WHITE AND ELM EVERYDAY SPF 15 (ZINC OXIDE) LOTION [WHITE & ELM LLC]

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WHITE AND ELM EVERYDAY SPF 15 (ZINC OXIDE) LOTION [WHITE & ELM LLC]
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NDC 70840-001-01
Set ID 47e93fa1-f12b-6ecd-e054-00144ff8d46c
Category HUMAN OTC DRUG LABEL
Packager White & Elm LLC
Generic Name
Product Class
Product Number
Application Number PART352
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  • Active Ingredient Listing

    Active Ingredients: Zinc Oxide12%. Purpose: Sunscreen

    active ingredients

  • ASK DOCTOR

    Children under 6 months of age: Ask a doctor.

    right panel

  • INACTIVE INGREDIENT

    Inactive Ingredients: Aloe Barbadensis (Aloe Vera) Leaf Juice, Helianthus Annuus (Sunflower) Seed Oil, Glycerin (Vegetable), Cetearyl Olivate, Benzyl Alcohol, Sorbitan Olivate, Tocopherols (Vitamin E), Xanthan Gum, Dehydroacetic Acid

    left panel

  • WARNINGS

    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.

    warnings

  • DO NOT USE

    Do not use on damaged or broken skin.

    do not use

  • KEEP OUT OF REACH OF CHILDREN

    Keep out of children’s reach.

    out of reach of children

  • PRINCIPAL DISPLAY PANEL

    Mineral Sunscreen

    Broad Spectrum SPF 15

    primary display panel

    package label

  • INGREDIENTS AND APPEARANCE
    WHITE AND ELM EVERYDAY SPF 15 
    zinc oxide lotion
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:70840-001
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    ZINC OXIDE (UNII: SOI2LOH54Z) (ZINC OXIDE - UNII:SOI2LOH54Z) ZINC OXIDE146 mg  in 1 mL
    Inactive Ingredients
    Ingredient NameStrength
    SUNFLOWER OIL (UNII: 3W1JG795YI)  
    ALOE (UNII: V5VD430YW9)  
    CETEARYL OLIVATE (UNII: 58B69Q84JO)  
    BENZYL ALCOHOL (UNII: LKG8494WBH)  
    TOCOPHEROL (UNII: R0ZB2556P8)  
    XANTHAN GUM (UNII: TTV12P4NEE)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    SORBITAN OLIVATE (UNII: MDL271E3GR)  
    DEHYDROACETIC ACID (UNII: 2KAG279R6R)  
    Product Characteristics
    ColorwhiteScore    
    ShapeSize
    FlavorImprint Code
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:70840-001-0130 mL in 1 BOTTLE, PUMP; Type 0: Not a Combination Product02/09/2017
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph finalpart35202/09/2017
    Labeler - White & Elm LLC (074096784)
    Establishment
    NameAddressID/FEIBusiness Operations
    White & Elm LLC074096784manufacture(70840-001)
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