Label: BALI BODY WATERMELON TANNING OIL SPF 15- avobenzone, octisalate, octocrylene oil

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

Drug Label Information

Updated October 16, 2023

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  • Drug Facts

  • Active ingredients:

    Octocrylene 9%

    Octisalate 5%

    Avobenzone 3%

    Purpose:

    Sunsreen

  • Uses

    • Helps prevent sunburn
    • If used as directed with other sun protection measures ( see Directions) decreases the risk of skin cancer and early skin ageing 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.

    If product is swallowed, get medical help or contact a poison control centre right away.

    • Please refer to balibodyco.com for further sun safety instructions.
  • Directions

    Shake well before use. Apply liberally 15 minutes before sun exposure. Re-apply your BB every 1-2 hours. Wear 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 this risk, regularly use a sunscreen with a Broad Spectrum SPF value 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-sleeved shirts, pants, hats, and sunglasses
  • Inactive ingredients

    Vitis Vinifera Seed Oil, Cocos Nucifera Oil, Prunus Amygdalus Dulcis Oil, Cocoglycerides, Dicaprylyl Carbonate, Vp/hexadecene Copolymer, Citrullus Lanatus Seed Oil, Ethylcellulose, Tocopherol, Parfum, Glycine Soja Oil, Benzyl Alcohol, Citronellol, Rose Ketone-4, Geranol, Linalool, Benzyl Benzoate, Benzyl Salicylate, Cinnamyl Alcohol.

  • Other information

    • Protect this product from excessive heat and direct sun
    • Report serious adverse events to: AMS Fulfilment, 29010 Commerce Drive, Valencia CA 91355
  • Package Labeling

    1

  • INGREDIENTS AND APPEARANCE
    BALI BODY WATERMELON TANNING OIL SPF 15 
    avobenzone, octisalate, octocrylene oil
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:70630-0035
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    AVOBENZONE (UNII: G63QQF2NOX) (AVOBENZONE - UNII:G63QQF2NOX) AVOBENZONE30 mg  in 1 mL
    OCTISALATE (UNII: 4X49Y0596W) (OCTISALATE - UNII:4X49Y0596W) OCTISALATE50 mg  in 1 mL
    OCTOCRYLENE (UNII: 5A68WGF6WM) (OCTOCRYLENE - UNII:5A68WGF6WM) OCTOCRYLENE90 mg  in 1 mL
    Inactive Ingredients
    Ingredient NameStrength
    VINYLPYRROLIDONE/HEXADECENE COPOLYMER (UNII: KFR5QEN0N9)  
    BENZYL ALCOHOL (UNII: LKG8494WBH)  
    GERANIOL (UNII: L837108USY)  
    LINALOOL, (+/-)- (UNII: D81QY6I88E)  
    BENZYL SALICYLATE (UNII: WAO5MNK9TU)  
    BENZYL BENZOATE (UNII: N863NB338G)  
    .BETA.-CITRONELLOL, (R)- (UNII: P01OUT964K)  
    CINNAMYL ALCOHOL (UNII: SS8YOP444F)  
    TOCOPHEROL (UNII: R0ZB2556P8)  
    ALMOND OIL (UNII: 66YXD4DKO9)  
    COCONUT OIL (UNII: Q9L0O73W7L)  
    DICAPRYLYL CARBONATE (UNII: 609A3V1SUA)  
    WATERMELON SEED OIL (UNII: L33J06UQTT)  
    SOYBEAN OIL (UNII: 241ATL177A)  
    COCO-GLYCERIDES (UNII: ISE9I7DNUG)  
    ETHYLCELLULOSE, UNSPECIFIED (UNII: 7Z8S9VYZ4B)  
    GRAPE SEED OIL (UNII: 930MLC8XGG)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:70630-0035-1100 mL in 1 BOTTLE; Type 0: Not a Combination Product01/01/2024
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC Monograph DrugM02001/01/2024
    Labeler - Bali Body Pty Ltd (757840223)
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