Label: VACATION CHARDONNAY BROAD SPECTRUM SPF 30 SUNSCREEN- avobenzone, homosalate, octisalate, and octocrylene oil

  • NDC Code(s): 80641-003-01, 80641-003-02
  • Packager: Vacation Inc.
  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None

Drug Label Information

Updated January 10, 2024

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  • SPL UNCLASSIFIED SECTION

    Drug Facts

  • Active ingredients

    Avobenzone (3%), Homosalate (10%), Octisalate (5%), Octocrylene (10%)

    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 at least every 2 hours
    • Use a water-resistant sunscreen if swimming or sweating.
    • 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

    Bisabolol, Butyloctyl Salicylate, Butyrospermum Parkii (Shea) Oil, C12-15 Alkyl Benzoate, Caprylic/ Capric Triglyceride, Fragrance, Methyl Dihydroabietate, Octyldodecanol, Passiflora Edulis (Passionfruit) Seed Oil, Phenoxyethanol, Sclerocarya Birrea (Marula) Seed Oil, Simmondsia Chinensis (Jojoba) Seed Oil, Tocopherol (Vitamin E), Vitis Vinifera (Chardonnay Grape) Seed Oil, VP/Hexadecene Copolymer

  • 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 Bottle Label

    Vacation®

    Chardonnay Oil
    BROAD SPECTRUM SPF 30 SUNSCREEN OIL

    Chardonnay Seed Sunscreen Oil
    by The Eternal Vacation® of Miami
    "Clean, Lightweight & Refreshing"
    "For an Enviable Shine"

    SPF 30

    3.4 FL OZ / 100 ML

    PRINCIPAL DISPLAY PANEL - 100 ML Bottle Label
  • INGREDIENTS AND APPEARANCE
    VACATION CHARDONNAY BROAD SPECTRUM SPF 30 SUNSCREEN 
    avobenzone, homosalate, octisalate, and octocrylene oil
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:80641-003
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    Avobenzone (UNII: G63QQF2NOX) (Avobenzone - UNII:G63QQF2NOX) Avobenzone3 g  in 100 mL
    Homosalate (UNII: V06SV4M95S) (Homosalate - UNII:V06SV4M95S) Homosalate10 g  in 100 mL
    Octisalate (UNII: 4X49Y0596W) (Octisalate - UNII:4X49Y0596W) Octisalate5 g  in 100 mL
    Octocrylene (UNII: 5A68WGF6WM) (Octocrylene - UNII:5A68WGF6WM) Octocrylene10 g  in 100 mL
    Inactive Ingredients
    Ingredient NameStrength
    Levomenol (UNII: 24WE03BX2T)  
    Butyloctyl Salicylate (UNII: 2EH13UN8D3)  
    Sheanut Oil (UNII: O88E196QRF)  
    ALKYL (C12-15) BENZOATE (UNII: A9EJ3J61HQ)  
    MEDIUM-CHAIN TRIGLYCERIDES (UNII: C9H2L21V7U)  
    Methyl Dihydroabietate (UNII: 7666FJ0J9F)  
    Octyldodecanol (UNII: 461N1O614Y)  
    Passiflora Edulis Seed Oil (UNII: F3VOA31UHQ)  
    Phenoxyethanol (UNII: HIE492ZZ3T)  
    SCLEROCARYA BIRREA SEED OIL (UNII: WDO4TLS35F)  
    Jojoba Oil (UNII: 724GKU717M)  
    .ALPHA.-TOCOPHEROL (UNII: H4N855PNZ1)  
    Vinylpyrrolidone/Hexadecene Copolymer (UNII: KFR5QEN0N9)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:80641-003-01100 mL in 1 BOTTLE; Type 0: Not a Combination Product05/19/2021
    2NDC:80641-003-027 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 drugM02005/19/2021
    Labeler - Vacation Inc. (117644631)
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