Label: BROAD SPECTRUM SPF 15 COCONUT LIP BALM- zinc oxide stick

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

Drug Label Information

Updated November 3, 2023

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  • SPL UNCLASSIFIED SECTION

    DRUG FACTS

  • ACTIVE INGREDIENT

    Active Ingredients: 

    Zinc Oxide 3.5%

  • PURPOSE

    Purpose

    Sunscreen

  • Uses

    • Helps prevent sunburn
  • WARNINGS

    Warnings

    For External Use Only 

  • DO NOT USE

    • Do not use on damaged or broken skin
  • STOP USE


    Stop use and as a doctor if rash occurs

  • WHEN USING

    • When using this product keep out of eyes.  Rinse well with water to remove.
  • KEEP OUT OF REACH OF CHILDREN

    Keep out of reach of children.

    If swallowed, get medical help or call a Poison Control Center right away.

  • DOSAGE & ADMINISTRATION

    Directions Apply liberally 15 minutes before sun exposure •
    • Use a water resistant sunscreen if swimming or sweatinb •Reapply
    at least every 2 hours • Children under 6 months of age: Ask a
    doctor. 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 protection measures
    including: limit time in the sun, especially from 10a.m. - 2p.m. • wear
    long-sleeved shirts, pants, hats and sunglasses.

  • INACTIVE INGREDIENT

    Inactive Ingredients:  Organic Calendula, Organic Comfrey,

    Organic Lavender, Organic Plantain and Organic Yarrow Infused in

    Organic Extra Virgin Olive Oil with Organic Beeswax, Organic

    Coconut Flavor and Non-GMO Vitamin E.

  • SPL UNCLASSIFIED SECTION

    Other Information

    Protect this product from excessive heart and direct sun.

  • Product Package Labeling

    UVA/UVB BROAD SPECTRUM SPF 15

    Coconut Lip Balm

    NET WT. 4.25g

    DIST. BY ALLGOODPRODUCTS.COM, MORRO BAY, CA 93443            L000000

    0307

    res

  • INGREDIENTS AND APPEARANCE
    BROAD SPECTRUM SPF 15 COCONUT LIP BALM 
    zinc oxide stick
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:65692-0307
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    ZINC OXIDE (UNII: SOI2LOH54Z) (ZINC CATION - UNII:13S1S8SF37) ZINC CATION35 mg  in 1 g
    Inactive Ingredients
    Ingredient NameStrength
    CALENDULA OFFICINALIS FLOWER (UNII: P0M7O4Y7YD)  
    COMFREY LEAF (UNII: DG4F8T839X)  
    LAVANDULA ANGUSTIFOLIA FLOWER (UNII: 19AH1RAF4M)  
    PLANTAGO MAJOR LEAF (UNII: 7DC28K241X)  
    ACHILLEA MILLEFOLIUM FLOWER (UNII: YQR8R0SQEA)  
    OLIVE OIL (UNII: 6UYK2W1W1E)  
    YELLOW WAX (UNII: 2ZA36H0S2V)  
    TOCOPHEROL (UNII: R0ZB2556P8)  
    Product Characteristics
    Color    Score    
    ShapeSize
    FlavorCOCONUTImprint Code
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:65692-0307-14.25 g in 1 TUBE; Type 0: Not a Combination Product04/27/2021
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC Monograph DrugM02004/27/2021
    Labeler - Raining Rose, Inc. (083819404)
    Registrant - Raining Rose, Inc. (083819404)
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