Label: BROAD SPECTRUM SPF 15 COCONUT 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 April 27, 2021

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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 finalpart35204/27/2021
    Labeler - Raining Rose, Inc. (083819404)
    Registrant - Raining Rose, Inc. (083819404)
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