Label: INGENUE- zinc oxide cream

  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None
  • Marketing Status: OTC monograph not 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 December 3, 2012

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

  • ACTIVE INGREDIENT

    Active Ingredient:

    Zinc Oxide 14.5%

  • PURPOSE

    Purpose:

    Sunscreen

  • KEEP OUT OF REACH OF CHILDREN

    Keep out of reach of children. If product is swallowed, get medical help or contact a poison control center right away.

  • INDICATIONS & USAGE

    Uses:

    Helps prevent sunburn

  • WARNINGS

    Warnings:

    • For external use only
    • Do not use on damaged or broken skin.
    • Stop use and ask a doctor if rash occurs.
    • When using this product keep out of eyes. Rinse with water to remove.


  • DOSAGE & ADMINISTRATION

    Directions:

    Apply liberally 15 minutes before sun exposure

    Use a water resistant sunscreen if swimming or sweating

    Reapply at least every 2 hours

    Children under 6 months: ask a doctor

    Sun protection measures: Spending time in the sun increases your risk of skin cancer and early skin aging. To decrease this risk, regularly use a
     
    sunscreen with a broad spectrum SPF value of 15 or higher and other sun protection measures including:
                   
                    limit time in the sun, especially from 10 a.m. -  2 p.m.

                    wear long-sleeved shirts, pants, hats and sunglasses.
  • INACTIVE INGREDIENT

    Inactive Ingredients:

    Alcohol, Aloe Barbadensis Leaf Juice, C12-15 Alkyl Benzoate, Glycerin, C13-14 Isoparaffin, Cyclomethicone, Glyceryl Stearate, Laureth-7, PEG-100 Stearate, Polyacrylamide, Citrullus Lanatus (Watermelon) Fruit Extract, Steareth-21, Synthetic Beeswax, Dimethicone, Olea Europaea (Olive) Fruit Oil, Helianthus Annuus (Sunflower) Seed Oil, Camellia Sinensis (Green Tea) Leaf Extract, Chamomilla Recutita (Matricaria) Flower Extract, Cucumis Sativus (Cucumber) Fruit Extract, Daucus Carota Sativa (Carrot) Extract, Glycyrrhiza Glabra (Licorice) Extract, Lentinus Edodes (Shiitake Mushroom) Extract, Macrocystis Pyrifera (Kelp) Extract, Pisum Sativum (Pea) Extract, Caprylyl Glycol, Castor Oil Phosphate, Sodium Benzoate, Potassium Sorbate, Annatto, Dipotassium Glycyrrhizinate, Disodium EDTA, Ferulic Acid, Maltodextrin, Phyllanthus Emblica Fruit Extract, Sodium Hyaluronate, Tetrahydro Curcuminoids, Sorbic Acid, Tetrahexyldecyl Ascorbate, Phospholipids, Retinyl Palmitate, Tocopheryl Acetate, Ascorbyl Palmitate, Tocopherol, Sodium Dehydroacetate, Phenoxyethanol, water.

  • PRINCIPAL DISPLAY PANEL

    image

  • INGREDIENTS AND APPEARANCE
    INGENUE 
    zinc oxide cream
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:54151-101
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    ZINC OXIDE (UNII: SOI2LOH54Z) (ZINC OXIDE - UNII:SOI2LOH54Z) ZINC OXIDE14.5 mg  in 1 mL
    Inactive Ingredients
    Ingredient NameStrength
    ALOE VERA LEAF (UNII: ZY81Z83H0X)  
    ALKYL (C12-15) BENZOATE (UNII: A9EJ3J61HQ)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    C13-14 ISOPARAFFIN (UNII: E4F12ROE70)  
    CYCLOMETHICONE (UNII: NMQ347994Z)  
    GLYCERYL MONOSTEARATE (UNII: 230OU9XXE4)  
    LAURETH-7 (UNII: Z95S6G8201)  
    PEG-100 STEARATE (UNII: YD01N1999R)  
    POLYACRYLAMIDE (10000 MW) (UNII: E2KR9C9V2I)  
    WATERMELON (UNII: 231473QB6R)  
    STEARETH-21 (UNII: 53J3F32P58)  
    SYNTHETIC WAX (1800 MW) (UNII: 248P1AUJ90)  
    DIMETHICONE (UNII: 92RU3N3Y1O)  
    OLIVE OIL (UNII: 6UYK2W1W1E)  
    SUNFLOWER OIL (UNII: 3W1JG795YI)  
    GREEN TEA LEAF (UNII: W2ZU1RY8B0)  
    CHAMOMILE (UNII: FGL3685T2X)  
    CUCUMBER (UNII: YY7C30VXJT)  
    CARROT (UNII: L56Z1JK48B)  
    GLYCYRRHIZA GLABRA (UNII: 2788Z9758H)  
    LENTINULA EDODES MYCELIUM (UNII: CU2S39TB8O)  
    MACROCYSTIS PYRIFERA (UNII: K31S3OG5C4)  
    PEA (UNII: W4X7H8GYFM)  
    CAPRYLYL GLYCOL (UNII: 00YIU5438U)  
    CASTOR OIL (UNII: D5340Y2I9G)  
    SODIUM BENZOATE (UNII: OJ245FE5EU)  
    POTASSIUM SORBATE (UNII: 1VPU26JZZ4)  
    ANNATTO (UNII: 6PQP1V1B6O)  
    GLYCYRRHIZINATE DIPOTASSIUM (UNII: CA2Y0FE3FX)  
    EDETATE DISODIUM (UNII: 7FLD91C86K)  
    FERULIC ACID (UNII: AVM951ZWST)  
    MALTODEXTRIN (UNII: 7CVR7L4A2D)  
    PHYLLANTHUS EMBLICA FRUIT (UNII: YLX4CW2576)  
    HYALURONATE SODIUM (UNII: YSE9PPT4TH)  
    TETRAHYDRODIFERULOYLMETHANE (UNII: 00U0645U03)  
    SORBIC ACID (UNII: X045WJ989B)  
    TETRAHEXYLDECYL ASCORBATE (UNII: 9LBV3F07AZ)  
    ASCORBYL PALMITATE (UNII: QN83US2B0N)  
    TOCOPHEROL (UNII: R0ZB2556P8)  
    SODIUM DEHYDROACETATE (UNII: 8W46YN971G)  
    PHENOXYETHANOL (UNII: HIE492ZZ3T)  
    WATER (UNII: 059QF0KO0R)  
    ALCOHOL (UNII: 3K9958V90M)  
    CYCLOMETHICONE 5 (UNII: 0THT5PCI0R)  
    CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP)  
    ETHYLHEXYLGLYCERIN (UNII: 147D247K3P)  
    SOYBEAN (UNII: L7HT8F1ZOD)  
    EGG PHOSPHOLIPIDS (UNII: 1Z74184RGV)  
    TRIETHOXYCAPRYLYLSILANE (UNII: LDC331P08E)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:54151-101-261 in 1 BOX
    150 mL in 1 TUBE
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph not finalpart35206/15/2012
    Labeler - Ingenue, LLC (078662060)
    Establishment
    NameAddressID/FEIBusiness Operations
    Smith & Vandiver Corp061973426manufacture(54151-101)