ULTRA UV DEFENSE SPF 30 (ZINC OXIDE) CREAM [JENELT COSMETICS]

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ULTRA UV DEFENSE SPF 30 (ZINC OXIDE) CREAM [JENELT COSMETICS]
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NDC 58469-6100-1
Set ID 244b582b-3509-382e-e054-00144ff8d46c
Category HUMAN OTC DRUG LABEL
Packager Jenelt Cosmetics
Generic Name
Product Class
Product Number
Application Number PART352
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  • ACTIVE INGREDIENT


    Active Ingredient:

    Zinc Oxide 13.5%

  • PURPOSE

    Purpose:  Sunscreen

  • KEEP OUT OF REACH OF CHILDREN

    Keep out of reach of children.  If the product is swallowed, get medical help or contact a Poison Control Center right away.

  • INDICATIONS & USAGE

    Uses: 

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

    Warnings:

    • For external use only.
    • Do not use on damaged or broken skin.
    • When using this product keep out of eyes.  Rinse with water to remove.
    • Stop use and ask a doctor if rash occurs.
    • Keep out of reach of children.  If the product is swallowed, get medical help or contact a Poison Control Center right away.
  • 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.
    • 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 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-sleeve shirts, pants, hats and sunglasses.
    • Children under 6 months:  Ask a doctor.
  • INACTIVE INGREDIENT

    Inactive Ingredients:  Aqua (Water), Caprylic/Capric Triglyceride, Candelilla/Jojoba/Rice Bran Polyglyceryl-3 Esters, Glycerin, Isodecyl Neopentanoate, Ethyl Macadamiate, Aleurites Moluccana Seed Oil, Hydroxypropyl Starch Phosphate, Glyceral Stearate, Hamamelis Virginiana (Witch Hazel) Water, Ergothioneine (L), Hordeum Distichon (Barley) Extract, Macadamia Ternifolia Seed Oil, Porphyra Umbilicalis (Red Algae) Extract, Santalum Album (Sandalwood) Extract, Phellodendron Amurense Bark Extract, Glyceryl Isostearate, Sodium Stearoyl Lactylate, Polyglyceryl-10 Pentastearate, Polyhydroxystearic Acid, Tocopheryl Acetate (D-alpha), Tocopherol (D-alpha), Lecithin, Malic Acid (L) Lonicera Caprifolium (Honeysuckle) Flower Extract, Lonicera Japonica (Honeysuckle) Flower Extract, Potassium Cetyl Phosphate, Hydrogenated Palm Glycerides, Alcohol, Cetearyl Alcohol, Behenyl Alchohol, Hydroxypropyl Methylcellulose, Sodium Lactate, Phytic Acid, Citric Acid, Sodium Hydroxide

  • OTHER SAFETY INFORMATION

    Other Information:

    • Protect this product from excessive heat and direct sun.
  • PRINCIPAL DISPLAY PANEL

    PDP

  • INGREDIENTS AND APPEARANCE
    ULTRA UV DEFENSE SPF 30 
    zinc oxide cream
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:58469-6100(NDC:66915-610)
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    ZINC OXIDE (UNII: SOI2LOH54Z) (ZINC OXIDE - UNII:SOI2LOH54Z) ZINC OXIDE0.135 mg  in 1 g
    Inactive Ingredients
    Ingredient NameStrength
    ISODECYL NEOPENTANOATE (UNII: W60VYE24XC)  
    ETHYL MACADAMIATE (UNII: ANA2NCS6V1)  
    KUKUI NUT OIL (UNII: TP11QR7B8R)  
    HAMAMELIS VIRGINIANA LEAF WATER (UNII: 8FP93ED6H2)  
    ERGOTHIONEINE (UNII: BDZ3DQM98W)  
    WATER (UNII: 059QF0KO0R)  
    MEDIUM-CHAIN TRIGLYCERIDES (UNII: C9H2L21V7U)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    BARLEY (UNII: 5PWM7YLI7R)  
    MACADAMIA OIL (UNII: 515610SU8C)  
    PORPHYRA UMBILICALIS (UNII: 14AN0J70WO)  
    SANDALWOOD (UNII: 3641YW25N2)  
    PHELLODENDRON AMURENSE BARK (UNII: PBG27B754G)  
    GLYCERYL ISOSTEARATE (UNII: HYE7O27HAO)  
    SODIUM STEAROYL LACTYLATE (UNII: IN99IT31LN)  
    POLYGLYCERIN-10 (UNII: P9060O936A)  
    POLYHYDROXYSTEARIC ACID (2300 MW) (UNII: YXH47AOU0F)  
    .ALPHA.-TOCOPHEROL ACETATE, D- (UNII: A7E6112E4N)  
    TOCOPHEROL (UNII: R0ZB2556P8)  
    EGG PHOSPHOLIPIDS (UNII: 1Z74184RGV)  
    MALIC ACID (UNII: 817L1N4CKP)  
    LONICERA CAPRIFOLIUM FLOWER (UNII: 5N1WD9784U)  
    LONICERA JAPONICA FLOWER (UNII: 4465L2WS4Y)  
    POTASSIUM CETYL PHOSPHATE (UNII: 03KCY6P7UT)  
    HYDROGENATED PALM GLYCERIDES (UNII: YCZ8EM144Q)  
    ALCOHOL (UNII: 3K9958V90M)  
    CETOSTEARYL ALCOHOL (UNII: 2DMT128M1S)  
    DOCOSANOL (UNII: 9G1OE216XY)  
    HYPROMELLOSE 2208 (100 MPA.S) (UNII: B1QE5P712K)  
    SODIUM LACTATE (UNII: TU7HW0W0QT)  
    PHYTIC ACID (UNII: 7IGF0S7R8I)  
    CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP)  
    SODIUM HYDROXIDE (UNII: 55X04QC32I)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:58469-6100-160 g in 1 TUBE; Type 0: Not a Combination Product03/26/2014
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph finalpart35203/26/2014
    Labeler - Jenelt Cosmetics (078802794)
    Registrant - CoValence Laboratories (070653204)
    Establishment
    NameAddressID/FEIBusiness Operations
    CoValence Laboratories070653204manufacture(58469-6100)
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