Label: COOLA BARE REPUBLIC CLEARSCREEN SPF100- avobenzone, homosalate, octisalate, octocrylene lotion

  • Category: HUMAN OTC DRUG LABEL

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 January 2, 2023

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  • Active ingredients

    Avobenzone 3.0%

    Homosalate 15.0%

    Octisalate 5.0%

    Octocrylene 10.0%

  • 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

    • rash occurs.
  • Keep out of the reach of children

    If 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

    • children under 6 months of age: 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

  • Other information

    • protect this product from excessive heat and direct sun
    • may stain or damage some fabrics, materials or surfaces
  • Inactive Ingredients

    Water, Butyloctyl Salicylate, Tridecyl Salicylate, Isodecyl Neopentanoate, Acrylates/Dimethicone Copolymer, Diisopropyl Sebacate, Lauryl Lactate, Daucus Carota Sativa (Carrot) Seed Oil, Rubus Idaeus (Raspberry) Seed Seed Oil, Vitis Vinifera (Grape) Seed Oil, Sodium Hyaluronate, Tocopherol, Behenyl Alcohol, Glycerin, Silica, Phenethyl Alcohol, Arachidyl Alcohol, Glyceryl Behenate, Arachidyl Glucoside, Lecithin, Glyceryl Caprylate, Polyurethane-62, Sodium Phytate, Sodium Poluacrylate, Ethylhexyl Stearate, Chlorphenesin, Ammonium Acryloyldimethyltaurate/VP Copolymer, Trideceth-6, Fragrance (Natural)

  • Label

    BR10224_v02

  • INGREDIENTS AND APPEARANCE
    COOLA BARE REPUBLIC CLEARSCREEN SPF100 
    avobenzone, homosalate, octisalate, octocrylene lotion
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:79753-022
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    HOMOSALATE (UNII: V06SV4M95S) (HOMOSALATE - UNII:V06SV4M95S) HOMOSALATE150 mg  in 1 mL
    AVOBENZONE (UNII: G63QQF2NOX) (AVOBENZONE - UNII:G63QQF2NOX) AVOBENZONE30 mg  in 1 mL
    OCTOCRYLENE (UNII: 5A68WGF6WM) (OCTOCRYLENE - UNII:5A68WGF6WM) OCTOCRYLENE100 mg  in 1 mL
    OCTISALATE (UNII: 4X49Y0596W) (OCTISALATE - UNII:4X49Y0596W) OCTISALATE50 mg  in 1 mL
    Inactive Ingredients
    Ingredient NameStrength
    WATER (UNII: 059QF0KO0R)  
    RASPBERRY SEED OIL (UNII: 9S8867952A)  
    CHLORPHENESIN (UNII: I670DAL4SZ)  
    HYALURONATE SODIUM (UNII: YSE9PPT4TH)  
    CARROT SEED OIL (UNII: 595AO13F11)  
    .ALPHA.-TOCOPHEROL, DL- (UNII: 7QWA1RIO01)  
    GRAPE SEED OIL (UNII: 930MLC8XGG)  
    ARACHIDYL ALCOHOL (UNII: 1QR1QRA9BU)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    BUTYLOCTYL SALICYLATE (UNII: 2EH13UN8D3)  
    TRIDECYL SALICYLATE (UNII: AZQ08K38Z1)  
    DOCOSANOL (UNII: 9G1OE216XY)  
    GLYCERYL MONOBEHENATE (UNII: A626UU0W2A)  
    PHYTATE SODIUM (UNII: 88496G1ERL)  
    POLYURETHANE-62 (UNII: TBK645J3J8)  
    LAURYL LACTATE (UNII: G5SU0BFK7O)  
    LECITHIN, SOYBEAN (UNII: 1DI56QDM62)  
    ARACHIDYL GLUCOSIDE (UNII: 6JVW35JOOJ)  
    SILICON DIOXIDE (UNII: ETJ7Z6XBU4)  
    AMMONIUM ACRYLOYLDIMETHYLTAURATE/VP COPOLYMER (UNII: W59H9296ZG)  
    ISODECYL NEOPENTANOATE (UNII: W60VYE24XC)  
    DIISOPROPYL SEBACATE (UNII: J8T3X564IH)  
    2-ETHYLHEXYL ACRYLATE, METHACRYLATE, METHYL METHACRYLATE, OR BUTYL METHACRYLATE/HYDROXYPROPYL DIMETHICONE COPOLYMER (30000-300000 MW) (UNII: S7ZA3CCJ4M)  
    SODIUM POLYACRYLATE (2500000 MW) (UNII: 05I15JNI2J)  
    ETHYLHEXYL STEARATE (UNII: EG3PA2K3K5)  
    TRIDECETH-6 (UNII: 3T5PCR2H0C)  
    GLYCERYL CAPRYLATE (UNII: TM2TZD4G4A)  
    PHENYLETHYL ALCOHOL (UNII: ML9LGA7468)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:79753-022-01148 mL in 1 TUBE; Type 0: Not a Combination Product10/21/2021
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph not finalpart35210/21/2021
    Labeler - COOLA, LLC (956990290)
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