Label: PAULAS CHOICE LIPSCREEN SPF 50- homosalate, octisalate, avobenzone, octocrylene lipstick

  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None
  • Marketing Status: OTC monograph not 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 January 6, 2022

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  • ACTIVE INGREDIENT

    Homosalate 5.0%, Octisalate 5.0%, Avobenzone 3.0%, Octocrylene 2.5%

  • INDICATIONS & USAGE

    Helps prevent sunburn. Decreases the risk of skin cancer and early skin aging caused by the sun if used as directed with other sun protection measures.

  • WARNINGS

    For external use only. do not use on damaged or broken skin.

  • STOP USE

    Stop use if rash occurs.

  • ASK DOCTOR

    Ask a doctor if rash occurs.

  • KEEP OUT OF REACH OF CHILDREN

    Keep out of reach of children. If product is swallowed, get medical help or contact a Poison Control Center immediately.

  • INACTIVE INGREDIENT

    Hydrogenated Soybean Oil, Bis-Diglyceryl Poluacyladipate-2, Hydrogenated Olive Oil, Polyglyceryl-3 Diisostearate, Beeswax, Ozokerite, Hydrogenated Jojoba Oil, Polyethylene, Hydrogenated Polycyclopentadiena, Microcrystalline Wax, Theobrome Cacao (Cocoa) Seed Butter, Silica, Tocopheryl Acetate, Phytosterols, Olea Europaea (Olive) Fruite Oil, Hydrogenated Vegetable Oil, Copernicia Cerifera (Caranauba) Wax, Water (Aqua), Phenoxyethanol.

  • PRINCIPAL DISPLAY PANEL

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  • INGREDIENTS AND APPEARANCE
    PAULAS CHOICE LIPSCREEN SPF 50 
    homosalate, octisalate, avobenzone, octocrylene lipstick
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:76144-256
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    HOMOSALATE (UNII: V06SV4M95S) (HOMOSALATE - UNII:V06SV4M95S) HOMOSALATE50 mg  in 1 mL
    OCTISALATE (UNII: 4X49Y0596W) (OCTISALATE - UNII:4X49Y0596W) OCTISALATE50 mg  in 1 mL
    AVOBENZONE (UNII: G63QQF2NOX) (AVOBENZONE - UNII:G63QQF2NOX) AVOBENZONE30 mg  in 1 mL
    OCTOCRYLENE (UNII: 5A68WGF6WM) (OCTOCRYLENE - UNII:5A68WGF6WM) OCTOCRYLENE25 mg  in 1 mL
    Inactive Ingredients
    Ingredient NameStrength
    WATER (UNII: 059QF0KO0R)  
    HYDROGENATED SOYBEAN OIL (UNII: A2M91M918C)  
    HYDROGENATED OLIVE OIL (UNII: 53839415GI)  
    POLYGLYCERYL-3 DIISOSTEARATE (UNII: 46P231IQV8)  
    YELLOW WAX (UNII: 2ZA36H0S2V)  
    CERESIN (UNII: Q1LS2UJO3A)  
    MICROCRYSTALLINE WAX (UNII: XOF597Q3KY)  
    HYDROGENATED JOJOBA OIL, RANDOMIZED (UNII: Q47ST02F58)  
    HIGH DENSITY POLYETHYLENE (UNII: UG00KM4WR7)  
    COCOA BUTTER (UNII: 512OYT1CRR)  
    SILICON DIOXIDE (UNII: ETJ7Z6XBU4)  
    .ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)  
    SHEANUT OIL (UNII: O88E196QRF)  
    TOCOPHEROL (UNII: R0ZB2556P8)  
    OLIVE OIL (UNII: 6UYK2W1W1E)  
    CARNAUBA WAX (UNII: R12CBM0EIZ)  
    PHENOXYETHANOL (UNII: HIE492ZZ3T)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:76144-256-014.15393 mL in 1 TUBE; Type 0: Not a Combination Product10/03/2014
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph not finalpart35210/03/2014
    Labeler - Paula's Choice, LLC (029583981)
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