Label: GM COLLIN SPF 25 UVA - UVB URBAN PROTECTION VEIL SUNSCREEN- zinc oxide and titanium dioxide cream

  • NDC Code(s): 64127-234-01
  • Packager: Laboratoires Dermo-Cosmetik Inc.
  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None

Drug Label Information

Updated October 27, 2023

If you are a consumer or patient please visit this version.

  • SPL UNCLASSIFIED SECTION

    Product Facts / Drug Facts

  • ACTIVE INGREDIENT

    Active ingredients:Purpose
    Zinc Oxide 13.3%Sunscreen
    Titanium Dioxide 3.8%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. Shake well before each use.

    Do not useon damaged or broken skin.

    When using this productkeep out of eyes. Rinse with water to remove.

    Stop use and ask a doctorif rash occurs.

    Keep out of reach of children.

    If swallowed, get medical help or contact a Poison Control Center right away.

  • Directions

    Adults over 18 years old:

    • apply liberally 15 minutes before sun exposure.
    • reapply at least every 2 hours
    • use a water-resistant sunscreen if swimming or sweating
    • Sun Protection Measures: Spending time in the sun increases your risk of skin cancer and early skin aging.
      To decrease 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.
  • Other information

    • protect this product from excessive heat and direct sun.
    • keep at room temperature (15 - 30°C / 59 - 86°F)
  • Inactive ingredients

    1,2-HEXANEDIOL, ALUMINA, AQUA/WATER/EAU, ARGANIA SPINOSA KERNEL OIL, ASCORBYL PALMITATE, BISABOLOL, C12-15 ALKYL BENZOATE, FARNESOL, FRAGRANCE/PARFUM, HYDROGEN DIMETHICONE, ISODECYL LAURATE, MAGNESIUM SULFATE, NEOPENTYL GLYCOL DIETHYLHEXANOATE, PHENOXYETHANOL, POLYGLYCERYL-6 POLYHYDROXYSTEARATE, POLYGLYCERYL-6 POLYRICINOLEATE, POLYHYDROXYSTEARIC ACID, POTASSIUM SORBATE, PROPANEDIOL DICAPRYLATE, TOCOPHEROL, TOCOPHERYL ACETATE, TRIETHOXYCAPRYLYLSILANE.

  • Questions?

    USA: 1 (800) 341-1531 / CANADA: 1 (800) 361-1263

  • SPL UNCLASSIFIED SECTION

    DISTRIBUTED BY:
    ® LABORATOIRES DERMO-COSMETIK INC.
    68 STINSON, MONTREAL, QUEBEC, CANADA H4N 2E7

  • PRINCIPAL DISPLAY PANEL - 100 ml Bottle Box

    G.M. COLLIN ®

    C

    SPF
    25
    UVA∙UVB

    URBAN PROTECTION VEIL

    Broad Spectrum
    Mineral Sunscreen

    NDC 64127-234-01
    NPN 801xxxxx
    06886

    100 ml - 3.4 fl. oz.

    PRINCIPAL DISPLAY PANEL - 100 ml Bottle Box
  • INGREDIENTS AND APPEARANCE
    GM COLLIN  SPF 25 UVA - UVB URBAN PROTECTION VEIL SUNSCREEN
    zinc oxide and titanium dioxide cream
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:64127-234
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    ZINC OXIDE (UNII: SOI2LOH54Z) (ZINC OXIDE - UNII:SOI2LOH54Z) ZINC OXIDE14.6 mg  in 100 mL
    TITANIUM DIOXIDE (UNII: 15FIX9V2JP) (TITANIUM DIOXIDE - UNII:15FIX9V2JP) TITANIUM DIOXIDE4.2 mg  in 100 mL
    Inactive Ingredients
    Ingredient NameStrength
    1,2-HEXANEDIOL (UNII: TR046Y3K1G)  
    ALUMINUM OXIDE (UNII: LMI26O6933)  
    WATER (UNII: 059QF0KO0R)  
    ARGAN OIL (UNII: 4V59G5UW9X)  
    ASCORBYL PALMITATE (UNII: QN83US2B0N)  
    LEVOMENOL (UNII: 24WE03BX2T)  
    ALKYL (C12-15) BENZOATE (UNII: A9EJ3J61HQ)  
    FARNESOL (UNII: EB41QIU6JL)  
    ISODECYL LAURATE (UNII: 254BX4O0JU)  
    MAGNESIUM SULFATE, UNSPECIFIED FORM (UNII: DE08037SAB)  
    NEOPENTYL GLYCOL DIETHYLHEXANOATE (UNII: U68ZV6W62C)  
    PHENOXYETHANOL (UNII: HIE492ZZ3T)  
    POLYGLYCERYL-6 POLYRICINOLEATE (UNII: YPM0ZOC2HR)  
    POTASSIUM SORBATE (UNII: 1VPU26JZZ4)  
    PROPANEDIOL DICAPRYLATE (UNII: C577OMC6UH)  
    TOCOPHEROL (UNII: R0ZB2556P8)  
    .ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)  
    TRIETHOXYCAPRYLYLSILANE (UNII: LDC331P08E)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:64127-234-011 in 1 BOX01/15/2021
    1100 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC Monograph DrugM02001/15/2021
    Labeler - Laboratoires Dermo-Cosmetik Inc. (249335480)
    Establishment
    NameAddressID/FEIBusiness Operations
    Dermolab Pharma Ltd245414743manufacture(64127-234)