Label: COOLA BARE REPUBLIC MINERAL SPORT SPF50- titanium dioxide, zinc oxide lotion

  • NDC Code(s): 79753-029-71, 79753-029-72
  • Packager: COOLA, LLC
  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None

Drug Label Information

Updated October 23, 2024

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

  • Active ingredients

    Titanium Dioxide 2.9%, Zinc Oxide 7.8

  • 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

    Alcohol, AleuritesMoluccana (Kukui) Seed Oil, Algae Exract, Allyl Heptoate, Aloe Barbadensis Leaf Juice, Butyloctyl Salicylate, C30-38 Olefin/Isopropyl Maleate/MA Copolymer, Caprylic/Capric Triglyceride, Caprylyl Glycol, Cetyl PEG/PPG-10/1 Dimethicone, Cocos Nucifera (Coconut) Oil, Dimethicone, Ethylhexyl Methoxycrylene, Ethylhexylglycerin, Gamma Decalactone, Gamma Nonalactone, Gamma Octalactone, Glycerin, Heliotropine, Isohecxadecane, Lauryl PEG-8 Dimethicone, Octyldodecyl Citrate Crosspolymer, PEG-8, Phenylpropenol, Raspberry Ketone, Silica, Sodium Chloride, Sodium Citrate, Tocopheryl Acetate, Triethoxycaprylylsilane, Triethyl Citrate, Vanillin, Vegan Beeswax, Water

  • Label

    CA00704

    CA00783

  • INGREDIENTS AND APPEARANCE
    COOLA BARE REPUBLIC MINERAL SPORT SPF50 
    titanium dioxide, zinc oxide lotion
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:79753-029
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    ZINC OXIDE (UNII: SOI2LOH54Z) (ZINC OXIDE - UNII:SOI2LOH54Z) ZINC OXIDE78 mg  in 1 mL
    TITANIUM DIOXIDE (UNII: 15FIX9V2JP) (TITANIUM DIOXIDE - UNII:15FIX9V2JP) TITANIUM DIOXIDE29 mg  in 1 mL
    Inactive Ingredients
    Ingredient NameStrength
    GLYCERIN (UNII: PDC6A3C0OX)  
    KUKUI NUT OIL (UNII: TP11QR7B8R)  
    ALLYL HEPTANOATE (UNII: AU4CYG9V68)  
    ISOHEXADECANE (UNII: 918X1OUF1E)  
    SILICON DIOXIDE (UNII: ETJ7Z6XBU4)  
    LAURYL PEG/PPG-18/18 METHICONE (UNII: ZJ5S27D9NX)  
    BUTYLOCTYL SALICYLATE (UNII: 2EH13UN8D3)  
    CETYL PEG/PPG-10/1 DIMETHICONE (HLB 5) (UNII: 035JKJ76MT)  
    COCONUT OIL (UNII: Q9L0O73W7L)  
    DIMETHICONE (UNII: 92RU3N3Y1O)  
    SODIUM CHLORIDE (UNII: 451W47IQ8X)  
    TRIETHOXYCAPRYLYLSILANE (UNII: LDC331P08E)  
    SYNTHETIC BEESWAX (UNII: 08MNR5YE2R)  
    MEDIUM-CHAIN TRIGLYCERIDES (UNII: C9H2L21V7U)  
    CAPRYLYL GLYCOL (UNII: 00YIU5438U)  
    ETHYLHEXYLGLYCERIN (UNII: 147D247K3P)  
    .GAMMA.-DECALACTONE (UNII: 7HLS05KP9O)  
    .GAMMA.-NONALACTONE (UNII: I1XGH66S8P)  
    PIPERONAL (UNII: KE109YAK00)  
    OCTYLDODECYL CITRATE CROSSPOLYMER (UNII: X323T6QO4M)  
    3-PHENYL-1-PROPANOL (UNII: U04IC2765C)  
    ALCOHOL (UNII: 3K9958V90M)  
    SODIUM CITRATE (UNII: 1Q73Q2JULR)  
    .GAMMA.-OCTALACTONE (UNII: UHD6M52X0K)  
    TRIETHYL CITRATE (UNII: 8Z96QXD6UM)  
    PHYMATOLITHON CALCAREUM (UNII: 6J1M3WA0ZK)  
    ALOE VERA LEAF (UNII: ZY81Z83H0X)  
    ETHYLHEXYL METHOXYCRYLENE (UNII: S3KFG6Q5X8)  
    POLYETHYLENE GLYCOL 4000 (UNII: 4R4HFI6D95)  
    4-(P-HYDROXYPHENYL)-2-BUTANONE (UNII: 7QY1MH15BG)  
    .ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)  
    VANILLIN (UNII: CHI530446X)  
    WATER (UNII: 059QF0KO0R)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:79753-029-71148 mL in 1 BOTTLE; Type 0: Not a Combination Product11/01/2018
    2NDC:79753-029-72946 mL in 1 BOTTLE; Type 0: Not a Combination Product11/01/2018
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC Monograph DrugM02011/01/2018
    Labeler - COOLA, LLC (956990290)