SWEET HONEY LIP BALM (ZINC OXIDE, CALENDULA OFFICIALS FLOWERS) SALVE [SIERRA SAGE HERBS LLC]

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SWEET HONEY LIP BALM (ZINC OXIDE, CALENDULA OFFICIALS FLOWERS) SALVE [SIERRA SAGE HERBS LLC]
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NDC 70994-401-07
Set ID 48c1c11d-296b-5e48-e054-00144ff8d46c
Category HUMAN OTC DRUG LABEL
Packager Sierra Sage Herbs LLC
Generic Name
Product Class
Product Number
Application Number PART352
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  • Purpose Section

    Sunscreen

    Skin Protectant

  • Active Ingredients

    Organic Calendula Officinalis (Calendula) Flower Oil 1X (HPUS)

  • Indications & Usage

    ■ temporarily helps protect and helps relieve chapped or cracked lips

    ■ helps protect from the drying effects of wind and cold weather

    ■ temporarily protects and helps relieve minor skin irritations due to

    ■ chafing ■ redness ■ windburn ■ sun exposure

  • Keep out of reach of children section

    Keep out of reach of children.

  • Warnings Section

    Warnings

    For external use only.

    ■ Do not use on ■ deep wounds ■ animal bites ■ serious burns

    ■ Stop use and ask a doctor if ■ condition worsens ■ symptoms last

    more than 7 days or clear up and occur again within a few days

    ■ When using this product keep out of eyes. Rinse with water to remove.

  • Storage

    Store at room temperature.

  • Dosage & Administration Section

    Apply as often as needed to affected area.

  • Inactive Ingredients

    Organic Olea Europaea (Olive) Fruit Oil, Organic Helianthus Annuus (Sunflower) Seed Oil, Organic Cera Alba (Beeswax), Organic Cocos Nucifera (Coconut) Oil, Citrus Sinensis (Orange) Fruit Extract, Organic Simmondsia Chinensis (Jojoba) Seed Oil, Tocopherol (Vitamin E), Vanilla Planifolia (Vanilla) Fruit Oil.

  • Principal Display Panel

    Honey Lip Green Goo

  • INGREDIENTS AND APPEARANCE
    SWEET HONEY LIP BALM 
    zinc oxide, calendula officials flowers salve
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:70994-401
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    CALENDULA OFFICINALIS FLOWER (UNII: P0M7O4Y7YD) (CALENDULA OFFICINALIS FLOWER - UNII:P0M7O4Y7YD) CALENDULA OFFICINALIS FLOWER1 [hp_X]  in 51.7 g
    ZINC OXIDE (UNII: SOI2LOH54Z) (ZINC OXIDE - UNII:SOI2LOH54Z) ZINC OXIDE3.6 g  in 51.7 g
    Inactive Ingredients
    Ingredient NameStrength
    ORANGE OIL (UNII: AKN3KSD11B)  
    LEMON OIL (UNII: I9GRO824LL)  
    YELLOW WAX (UNII: 2ZA36H0S2V)  
    ALPHA-TOCOPHEROL (UNII: H4N855PNZ1)  
    OLIVE OIL (UNII: 6UYK2W1W1E)  
    SUNFLOWER OIL (UNII: 3W1JG795YI)  
    JOJOBA OIL (UNII: 724GKU717M)  
    COCONUT OIL (UNII: Q9L0O73W7L)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:70994-401-074.25 g in 1 TUBE; Type 0: Not a Combination Product02/19/2019
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    unapproved homeopathic04/01/2016
    Labeler - Sierra Sage Herbs LLC (006970452)
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