Label: VACATION CLASSIC BROAD SPECTRUM SPF 30 SUNSCREEN- avobenzone, homosalate, octisalate, and octocrylene lotion

  • NDC Code(s): 80641-001-01, 80641-001-02, 80641-001-03
  • Packager: Vacation Inc.
  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None

Drug Label Information

Updated March 5, 2024

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  • SPL UNCLASSIFIED SECTION

    Drug Facts

  • Active ingredients

    Avobenzone (2.5%), Homosalate (10%), Octisalate (5%), Octocrylene (8%)

  • Purpose

    Sunscreen

  • 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
  • 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. In case of ingestion, get medical help or contact a Poison Control Center right away.

  • Directions

    • Apply liberally 15 minutes before sun exposure.
    • Reapply:
      • after 80 minutes of swimming or sweating
      • immediately after towel drying
      • at least every 2 hours
    • Sun Protection Measures. Spending time in the sun increases your risk of skin cancer and early skin aging. To decrease the risk, regularly use a sunscreen with a broad spectrum SPF 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-sleeve shirts, pants, hats, and sunglasses
      • children under 6 months of age: ask a physician.
  • Inactive ingredients

    Aloe Barbadensis (Aloe Vera) Leaf Juice, Butyrospermum Parkii (Shea) Butter, Cetearyl Alcohol, Cocos Nucifera (Coconut) Oil, Dimethicone, Ethylhexyl Cocoate, Ethylhexyl Palmitate, Ethylhexylglycerin, Fragrance, Glycerin, Musa Sapientum (Banana) Fruit Extract, Niacinamide (Vitamin B3), Phenoxyethanol, Polyurethane-35, Silica, Sodium Hyaluronate, Sodium Phytate, Sodium Polyacrylate, Sodium Stearoyl Glutamate, Tocopheryl (Vitamin E) Acetate, Water

  • Other information

    • Protect this product from excessive heat and direct sun
  • SPL UNCLASSIFIED SECTION

    Distributed by
    Vacation Inc.
    936 SW 1st Ave #888
    Miami, FL 33130

  • PRINCIPAL DISPLAY PANEL - 100 ML Tube Label

    Vacation®

    Classic Lotion
    BROAD SPECTRUM SPF 30 SUNSCREEN

    By the "Legendary" Vacation® of Miami—
    "Leisure-Enhancing" & "Excessively Good"
    Sunscreen for "Long Days by the Pool"
    Water-Resistant (80 Minutes)
    "The Scent of Summer"

    SPF 30

    3.4 FL OZ / 100 ML

    PRINCIPAL DISPLAY PANEL - 100 ML Tube Label
  • INGREDIENTS AND APPEARANCE
    VACATION CLASSIC BROAD SPECTRUM SPF 30 SUNSCREEN 
    avobenzone, homosalate, octisalate, and octocrylene lotion
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:80641-001
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    Avobenzone (UNII: G63QQF2NOX) (Avobenzone - UNII:G63QQF2NOX) Avobenzone25 mg  in 1 mL
    Homosalate (UNII: V06SV4M95S) (Homosalate - UNII:V06SV4M95S) Homosalate100 mg  in 1 mL
    Octisalate (UNII: 4X49Y0596W) (Octisalate - UNII:4X49Y0596W) Octisalate50 mg  in 1 mL
    Octocrylene (UNII: 5A68WGF6WM) (Octocrylene - UNII:5A68WGF6WM) Octocrylene80 mg  in 1 mL
    Inactive Ingredients
    Ingredient NameStrength
    Aloe Vera Leaf (UNII: ZY81Z83H0X)  
    Shea Butter (UNII: K49155WL9Y)  
    Cetostearyl Alcohol (UNII: 2DMT128M1S)  
    Coconut Oil (UNII: Q9L0O73W7L)  
    Dimethicone (UNII: 92RU3N3Y1O)  
    Ethylhexyl Cocoate (UNII: I1MPW273QS)  
    Ethylhexyl Palmitate (UNII: 2865993309)  
    Ethylhexylglycerin (UNII: 147D247K3P)  
    Glycerin (UNII: PDC6A3C0OX)  
    Banana (UNII: 4AJZ4765R9)  
    Niacin (UNII: 2679MF687A)  
    Phenoxyethanol (UNII: HIE492ZZ3T)  
    Silicon Dioxide (UNII: ETJ7Z6XBU4)  
    Hyaluronate Sodium (UNII: YSE9PPT4TH)  
    Phytate Sodium (UNII: 88496G1ERL)  
    Sodium Stearoyl Glutamate (UNII: 65A9F4P024)  
    .Alpha.-Tocopherol (UNII: H4N855PNZ1)  
    Water (UNII: 059QF0KO0R)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:80641-001-01100 mL in 1 TUBE; Type 0: Not a Combination Product04/15/2021
    2NDC:80641-001-0230 mL in 1 TUBE; Type 0: Not a Combination Product04/06/2022
    3NDC:80641-001-037 mL in 1 PACKET; Type 0: Not a Combination Product04/06/2022
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph drugM02004/15/2021
    Labeler - Vacation Inc. (117644631)
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