Label: DROPS- avobenzone octisalate octocrylene liquid

  • NDC Code(s): 80641-013-80, 80641-013-94
  • Packager: Vacation Inc.
  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None

Drug Label Information

Updated March 13, 2024

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  • Dosage and administration

    Shake well

    Apply liberally 15 minutes before sun exposure

    Reapply at least every 2 hours

    Use a water resistant sunscreen if swimming or sweating

  • Warning

    For external use only

    Do not use on damaged or broken skin

    When using this product, keep out of eyes. Rinsed with water to remove.

    Stop use and ask a doctor is rash occurs

  • Inactives

    Butyloctyl Salicylate, C13-14 Alkane, Calcium Sodium Borosilicate, Caprylhydroxamic Acid, Caprylyl Glycol, Carbomer, Cellulose Gum, Ceramide AP, Ceramide EOP, Ceramide NP, Cetearyl Alcohol, Chlorella Vulgaris Extract, Cholesterol, Coco-Glucoside, Coffea Arabica (Coffee) Seed Extract , Corylus Avellana (Hazel) Seed Oil, Ethyl Ferulate, Ferulic Acid, Fragrance, Glycerin, Glyceryl Stearate, Helianthus Annuus (Sunflower) Seed Oil, Hyaluronic Acid, Iron Oxides, Mica, Microcrystalline Cellulose, Niacinamide

    Octyldodecyl Oleate, Phytosphingosine, Propanediol, Sodium Benzoate, Sodium Gluconate, Sodium Lauroyl Lactylate

    Sodium Stearoyl Glutamate, sr-Hydrozoan Polypeptide-1, Theobroma Cacao (Cocoa) Extract, Titanium Dioxide, Tocopherol, Tridecane

    Trimethylpentanediol/Adipic Acid/Glycerin Crosspolymer, Undecane, Water, Xanthan Gum

  • Indications and Usage

    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

  • Purpose

    Sunscreen

  • Vacation Studio Tone Bronzing Drops

    Bronzing Drops

  • INGREDIENTS AND APPEARANCE
    DROPS 
    avobenzone octisalate octocrylene liquid
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:80641-013
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    AVOBENZONE (UNII: G63QQF2NOX) (AVOBENZONE - UNII:G63QQF2NOX) AVOBENZONE2.9 g  in 100 mL
    OCTISALATE (UNII: 4X49Y0596W) (OCTISALATE - UNII:4X49Y0596W) OCTISALATE4.9 g  in 100 mL
    OCTOCRYLENE (UNII: 5A68WGF6WM) (OCTOCRYLENE - UNII:5A68WGF6WM) OCTOCRYLENE7.6 g  in 100 mL
    Inactive Ingredients
    Ingredient NameStrength
    BUTYLOCTYL SALICYLATE (UNII: 2EH13UN8D3)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:80641-013-9430 mL in 1 BOTTLE, DROPPER; Type 0: Not a Combination Product03/07/2024
    2NDC:80641-013-8030 mL in 1 BOTTLE, DROPPER; Type 0: Not a Combination Product03/07/2024
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC Monograph DrugM02003/07/2024
    Labeler - Vacation Inc. (117644631)
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