Label: SKINUVA SCAR PLUS- zinc oxide cream

  • NDC Code(s): 82350-352-15, 82350-352-30
  • Packager: MD Medical Designs, Inc.
  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None

Drug Label Information

Updated January 12, 2024

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  • SPL UNCLASSIFIED SECTION

    Drug Facts

  • ACTIVE INGREDIENT

    Active ingredientsPurpose*
    *
    Data on file
    Zinc Oxide 10%Sunscreen
    Dosage FormCream
  • Uses

    Helps prevent sunburn. If used as directed with other sun protection measures, decreases the risk of skin cancer and early skin aging caused by the sun.

  • Warnings

    For external use only.

    Do not use on damaged/broken skin or open wounds.

    When using this product keep out of eyes. If contact occurs, rinse eyes thoroughly with plenty of water to remove. If swallowed immediately seek medical advice and show container or label.

    Stop use and ask a doctor if rash or irritation occurs.

    Keep out of reach of children.

  • Directions

    Make sure the affected area is clean and dry. Apply a thin film over the affected area twice a day, morning and night. Wait 15 minutes before sun exposure. Children under 6 months of age: Ask a doctor. See insert for detailed instructions.

  • Other information

    Do not use if inner seal is broken. Store at room temperature. Avoid excessive heat.

  • Inactive ingredients

    Water/Aqua, Dimethicone, Dimethiconol, Cyclopentasiloxane, Dimethicone Crosspolymer, Butylene Glycol, Glycerin, Diethylhexyl 2,6-Naphthalate, Dimethicone/PEG-10/15 Crosspolymer, Tetrahexyldecyl Ascorbate, Centella Asiatica Extract, Diphenylsiloxy Phenyl Trimethicone, Dimethicone/Phenyl Vinyl Dimethicone Crosspolymer, Phenoxyethanol, Ethylhexylglycerin, Sodium Chloride, Lauryl PEG-9 Polydimethylsiloxyethyl Dimethicone, Sodium Hyaluronate, Aloe Barbadensis Leaf Juice, sh-Polypeptide-1, Tocopherol, sh-Polypeptide-6, sh-Polypeptide-5

  • SPL UNCLASSIFIED SECTION

    Dist. by: MD Medical Designs, Inc.
    Beverly Hills, CA 90210

  • PRINCIPAL DISPLAY PANEL - 30 mL Bottle Carton

    NDC: 82350-352-30

    SKINUVA®
    scar+

    BROAD SPECTRUM SPF 30

    Scar photoaging defense cream using
    highly selective growth factors with
    Zinc Oxide mineral sunscreen

    Developed and tested
    by physicians

    30 mL / 1 fl. oz e

    Principal Display Panel - 30 mL Bottle Carton
  • INGREDIENTS AND APPEARANCE
    SKINUVA SCAR PLUS 
    zinc oxide cream
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:82350-352
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    Zinc Oxide (UNII: SOI2LOH54Z) (Zinc Oxide - UNII:SOI2LOH54Z) Zinc Oxide0.1 g  in 1 mL
    Inactive Ingredients
    Ingredient NameStrength
    Water (UNII: 059QF0KO0R)  
    Dimethicone (UNII: 92RU3N3Y1O)  
    Cyclomethicone 5 (UNII: 0THT5PCI0R)  
    Butylene Glycol (UNII: 3XUS85K0RA)  
    Glycerin (UNII: PDC6A3C0OX)  
    Diethylhexyl 2,6-Naphthalate (UNII: I0DQJ7YGXM)  
    Dimethicone/PEG-10/15 Crosspolymer (UNII: 21AS8B1BSS)  
    Tetrahexyldecyl Ascorbate (UNII: 9LBV3F07AZ)  
    Centella Asiatica Triterpenoids (UNII: 4YS74Q4G4J)  
    Diphenylsiloxy Phenyl Trimethicone (UNII: I445L28B12)  
    Dimethicone/Phenyl Vinyl Dimethicone Crosspolymer (UNII: ST6ZC4KVH2)  
    Ethylhexylglycerin (UNII: 147D247K3P)  
    Sodium Chloride (UNII: 451W47IQ8X)  
    Lauryl PEG-9 Polydimethylsiloxyethyl Dimethicone (UNII: 25G622K2RA)  
    Hyaluronate Sodium (UNII: YSE9PPT4TH)  
    Aloe Vera Leaf (UNII: ZY81Z83H0X)  
    BASIC FIBROBLAST GROWTH FACTOR (HUMAN) (UNII: S3529G9M9V)  
    Tocopherol (UNII: R0ZB2556P8)  
    Phenoxyethanol (UNII: HIE492ZZ3T)  
    Interleukin-10 (UNII: 9SC4O216V9)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:82350-352-151 in 1 CARTON06/30/2022
    115 mL in 1 BOTTLE; Type 0: Not a Combination Product
    2NDC:82350-352-301 in 1 CARTON06/30/2022
    230 mL in 1 BOTTLE; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph drugM02006/30/2022
    Labeler - MD Medical Designs, Inc. (094586004)
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