Label: ALL GOOD COCONUT SPF 20 ZINC OXIDE LIP BALM- zinc oxide stick

  • 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 June 14, 2023

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  • SPL UNCLASSIFIED SECTION

    Drug Facts:

  • ACTIVE INGREDIENT

    Active Ingredient:

    Zinc Oxide 8% (Non-nano)

  • PURPOSE

    Purpose:

    Sunscreen

  • INDICATIONS & USAGE

    Use: Helps prevent sunburn.

  • WARNINGS

    Warnings: For external use only

    Do not use on damaged or broken skin.

    Stop use and ask a doctor if rash occurs.

    When using this product, keep out of eyes. Rinse with water to remove.

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

  • DOSAGE & ADMINISTRATION

    Directions: Apply liberally 15 minutes before sun exposure. Use a water resistant sunscreen if swimming or sweating. Reapply at least every 2 hours. Children under 6 months of age: ask a doctor.

  • OTHER SAFETY INFORMATION

    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 help prevent sunburn, not skin cancer or early skin aging.

  • INACTIVE INGREDIENT

    Inactive Ingredients: Organic Calendula, Organic Comfrey, Organic Lavender, Organic Plantain and Organic Yarrow Infused in Organic Extra Virgin Olive Oil, Organic Beeswax, Organic Castor Oil, Raspberry Seed Oil, Organic Coconut Flavor, and Non-GMO Vitamin E.

  • SPL UNCLASSIFIED SECTION

    All Good SPF 20 Coconut Lip Balm

    NET WT 0.15 OZ / 4.25 G

    Oxybenzone-free

    Made from Plants

    ultra zinc protection

    MADE IN USA

    ALL GOOD

    PO BOX 203 MORRO BAY CA 93443

    ALLGOODPRODUCTS.COM

  • PRINCIPAL DISPLAY PANEL

    Carton

  • INGREDIENTS AND APPEARANCE
    ALL GOOD COCONUT SPF 20 ZINC OXIDE LIP BALM 
    zinc oxide stick
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:75786-224
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    ZINC OXIDE (UNII: SOI2LOH54Z) (ZINC OXIDE - UNII:SOI2LOH54Z) ZINC OXIDE8 g  in 100 g
    Inactive Ingredients
    Ingredient NameStrength
    RASPBERRY SEED OIL (UNII: 9S8867952A)  
    TOCOPHEROL (UNII: R0ZB2556P8)  
    CALENDULA OFFICINALIS FLOWER (UNII: P0M7O4Y7YD)  
    COMFREY LEAF (UNII: DG4F8T839X)  
    LAVENDER OIL (UNII: ZBP1YXW0H8)  
    MUSA X PARADISIACA LEAF (UNII: 2UIJ27N6ED)  
    CASTOR OIL (UNII: D5340Y2I9G)  
    ACHILLEA MILLEFOLIUM ROOT OIL (UNII: 0S45F449MJ)  
    YELLOW WAX (UNII: 2ZA36H0S2V)  
    OLIVE OIL (UNII: 6UYK2W1W1E)  
    Product Characteristics
    ColorwhiteScore    
    ShapeSize
    FlavorImprint Code
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:75786-224-011 in 1 BOX01/08/2014
    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 finalM02001/08/2014
    Labeler - Elemental Herbs, Inc. (132776357)
    Establishment
    NameAddressID/FEIBusiness Operations
    Eco Lips, Inc.138732727manufacture(75786-224)
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