Label: BRIGHTENING PERFECTOR SPF 20 SUNSCREEN- 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 November 6, 2018

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  • SPL UNCLASSIFIED SECTION

    Drug Facts

  • ACTIVE INGREDIENT

    Active ingredientsPurpose
    Titanium Dioxide 2.5%Sunscreen
    Zinc Oxide 3.9%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, Ethylhexyl Hydroxystearate Benzoate, Glycerin, Dimethicone/Vinyl Dimethicone Crosspolymer, Water, Dimethiconol, Tocopheryl Acetate, Simmondsia Chinensis (Jojoba) Seed Oil, Dimethicone, Stearic Acid, Citrus Paradisi (Grapefruit) Seed Extract, Cyclohexasiloxane, Spirulina Maxima Extract, Melaleuca Alternifolia (Tea Tree) Leaf Oil, Lavandula Angustifolia (Lavender) Oil, Citrus Reticulata (Tangerine) Peel Oil, Avena Sativa (Oat) Kernel Protein, Melissa Officinalis Leaf Powder, Aloe Barbadensis Leaf Extract, Glycine Soja (Soybean) Oil, Palmeria Palmata Extract, Camellia Sinensis Leaf Extract, Beta-Glucan, Avena Sativa (Oat) Kernel Extract, Triethoxycaprylylsilane, Ascorbic Acid, Aluminum Hydroxide, Phenoxyethanol, 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

  • SPL UNCLASSIFIED SECTION

    Distributed in USA by
    Colorescience®
    Carlsbad, CA 92011

  • PRINCIPAL DISPLAY PANEL - 30 mL Tube Carton

    colorescience®

    BRIGHTENING
    PERFECTOR

    3-IN-1 FACE PRIMER

    Illuminates skin tone

    Revives dull looking skin

    Water resistant
    (40 minutes)

    20
    Broad Spectrum
    SPF 20
    Sunscreen

    1 fl. oz. / 30 mL

    PRINCIPAL DISPLAY PANEL - 30 mL Tube Carton
  • INGREDIENTS AND APPEARANCE
    BRIGHTENING PERFECTOR SPF 20 SUNSCREEN 
    titanium dioxide and zinc oxide liquid
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:68078-015
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    Titanium Dioxide (UNII: 15FIX9V2JP) (Titanium Dioxide - UNII:15FIX9V2JP) Titanium Dioxide25 mg  in 1 mL
    Zinc Oxide (UNII: SOI2LOH54Z) (Zinc Oxide - UNII:SOI2LOH54Z) Zinc Oxide39 mg  in 1 mL
    Inactive Ingredients
    Ingredient NameStrength
    Cyclomethicone 5 (UNII: 0THT5PCI0R)  
    DIMETHICONE CROSSPOLYMER (450000 MPA.S AT 12% IN CYCLOPENTASILOXANE) (UNII: UF7620L1W6)  
    Ethylhexyl Hydroxystearate Benzoate (UNII: 3W8F25684B)  
    Glycerin (UNII: PDC6A3C0OX)  
    DIMETHICONE/VINYL DIMETHICONE CROSSPOLYMER (SOFT PARTICLE) (UNII: 9E4CO0W6C5)  
    Water (UNII: 059QF0KO0R)  
    DIMETHICONOL (100000 CST) (UNII: OSA9UP217S)  
    .Alpha.-Tocopherol Acetate (UNII: 9E8X80D2L0)  
    JOJOBA OIL (UNII: 724GKU717M)  
    Dimethicone (UNII: 92RU3N3Y1O)  
    Stearic Acid (UNII: 4ELV7Z65AP)  
    CITRUS PARADISI SEED (UNII: 12F08874Y7)  
    Cyclomethicone 6 (UNII: XHK3U310BA)  
    ARTHROSPIRA MAXIMA (UNII: 9K7IG15M0Q)  
    TEA TREE OIL (UNII: VIF565UC2G)  
    LAVENDER OIL (UNII: ZBP1YXW0H8)  
    CITRUS RETICULATA LEAF OIL (UNII: 1515UE78IH)  
    OAT (UNII: Z6J799EAJK)  
    MELISSA OFFICINALIS LEAF (UNII: 50D2ZE9219)  
    ALOE VERA LEAF (UNII: ZY81Z83H0X)  
    SOYBEAN OIL (UNII: 241ATL177A)  
    DULSE (UNII: 7832HOY4ZQ)  
    GREEN TEA LEAF (UNII: W2ZU1RY8B0)  
    POLYSACCHARIDE-K (UNII: 3X48A86C8K)  
    Triethoxycaprylylsilane (UNII: LDC331P08E)  
    Ascorbic Acid (UNII: PQ6CK8PD0R)  
    Aluminum Hydroxide (UNII: 5QB0T2IUN0)  
    Phenoxyethanol (UNII: HIE492ZZ3T)  
    Limonene, (+)- (UNII: GFD7C86Q1W)  
    .BETA.-CAROTENE (UNII: 01YAE03M7J)  
    LINALOOL, (+/-)- (UNII: D81QY6I88E)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:68078-015-161 in 1 CARTON02/01/2017
    130 mL in 1 TUBE; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC MONOGRAPH NOT FINALpart35202/01/2017
    Labeler - Colorescience (128731929)
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