, titanium dioxide and zinc oxide gel
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:11559-062
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    OCTINOXATE (UNII: 4Y5P7MUD51) (OCTINOXATE - UNII:4Y5P7MUD51) OCTINOXATE68 mg  in 1 g
    TITANIUM DIOXIDE (UNII: 15FIX9V2JP) (TITANIUM DIOXIDE - UNII:15FIX9V2JP) TITANIUM DIOXIDE76 mg  in 1 g
    ZINC OXIDE (UNII: SOI2LOH54Z) (ZINC OXIDE - UNII:SOI2LOH54Z) ZINC OXIDE36 mg  in 1 g
    Inactive Ingredients
    Ingredient NameStrength
    MEDIUM-CHAIN TRIGLYCERIDES (UNII: C9H2L21V7U)  
    CANOLA OIL (UNII: 331KBJ17RK)  
    GLYCERYL TRIOLEATE (UNII: O05EC62663)  
    .ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)  
    HYDROGENATED COCO-GLYCERIDES (UNII: XDD37N2GPR)  
    METHICONE (20 CST) (UNII: 6777U11MKT)  
    CAESALPINIA SPINOSA RESIN (UNII: WL3883U2PO)  
    POTASSIUM HYDROLYZED JOJOBA ESTERS (UNII: CH428W5O62)  
    ACETYL HEXAPEPTIDE-8 (UNII: L4EL31FWIL)  
    PEG-75 DILAURATE (UNII: K881554QIN)  
    TRIETHOXYCAPRYLYLSILANE (UNII: LDC331P08E)  
    ALUMINUM OXIDE (UNII: LMI26O6933)  
    DISTEARDIMONIUM HECTORITE (UNII: X687XDK09L)  
    PROPYLENE CARBONATE (UNII: 8D08K3S51E)  
    BETAINE (UNII: 3SCV180C9W)  
    SILICA DIMETHYL SILYLATE (UNII: EU2PSP0G0W)  
    TOCOPHEROL (UNII: R0ZB2556P8)  
    DIMETHICONE/PEG-10/15 CROSSPOLYMER (UNII: 21AS8B1BSS)  
    MAGNESIUM SULFATE, UNSPECIFIED FORM (UNII: DE08037SAB)  
    PALMITIC ACID (UNII: 2V16EO95H1)  
    OLEIC ACID (UNII: 2UMI9U37CP)  
    POLYMETHYLSILSESQUIOXANE (11 MICRONS) (UNII: Z570VEV8XK)  
    BUTYLENE GLYCOL (UNII: 3XUS85K0RA)  
    DIPROPYLENE GLYCOL (UNII: E107L85C40)  
    STEARIC ACID (UNII: 4ELV7Z65AP)  
    DIMETHICONE/VINYL DIMETHICONE CROSSPOLYMER (SOFT PARTICLE) (UNII: 9E4CO0W6C5)  
    SODIUM CITRATE, UNSPECIFIED FORM (UNII: 1Q73Q2JULR)  
    GLYCERYL STEARATE SE (UNII: FCZ5MH785I)  
    STEARYL ALCOHOL (UNII: 2KR89I4H1Y)  
    CETOSTEARYL ALCOHOL (UNII: 2DMT128M1S)  
    AMMONIUM POLYACRYLOYLDIMETHYL TAURATE (55000 MPA.S) (UNII: F01RIY4371)  
    POLYSORBATE 80 (UNII: 6OZP39ZG8H)  
    TRIMETHYLSILOXYSILICATE (M/Q 0.6-0.8) (UNII: 5041RX63GN)  
    POLYSORBATE 20 (UNII: 7T1F30V5YH)  
    DOCOSANOL (UNII: 9G1OE216XY)  
    DIMETHICONE/DIVINYLDIMETHICONE/SILSESQUIOXANE CROSSPOLYMER (UNII: T3064TZ75A)  
    FRAGRANCE CLEAN ORC0600327 (UNII: 329LCV5BTF)  
    LINALOOL, (+)- (UNII: F4VNO44C09)  
    LIMONENE, (+)- (UNII: GFD7C86Q1W)  
    ISOMETHYL-.ALPHA.-IONONE (UNII: 9XP4LC555B)  
    DISODIUM EDTA-COPPER (UNII: 6V475AX06U)  
    BUTYLATED HYDROXYTOLUENE (UNII: 1P9D0Z171K)  
    PHENOXYETHANOL (UNII: HIE492ZZ3T)  
    POTASSIUM SORBATE (UNII: 1VPU26JZZ4)  
    FERRIC OXIDE YELLOW (UNII: EX438O2MRT)  
    FERRIC OXIDE RED (UNII: 1K09F3G675)  
    FERROSOFERRIC OXIDE (UNII: XM0M87F357)  
    MICA (UNII: V8A1AW0880)  
    WATER (UNII: 059QF0KO0R)  
    PHENYL TRIMETHICONE (UNII: DR0K5NOJ4R)  
    DIMETHICONE (UNII: 92RU3N3Y1O)  
    PENTAERYTHRITYL TETRAISOSTEARATE (UNII: 9D7IK5483F)  
    METHYL TRIMETHICONE (UNII: S73ZQI0GXM)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    PROPANEDIOL (UNII: 5965N8W85T)  
    LAURYL PEG-9 POLYDIMETHYLSILOXYETHYL DIMETHICONE (UNII: 25G622K2RA)  
    SILICA, TRIMETHYLSILYL CAPPED (UNII: VU10KU4B9S)  
    ISOHEXADECANE (UNII: 918X1OUF1E)  
    CETYL PEG/PPG-10/1 DIMETHICONE (HLB 2) (UNII: V2W71V8T0X)  
    HYDROXYETHYL UREA (UNII: MBQ7DDQ7AR)  
    SAPINDUS MUKOROSSI FRUIT (UNII: 66H9NW427Y)  
    HYALURONATE SODIUM (UNII: YSE9PPT4TH)  
    TREMELLA FUCIFORMIS FRUITING BODY (UNII: GG8N28393G)  
    SOYBEAN (UNII: L7HT8F1ZOD)  
    SACCHARINA LATISSIMA (UNII: 68CMP2MB55)  
    LIMOSILACTOBACILLUS REUTERI (UNII: 9913I24QEE)  
    TREHALOSE (UNII: B8WCK70T7I)  
    DIMETHICONE/VINYL DIMETHICONE CROSSPOLYMER (HARD PARTICLE) (UNII: H895X08VNQ)  
    CAPRYLYL GLYCOL (UNII: 00YIU5438U)  
    DIISOSTEARYL MALATE (UNII: QBS8A3XZGQ)  
    CAFFEINE (UNII: 3G6A5W338E)  
    LINOLEIC ACID (UNII: 9KJL21T0QJ)  
    PHOSPHOLIPID PHOSPHATASE 1 (UNII: IP029363WQ)  
    POLYGLYCERYL-2 TRIISOSTEARATE (UNII: 68DUY2D39A)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:11559-062-011 in 1 CARTON07/07/202112/31/2023
    128 g in 1 CARTRIDGE; Type 0: Not a Combination Product
    2NDC:11559-062-021 in 1 CARTON12/21/2023
    224 g in 1 CARTRIDGE; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC Monograph DrugM02007/07/2021
    Labeler - ESTEE LAUDER INC (005914387)
    Registrant - Estee Lauder Companies Inc. (790802086)
    Establishment
    NameAddressID/FEIBusiness Operations
    Estee Lauder N.V.370151326manufacture(11559-062) , pack(11559-062) , label(11559-062)
    Establishment
    NameAddressID/FEIBusiness Operations
    COSMAX INC689049693manufacture(11559-062)