Label: SKINPIA 10 SKIN SHIELD RENEWAL- dimethicone cream

  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None
  • Marketing Status: OTC monograph final

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 March 4, 2014

If you are a consumer or patient please visit this version.

  • ACTIVE INGREDIENT

    Active Ingredient: Dimethicone 1%

  • INACTIVE INGREDIENT

    Inactive Ingredients:
    Water, Caprylic/Capric Triglyceride, Glycerin, Cetyl Alcohol, Butylene Glycol, Sorbitan Stearate, Glyceryl Stearate, Simmondsia chinensis (jojoba) seed oil, Cetyl Ethylhexanoate, Butyrospermum Parkii (Shea Butter), Stearic Acid, Beeswax, Sorbitan Sesquioleate,
    Polysorbate 60, Glycine Soja (Soybean) Phytoplacenta Extract, 1,2-Hexanediol, Triethanolamine, Tocopheryl Acetate, Polyacrylamide, Panthenol, Carbomer, Acrylates/C10-30 Alkyl Acrylate Crosspolymer, Fragrance, Phenoxyethanol, Linum Usitatissimum (Linseed) Seed Extract, Hibiscus Esculentus Fruit Extract, Arctium Lappa Root Extract, Hibiscus Mutabilis Flower Extract, Corchorus Olitorius Leaf Extract, Hydrolyzed Pea Protein, Caprylhydroxamic Acid, Chamaecyparis Obtusa Water, Portulaca Oleracea Extract,
    Salix Nigra (Willow) Bark Extract, C13-14 Isoparaffin, Sodium Hyaluronate, Olea Europaea (Olive) Fruit Oil, Squalane, Larix Sibirica Wood Extract, Chrysanthellum Indicum Extract, Rheum Palmatum Root/Stalk Extract, Asarum Sieboldi Root Extract, Quercus Mongolia Leaf Extract, Persicaria Hydropiper Extract, Illicium Verum (Anise) Fruit Extract, Corydalis Turtschaninovii Root Extract, Coptis Japonica Root Extract, Machilus Thunbergii Bark Extract, Allantoin, Disodium EDTA, Adenosine, Aloe Barbadensis Leaf Juice Powder, Laureth-7, Lecithin, Ethylhexylglycerin, Glycine, Glutamic acid, Serine, Aspartic acid, Leucine, Alanine, Lysine, Arginine, Tyrosine, Phenylalanine, Threonine, Proline, Valine, Isoleucine, Histidine, Methionine, Cysteine, Ceramide 3, Polyglutamic Acid, Oryza Sativa (Rice) Callus Culture Extract, Panax Ginseng Callus Culture Extract, Zanthoxylum Piperitum Fruit Extract, Pulsatilla Koreana Extract, Usnea Barbata (Lichen) Extract,
    Xanthan Gum

  • PURPOSE

    Purpose: Skin Protectant

  • WARNINGS

    Warnings:
    1. In case of having following symptoms after using this, you're advised to stop using it immediately.
    If you keep using it, the symptoms will get worse and need to consult a dermatologist.
    - In case of haviong problems such as red rash, swollenness, itching, stimulation during usage.
    - In case of having the same symptoms above on the part you put this product on by direct sunlight.
    2. You are banned to use it on the part where you have a scar, eczema, or dermatitis.
    3. In case of getting it into your eyes, you have to wash it immediately.

  • KEEP OUT OF REACH OF CHILDREN

    Keep out of reach of children: Keep out of reach of babies and children

  • INDICATIONS AND USAGE

    Indications and usage: After basic skin care, apply adequate amount following the skin texture and gently tap to enhance absorption.

  • DOSAGE AND ADMINISTRATION

    Dosage and administration: Take an adequate amount of this product.

  • PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

    Image of carton

  • INGREDIENTS AND APPEARANCE
    SKINPIA 10 SKIN SHIELD RENEWAL 
    dimethicone cream
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:62242-030
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    Dimethicone (UNII: 92RU3N3Y1O) (DIMETHICONE - UNII:92RU3N3Y1O) Dimethicone0.5 mg  in 50 mL
    Inactive Ingredients
    Ingredient NameStrength
    Water (UNII: 059QF0KO0R)  
    Glycerin (UNII: PDC6A3C0OX)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:62242-030-0150 mL in 1 CARTON
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph finalpart34701/02/2014
    Labeler - EBAIN Corporation Co., Ltd. (689048989)
    Registrant - EBAIN Corporation Co., Ltd. (689048989)
    Establishment
    NameAddressID/FEIBusiness Operations
    EBAIN Corporation Co., Ltd.689048989manufacture(62242-030)