Label: CALMING 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 2, 2018

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  • SPL UNCLASSIFIED SECTION

    Drug Facts

  • ACTIVE INGREDIENT

    Active ingredientsPurpose
    Titanium Dioxide 5.4%Sunscreen
    Zinc Oxide 5.4%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, Caprylic/Capric Triglyceride, Dimethicone Crosspolymer, Glycerin, Water, Dimethicone/Vinyl Dimethicone Crosspolymer, Cucumis Sativus (Cucumber) Fruit Extract, Spirulina Maxima Extract, Camellia Sinensis Leaf Extract, Opuntia Ficus-Indica Stem Extract, Palmaria Palmata Extract, Disodium Lauriminodipropionate Tocopheryl Phosphates, Citrus Paradisi (Grapefruit) Seed Extract, Ascorbic Acid, Dimethiconol, Dimethicone, Triethoxycaprylylsilane, Benzoic Acid, Dehydroacetic Acid, Phenoxyethanol, Iron Oxides (CI 77491, CI 77492, CI 77499)

  • 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®

    CALMING
    PERFECTOR

    3-IN-1 FACE PRIMER

    Neutralizes redness

    Soothes & nourishes 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
    CALMING PERFECTOR SPF 20 SUNSCREEN 
    titanium dioxide and zinc oxide liquid
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:68078-017
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    Titanium Dioxide (UNII: 15FIX9V2JP) (Titanium Dioxide - UNII:15FIX9V2JP) Titanium Dioxide54 mg  in 1 mL
    Zinc Oxide (UNII: SOI2LOH54Z) (Zinc Oxide - UNII:SOI2LOH54Z) Zinc Oxide54 mg  in 1 mL
    Inactive Ingredients
    Ingredient NameStrength
    Cyclomethicone 5 (UNII: 0THT5PCI0R)  
    Medium-Chain Triglycerides (UNII: C9H2L21V7U)  
    Dimethicone Crosspolymer (450000 MPA.S at 12% in Cyclopentasiloxane) (UNII: UF7620L1W6)  
    Glycerin (UNII: PDC6A3C0OX)  
    Water (UNII: 059QF0KO0R)  
    Dimethicone/Vinyl Dimethicone Crosspolymer (Soft Particle) (UNII: 9E4CO0W6C5)  
    Cucumber (UNII: YY7C30VXJT)  
    Arthrospira Maxima (UNII: 9K7IG15M0Q)  
    Green Tea Leaf (UNII: W2ZU1RY8B0)  
    Opuntia Ficus-Indica Stem (UNII: MUD8892KHL)  
    Dulse (UNII: 7832HOY4ZQ)  
    Disodium Lauriminodipropionate Tocopheryl Phosphates (UNII: 0K5Y9U1P6M)  
    Citrus Paradisi Seed (UNII: 12F08874Y7)  
    Ascorbic Acid (UNII: PQ6CK8PD0R)  
    Dimethiconol (100000 CST) (UNII: OSA9UP217S)  
    Dimethicone (UNII: 92RU3N3Y1O)  
    Triethoxycaprylylsilane (UNII: LDC331P08E)  
    Benzoic Acid (UNII: 8SKN0B0MIM)  
    Dehydroacetic Acid (UNII: 2KAG279R6R)  
    Phenoxyethanol (UNII: HIE492ZZ3T)  
    Ferric Oxide Yellow (UNII: EX438O2MRT)  
    Ferric Oxide Red (UNII: 1K09F3G675)  
    Ferrosoferric Oxide (UNII: XM0M87F357)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:68078-017-181 in 1 CARTON02/01/2017
    130 mL in 1 TUBE; Type 0: Not a Combination Product
    2NDC:68078-017-021 mL in 1 PACKET; Type 0: Not a Combination Product02/01/2017
    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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