ZO MEDICAL OCLIPSE-C BROAD-SPECTRUM SUNSCREEN SPF 50 (TITANIUM DIOXIDE) LOTION [ZO SKIN HEALTH, INC.]

ZO MEDICAL OCLIPSE-C BROAD-SPECTRUM SUNSCREEN SPF 50 (TITANIUM DIOXIDE) LOTION [ZO SKIN HEALTH, INC.]
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NDC 42851-052-12
Set ID 6f64dd44-b54f-497b-adb4-7655f0418070
Category HUMAN OTC DRUG LABEL
Packager ZO Skin Health, Inc.
Generic Name
Product Class
Product Number
Application Number PART352
  • SPL UNCLASSIFIED SECTION

    Drug Facts

  • Active ingredients

    Titanium Dioxide 8%

  • Purpose

    Sunscreen

  • 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

    For external use only.

    Do not use on damaged or broken skin.

    Stop and ask a doctor if rash occurs.

    When using this product keep out of eyes.

    Rinse with water to remove.

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

  • Directions

    • For full protection, apply liberally 15 minutes before sun exposure.
    • Use a water resistant sunscreen if swimming or sweating.
    • Reapply at least every 2 hours.
    • For children under 6 months of age: 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.
    • Apply to all skin exposed to the sun.
  • Other information

    • Store product in a cool place away from direct heat and sunlight
    • You may report a serious adverse reaction to: 1 Technology Dr. B123, Irvine, CA 92618
  • Inactive ingredients

    Water (Aqua), Cyclopentasiloxane, Phenyl Trimethicone, Styrene/Acrylates Copolymer, Pentylene Glycol, Dimethicone, Polyglyceryl-3 Polydimethylsiloxyethyl Dimethicone, Diisopropyl Sebacate, Glycerin, Isodecyl Neopentanoate, Lauryl Lactate, Polyacrylamide, Sodium Dihydroxycetyl Phosphate, Phytosphingosine, Hydrogenated Palm Glycerides, Melanin, Erythritol, Homarine HCL, Nephelium Lappaceum Branch/Fruit/Leaf Extract, Silica, Glycine Soja (Soybean) Seed Extract, C13-14 Isoparaffin, Laureth-7, Ceteareth-20, Cetearyl Alcohol, PEG-100 Stearate, Glyceryl Stearate, Aluminum Hydroxide, Stearic Acid, Disodium EDTA, Phenoxyethanol, Caprylyl Glycol, Chlorphenesin.

  • SPL UNCLASSIFIED SECTION

    DIST BY
    ZO Skin Health, Inc. Irvine, CA 92618

  • PRINCIPAL DISPLAY PANEL - 118 g Tube Carton

    ZO®MEDICAL

    BY ZEIN OBAGI, MD

    OCLIPSE-C™
    Broad-Spectrum Sunscreen
    SPF 50

    Net Wt. 118 g / 4.0 Oz.

    Principal Display Panel - 118 g Tube Carton
  • INGREDIENTS AND APPEARANCE
    ZO MEDICAL OCLIPSE-C BROAD-SPECTRUM SUNSCREEN SPF 50 
    titanium dioxide lotion
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:42851-052
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    Titanium Dioxide (UNII: 15FIX9V2JP) (Titanium Dioxide - UNII:15FIX9V2JP) Titanium Dioxide0.08 g  in 1 g
    Inactive Ingredients
    Ingredient NameStrength
    Water (UNII: 059QF0KO0R)  
    Cyclomethicone 5 (UNII: 0THT5PCI0R)  
    Phenyl Trimethicone (UNII: DR0K5NOJ4R)  
    Pentylene Glycol (UNII: 50C1307PZG)  
    Dimethicone (UNII: 92RU3N3Y1O)  
    Diisopropyl Sebacate (UNII: J8T3X564IH)  
    Glycerin (UNII: PDC6A3C0OX)  
    Isodecyl Neopentanoate (UNII: W60VYE24XC)  
    Lauryl Lactate (UNII: G5SU0BFK7O)  
    Sodium Dihydroxycetyl Phosphate (UNII: YWI33EV595)  
    Phytosphingosine (UNII: GIN46U9Q2Q)  
    Hydrogenated Palm Glycerides (UNII: YCZ8EM144Q)  
    Erythritol (UNII: RA96B954X6)  
    Homarine Hydrochloride (UNII: 8866LNG61N)  
    Silicon Dioxide (UNII: ETJ7Z6XBU4)  
    Soybean (UNII: L7HT8F1ZOD)  
    C13-14 Isoparaffin (UNII: E4F12ROE70)  
    Laureth-7 (UNII: Z95S6G8201)  
    Polyoxyl 20 Cetostearyl Ether (UNII: YRC528SWUY)  
    Cetostearyl Alcohol (UNII: 2DMT128M1S)  
    PEG-100 stearate (UNII: YD01N1999R)  
    Aluminum Hydroxide (UNII: 5QB0T2IUN0)  
    Stearic Acid (UNII: 4ELV7Z65AP)  
    Edetate Disodium (UNII: 7FLD91C86K)  
    Phenoxyethanol (UNII: HIE492ZZ3T)  
    Caprylyl Glycol (UNII: 00YIU5438U)  
    Chlorphenesin (UNII: I670DAL4SZ)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:42851-052-121 in 1 CARTON
    1118 g in 1 TUBE
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC MONOGRAPH FINALpart35201/01/2012
    Labeler - ZO Skin Health, Inc. (826468527)
    Establishment
    NameAddressID/FEIBusiness Operations
    Sanitor Corporation797472792MANUFACTURE(42851-052)

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