Label: ATONO2 BABY AROMA (helianthus annuus- sunflower seed oil, macadamia ternifolia seed oil oil

  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None
  • Marketing Status: unapproved drug other

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Drug Label Information

Updated October 12, 2016

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  • ACTIVE INGREDIENT

    Helianthus Annuus (Sunflower) Seed Oil, Macadamia Ternifolia seed Oil

  • INACTIVE INGREDIENT

    Caprylic/Capric Triglyceride, Argania Spinosa Kernel Oil, Citrus Aurantifolia (Lime) Oil, Citrus Grandis (Grapefruit) Peel Oil, Tocopherol

  • PURPOSE

    Skin Protectant

  • KEEP OUT OF REACH OF CHILDREN

    keep out of reach of the children

  • INDICATIONS & USAGE

    Apply proper amount to the skin.

  • WARNINGS

    • For external use only
    • When using this product

    1. If any one of following symptoms occurs when using cosmetics, stop using it and consult a dermatologist.
    A. red spot, swelling, itching, stimulus
    B. symptoms mentioned above are caused by sunlight.

    2. Do not apply on skin where there is wound, eczema, or irritation.

    3. Storage and cautions for handling
    A. Close stopper after using.
    B. Keep out of reach of children.
    C. Keep away from high or low temperature and direct sunlight.

    4. This is not a medicinal product. Made of 100% cosmetic ingredients, it is a sensitive-skin care product for all skin types.

  • DOSAGE & ADMINISTRATION

    for external use only

  • PRINCIPAL DISPLAY PANEL

    L

  • INGREDIENTS AND APPEARANCE
    ATONO2 BABY AROMA 
    helianthus annuus (sunflower) seed oil, macadamia ternifolia seed oil oil
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:70993-0002
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    SUNFLOWER OIL (UNII: 3W1JG795YI) (SUNFLOWER OIL - UNII:3W1JG795YI) SUNFLOWER OIL14 g  in 100 mL
    MACADAMIA OIL (UNII: 515610SU8C) (MACADAMIA OIL - UNII:515610SU8C) MACADAMIA OIL11 g  in 100 mL
    Inactive Ingredients
    Ingredient NameStrength
    TOCOPHEROL (UNII: R0ZB2556P8)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:70993-0002-1150 mL in 1 BOTTLE, PUMP; Type 0: Not a Combination Product09/01/2016
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    unapproved drug other11/01/2014
    Labeler - LAORGANIC Co., Ltd. (689844148)
    Registrant - LAORGANIC Co., Ltd. (689844148)
    Establishment
    NameAddressID/FEIBusiness Operations
    LAORGANIC Co., Ltd.689844148manufacture(70993-0002)
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