Label: OBAGI MEDICAL PHYSICAL DEFENSE BROAD SPECTRUM MINERAL SUNSCREEN SPF 40 BY SUZANOBAGIMD- titanium dioxide and zinc oxide cream

  • NDC Code(s): 62032-607-35
  • Packager: Obagi Cosmeceuticals LLC
  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None
  • Marketing Status: OTC monograph final

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 May 4, 2021

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  • SPL UNCLASSIFIED SECTION

    Drug Facts

  • ACTIVE INGREDIENT

    Active Ingredients
    Titanium Dioxide 4.5%Sunscreen
    Zinc Oxide 12.8%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

    When using this product keep out of eyes. Rinse with water to remove.

    Stop use and ask doctor if rash occurs

    Keep out of reach of children. If product is 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
    • 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 physician
  • Inactive Ingredients

    Water (Aqua), Caprylic/Capric Triglyceride, Dicaprylyl Carbonate, Glycerin, Cetearyl Alcohol, Dimethicone, Propanediol, Polyhydroxystearic Acid, Cetearyl Glucoside, Aloe Barbadensis Leaf Extract, Brassica Oleracea Italica (Broccoli) Extract, Bioflavonoids, Dipotassium Glycyrrhizate, Polyglyceryl- 2, Dipolyhydroxystearate, Sodium Stearoyl Glutamate, Stearic Acid, Lauryl Glucoside, Triethoxycaprylylsilane, Xanthan Gum, Silica, Alumina, Caprylhydroxamic Acid, Disodium EDTA, Caprylyl Glycol, Phenoxyethanol

  • 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

    Distributed by Obagi Cosmeceuticals LLC,
    Long Beach, CA 90806

  • PRINCIPAL DISPLAY PANEL - 96.3 g Tube Carton

    OBAGI®
    MEDICAL

    PHYSICAL DEFENSE
    40
    Broad Spectrum Mineral Sunscreen
    SPF 40 • PA++++
    Lightweight and Sheer

    BY SUZANOBAGIMD™

    HEV • VIS • IR Protection

    Net wt. 3.4 oz. (96.3 g)

    PRINCIPAL DISPLAY PANEL - 96.3 g Tube Carton
  • INGREDIENTS AND APPEARANCE
    OBAGI MEDICAL PHYSICAL DEFENSE BROAD SPECTRUM MINERAL SUNSCREEN SPF 40 BY SUZANOBAGIMD 
    titanium dioxide and zinc oxide cream
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:62032-607
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    Titanium Dioxide (UNII: 15FIX9V2JP) (Titanium Dioxide - UNII:15FIX9V2JP) Titanium Dioxide45 mg  in 1 g
    Zinc Oxide (UNII: SOI2LOH54Z) (Zinc Oxide - UNII:SOI2LOH54Z) Zinc Oxide128 mg  in 1 g
    Inactive Ingredients
    Ingredient NameStrength
    Water (UNII: 059QF0KO0R)  
    MEDIUM-CHAIN TRIGLYCERIDES (UNII: C9H2L21V7U)  
    Dicaprylyl Carbonate (UNII: 609A3V1SUA)  
    Glycerin (UNII: PDC6A3C0OX)  
    CETOSTEARYL ALCOHOL (UNII: 2DMT128M1S)  
    Dimethicone (UNII: 92RU3N3Y1O)  
    Propanediol (UNII: 5965N8W85T)  
    Cetearyl Glucoside (UNII: 09FUA47KNA)  
    ALOE VERA LEAF (UNII: ZY81Z83H0X)  
    Broccoli (UNII: UOI4FT57BZ)  
    CITRUS BIOFLAVONOIDS (UNII: BD70459I50)  
    GLYCYRRHIZINATE DIPOTASSIUM (UNII: CA2Y0FE3FX)  
    Sodium Stearoyl Glutamate (UNII: 65A9F4P024)  
    Stearic Acid (UNII: 4ELV7Z65AP)  
    Lauryl Glucoside (UNII: 76LN7P7UCU)  
    Triethoxycaprylylsilane (UNII: LDC331P08E)  
    Xanthan Gum (UNII: TTV12P4NEE)  
    SILICON DIOXIDE (UNII: ETJ7Z6XBU4)  
    ALUMINUM OXIDE (UNII: LMI26O6933)  
    Caprylhydroxamic Acid (UNII: UPY805K99W)  
    EDETATE DISODIUM ANHYDROUS (UNII: 8NLQ36F6MM)  
    Caprylyl Glycol (UNII: 00YIU5438U)  
    Phenoxyethanol (UNII: HIE492ZZ3T)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:62032-607-351 in 1 CARTON04/01/2020
    196.3 g in 1 TUBE; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph finalpart35204/01/2020
    Labeler - Obagi Cosmeceuticals LLC (790553353)
    Establishment
    NameAddressID/FEIBusiness Operations
    G.S.COSMECEUTICAL USA017014734MANUFACTURE(62032-607)
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