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

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

ROSACLEAR SKIN BALANCING SUN PROTECTION SPF 30 SUNCREEN (TITANIUM DIOXIDE AND ZINC OXIDE) LOTION [OMP, INC.]
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NDC 62032-103-90
Set ID 8017e35e-ddf7-4d57-84b4-7e591448095e
Category HUMAN OTC DRUG LABEL
Packager OMP, Inc.
Generic Name
Product Class
Product Number
Application Number PART352
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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
    • higher SPF gives more sunburn protection.
  • Warnings

    For external use only.

    When using this product

    • keep out of eyes. Rinse with water to remove.

    Stop use and ask a doctor if

    • rash or irritation develops and lasts.

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

  • Directions

    • apply liberally before sun exposure and as needed.
    • children under 6 months of age: ask a doctor.
    • reapply as needed or after towel drying, swimming, or sweating.
  • Other information

    • store at controlled room temperature: 15-25°C (59-77°F).
    • Sun Alert: Limiting sun exposure, wearing protective clothing, and using sunscreens may reduce the risks of skin aging, skin cancer and other harmful effects of the sun.
  • Inactive ingredients

    Alumina, Butylparaben, Cetearyl Alcohol, Coco-Glucoside, C12-15 Alkyl Benzoate, Dipropylene Glycol, PEG-6, Ethylparaben, Glycerin, Hydroxyethyl Acrylate/ Sodium Acryloyldimethyl Taurate Copolymer, Iron Oxides, Isobutylparaben, Isohexadecane, Isopropyl Titanium Triisostearate/Triethoxycaprylylsilane Crosspolymer, Methylparaben, Mica, Phenoxyethanol, Polyhydroxystearic Acid, Propylparaben,Tocopheryl Acetate, Triethoxycaprylylsilane, Water.

  • SPL UNCLASSIFIED SECTION

    Dist. by OMP, Inc.
    3760 Kilroy Airport Way Suite 500
    Long Beach, CA 90806

  • PRINCIPAL DISPLAY PANEL - 88 mL Bottle Label

    OBAGI®
    MEDICAL

    rosaclear®
    system

    ∙ NON-COMEDOGENIC ∙ NON-COMEDOGENIC

    SKIN BALANCING
    SUN PROTECTION
    SPF 30
    SUNSCREEN LOTION

    3 FL.OZ. (88 mL)

    Principal Display Panel - 88 mL Bottle Label
  • INGREDIENTS AND APPEARANCE
    ROSACLEAR SKIN BALANCING SUN PROTECTION SPF 30   SUNCREEN
    titanium dioxide and zinc oxide lotion
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:62032-103
    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:62032-103-9088 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(62032-103)
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