Label: COOLA ROSILLIANCE MINERAL TINTED FACE MOISTURIZER SPF 30 GOLDEN HOUR- titanium dioxide lotion

  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None

Drug Label Information

Updated February 2, 2024

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  • 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 a doctor if skin rash occurs.
  • KEEP OUT OF REACH OF CHILDREN

    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 swimming or sweating. • Immediately after towel drying • At least every 2 hours
    • Sun Protection Measure: 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. to 2 p.m.
      • Wear long-sleeved shirts, pants, hats, and sun glasses.

  • INACTIVE INGREDIENT

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

  • OTHER SAFETY INFORMATION

    • Protect this product from excessive heat and direct sun
  • QUESTIONS

    Call 760-940-2125

  • PRINCIPAL DISPLAY PANEL

    1

  • INGREDIENTS AND APPEARANCE
    COOLA ROSILLIANCE MINERAL TINTED FACE MOISTURIZER SPF 30 GOLDEN HOUR 
    titanium dioxide lotion
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:79753-047
    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
    CUCUMBER (UNII: YY7C30VXJT)  
    DICAPRYLYL CARBONATE (UNII: 609A3V1SUA)  
    ROSEMARY (UNII: IJ67X351P9)  
    XANTHAN GUM (UNII: TTV12P4NEE)  
    ORANGE (UNII: 5EVU04N5QU)  
    ROSA X ALBA FLOWER OIL (UNII: FF1Y064QVO)  
    CAPRYLYL GLYCOL (UNII: 00YIU5438U)  
    SAFFLOWER OIL (UNII: 65UEH262IS)  
    ROSA CENTIFOLIA WHOLE (UNII: FQ84CRP97P)  
    CAPRYLHYDROXAMIC ACID (UNII: UPY805K99W)  
    PROPANEDIOL (UNII: 5965N8W85T)  
    FERRIC OXIDE YELLOW (UNII: EX438O2MRT)  
    ROSA DAMASCENA FLOWER (UNII: JWB78P295A)  
    ALUMINUM HYDROXIDE (UNII: 5QB0T2IUN0)  
    ROSA GALLICA FLOWER (UNII: X8W61WUV70)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    COMMIPHORA MYRRHA WHOLE (UNII: UU81N77RI7)  
    SUNFLOWER SEED (UNII: R9N3379M4Z)  
    SODIUM CITRATE (UNII: 1Q73Q2JULR)  
    ACAI OIL (UNII: Z0W6766A2W)  
    SUNFLOWER OIL (UNII: 3W1JG795YI)  
    POVIDONE, UNSPECIFIED (UNII: FZ989GH94E)  
    COCO-GLYCERIDES (UNII: ISE9I7DNUG)  
    TRISODIUM ETHYLENEDIAMINE DISUCCINATE (UNII: YA22H34H9Q)  
    RICE BRAN OIL (UNII: LZO6K1506A)  
    FERRIC OXIDE RED (UNII: 1K09F3G675)  
    FERROSOFERRIC OXIDE (UNII: XM0M87F357)  
    WATER (UNII: 059QF0KO0R)  
    HYDROXYETHYL ACRYLATE/SODIUM ACRYLOYLDIMETHYL TAURATE COPOLYMER (100000 MPA.S AT 1.5%) (UNII: 86FQE96TZ4)  
    HYDROLYZED WHEAT PROTEIN (ENZYMATIC, 3000 MW) (UNII: J2S07SB0YL)  
    OCTYLDODECYL OLEATE (UNII: MCA43PK7MH)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:79753-047-011 in 1 CARTON01/01/2017
    144 mL in 1 BOTTLE, GLASS; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC Monograph DrugM02001/01/2017
    Labeler - COOLA, LLC (956990290)
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