YELLOW SUNBLOCK (ZINC OXIDE) CREAM [IRURI NATURE HANDMADE SOAP & COSMETIC INC]

YELLOW SUNBLOCK (ZINC OXIDE) CREAM [IRURI NATURE HANDMADE SOAP & COSMETIC INC]
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NDC 71547-107-01, 71547-107-02
Set ID 5516b784-23be-2582-e054-00144ff88e88
Category HUMAN OTC DRUG LABEL
Packager Iruri Nature Handmade Soap & Cosmetic Inc
Generic Name
Product Class
Product Number
Application Number PART352
  • Active Ingredients

    Zinc oxide (8%)

  • Purpose

    Sunscreen

  • Uses

    Helps prevent sunburn

  • Warnings

    For external use only

    Do not use when skin is red, inflamed, irritated, or painful

    When using this product

    - do not apply on other parts of the body

    - do not use on damaged or broken skin

    - avoid contact with eyes. If contact occurs, rinse eyes thoroughly with water

    - do not apply directly to wound or open cut

    Stop use and ask a doctor if

    - Rash or irritation on skin develops and lasts

  • Keep out of reach of children

    If swallowed, get medical help or contact a Poison Control Center (1-800-222-1222) right away.

  • Directions

    1. Apply the adequate amount on the palm of the hands and pat lightly with the fingertips.

    2. Apply liberally 15 minutes before sun exposure.

    3. Reapply at least every 2 hours.

    4. Use a water-resistant sunscreen if swimming or sweating.

    5. 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 sun protection measures including:

    - Limit time in the sun, especially from 10 a.m.- 2 p.m.

    - Wear long-sleeved shirts, pants, hats, and sunglasses.

    6. Children under 6 months of age: ask a doctor

  • Inactive Ingredients

    Shea butter, Castor oil, Camellia oil, Emulsifying wax, Allantoin, Distilled water, Rose water, Glycerin, Vitamin E oil, Optiphen plus, Aspen Grass Fragrance oil

  • Yellow Sunblock (Shea Butter Sunblock)

    Yellow Sunblock (Shea Butter Sunblock)

  • INGREDIENTS AND APPEARANCE
    YELLOW SUNBLOCK 
    zinc oxide cream
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:71547-107
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    ZINC OXIDE (UNII: SOI2LOH54Z) (ZINC OXIDE - UNII:SOI2LOH54Z) ZINC OXIDE1.6 g  in 20 mL
    Inactive Ingredients
    Ingredient NameStrength
    ALLANTOIN (UNII: 344S277G0Z)  
    CASTOR OIL (UNII: D5340Y2I9G)  
    CAMELLIA OIL (UNII: T1PE06G0VE)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    .ALPHA.-TOCOPHEROL (UNII: H4N855PNZ1)  
    SHEA BUTTER (UNII: K49155WL9Y)  
    WATER (UNII: 059QF0KO0R)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:71547-107-021 in 1 PACKAGE07/24/2017
    1NDC:71547-107-0120 mL in 1 CONTAINER; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph not finalpart35207/24/2017
    Labeler - Iruri Nature Handmade Soap & Cosmetic Inc (095675041)
    Registrant - Iruri Nature Handmade Soap & Cosmetic Inc (095675041)
    Establishment
    NameAddressID/FEIBusiness Operations
    Iruri Nature Handmade Soap & Cosmetic Inc095675041manufacture(71547-107)

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