ROSACLEAR SKIN BALANCING SUN PROTECTION BROAD SPECTRUM SPF 30 SUNCREEN (TITANIUM DIOXIDE AND ZINC OXIDE) LOTION [OMP, INC.]

ROSACLEAR SKIN BALANCING SUN PROTECTION BROAD SPECTRUM SPF 30 SUNCREEN (TITANIUM DIOXIDE AND ZINC OXIDE) LOTION [OMP, INC.]
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NDC 62032-072-64
Set ID affadfae-ce06-42b6-a044-ee621d6ea727
Category HUMAN OTC DRUG LABEL
Packager OMP, Inc.
Generic Name
Product Class
Product Number
Application Number PART352
  • SPL UNCLASSIFIED SECTION

    Drug Facts

  • ACTIVE INGREDIENT

    Active ingredientsPurpose
    Titanium Dioxide 2.0%Sunscreen
    Zinc Oxide 15.5%Sunscreen
  • Uses

    • helps prevent sunburn
  • 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.

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

  • 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 ingredients

    alumina, butylparaben, C12-15 alkyl benzoate, cetearyl alcohol, coco-glucoside, dipropylene glycol, ethylparaben, glycerin, hydroxyethyl acrylate/sodium acryloyldimethyl taurate copolymer, iron oxides, isobutylparaben, isohexadecane, isopropyl titanium triisostearate/triethoxycaprylylsilane crosspolymer, methylparaben, mica, PEG-6, phenoxyethanol, polyhydroxystearic acid, propylparaben, titanium dioxide, tocopheryl acetate, triethoxycaprylylsilane, water

  • Other information

    • store at controlled room temperature: 15°C-25°C (59°F-77°F).
    • protect this product from excessive heat and direct sun
  • Questions or comments?

    1.800.636.7546
    Monday-Friday 9 a.m.-4 p.m. Pacific Time

  • SPL UNCLASSIFIED SECTION

    Except as otherwise indicated, all product names, slogans and other marks are trademarks of the Valeant family of companies.

    Distributed by OMP, Inc., Long Beach, CA 90806

    ©2013 Obagi Medical Products, Inc., a division of Valeant Pharmaceuticals North America LLC.

    www.obagi.com
    Made in USA

    10726414Z 7264
    Rev. 12/13

  • PRINCIPAL DISPLAY PANEL - 85 g Bottle Label

    OBAGI®
    MEDICAL

    rosaclear®

    ∙ NON-COMEDOGENIC ∙ NON-COMEDOGENIC

    SKIN BALANCING
    SUN PROTECTION

    BROAD SPECTRUM SPF 30
    SUNSCREEN LOTION

    Net wt. 3 oz. (85 g)

    Principal Display Panel - 85 g Bottle Label
  • INGREDIENTS AND APPEARANCE
    ROSACLEAR SKIN BALANCING SUN PROTECTION BROAD SPECTRUM SPF 30   SUNCREEN
    titanium dioxide and zinc oxide lotion
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:62032-072
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    TITANIUM DIOXIDE (UNII: 15FIX9V2JP) (TITANIUM DIOXIDE - UNII:15FIX9V2JP) TITANIUM DIOXIDE20 mg  in 1 mL
    ZINC OXIDE (UNII: SOI2LOH54Z) (ZINC OXIDE - UNII:SOI2LOH54Z) ZINC OXIDE155 mg  in 1 mL
    Inactive Ingredients
    Ingredient NameStrength
    ALKYL (C12-15) BENZOATE (UNII: A9EJ3J61HQ)  
    WATER (UNII: 059QF0KO0R)  
    POLYHYDROXYSTEARIC ACID (2300 MW) (UNII: YXH47AOU0F)  
    DIPROPYLENE GLYCOL (UNII: E107L85C40)  
    POLYETHYLENE GLYCOL 300 (UNII: 5655G9Y8AQ)  
    CETOSTEARYL ALCOHOL (UNII: 2DMT128M1S)  
    COCO GLUCOSIDE (UNII: ICS790225B)  
    METHYLPARABEN (UNII: A2I8C7HI9T)  
    ALUMINUM OXIDE (UNII: LMI26O6933)  
    PROPYLPARABEN (UNII: Z8IX2SC1OH)  
    ISOHEXADECANE (UNII: 918X1OUF1E)  
    MICA (UNII: V8A1AW0880)  
    FERRIC OXIDE RED (UNII: 1K09F3G675)  
    FERROSOFERRIC OXIDE (UNII: XM0M87F357)  
    ALPHA-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)  
    TRIETHOXYCAPRYLYLSILANE (UNII: LDC331P08E)  
    ETHYLPARABEN (UNII: 14255EXE39)  
    ISOBUTYLPARABEN (UNII: 0QQJ25X58G)  
    BUTYLPARABEN (UNII: 3QPI1U3FV8)  
    PHENOXYETHANOL (UNII: HIE492ZZ3T)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    FERRIC OXIDE YELLOW (UNII: EX438O2MRT)  
    Product Characteristics
    ColorGRAYScore    
    ShapeSize
    FlavorImprint Code
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:62032-072-6488 mL in 1 BOTTLE, PLASTIC
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC MONOGRAPH FINALpart35201/01/2009
    Labeler - OMP, Inc. (790553353)
    Establishment
    NameAddressID/FEIBusiness Operations
    Swiss-American Products611921669MANUFACTURE(62032-072)

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