SUNTAN LOTION (OCTINOXATE OXYBENZONE TITANIUM DIOXIDE) LOTION [TRI-COASTAL DESIGN COMPANY INC. ]

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SUNTAN LOTION (OCTINOXATE OXYBENZONE TITANIUM DIOXIDE) LOTION [TRI-COASTAL DESIGN COMPANY INC. ]
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NDC 49852-200-60
Set ID 8b530719-0124-4eca-a6ae-16c0cd300d2a
Category HUMAN OTC DRUG LABEL
Packager Tri-Coastal Design Company Inc.
Generic Name
Product Class
Product Number
Application Number PART352
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  • Active Ingredient

    Octyl Methoxycinnamate 7%

    Oxybenzone 6%

    Titanium Dioxide 1%



  • Purpose

    Sunscreen

  • Uses

    • Helps prevent sunburn
  • Warnings

    • Keep out of eyes. If contact occurs, rinse thoroughly with water.

  • Stop use and ask a doctor if

    • irritation develops
  • Keep out of reach of children

    • If swallowed, get medical help promptly or contact Poison Control immediately.
  • Directions

    • Apply generously and evenly before sun exposure. Reapply as needed or after towel drying, swimming or perspiring. Ask doctor before use on children under 6 months of age
  • Inactive Ingredients

    Caprylic/Capric Triglyceride, Cetearyl Alcohol, Cylcomethicone, Disodium EDTA, Fragrance, Glycerin, Imidazolidinyl Urea, Isopropyl Myristate, Methylparaben, Potassium Cetyl Phosphate, Propylparaben, Tocopheryl Acetate, Water (Aqua), Xanthan Gum

  • Package Label

    Package Label
    image of package label






  • INGREDIENTS AND APPEARANCE
    SUNTAN LOTION 
    octinoxate oxybenzone titanium dioxide lotion
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:49852-200
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    OCTINOXATE (UNII: 4Y5P7MUD51) (OCTINOXATE - UNII:4Y5P7MUD51) OCTINOXATE7 mL  in 100 mL
    OXYBENZONE (UNII: 95OOS7VE0Y) (OXYBENZONE - UNII:95OOS7VE0Y) OXYBENZONE6 mL  in 100 mL
    TITANIUM DIOXIDE (UNII: 15FIX9V2JP) (TITANIUM DIOXIDE - UNII:15FIX9V2JP) TITANIUM DIOXIDE1 mL  in 100 mL
    Inactive Ingredients
    Ingredient NameStrength
    MEDIUM-CHAIN TRIGLYCERIDES (UNII: C9H2L21V7U)  
    CETOSTEARYL ALCOHOL (UNII: 2DMT128M1S)  
    CYCLOMETHICONE (UNII: NMQ347994Z)  
    EDETATE DISODIUM (UNII: 7FLD91C86K)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    ISOPROPYL MYRISTATE (UNII: 0RE8K4LNJS)  
    METHYLPARABEN (UNII: A2I8C7HI9T)  
    POTASSIUM CETYL PHOSPHATE (UNII: 03KCY6P7UT)  
    PROPYLPARABEN (UNII: Z8IX2SC1OH)  
    WATER (UNII: 059QF0KO0R)  
    XANTHAN GUM (UNII: TTV12P4NEE)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:49852-200-6060 mL in 1 TUBE
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph finalpart35202/28/2010
    Labeler - Tri-Coastal Design Company Inc. (609734900)
    Establishment
    NameAddressID/FEIBusiness Operations
    Guangzhou St Eva Fine Chemical Co Ltd 528039793manufacture
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