Label: TAN-LUXE SUPER GLOSS SPF 30 ILLUMINATING BRONZING DROPS- avobenzone, homosalate, octisalate, octocylene liquid

  • NDC Code(s): 84782-271-01, 84782-271-02
  • Packager: Paris Presents Incorporated
  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None

Drug Label Information

Updated October 2, 2024

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

  • Directions

    Shake well
    Apply generously and evenly 15 minutes before sun exposure
    Use a water resistant sunscreen if swimming or sweating
    Reapply at least every 2 hours
    Children under 6 months of age: ask a doctor

  • 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.

  • Inactive Ingredients

    C13-15 Alkane, Isododecane, Cetyl Ethylhexanoate, Isosorbide Dicaprylate, Ethyl Macadamiate, Dextrin Palmitate, Polyester-7, Mica, Argania Spinosa Kernel Oil, Tocopheryl Acetate, Polymethylsilsesquioxane, Neopentyl Glycol Diheptanoate, Squalane, Caprylic/Capric Triglyceride, Dextrin Palmitate/Hexyldecanoate, Methyl Methacrylate Crosspolymer, Hyaluronic Acid, Tocopherol, Phenoxyethanol, Bisabolol, Citrus Aurantium Bergamia (Bergamot) Fruit Oil, Polyglyceryl-10 Laurate, Glycerin, Water (Aqua), Polyglyceryl-10 Myristate, Isochrysis Galbana Extract, Iron Oxides (CI 77491), Iron Oxides (CI 77499), Titanium Dioxide (CI 77891).

  • Uses

    Helps prevent sunburn
    If used as directed with other sun protection measures (see Directions), decreases the risk of skin cancer and early skin aging caused by the sun

  • Keep out of reach of children

    Keep out of reach of children. If swallowed, get medical help or contact Poison Control Center right away.

  • Purpose

    Sunscreen

  • Active Ingredients

    Avobenzone 3.0%, Homosalate 3.6%, Octisalate 5.0%, Octocrylene 8.0%

  • Image Reference

    Outer Box ArtworkSee Figure 1 (Image identifier: Product Image ) for a visual representation of the product.

  • INGREDIENTS AND APPEARANCE
    TAN-LUXE SUPER GLOSS SPF 30 ILLUMINATING BRONZING DROPS 
    avobenzone, homosalate, octisalate, octocylene liquid
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:84782-271
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    HOMOSALATE (UNII: V06SV4M95S) (HOMOSALATE - UNII:V06SV4M95S) HOMOSALATE36 mg  in 1 mL
    OCTOCRYLENE (UNII: 5A68WGF6WM) (OCTOCRYLENE - UNII:5A68WGF6WM) OCTOCRYLENE80 mg  in 1 mL
    AVOBENZONE (UNII: G63QQF2NOX) (AVOBENZONE - UNII:G63QQF2NOX) AVOBENZONE30 mg  in 1 mL
    OCTISALATE (UNII: 4X49Y0596W) (OCTISALATE - UNII:4X49Y0596W) OCTISALATE50 mg  in 1 mL
    Inactive Ingredients
    Ingredient NameStrength
    TOCOPHEROL (UNII: R0ZB2556P8)  
    PHENOXYETHANOL (UNII: HIE492ZZ3T)  
    WATER (UNII: 059QF0KO0R)  
    ISOCHRYSIS GALBANA WHOLE (UNII: H22FH39EGN)  
    FERRIC OXIDE RED (UNII: 1K09F3G675)  
    FERROSOFERRIC OXIDE (UNII: XM0M87F357)  
    TITANIUM DIOXIDE (UNII: 15FIX9V2JP)  
    HYALURONIC ACID (UNII: S270N0TRQY)  
    LEVOMENOL (UNII: 24WE03BX2T)  
    CETYL ETHYLHEXANOATE (UNII: 134647WMX4)  
    ISODODECANE (UNII: A8289P68Y2)  
    MICA (UNII: V8A1AW0880)  
    ISOSORBIDE DICAPRYLATE (UNII: 0IK29C4889)  
    DEXTRIN PALMITATE (CORN; 20000 MW) (UNII: 89B2BSF9I3)  
    ARGAN OIL (UNII: 4V59G5UW9X)  
    .ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)  
    NEOPENTYL GLYCOL DIHEPTANOATE (UNII: 5LKW3C543X)  
    MEDIUM-CHAIN TRIGLYCERIDES (UNII: C9H2L21V7U)  
    POLYESTER-7 (UNII: 0841698D2F)  
    POLYMETHYLSILSESQUIOXANE (4.5 MICRONS) (UNII: 59Z907ZB69)  
    SQUALANE (UNII: GW89575KF9)  
    ETHYL MACADAMIATE (UNII: ANA2NCS6V1)  
    C13-15 ALKANE (UNII: 114P5I43UJ)  
    BERGAMOT OIL (UNII: 39W1PKE3JI)  
    POLYGLYCERYL-10 LAURATE (UNII: MPJ2Q8WI8G)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    POLYGLYCERYL-10 MYRISTATE (UNII: Y9WL8QN3ZB)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:84782-271-0130 mL in 1 BOTTLE, DROPPER; Type 0: Not a Combination Product10/02/2024
    2NDC:84782-271-0230 mL in 1 CARTON; Type 0: Not a Combination Product10/02/2024
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC Monograph DrugM02010/02/2024
    Labeler - Paris Presents Incorporated (005439773)
    Establishment
    NameAddressID/FEIBusiness Operations
    Englewood LAB172198223manufacture(84782-271)
    Establishment
    NameAddressID/FEIBusiness Operations
    Paris Presents Incorporated005439773label(84782-271)