Label: ROSACLEAR SKIN BALANCING SUN PROTECTION BROAD SPECTRUM SPF 30 SUNCREEN- titanium dioxide and zinc oxide lotion

  • Category: HUMAN OTC DRUG LABEL

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 October 10, 2014

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  • 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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