Label: VACATION LIP TRIPS DESSERTS- avobenzone, homosalate, octisalate, and octocrylene kit

  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None
  • Marketing Status: OTC monograph final

DISCLAIMER: Most OTC drugs are not reviewed and approved by FDA, however they may be marketed if they comply with applicable regulations and policies. FDA has not evaluated whether this product complies.

Drug Label Information

Updated January 5, 2022

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  • SPL UNCLASSIFIED SECTION

    Drug Facts

  • Active ingredients

    Avobenzone (3%), Homosalate (5%), Octisalate (3%), 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: 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.
  • Other information

    • Protect this product from excessive heat and direct sun
  • Inactive ingredients

    Aloe Barbadensis (Aloe Vera) Leaf Extract, Butyloctyl Salicylate, C18-38 Alkyl Hydroxystearoyl Stearate, Canola Oil, Cocos Nucifera (Coconut) Oil, Euphorbia Cerifera (Candelilla) Wax, Flavor, Glycine Soja (Soybean) Oil, Helianthus Annuus (Sunflower) Seed Wax, Olea Europaea (Olive) Fruit Oil, Ricinus Communis (Castor) Seed Oil, Rosmarinus Officinalis (Rosemary) Leaf Extract, Simmondsia Chinensis (Jojoba) Seed Oil, Stevia Rebaudiana Leaf Extract, Sunflower Seed Oil Glycerides, Theobroma Cacao (Cocoa) Seed Butter, Tocopherol (Vitamin E), Tocopheryl Acetate

  • SPL UNCLASSIFIED SECTION

    Distributed by Vacation Inc.

  • PRINCIPAL DISPLAY PANEL - Kit Carton

    5 TUBE COLLECTER'S SET

    VACATION®
    LIP TRIPS:

    Desserts

    SPF 30 SUNSCREEN LIP BALM

    BROAD SPECTRUM SPF 30 | VEGAN & CRUELTY FREE
    WATER RESISTANT (80 MINUTES)

    5 - 0.15 OZ (4.25 G) BALMS
    TOTAL NET WT. 0.75 OZ (21.25 G)

    Principal Display Panel - Kit Carton
  • INGREDIENTS AND APPEARANCE
    VACATION LIP TRIPS DESSERTS 
    avobenzone, homosalate, octisalate, and octocrylene kit
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:80641-201
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:80641-201-011 in 1 CARTON01/15/2022
    Quantity of Parts
    Part #Package QuantityTotal Product Quantity
    Part 11 TUBE 4.25 g
    Part 21 TUBE 4.25 g
    Part 31 TUBE 4.25 g
    Part 41 TUBE 4.25 g
    Part 51 TUBE 4.25 g
    Part 1 of 5
    VACATION LIP TRIPS DESSERTS   PINEAPPLE UPSIDE DOWN CAKE
    avobenzone, homosalate, octisalate, and octocrylene stick
    Product Information
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    Avobenzone (UNII: G63QQF2NOX) (Avobenzone - UNII:G63QQF2NOX) Avobenzone0.03 g  in 1 g
    Homosalate (UNII: V06SV4M95S) (Homosalate - UNII:V06SV4M95S) Homosalate0.05 g  in 1 g
    Octisalate (UNII: 4X49Y0596W) (Octisalate - UNII:4X49Y0596W) Octisalate0.03 g  in 1 g
    Octocrylene (UNII: 5A68WGF6WM) (Octocrylene - UNII:5A68WGF6WM) Octocrylene0.1 g  in 1 g
    Inactive Ingredients
    Ingredient NameStrength
    Aloe Vera Leaf (UNII: ZY81Z83H0X)  
    Butyloctyl Salicylate (UNII: 2EH13UN8D3)  
    C18-38 Alkyl Hydroxystearoyl Stearate (UNII: WW4FVB2PEM)  
    Canola Oil (UNII: 331KBJ17RK)  
    Coconut Oil (UNII: Q9L0O73W7L)  
    Candelilla Wax (UNII: WL0328HX19)  
    Soybean Oil (UNII: 241ATL177A)  
    Helianthus Annuus Seed Wax (UNII: 42DG15CHXV)  
    Olive Oil (UNII: 6UYK2W1W1E)  
    Castor Oil (UNII: D5340Y2I9G)  
    Rosemary (UNII: IJ67X351P9)  
    Jojoba Oil (UNII: 724GKU717M)  
    Stevia Rebaudiuna Leaf (UNII: 6TC6NN0876)  
    Cocoa Butter (UNII: 512OYT1CRR)  
    .Alpha.-Tocopherol (UNII: H4N855PNZ1)  
    .Alpha.-Tocopherol Acetate (UNII: 9E8X80D2L0)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    14.25 g in 1 TUBE; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC MONOGRAPH FINALpart35201/15/2022
    Part 2 of 5
    VACATION LIP TRIPS DESSERTS   BOMBE ALASKA
    avobenzone, homosalate, octisalate, and octocrylene stick
    Product Information
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    Avobenzone (UNII: G63QQF2NOX) (Avobenzone - UNII:G63QQF2NOX) Avobenzone0.03 g  in 1 g
    Homosalate (UNII: V06SV4M95S) (Homosalate - UNII:V06SV4M95S) Homosalate0.05 g  in 1 g
    Octisalate (UNII: 4X49Y0596W) (Octisalate - UNII:4X49Y0596W) Octisalate0.03 g  in 1 g
    Octocrylene (UNII: 5A68WGF6WM) (Octocrylene - UNII:5A68WGF6WM) Octocrylene0.1 g  in 1 g
    Inactive Ingredients
    Ingredient NameStrength
    Aloe Vera Leaf (UNII: ZY81Z83H0X)  
    Butyloctyl Salicylate (UNII: 2EH13UN8D3)  
    C18-38 Alkyl Hydroxystearoyl Stearate (UNII: WW4FVB2PEM)  
    Canola Oil (UNII: 331KBJ17RK)  
    Coconut Oil (UNII: Q9L0O73W7L)  
    Candelilla Wax (UNII: WL0328HX19)  
    Soybean Oil (UNII: 241ATL177A)  
    Helianthus Annuus Seed Wax (UNII: 42DG15CHXV)  
    Olive Oil (UNII: 6UYK2W1W1E)  
    Castor Oil (UNII: D5340Y2I9G)  
    Rosemary (UNII: IJ67X351P9)  
    Jojoba Oil (UNII: 724GKU717M)  
    Stevia Rebaudiuna Leaf (UNII: 6TC6NN0876)  
    Cocoa Butter (UNII: 512OYT1CRR)  
    .Alpha.-Tocopherol (UNII: H4N855PNZ1)  
    .Alpha.-Tocopherol Acetate (UNII: 9E8X80D2L0)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    14.25 g in 1 TUBE; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC MONOGRAPH FINALpart35201/15/2022
    Part 3 of 5
    VACATION LIP TRIPS DESSERTS   AFTER DINNER MINT
    avobenzone, homosalate, octisalate, and octocrylene stick
    Product Information
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    Avobenzone (UNII: G63QQF2NOX) (Avobenzone - UNII:G63QQF2NOX) Avobenzone0.03 g  in 1 g
    Homosalate (UNII: V06SV4M95S) (Homosalate - UNII:V06SV4M95S) Homosalate0.05 g  in 1 g
    Octisalate (UNII: 4X49Y0596W) (Octisalate - UNII:4X49Y0596W) Octisalate0.03 g  in 1 g
    Octocrylene (UNII: 5A68WGF6WM) (Octocrylene - UNII:5A68WGF6WM) Octocrylene0.1 g  in 1 g
    Inactive Ingredients
    Ingredient NameStrength
    Aloe Vera Leaf (UNII: ZY81Z83H0X)  
    Butyloctyl Salicylate (UNII: 2EH13UN8D3)  
    C18-38 Alkyl Hydroxystearoyl Stearate (UNII: WW4FVB2PEM)  
    Canola Oil (UNII: 331KBJ17RK)  
    Coconut Oil (UNII: Q9L0O73W7L)  
    Candelilla Wax (UNII: WL0328HX19)  
    Soybean Oil (UNII: 241ATL177A)  
    Helianthus Annuus Seed Wax (UNII: 42DG15CHXV)  
    Olive Oil (UNII: 6UYK2W1W1E)  
    Castor Oil (UNII: D5340Y2I9G)  
    Rosemary (UNII: IJ67X351P9)  
    Jojoba Oil (UNII: 724GKU717M)  
    Stevia Rebaudiuna Leaf (UNII: 6TC6NN0876)  
    Cocoa Butter (UNII: 512OYT1CRR)  
    .Alpha.-Tocopherol (UNII: H4N855PNZ1)  
    .Alpha.-Tocopherol Acetate (UNII: 9E8X80D2L0)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    14.25 g in 1 TUBE; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC MONOGRAPH FINALpart35201/15/2022
    Part 4 of 5
    VACATION LIP TRIPS DESSERTS   STRAWBERRY JELLO
    avobenzone, homosalate, octisalate, and octocrylene stick
    Product Information
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    Avobenzone (UNII: G63QQF2NOX) (Avobenzone - UNII:G63QQF2NOX) Avobenzone0.03 g  in 1 g
    Homosalate (UNII: V06SV4M95S) (Homosalate - UNII:V06SV4M95S) Homosalate0.05 g  in 1 g
    Octisalate (UNII: 4X49Y0596W) (Octisalate - UNII:4X49Y0596W) Octisalate0.03 g  in 1 g
    Octocrylene (UNII: 5A68WGF6WM) (Octocrylene - UNII:5A68WGF6WM) Octocrylene0.1 g  in 1 g
    Inactive Ingredients
    Ingredient NameStrength
    Aloe Vera Leaf (UNII: ZY81Z83H0X)  
    Butyloctyl Salicylate (UNII: 2EH13UN8D3)  
    C18-38 Alkyl Hydroxystearoyl Stearate (UNII: WW4FVB2PEM)  
    Canola Oil (UNII: 331KBJ17RK)  
    Coconut Oil (UNII: Q9L0O73W7L)  
    Candelilla Wax (UNII: WL0328HX19)  
    Soybean Oil (UNII: 241ATL177A)  
    Helianthus Annuus Seed Wax (UNII: 42DG15CHXV)  
    Olive Oil (UNII: 6UYK2W1W1E)  
    Castor Oil (UNII: D5340Y2I9G)  
    Rosemary (UNII: IJ67X351P9)  
    Jojoba Oil (UNII: 724GKU717M)  
    Stevia Rebaudiuna Leaf (UNII: 6TC6NN0876)  
    Cocoa Butter (UNII: 512OYT1CRR)  
    .Alpha.-Tocopherol (UNII: H4N855PNZ1)  
    .Alpha.-Tocopherol Acetate (UNII: 9E8X80D2L0)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    14.25 g in 1 TUBE; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC MONOGRAPH FINALpart35201/15/2022
    Part 5 of 5
    VACATION LIP TRIPS DESSERTS   BANANAS FOSTER
    avobenzone, homosalate, octisalate, and octocrylene stick
    Product Information
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    Avobenzone (UNII: G63QQF2NOX) (Avobenzone - UNII:G63QQF2NOX) Avobenzone0.03 g  in 1 g
    Homosalate (UNII: V06SV4M95S) (Homosalate - UNII:V06SV4M95S) Homosalate0.05 g  in 1 g
    Octisalate (UNII: 4X49Y0596W) (Octisalate - UNII:4X49Y0596W) Octisalate0.03 g  in 1 g
    Octocrylene (UNII: 5A68WGF6WM) (Octocrylene - UNII:5A68WGF6WM) Octocrylene0.1 g  in 1 g
    Inactive Ingredients
    Ingredient NameStrength
    Aloe Vera Leaf (UNII: ZY81Z83H0X)  
    Butyloctyl Salicylate (UNII: 2EH13UN8D3)  
    C18-38 Alkyl Hydroxystearoyl Stearate (UNII: WW4FVB2PEM)  
    Canola Oil (UNII: 331KBJ17RK)  
    Coconut Oil (UNII: Q9L0O73W7L)  
    Candelilla Wax (UNII: WL0328HX19)  
    Soybean Oil (UNII: 241ATL177A)  
    Helianthus Annuus Seed Wax (UNII: 42DG15CHXV)  
    Olive Oil (UNII: 6UYK2W1W1E)  
    Castor Oil (UNII: D5340Y2I9G)  
    Rosemary (UNII: IJ67X351P9)  
    Jojoba Oil (UNII: 724GKU717M)  
    Stevia Rebaudiuna Leaf (UNII: 6TC6NN0876)  
    Cocoa Butter (UNII: 512OYT1CRR)  
    .Alpha.-Tocopherol (UNII: H4N855PNZ1)  
    .Alpha.-Tocopherol Acetate (UNII: 9E8X80D2L0)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    14.25 g in 1 TUBE; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC MONOGRAPH FINALpart35201/15/2022
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC MONOGRAPH FINALpart35201/15/2022
    Labeler - Vacation Inc. (117644631)
    Establishment
    NameAddressID/FEIBusiness Operations
    Raining Rose083819404MANUFACTURE(80641-201)
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