UV PROTECT FACE SPF 50 (ZINC OXIDE, TITANIUM DIOXIDE) CREAM [NAOS]

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  • UV PROTECT FACE SPF 50 (ZINC OXIDE, TITANIUM DIOXIDE) CREAM [NAOS]

UV PROTECT FACE SPF 50 (ZINC OXIDE, TITANIUM DIOXIDE) CREAM [NAOS]
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NDC 14324-011-00
Set ID 64431eff-e7a8-2a22-e053-2991aa0aecf9
Category HUMAN OTC DRUG LABEL
Packager NAOS
Generic Name
Product Class
Product Number
Application Number PART352
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  • Drug Facts

  • Active Ingredients

    Zinc Oxide 20%

    Titanium Dioxide 8.82%

    Purpose

    Sunscreen

  • Uses

    Help prevent sunburn.

  • 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 a doctor if

    rash occurs

    Keep out reach of children.

    If swallowed, get medical help or contact a Poison Control Center right away.

  • Directions

    • Apply liberally, and spread evenly by hand 15 min before sun exposure. 
    • Reapply at least every 2 hours.
    • Use a water resistant sunscreen if swimming or sweating
    • 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-sleeve shirts, pants, hats and sunglasses.
    • Children under 6 months of age: Ask a doctor.
  • Other information

    • Keep the product between 15-30ºC.
    • Protect the product in this container from excessive heat and direct sun.
  • Inactive Ingredients

    Coco-caprylate/caprate, Caprylic/Capric Triglyceride, Methyl Methacrylate Crosspolymer, Dicaprylyl Ether, Dicaprylyl Carbonate, Silica Dimethyl Silylate, Oryza Sativa (Rice) Bran Oil, Polyhydroxystearic Acid, Tocopheryl Acetate, Stearic Acid, Alumina, Fragrance (Parfum), Stearyl Glycyrrhetinate, Tocopherol, Farnesol.

  • Questions?

    Call to 1 877 443 3762

  • Package Labeling:

    Outer Package2Inner Package2

  • INGREDIENTS AND APPEARANCE
    UV PROTECT FACE SPF 50 
    zinc oxide, titanium dioxide cream
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:14324-011
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    ZINC OXIDE (UNII: SOI2LOH54Z) (ZINC CATION - UNII:13S1S8SF37) ZINC CATION200 mg  in 1 mL
    TITANIUM DIOXIDE (UNII: 15FIX9V2JP) (TITANIUM DIOXIDE - UNII:15FIX9V2JP) TITANIUM DIOXIDE882 mg  in 1 mL
    Inactive Ingredients
    Ingredient NameStrength
    COCO-CAPRYLATE/CAPRATE (UNII: 8D9H4QU99H)  
    MEDIUM-CHAIN TRIGLYCERIDES (UNII: C9H2L21V7U)  
    DICAPRYLYL ETHER (UNII: 77JZM5516Z)  
    DICAPRYLYL CARBONATE (UNII: 609A3V1SUA)  
    SILICA DIMETHYL SILYLATE (UNII: EU2PSP0G0W)  
    WHITE RICE (UNII: A195V20H7A)  
    .ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)  
    STEARIC ACID (UNII: 4ELV7Z65AP)  
    ALUMINUM OXIDE (UNII: LMI26O6933)  
    STEARYL GLYCYRRHETINATE (UNII: 3YYE6VJS0P)  
    TOCOPHEROL (UNII: R0ZB2556P8)  
    FARNESOL (UNII: EB41QIU6JL)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:14324-011-001 in 1 BOX01/31/2018
    130 mL in 1 BOTTLE; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph not finalpart35201/31/2018
    Labeler - NAOS (263520841)
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