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
  • 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 February 22, 2021

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  • 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)  
    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)  
    SILICON DIOXIDE (UNII: ETJ7Z6XBU4)  
    SODIUM CHLORIDE (UNII: 451W47IQ8X)  
    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)  
    TRIETHOXYCAPRYLYLSILANE (UNII: LDC331P08E)  
    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 not finalpart35211/01/2018
    Labeler - COOLA, LLC (956990290)
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