Label: CLINIQUE BROAD SPECTRUM SPF 30 OIL FREE FACE WITH SOLAR SMART- octinoxate, octisalate, titanium dioxide, and zinc oxide cream

  • NDC Code(s): 49527-067-01
  • Packager: CLINIQUE LABORATORIES LLC
  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None

Drug Label Information

Updated October 13, 2023

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  • SPL UNCLASSIFIED SECTION

    Drug Facts

  • Active ingredients

    Octinoxate 7.5%
    Octisalate 4.5%
    Titanium dioxide 4.6%
    Zinc oxide 5.0%

  • Purpose

    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" or "generously" 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 • c12-15 alkyl benzoate • caprylyl methicone • neopentyl glycol diheptanoate • sucrose • polyglyceryl-10 pentastearate • pentylene glycol • ethylhexyl methoxycrylene • dimethicone • behenyl alcohol • peg-100 stearate • hydrogenated lecithin • butylene glycol • dipentaerythrityl tri-polyhydroxystearate • cucumis sativus (cucumber) fruit extract • hordeum vulgare (barley) extract\extrait d'orge • sigesbeckia orientalis (st. paul's wort) extract • glycerin • caffeine • sodium rna • sodium hyaluronate • tocopheryl acetate • propylene glycol dicaprate • isohexadecane • helianthus annuus (sunflower) seedcake • pvp/hexadecene copolymer • isostearic acid • sodium stearoyl lactylate • polyhydroxystearic acid • silica • acrylamide/sodium acryloyldimethyltaurate copolymer • xanthan gum • polysorbate 80 • dimethicone silylate • polyethylene • trisodium edta • bht • phenoxyethanol [iln43113]

  • Other information

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

  • PRINCIPAL DISPLAY PANEL - 50 ml Tube Carton

    CLINIQUE

    broad
    spectrum
    SPF 30
    sunscreen
    with
    SolarSmart+
    UVA UVB
    advanced
    protection

    oil-free
    face cream

    1.7 FL. OZ.
    50 ml e

    PRINCIPAL DISPLAY PANEL - 50 ml Tube Carton
  • INGREDIENTS AND APPEARANCE
    CLINIQUE BROAD SPECTRUM SPF 30 OIL FREE FACE WITH SOLAR SMART 
    octinoxate, octisalate, titanium dioxide, and zinc oxide cream
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:49527-067
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    OCTINOXATE (UNII: 4Y5P7MUD51) (OCTINOXATE - UNII:4Y5P7MUD51) OCTINOXATE75 mg  in 1 mL
    OCTISALATE (UNII: 4X49Y0596W) (OCTISALATE - UNII:4X49Y0596W) OCTISALATE45 mg  in 1 mL
    TITANIUM DIOXIDE (UNII: 15FIX9V2JP) (TITANIUM DIOXIDE - UNII:15FIX9V2JP) TITANIUM DIOXIDE46 mg  in 1 mL
    ZINC OXIDE (UNII: SOI2LOH54Z) (ZINC OXIDE - UNII:SOI2LOH54Z) ZINC OXIDE50 mg  in 1 mL
    Inactive Ingredients
    Ingredient NameStrength
    WATER (UNII: 059QF0KO0R)  
    ALKYL (C12-15) BENZOATE (UNII: A9EJ3J61HQ)  
    CAPRYLYL TRISILOXANE (UNII: Q95M2P1KJL)  
    NEOPENTYL GLYCOL DIHEPTANOATE (UNII: 5LKW3C543X)  
    SUCROSE (UNII: C151H8M554)  
    POLYGLYCERYL-10 PENTASTEARATE (UNII: PMX5872701)  
    PENTYLENE GLYCOL (UNII: 50C1307PZG)  
    ETHYLHEXYL METHOXYCRYLENE (UNII: S3KFG6Q5X8)  
    DIMETHICONE (UNII: 92RU3N3Y1O)  
    DOCOSANOL (UNII: 9G1OE216XY)  
    PEG-100 STEARATE (UNII: YD01N1999R)  
    HYDROGENATED SOYBEAN LECITHIN (UNII: H1109Z9J4N)  
    BUTYLENE GLYCOL (UNII: 3XUS85K0RA)  
    DIPENTAERYTHRITYL TRI-POLYHYDROXYSTEARATE (UNII: D21K655H52)  
    CUCUMBER (UNII: YY7C30VXJT)  
    BARLEY (UNII: 5PWM7YLI7R)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    CAFFEINE (UNII: 3G6A5W338E)  
    HYALURONATE SODIUM (UNII: YSE9PPT4TH)  
    PROPYLENE GLYCOL DICAPRATE (UNII: U783H9JHWY)  
    ISOHEXADECANE (UNII: 918X1OUF1E)  
    HELIANTHUS ANNUUS SEEDCAKE (UNII: 482WYF7XLC)  
    ISOSTEARIC ACID (UNII: X33R8U0062)  
    SODIUM STEAROYL LACTYLATE (UNII: IN99IT31LN)  
    SILICON DIOXIDE (UNII: ETJ7Z6XBU4)  
    XANTHAN GUM (UNII: TTV12P4NEE)  
    POLYSORBATE 80 (UNII: 6OZP39ZG8H)  
    HIGH DENSITY POLYETHYLENE (UNII: UG00KM4WR7)  
    EDETATE TRISODIUM (UNII: 420IP921MB)  
    BUTYLATED HYDROXYTOLUENE (UNII: 1P9D0Z171K)  
    PHENOXYETHANOL (UNII: HIE492ZZ3T)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:49527-067-011 in 1 CARTON01/01/2017
    150 mL in 1 TUBE; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC Monograph DrugM02001/01/2017
    Labeler - CLINIQUE LABORATORIES LLC (044475127)
    Registrant - Estee Lauder Companies Inc. (790802086)
    Establishment
    NameAddressID/FEIBusiness Operations
    Estee Lauder N.V.370151326manufacture(49527-067) , pack(49527-067) , label(49527-067)
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