Label: SANDAWHA MOISTURIZING BABY- glycerin cream

  • Category: HUMAN OTC DRUG LABEL

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 February 24, 2019

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  • ACTIVE INGREDIENT

    glycerin

  • INACTIVE INGREDIENT

    Camellia Japonica Flower Extract
    Caprylic/Capric Triglyceride
    Glycerin
    Water(Aqua)
    Pentylene Glycol
    Camellia Japonica Seed Oil
    Propanediol
    Hydrogenated Palm Kernel Oil
    Phosphatidylcholine
    Phytosteryl Macadamiate
    Butyrospermum Parkii (Shea) Butter
    Mangifera Indica (Mango) Seed Butter
    Xanthan Gum
    Panthenol
    Camellia Sinensis Leaf Extract
    Chamomilla Recutita (Matricaria) Leaf Extract
    Thujopsis Dolabrata Branch Extract
    Sorbitan Caprylate
    Arginine
    Squalane
    Trehalose
    Magnolia Kobus Bark Extract
    Salix Alba (Willow) Bark Extract
    Dipotassium Glycyrrhizate
    Centella Asiatica Extract
    Dimethyl Sulfone
    Hizikia Fusiforme Extract
    Glycyrrhiza Glabra (Licorice) Root Extract
    Yeast Beta-Glucan
    Levulinic Acid
    Betaine
    Houttuynia Cordata Extract
    Portulaca Oleracea Extract
    Hyaluronic Acid
    Aloe Barbadensis Leaf Extract
    Olea Europaea (Olive) Fruit Oil
    Citrus Unshiu Peel Extract
    Opuntia Ficus-Indica Fruit Extract
    Polygonum Cuspidatum Root Extract
    Scutellaria Baicalensis Root Extract
    Vitis Vinifera (Grape) Skin Extract
    Tocopherol
    Pyrus Malus (Apple) Fruit Extract
    Rosmarinus Officinalis (Rosemary) Leaf Extract
    Silybum Marianum Extract
    Vaccinium Angustifolium (Blueberry) Fruit Extract
    Bioflavonoids
    Bisabolol
    Rosa Canina Fruit Oil
    Brassica Oleracea Italica (Broccoli) Extract
    Linoleic Acid
    Rutin
    Astaxanthin
    Quercetin
    Aniba Rosodora (Rosewood) Wood Oil
    Jasminum Sambac (Jasmine) Flower Extract
    Lavandula Angustifolia (Lavender) Oil
    Rosmarinus Officinalis (Rosemary) Leaf Oil

  • PURPOSE

    suitable for delicate baby's skin

    soothes and protects sensitive skin

  • KEEP OUT OF REACH OF CHILDREN

    keep out of reach of the children

  • INDICATIONS & USAGE

    Gently massage into skin as often as needed

  • WARNINGS

    for external use only

    do not use if sensitive to any of the ingredients

    discontinue use if signs of irritation or rash appear

    if irritation or rash persists, contact a doctor

  • DOSAGE & ADMINISTRATION

    for external use only

  • PRINCIPAL DISPLAY PANEL

    label

  • INGREDIENTS AND APPEARANCE
    SANDAWHA MOISTURIZING BABY 
    glycerin cream
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:72289-0006
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    GLYCERIN (UNII: PDC6A3C0OX) (GLYCERIN - UNII:PDC6A3C0OX) GLYCERIN3.1545 g  in 100 g
    Inactive Ingredients
    Ingredient NameStrength
    PANTHENOL (UNII: WV9CM0O67Z)  
    SQUALENE (UNII: 7QWM220FJH)  
    WATER (UNII: 059QF0KO0R)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:72289-0006-175 g in 1 BOTTLE; Type 0: Not a Combination Product02/24/2019
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph not finalpart34702/24/2019
    Labeler - SKINCURE INC (557830240)
    Registrant - SKINCURE INC (557830240)
    Establishment
    NameAddressID/FEIBusiness Operations
    SKINCURE INC557830240label(72289-0006) , manufacture(72289-0006)