Label: ALOE UP DARK TANNING OIL SPF 4- avobenzone, octocrylene spray

  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None

Drug Label Information

Updated May 2, 2024

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  • Active Ingredients

    Avobenzone 1%

    Octocrylene 0.85%

  • Purpose

    Sunscreen

  • Uses

    • helps prevent sunburn
  • Warnings

    Skin Cancer/Skin Aging Alert: Spending time in the sun increases your risk of skin cancer and early skin aging. This product has been shown only to prevent sunburn, not skin cancer or early skin aging.

    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. Keep away from face to avoid breathing it. Contents under pressure - do not puncture or incinerate. Do not store at temperatures above 120 oF

    Stop use and ask a doctor if rash occurs.

    Keep out of reach of children. If product is swallowed, get medical help or contact a Poison Control Center right away.

    Flammable: Do not use near heat, flame or while smoking.

  • Directions

    • spray liberally and spread by hand 15 minutes before sun exposure
    • hold container 4 to 6 inches from the skin to apply
    • do not spray directly into face. Spray on hands then apply to face.
    • do not apply in windy condiions
    • use in well-ventillated area
    • reapply:
      • after 80 minutes of swimming or sweating
      • immediately after towel drying
      • at least every 2 hours
    • children under 6 months: Ask a doctor
  • Inactive Ingredients

    Aloe Barbadensis Leaf Extract, Ascorbic Acid, C12-15 Alkyl Benzoate, Cocos Nucifera (Coconut) Oil, Fragrance, Mineral Oil, Retinyl Palmitate, Ricinus Communis (Castor) Seed Oil, SD Alcohol 40-B, Tocopheryl Acetate, VA/Butyl Maleate/Isobornyl Acrylate Copolymer

  • Other information

    • protect this product from excesive heat and direct sun
    • avoid spraying on fabrics - could cause discoloration
  • Questions or Comments?

    Call toll free 1-800-950-2563

  • Aloe Up Dark Tanning Oil SPF 4 Sunscreen Mist

    Principal Display Label

  • INGREDIENTS AND APPEARANCE
    ALOE UP  DARK TANNING OIL SPF 4
    avobenzone, octocrylene spray
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:13630-0152
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    AVOBENZONE (UNII: G63QQF2NOX) (AVOBENZONE - UNII:G63QQF2NOX) AVOBENZONE8.02 mg  in 1 mL
    OCTOCRYLENE (UNII: 5A68WGF6WM) (OCTOCRYLENE - UNII:5A68WGF6WM) OCTOCRYLENE6.817 mg  in 1 mL
    Inactive Ingredients
    Ingredient NameStrength
    ASCORBIC ACID (UNII: PQ6CK8PD0R)  
    CASTOR OIL (UNII: D5340Y2I9G)  
    MINERAL OIL (UNII: T5L8T28FGP)  
    COCONUT OIL (UNII: Q9L0O73W7L)  
    ALOE VERA LEAF (UNII: ZY81Z83H0X)  
    VITAMIN A PALMITATE (UNII: 1D1K0N0VVC)  
    ALCOHOL (UNII: 3K9958V90M)  
    .ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)  
    ALKYL (C12-15) BENZOATE (UNII: A9EJ3J61HQ)  
    DIBUTYL MALEATE (UNII: 4X371TMK9K)  
    VINYL ACETATE (UNII: L9MK238N77)  
    ISOBORNYL ACRYLATE (UNII: IX0PRH184P)  
    Product Characteristics
    Coloryellow (Colorless to light Yellow) Score    
    ShapeSize
    FlavorImprint Code
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:13630-0152-4177 mL in 1 CAN; Type 0: Not a Combination Product04/02/2019
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC Monograph DrugM02004/02/2019
    Labeler - Prime Packaging, Inc. (805987059)
    Registrant - Prime Packaging, Inc. (805987059)
    Establishment
    NameAddressID/FEIBusiness Operations
    Prime Enterprises, Inc.101946028manufacture(13630-0152) , analysis(13630-0152)
    Establishment
    NameAddressID/FEIBusiness Operations
    Prime Packaging, Inc.805987059label(13630-0152) , pack(13630-0152)
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