Label: BALI BLOC SPF 30 COCOA SUNSCREEN- zinc oxide cream

  • 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 October 2, 2023

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  • Active Ingredients

    Zinc Oxide** USP 25%

  • 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 if used as directed with other sun protection measures

    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 Center right away

  • Directions

    • apply liberally 15 minutes before sun exposure
    • use a water resistant sunscreen if swimming or sweating
    • 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 this 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: Ask a Doctor
  • Inactive Ingredients

    Virgin coconut oil* (Cocos nucifera seed oil), beeswax* (cera alba), cocoa powder* (Theobroma cacao seed powder)

    * certified organic by USDA/NOP **non-nano, uncoated, French Process zinc oxide

  • Other Information

    • protect this product from excessive heat and direct sun
  • Questions or comments?

    Call Kabana Skin Care toll free at 1-888-517-0414 or visit www.kabanaskincare.com

  • Drug Facts

    Bali Bloc SPF 30 Cocoa Package Insert

  • INGREDIENTS AND APPEARANCE
    BALI BLOC SPF 30 COCOA SUNSCREEN 
    zinc oxide cream
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:73369-0008
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    ZINC OXIDE (UNII: SOI2LOH54Z) (ZINC OXIDE - UNII:SOI2LOH54Z) ZINC OXIDE25 g  in 100 g
    Inactive Ingredients
    Ingredient NameStrength
    COCOA (UNII: D9108TZ9KG) 15 g  in 100 g
    YELLOW WAX (UNII: 2ZA36H0S2V) 15 g  in 100 g
    COCONUT OIL (UNII: Q9L0O73W7L) 45 g  in 100 g
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:73369-0008-1110 g in 1 TUBE; Type 0: Not a Combination Product10/08/2014
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph finalpart35210/08/2014
    Labeler - Kabana Skin Care LLC (080237112)
    Registrant - Kabana Skin Care LLC (080237112)
    Establishment
    NameAddressID/FEIBusiness Operations
    Kabana Skin Care LLC080237112manufacture(73369-0008)
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