Label: VACATION SPF 50 SUPER SPRITZ FACE MIST- avobenzone, octisalate, octocrylene spray

  • NDC Code(s): 80641-010-01, 80641-010-03
  • Packager: Vacation Inc.
  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None

Drug Label Information

Updated March 6, 2024

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

  • ACTIVE INGREDIENT

    Avobenzone (2.9%)

    Homosalate (4.9%)

    Octocrylene (9.5%)

  • 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

    Flammable. Do not spray near heat, sparks, sources of ignition, or flames.
    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

    Keep out of reach of children. In case of ingestion, get medical help or contact a Poison Control Center right away.

  • Directions

    • Hold spray 8-10 inches from face with eyes and mouth closed before using

    • 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 INGREDIENT

    Alcohol, Aloe Barbadensis (Aloe Vera) Leaf Extract, Bisabolol, Butyloctyl Salicylate, Butyrospermum Parkii (Shea) Oil, Caffeine, Camellia Sinensis (Green Tea) Leaf Extract, Carthamus Tinctorius (Safflower) Seed Oil, Chlorella Vulgaris Extract, Cocos Nucifera (Coconut) Extract, Cucumis Sativus (Cucumber) Seed Oil, Diisooctyl Succinate, Ethyl Ferulate, Ethylhexyl Methoxycrylene, Fragrance, Musa Sapientum (Banana) Fruit Extract, Passiflora Edulis Seed Oil, Polyester-8, Tocopherol (Vitamin E), VA/Butyl Maleate/Isobornyl Acrylate Copolymer, Water

  • OTHER SAFETY INFORMATION

    Protect this product from excessive heat and direct sun.

  • PRINCIPAL DISPLAY PANEL

    1

  • INGREDIENTS AND APPEARANCE
    VACATION SPF 50 SUPER SPRITZ FACE MIST 
    avobenzone, octisalate, octocrylene spray
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:80641-010
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    OCTOCRYLENE (UNII: 5A68WGF6WM) (OCTOCRYLENE - UNII:5A68WGF6WM) OCTOCRYLENE9.5 g  in 100 mL
    OCTISALATE (UNII: 4X49Y0596W) (OCTISALATE - UNII:4X49Y0596W) OCTISALATE4.9 g  in 100 mL
    AVOBENZONE (UNII: G63QQF2NOX) (AVOBENZONE - UNII:G63QQF2NOX) AVOBENZONE2.9 g  in 100 mL
    Inactive Ingredients
    Ingredient NameStrength
    SUCCINIC ACID (UNII: AB6MNQ6J6L)  
    ETHYL FERULATE (UNII: 5B8915UELW)  
    VINYL ACETATE (UNII: L9MK238N77)  
    WATER (UNII: 059QF0KO0R)  
    POLYESTER-8 (1400 MW, CYANODIPHENYLPROPENOYL CAPPED) (UNII: T9296U138P)  
    SHEANUT OIL (UNII: O88E196QRF)  
    CAFFEINE (UNII: 3G6A5W338E)  
    ISOBORNYL ACRYLATE (UNII: IX0PRH184P)  
    GREEN TEA LEAF (UNII: W2ZU1RY8B0)  
    CUCUMBER SEED OIL (UNII: AKP926H71P)  
    COCONUT (UNII: 3RT3536DHY)  
    TOCOPHEROL (UNII: R0ZB2556P8)  
    DIBUTYL MALEATE (UNII: 4X371TMK9K)  
    LEVOMENOL (UNII: 24WE03BX2T)  
    BUTYLOCTYL SALICYLATE (UNII: 2EH13UN8D3)  
    ALCOHOL (UNII: 3K9958V90M)  
    ALOE VERA LEAF (UNII: ZY81Z83H0X)  
    SAFFLOWER OIL (UNII: 65UEH262IS)  
    CHLORELLA VULGARIS (UNII: RYQ4R60M02)  
    ETHYLHEXYL METHOXYCRYLENE (UNII: S3KFG6Q5X8)  
    BANANA (UNII: 4AJZ4765R9)  
    PASSIFLORA EDULIS SEED OIL (UNII: F3VOA31UHQ)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:80641-010-0165 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product02/01/2023
    2NDC:80641-010-0330 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product02/01/2023
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC Monograph DrugM02002/01/2023
    Labeler - Vacation Inc. (117644631)