Label: COOLA CLASSIC SUNSCREEN FRAGRANCE FREE- avobenzone, homosalate, octisalate, octocrylene lotion

  • 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 1, 2021

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  • Active ingredients

    Avobenzone 3.0%

    Homosalate 10.0%

    Octisalate 4.5%

    Octocrylene 8.0%

  • 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

    Alkyl Heptoate, Behenyl Alcohol, Butylated PVP, Butylene Glycol, Butyloctyl Salicylate, Caprylic/Capric Triglyceride, Cellulose Gum, Cetyl Alcohol, Citrus Aurantium Bergamia (Bergamot) Leaf Extract, Disodium EDTA, Ethylhexylglycerin, Gamma-Decalactone, Gamma-Nonalactone, Glycerin, Glyceryl Stearate, Heliotropine, Lauryl Alcohol, Lecithin, Linum Usitatissimum (Linseed) Seed Oil, Lycium Barbarum Fruit Extract, Microcrystalline Cellulose, Myristyl Alcohol, Palmitic Acid, Phenoxyethanol, Propylene Glycol, Raspberry Ketone, Rubus Idaeus (Raspberry) Seed Extract, Sodium Ascorbyl Phosphate, Stearic Acid, Tocopherol, Triethyl Citrate, Vanillin, Water (Aqua)

  • Label

    CA61410

    CA00770

    CA00761

  • INGREDIENTS AND APPEARANCE
    COOLA CLASSIC SUNSCREEN FRAGRANCE FREE 
    avobenzone, homosalate, octisalate, octocrylene lotion
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:79753-045
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    HOMOSALATE (UNII: V06SV4M95S) (HOMOSALATE - UNII:V06SV4M95S) HOMOSALATE100 mg  in 1 mL
    AVOBENZONE (UNII: G63QQF2NOX) (AVOBENZONE - UNII:G63QQF2NOX) AVOBENZONE30 mg  in 1 mL
    OCTOCRYLENE (UNII: 5A68WGF6WM) (OCTOCRYLENE - UNII:5A68WGF6WM) OCTOCRYLENE80 mg  in 1 mL
    OCTISALATE (UNII: 4X49Y0596W) (OCTISALATE - UNII:4X49Y0596W) OCTISALATE45 mg  in 1 mL
    Inactive Ingredients
    Ingredient NameStrength
    WATER (UNII: 059QF0KO0R)  
    CETYL ALCOHOL (UNII: 936JST6JCN)  
    RASPBERRY SEED OIL (UNII: 9S8867952A)  
    GLYCERYL 1-STEARATE (UNII: 258491E1RZ)  
    .ALPHA.-TOCOPHEROL, DL- (UNII: 7QWA1RIO01)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    BUTYLOCTYL SALICYLATE (UNII: 2EH13UN8D3)  
    MEDIUM-CHAIN TRIGLYCERIDES (UNII: C9H2L21V7U)  
    ETHYLHEXYLGLYCERIN (UNII: 147D247K3P)  
    PHENOXYETHANOL (UNII: HIE492ZZ3T)  
    MONARDA DIDYMA LEAF (UNII: JY15982UBB)  
    .GAMMA.-NONALACTONE (UNII: I1XGH66S8P)  
    .GAMMA.-DECALACTONE (UNII: 7HLS05KP9O)  
    SODIUM ASCORBYL PHOSPHATE (UNII: 836SJG51DR)  
    ALLYL HEPTANOATE (UNII: AU4CYG9V68)  
    4-(P-HYDROXYPHENYL)-2-BUTANONE (UNII: 7QY1MH15BG)  
    STEARIC ACID (UNII: 4ELV7Z65AP)  
    PALMITIC ACID (UNII: 2V16EO95H1)  
    LAURYL ALCOHOL (UNII: 178A96NLP2)  
    EDETATE DISODIUM (UNII: 7FLD91C86K)  
    PIPERONAL (UNII: KE109YAK00)  
    MYRISTYL ALCOHOL (UNII: V42034O9PU)  
    PROPYLENE GLYCOL (UNII: 6DC9Q167V3)  
    CARBOXYMETHYLCELLULOSE SODIUM (0.7 CARBOXYMETHYL SUBSTITUTION PER SACCHARIDE; 1200 MPA.S AT 1%) (UNII: 4J4P6L645M)  
    LECITHIN, SOYBEAN (UNII: 1DI56QDM62)  
    DOCOSANOL (UNII: 9G1OE216XY)  
    VANILLIN (UNII: CHI530446X)  
    TRIETHYL CITRATE (UNII: 8Z96QXD6UM)  
    CELLULOSE, MICROCRYSTALLINE (UNII: OP1R32D61U)  
    BUTYLENE GLYCOL (UNII: 3XUS85K0RA)  
    LINSEED OIL (UNII: 84XB4DV00W)  
    .GAMMA.-OCTALACTONE (UNII: UHD6M52X0K)  
    LYCIUM BARBARUM FRUIT (UNII: 930626MWDL)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:79753-045-72946 mL in 1 BOTTLE; Type 0: Not a Combination Product01/01/2018
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph not finalpart35201/01/2018
    Labeler - COOLA, LLC (956990290)
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