Label: CLINIQUE BROAD SPECTRUM SPF 50 SUNSCREEN BODY WITH SOLAR SMART- avobenzone, homosalate, octisalate, octocrylene, and oxybenzone cream

  • NDC Code(s): 49527-069-01
  • Packager: CLINIQUE LABORATORIES LLC
  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None

Drug Label Information

Updated October 13, 2023

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

  • SPL UNCLASSIFIED SECTION

    Drug Facts

  • Active ingredients

    Avobenzone 3.0%
    Homosalate 5.0%
    Octisalate 5.0%
    Octocrylene 2.7%
    Oxybenzone 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 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 • butylene glycol • butyloctyl salicylate • neopentyl glycol diheptanoate • butyrospermum parkii (shea butter) • peg-100 stearate • silica • dipentaerythrityl tri-polyhydroxystearate • lauryl peg-9 polydimethylsiloxyethyl dimethicone • dimethicone • glyceryl stearate • laurdimonium hydroxypropyl hydrolyzed soy protein • rosmarinus officinalis (rosemary) extract • perilla ocymoides leaf extract • caffeine • potassium cetyl phosphate • sucrose • styrene/acrylates copolymer • c30-38 olefin/isopropyl maleate/ma copolymer • cetyl alcohol • vp/eicosene copolymer • ethylhexylglycerin • ammonium acryloyldimethyltaurate/vp copolymer • peg-8 laurate • sodium rna • lecithin • arginine ferulate • tocopheryl acetate • caprylyl glycol • propyl gallate • ascorbyl tocopheryl maleate • stearic acid • xanthan gum • hexylene glycol • nordihydroguaiaretic acid • disodium edta • phenoxyethanol • mica • sodium dehydroacetate [iln37121]

  • Other information

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

  • PRINCIPAL DISPLAY PANEL - 150 ml Tube Carton

    CLINIQUE

    broad
    spectrum
    SPF 50
    sunscreen
    with
    SolarSmart

    UVA UVB
    PROTECTION

    body cream

    5 FL. OZ.
    150 ml e

    PRINCIPAL DISPLAY PANEL - 150 ml Tube Carton
  • INGREDIENTS AND APPEARANCE
    CLINIQUE BROAD SPECTRUM SPF 50 SUNSCREEN BODY WITH SOLAR SMART 
    avobenzone, homosalate, octisalate, octocrylene, and oxybenzone cream
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:49527-069
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    AVOBENZONE (UNII: G63QQF2NOX) (AVOBENZONE - UNII:G63QQF2NOX) AVOBENZONE30 mg  in 1 mL
    HOMOSALATE (UNII: V06SV4M95S) (HOMOSALATE - UNII:V06SV4M95S) HOMOSALATE50 mg  in 1 mL
    OCTISALATE (UNII: 4X49Y0596W) (OCTISALATE - UNII:4X49Y0596W) OCTISALATE50 mg  in 1 mL
    OCTOCRYLENE (UNII: 5A68WGF6WM) (OCTOCRYLENE - UNII:5A68WGF6WM) OCTOCRYLENE27 mg  in 1 mL
    OXYBENZONE (UNII: 95OOS7VE0Y) (OXYBENZONE - UNII:95OOS7VE0Y) OXYBENZONE50 mg  in 1 mL
    Inactive Ingredients
    Ingredient NameStrength
    ASCORBYL TOCOPHERYL MALEATE (UNII: D2G6259XR5)  
    STEARIC ACID (UNII: 4ELV7Z65AP)  
    XANTHAN GUM (UNII: TTV12P4NEE)  
    HEXYLENE GLYCOL (UNII: KEH0A3F75J)  
    EDETATE DISODIUM ANHYDROUS (UNII: 8NLQ36F6MM)  
    PHENOXYETHANOL (UNII: HIE492ZZ3T)  
    MICA (UNII: V8A1AW0880)  
    SODIUM DEHYDROACETATE (UNII: 8W46YN971G)  
    WATER (UNII: 059QF0KO0R)  
    METHYL TRIMETHICONE (UNII: S73ZQI0GXM)  
    BUTYLENE GLYCOL (UNII: 3XUS85K0RA)  
    BUTYLOCTYL SALICYLATE (UNII: 2EH13UN8D3)  
    NEOPENTYL GLYCOL DIHEPTANOATE (UNII: 5LKW3C543X)  
    SHEA BUTTER (UNII: K49155WL9Y)  
    PEG-100 STEARATE (UNII: YD01N1999R)  
    SILICON DIOXIDE (UNII: ETJ7Z6XBU4)  
    DIPENTAERYTHRITYL TRI-POLYHYDROXYSTEARATE (UNII: D21K655H52)  
    LAURYL PEG-9 POLYDIMETHYLSILOXYETHYL DIMETHICONE (UNII: 25G622K2RA)  
    DIMETHICONE (UNII: 92RU3N3Y1O)  
    GLYCERYL MONOSTEARATE (UNII: 230OU9XXE4)  
    ROSEMARY (UNII: IJ67X351P9)  
    CAFFEINE (UNII: 3G6A5W338E)  
    POTASSIUM CETYL PHOSPHATE (UNII: 03KCY6P7UT)  
    SUCROSE (UNII: C151H8M554)  
    CETYL ALCOHOL (UNII: 936JST6JCN)  
    ETHYLHEXYLGLYCERIN (UNII: 147D247K3P)  
    AMMONIUM ACRYLOYLDIMETHYLTAURATE/VP COPOLYMER (UNII: W59H9296ZG)  
    PEG-8 LAURATE (UNII: 762O8IWA10)  
    ARGININE FERULATE (UNII: 0774Y45BEE)  
    CAPRYLYL GLYCOL (UNII: 00YIU5438U)  
    PROPYL GALLATE (UNII: 8D4SNN7V92)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:49527-069-011 in 1 CARTON06/01/2011
    1150 mL in 1 TUBE; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC Monograph DrugM02006/01/2011
    Labeler - CLINIQUE LABORATORIES LLC (044475127)
    Registrant - Estee Lauder Companies Inc. (790802086)
    Establishment
    NameAddressID/FEIBusiness Operations
    The Estee Lauder Inc802599436manufacture(49527-069) , pack(49527-069) , label(49527-069)