Label: CLINIQUE TARGETED PROTECTION SPF 45 BROAD SPECTRUM SUNSCREEN- homosalate, octisalate, and avobenzone stick

  • NDC Code(s): 49527-041-01
  • Packager: CLINIQUE LABORATORIES LLC
  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None
  • Marketing Status: OTC monograph final

DISCLAIMER: Most OTC drugs are not reviewed and approved by FDA, however they may be marketed if they comply with applicable regulations and policies. FDA has not evaluated whether this product complies.

Drug Label Information

Updated July 28, 2023

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  • SPL UNCLASSIFIED SECTION

    Drug Facts

  • Active ingredients

    Avobenzone 3.0%
    Homosalate 5.0%
    Octisalate 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

    microcrystalline wax\cera microcristallina\cire microcristalline • jojoba esters • phenyl trimethicone • simmondsia chinensis (jojoba) butter • cetyl ricinoleate • butyloctyl salicylate • polyester-8 • beeswax\cera alba\cire d'abeille • polyethylene • tocopheryl acetate • vp/eicosene copolymer • tocopherol [iln35001]

  • Other information

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

  • PRINCIPAL DISPLAY PANEL - 6 g Cylinder Carton

    CLINIQUE

    broad
    spectrum
    SPF 45
    sunscreen

    UVA | UVB
    PROTECTION

    targeted
    protection
    stick

    NET WT. .21 OZ.
    6g e

    Principal Display Panel - 6 g Cylinder Carton
  • INGREDIENTS AND APPEARANCE
    CLINIQUE TARGETED PROTECTION SPF 45 BROAD SPECTRUM SUNSCREEN 
    homosalate, octisalate, and avobenzone stick
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:49527-041
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    HOMOSALATE (UNII: V06SV4M95S) (HOMOSALATE - UNII:V06SV4M95S) HOMOSALATE5 g  in 100 g
    OCTISALATE (UNII: 4X49Y0596W) (OCTISALATE - UNII:4X49Y0596W) OCTISALATE5 g  in 100 g
    AVOBENZONE (UNII: G63QQF2NOX) (AVOBENZONE - UNII:G63QQF2NOX) AVOBENZONE3 g  in 100 g
    Inactive Ingredients
    Ingredient NameStrength
    MICROCRYSTALLINE WAX (UNII: XOF597Q3KY)  
    PHENYL TRIMETHICONE (UNII: DR0K5NOJ4R)  
    JOJOBA BUTTER (UNII: XIA46H803R)  
    CETYL RICINOLEATE (UNII: 1P677500YD)  
    BUTYLOCTYL SALICYLATE (UNII: 2EH13UN8D3)  
    YELLOW WAX (UNII: 2ZA36H0S2V)  
    HIGH DENSITY POLYETHYLENE (UNII: UG00KM4WR7)  
    .ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)  
    TOCOPHEROL (UNII: R0ZB2556P8)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:49527-041-011 in 1 CARTON12/01/2008
    16 g in 1 CYLINDER; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph finalM02012/01/2008
    Labeler - CLINIQUE LABORATORIES LLC (044475127)
    Registrant - Estee Lauder Companies Inc. (790802086)
    Establishment
    NameAddressID/FEIBusiness Operations
    Estee Lauder Cosmetics Ltd.202952982manufacture(49527-041)
    Establishment
    NameAddressID/FEIBusiness Operations
    Estee Lauder Cosmetics Ltd.204132062pack(49527-041) , label(49527-041)
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