Label: FUTURIST HYDRA RESCUE MOISTURIZING MAKEUP BROAD SPECTRUM SPF 45- ensulizole, octinoxate, octisalate, and zinc oxide liquid

  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None

Drug Label Information

Updated August 13, 2024

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

  • SPL UNCLASSIFIED SECTION

    Drug Facts

  • ACTIVE INGREDIENT

    Active ingredientsPurpose
    Ensulizole 2.7%Sunscreen
    Octinoxate 6.7%Sunscreen
    Octisalate 4.5%Sunscreen
    Zinc Oxide 3.8%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 • phenyl trimethicone • butylene glycol • glycerin • polymethylsilsesquioxane • lauryl peg-9 polydimethylsiloxyethyl dimethicone • hdi/ppg/polycaprolactone crosspolymer • trimethylsiloxysilicate/dimethiconol crosspolymer • tromethamine • polysilicone-11 • hexyl laurate • cetyl peg/ppg-10/1 dimethicone • lactobacillus ferment • cucumis sativus (cucumber) fruit extract • sodium hyaluronate • salvia hispanica seed extract • hylocereus undatus fruit extract • helianthus annuus (sunflower) seedcake • algae extract • euterpe oleracea fruit oil • carapa guaianensis seed oil • caffeine • jojoba esters • tremella fuciformis sporocarp extract • camelina sativa seed oil • sapindus mukorossi fruit extract • caesalpinia spinosa gum • copaifera officinalis (balsam copaiba) resin • caprylic/capric triglyceride • propylene glycol dicaprate • acetyl glucosamine • tocopheryl acetate • acetyl hexapeptide-8 • lecithin • trehalose • disteardimonium hectorite • hydroxyethyl urea • neopentyl glycol diheptanoate • dimethicone/divinyldimethicone silsesquioxane crosspolymer • hydrogenated coco-glycerides • phospholipids • trimethylsiloxysilicate • polyhydroxystearic acid • polyglyceryl-4 isostearate • glyceryl stearate • triethoxycaprylylsilane • triethyl citrate • laureth-7 • linoleic acid • methicone • stearyl alcohol • cetearyl alcohol • ammonium polyacryloyldimethyl taurate • silica • hordeum vulgare (barley) extract\extrait d'orge • tocopherol • palmitic acid • phytosteryl canola glycerides • stearic acid • oleic acid • sodium chloride • polysorbate 80 • polysorbate 20 • behenyl alcohol • triolein • betaine • fragrance (parfum) • disodium edta • bht • phenoxyethanol • sodium dehydroacetate • potassium sorbate • [+/- mica • iron oxides (ci 77491) • iron oxides (ci 77492) • iron oxides (ci 77499) • titanium dioxide (ci 77891)] <iln47153>

  • Other information

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

  • PRINCIPAL DISPLAY PANEL - 35 ml Tube Carton

    ESTĒE LAUDER

    Futurist
    Hydra Rescue
    Moisturizing Makeup
    Broad Spectrum
    SPF 45

    1.2 FL. OZ. LIQ.
    35ml e

    PRINCIPAL DISPLAY PANEL - 35 ml Tube Carton
  • INGREDIENTS AND APPEARANCE
    FUTURIST HYDRA RESCUE MOISTURIZING MAKEUP BROAD SPECTRUM SPF 45 
    ensulizole, octinoxate, octisalate, and zinc oxide liquid
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:11559-058
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    ENSULIZOLE (UNII: 9YQ9DI1W42) (ENSULIZOLE - UNII:9YQ9DI1W42) ENSULIZOLE27 mg  in 1 mL
    OCTINOXATE (UNII: 4Y5P7MUD51) (OCTINOXATE - UNII:4Y5P7MUD51) OCTINOXATE67 mg  in 1 mL
    OCTISALATE (UNII: 4X49Y0596W) (OCTISALATE - UNII:4X49Y0596W) OCTISALATE45 mg  in 1 mL
    ZINC OXIDE (UNII: SOI2LOH54Z) (ZINC OXIDE - UNII:SOI2LOH54Z) ZINC OXIDE38 mg  in 1 mL
    Inactive Ingredients
    Ingredient NameStrength
    HYALURONATE SODIUM (UNII: YSE9PPT4TH)  
    CHIA SEED (UNII: NU0OLX06F8)  
    SELENICEREUS UNDATUS FRUIT (UNII: WUG58TD53X)  
    HELIANTHUS ANNUUS SEEDCAKE (UNII: 482WYF7XLC)  
    ACAI OIL (UNII: Z0W6766A2W)  
    CARAPA GUIANENSIS SEED OIL (UNII: Y82418EH2I)  
    CAFFEINE (UNII: 3G6A5W338E)  
    TREMELLA FUCIFORMIS FRUITING BODY (UNII: GG8N28393G)  
    CAMELINA SATIVA SEED OIL (UNII: 12824X01L0)  
    SAPINDUS MUKOROSSI FRUIT (UNII: 66H9NW427Y)  
    CAESALPINIA SPINOSA RESIN (UNII: WL3883U2PO)  
    COPAIFERA OFFICINALIS RESIN (UNII: 1VH544O5AT)  
    MEDIUM-CHAIN TRIGLYCERIDES (UNII: C9H2L21V7U)  
    PROPYLENE GLYCOL DICAPRATE (UNII: U783H9JHWY)  
    N-ACETYLGLUCOSAMINE (UNII: V956696549)  
    .ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)  
    ACETYL HEXAPEPTIDE-8 (UNII: L4EL31FWIL)  
    TREHALOSE (UNII: B8WCK70T7I)  
    DISTEARDIMONIUM HECTORITE (UNII: X687XDK09L)  
    HYDROXYETHYL UREA (UNII: MBQ7DDQ7AR)  
    NEOPENTYL GLYCOL DIHEPTANOATE (UNII: 5LKW3C543X)  
    HYDROGENATED COCO-GLYCERIDES (UNII: XDD37N2GPR)  
    LECITHIN, SOYBEAN (UNII: 1DI56QDM62)  
    POLYGLYCERYL-4 ISOSTEARATE (UNII: 820DPX33S7)  
    GLYCERYL MONOSTEARATE (UNII: 230OU9XXE4)  
    TRIETHOXYCAPRYLYLSILANE (UNII: LDC331P08E)  
    TRIETHYL CITRATE (UNII: 8Z96QXD6UM)  
    LAURETH-7 (UNII: Z95S6G8201)  
    LINOLEIC ACID (UNII: 9KJL21T0QJ)  
    METHICONE (20 CST) (UNII: 6777U11MKT)  
    STEARYL ALCOHOL (UNII: 2KR89I4H1Y)  
    CETOSTEARYL ALCOHOL (UNII: 2DMT128M1S)  
    SODIUM CHLORIDE (UNII: 451W47IQ8X)  
    POLYSORBATE 80 (UNII: 6OZP39ZG8H)  
    POLYSORBATE 20 (UNII: 7T1F30V5YH)  
    DOCOSANOL (UNII: 9G1OE216XY)  
    GLYCERYL TRIOLEATE (UNII: O05EC62663)  
    BETAINE (UNII: 3SCV180C9W)  
    EDETATE DISODIUM ANHYDROUS (UNII: 8NLQ36F6MM)  
    BUTYLATED HYDROXYTOLUENE (UNII: 1P9D0Z171K)  
    PHENOXYETHANOL (UNII: HIE492ZZ3T)  
    SODIUM DEHYDROACETATE (UNII: 8W46YN971G)  
    POTASSIUM SORBATE (UNII: 1VPU26JZZ4)  
    MICA (UNII: V8A1AW0880)  
    FERRIC OXIDE RED (UNII: 1K09F3G675)  
    FERRIC OXIDE YELLOW (UNII: EX438O2MRT)  
    FERROSOFERRIC OXIDE (UNII: XM0M87F357)  
    TITANIUM DIOXIDE (UNII: 15FIX9V2JP)  
    AMMONIUM POLYACRYLOYLDIMETHYL TAURATE (55000 MPA.S) (UNII: F01RIY4371)  
    SILICON DIOXIDE (UNII: ETJ7Z6XBU4)  
    BARLEY (UNII: 5PWM7YLI7R)  
    TOCOPHEROL (UNII: R0ZB2556P8)  
    PALMITIC ACID (UNII: 2V16EO95H1)  
    STEARIC ACID (UNII: 4ELV7Z65AP)  
    OLEIC ACID (UNII: 2UMI9U37CP)  
    WATER (UNII: 059QF0KO0R)  
    DIMETHICONE (UNII: 92RU3N3Y1O)  
    PHENYL TRIMETHICONE (UNII: DR0K5NOJ4R)  
    BUTYLENE GLYCOL (UNII: 3XUS85K0RA)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    POLYMETHYLSILSESQUIOXANE (4.5 MICRONS) (UNII: 59Z907ZB69)  
    LAURYL PEG-9 POLYDIMETHYLSILOXYETHYL DIMETHICONE (UNII: 25G622K2RA)  
    TROMETHAMINE (UNII: 023C2WHX2V)  
    DIMETHICONE/VINYL DIMETHICONE CROSSPOLYMER (SOFT PARTICLE) (UNII: 9E4CO0W6C5)  
    HEXYL LAURATE (UNII: 4CG9F9W01Q)  
    LIMOSILACTOBACILLUS REUTERI (UNII: 9913I24QEE)  
    CUCUMBER (UNII: YY7C30VXJT)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:11559-058-011 in 1 CARTON10/04/2019
    135 mL in 1 TUBE; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC Monograph DrugM02010/04/2019
    Labeler - ESTEE LAUDER INC (005914387)
    Registrant - Estee Lauder Companies Inc. (790802086)
    Establishment
    NameAddressID/FEIBusiness Operations
    Estee Lauder Cosmetics Ltd.202952982manufacture(11559-058)
    Establishment
    NameAddressID/FEIBusiness Operations
    Estee Lauder Cosmetics Ltd.204132062pack(11559-058) , label(11559-058)
    Establishment
    NameAddressID/FEIBusiness Operations
    LE PAPILLON, LTD.040070823label(11559-058) , pack(11559-058)