Label: BRIGHTENING PRIMER SPF 20- titanium dioxide and zinc oxide liquid

  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None
  • Marketing Status: OTC monograph not 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 October 29, 2021

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  • SPL UNCLASSIFIED SECTION

    Drug Facts

  • ACTIVE INGREDIENT

    Active ingredientsPurpose
    Titanium Dioxide 5.0%Sunscreen
    Zinc Oxide 4.5%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 rash occurs.

    Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center right away.

  • Directions

    • Apply liberally 15 minutes before sun exposure. Works best on moisturized skin.
    • Reapply:
      • After 40 minutes of swimming or sweating.
      • Immediately after towel drying.
      • At least every 2 hours.
    • Children under 6 months: ask a doctor.
    • 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-sleeved shirts, pants, hats, and sunglasses.
  • Inactive ingredients

    Cyclopentasiloxane, Dimethicone Crosspolymer, Caprylic/Capric Triglyceride, Aqua/Water, Glycerin, Dimethicone/Vinyl Dimethicone Crosspolymer, Tocopherol Acetate, Mica, Simmondsia Chinensis (Jojoba) Seed Oil, Hydrolyzed Rice Protein, Dimethiconol, Avena Sativa (Oat) Kernel Protein, Spirulina Maxima Extract, Alumina, Silica, Jojoba Esters, Polyhydroxystearic Acid, Glyceryl Behenate/Eicosadioate, Aloe Barbadensis Leaf Extract, Melaleuca Alternifolia (Tea Tree) Leaf Oil, Lavandula Angustifolia (Lavender) Oil, Citrus Reticulata (Tangerine) Peel Oil, Palmeria Palmata Extract, Camellia Sinensis Leaf Extract, Lauroyl Lysine, Palmitoyl Tripeptide-5, Glycine Soja (Soybean) Oil, Tocopherol, Phenoxyethanol, Ethylhexylglycerin, Sodium Benzoate, Limonene, Linalool, Beta Carotene (CI 40800).

  • Other information

    • Protect this product from excessive heat and direct sun.
  • Questions or comments?

    Call toll free 866.426.5673

  • PRINCIPAL DISPLAY PANEL - 30 mL Bottle Carton

    colorescience®

    BRIGHTENING
    PRIMER

    3-IN-1 FACE PRIMER

    Illuminates skin tone
    Revives dull looking skin
    Extends makeup wear

    20
    Broad Spectrum
    SPF 20 Sunscreen
    PA+++

    CHEMICAL-FREE ACTIVES | 100% MINERAL
    WATER/SWEAT RESISTANT (40 MINUTES)

    1 fl. oz. / 30 mL

    Principal Display Panel - 30 mL Bottle Carton
  • INGREDIENTS AND APPEARANCE
    BRIGHTENING PRIMER SPF 20 
    titanium dioxide and zinc oxide liquid
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:68078-037
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    Titanium Dioxide (UNII: 15FIX9V2JP) (Titanium Dioxide - UNII:15FIX9V2JP) Titanium Dioxide50 mg  in 1 mL
    Zinc Oxide (UNII: SOI2LOH54Z) (Zinc Oxide - UNII:SOI2LOH54Z) Zinc Oxide4.5 mg  in 1 mL
    Inactive Ingredients
    Ingredient NameStrength
    CYCLOMETHICONE 5 (UNII: 0THT5PCI0R)  
    DIMETHICONE CROSSPOLYMER (450000 MPA.S AT 12% IN CYCLOPENTASILOXANE) (UNII: UF7620L1W6)  
    MEDIUM-CHAIN TRIGLYCERIDES (UNII: C9H2L21V7U)  
    WATER (UNII: 059QF0KO0R)  
    Glycerin (UNII: PDC6A3C0OX)  
    DIMETHICONE (UNII: 92RU3N3Y1O)  
    .ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)  
    Mica (UNII: V8A1AW0880)  
    JOJOBA OIL (UNII: 724GKU717M)  
    DIMETHICONOL (100000 CST) (UNII: OSA9UP217S)  
    OAT (UNII: Z6J799EAJK)  
    ARTHROSPIRA MAXIMA (UNII: 9K7IG15M0Q)  
    ALUMINUM OXIDE (UNII: LMI26O6933)  
    SILICON DIOXIDE (UNII: ETJ7Z6XBU4)  
    POLYHYDROXYSTEARIC ACID (2300 MW) (UNII: YXH47AOU0F)  
    Glyceryl Behenate/Eicosadioate (UNII: 73CJJ317SR)  
    ALOE VERA LEAF (UNII: ZY81Z83H0X)  
    TEA TREE OIL (UNII: VIF565UC2G)  
    LAVENDER OIL (UNII: ZBP1YXW0H8)  
    MANDARIN OIL (UNII: NJO720F72R)  
    PALMARIA PALMATA (UNII: 7832HOY4ZQ)  
    GREEN TEA LEAF (UNII: W2ZU1RY8B0)  
    Lauroyl Lysine (UNII: 113171Q70B)  
    Palmitoyl Tripeptide-5 (UNII: 2A3916MQHO)  
    SOYBEAN OIL (UNII: 241ATL177A)  
    Tocopherol (UNII: R0ZB2556P8)  
    Phenoxyethanol (UNII: HIE492ZZ3T)  
    Ethylhexylglycerin (UNII: 147D247K3P)  
    Sodium Benzoate (UNII: OJ245FE5EU)  
    LIMONENE, (+)- (UNII: GFD7C86Q1W)  
    LINALOOL, (+/-)- (UNII: D81QY6I88E)  
    BETA CAROTENE (UNII: 01YAE03M7J)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:68078-037-011 in 1 CARTON01/01/2020
    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 FINALpart35201/01/2020
    Labeler - Colorescience (128731929)
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