ROSILLIANCE MEDIUM/DARK SPF 30 BROAD SPECTRUM (SUNSCREEN) LIQUID [BELL INTERNATIONAL LABORATORIES, INC]

ROSILLIANCE MEDIUM/DARK SPF 30 BROAD SPECTRUM (SUNSCREEN) LIQUID [BELL INTERNATIONAL LABORATORIES, INC]
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NDC 76150-159-33
Set ID 5bd51da9-429e-f670-e053-2a91aa0a95b3
Category HUMAN OTC DRUG LABEL
Packager Bell International Laboratories, Inc
Generic Name
Product Class
Product Number
Application Number PART352
  • Active Ingredient

    Titanium Dioxide 5.6%

    Purpose

    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 skin 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

    reapply:

    • after 80 minutes of swiming or sweating
    • immediately after towel drying
    • 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 10am-2pm
    • wear long-sleeve shirts, pants, hats, and sunglasses

    Children under 6 months: Ask a doctor

  • Inactive ingredients

    Aluminum Hydroxide, Caprylhydroxamic acid, Caprylyl Glycol, Carthamus Tinctorius (ORGANIC Safflower) Seed Oil, Citrus Aurantium Dulcis (ORGANIC Orange) Fruit Water, Cocoglycerides, Commiphora Myrrha Leaf Cell Extract, Cucumis Sativus (ORGANIC Cucumber) Fruit Extract, Dicaprylyl Carbonate, Euterpe Oleracea Pulp Oil (ORGANIC) Flavor, Glycerin (ORGANIC), Helianthus Annuus (ORGANIC Sunflower) Seed Extract, Helianthus Annuus (ORGANIC Sunflower) Seed Oil, Hydrogen Dimethicone, Hydrolyzed Wheat Protein/PVP Crosspolymer, Hydroxyethyl Acrylate/Sodium Acryloyldimethyl Taurate Copolymer, Iron Oxides, Octyldodecyl Oleate, Oryza Sativa (ORGANIC Rise) Bran Oil, Plankton Extract, Propanediol, Rosa Samascena Leaf Cell Extract, ROsmarinus Officinalis (ORGANIC Rosemary) Leaf Extract, Sodium Citrate, Trisodium Ethylenediamine Disuccinate, Water, Xanthan Gum

  • Other information

    protect this product from excessive heat and direct sun

  • PDP

    PDP

  • INGREDIENTS AND APPEARANCE
    ROSILLIANCE MEDIUM/DARK  SPF 30 BROAD SPECTRUM
    sunscreen liquid
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:76150-159
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    TITANIUM DIOXIDE (UNII: 15FIX9V2JP) (TITANIUM DIOXIDE - UNII:15FIX9V2JP) TITANIUM DIOXIDE5.6 g  in 100 mL
    Inactive Ingredients
    Ingredient NameStrength
    WATER (UNII: 059QF0KO0R)  
    FERRIC OXIDE YELLOW (UNII: EX438O2MRT)  
    ORANGE (UNII: 5EVU04N5QU)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    SUNFLOWER SEED (UNII: R9N3379M4Z)  
    CAPRYLHYDROXAMIC ACID (UNII: UPY805K99W)  
    TRISODIUM ETHYLENEDIAMINE DISUCCINATE (UNII: YA22H34H9Q)  
    RICE BRAN OIL (UNII: LZO6K1506A)  
    SODIUM CITRATE (UNII: 1Q73Q2JULR)  
    XANTHAN GUM (UNII: TTV12P4NEE)  
    PROPANEDIOL (UNII: 5965N8W85T)  
    FERRIC OXIDE RED (UNII: 1K09F3G675)  
    FERROSOFERRIC OXIDE (UNII: XM0M87F357)  
    COCO-GLYCERIDES (UNII: ISE9I7DNUG)  
    CUCUMBER (UNII: YY7C30VXJT)  
    DICAPRYLYL CARBONATE (UNII: 609A3V1SUA)  
    CAPRYLYL GLYCOL (UNII: 00YIU5438U)  
    OCTYLDODECYL OLEATE (UNII: MCA43PK7MH)  
    ACAI OIL (UNII: Z0W6766A2W)  
    ALUMINUM HYDROXIDE (UNII: 5QB0T2IUN0)  
    HYDROGEN DIMETHICONE (13 CST) (UNII: 4QGR4P2YOI)  
    SAFFLOWER OIL (UNII: 65UEH262IS)  
    ROSEMARY (UNII: IJ67X351P9)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:76150-159-3345 mL in 1 BOTTLE, GLASS; Type 0: Not a Combination Product01/01/2016
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph not finalpart35201/01/2016
    Labeler - Bell International Laboratories, Inc (967781555)

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