Label: COOLA CLASSIC BODY SPF 30 PINA COLADA- avobenzone, octisalate, octocrylene spray

  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None
  • Marketing Status: OTC monograph 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 18, 2022

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

  • ACTIVE INGREDIENT

    Avobenzone - 2.8%

    Octisalate - 4.9%

    Octocrylene - 7.6%

  • PURPOSE

    Sunscreen

  • Uses

    • Helps prevent sunburn
    • If used as directed with other sun protection measures (see Directions), decreases the nsk of skin cancer and early skin aging caused by the sun
  • WARNINGS

    • For external use only
    • Flammable: Contents under pressure. Do not puncture or incinerat. Do not store at temperatures above 120 F. Do not use in the presence of a flame or spark, or while smoking.
    • Do not use on damaged or broken skin.
    • When using this product keep away from face to avoid breathing. Keep out of eyes. Rinse with water to remove. Apply outdoors. Avoid overspray as it could cause surface to become slippery. Do not apply in windy conditions. Use in a well-ventilated area.
    • Stop use and ask a doctor if rash occurs.
  • KEEP OUT OF REACH OF CHILDREN

    Keep out of reach of children. If product is swallowed, get medical help or contact a Poison Control Center right away.

  • Directions

    • Shake Well
    • Apply liberally 15 minutes before sun exposure.
    • Hold container 4 to 6 inches from skin to apply.
    • Rub in. Do not spray directly on face.
    • Spray onto hands and apply to face.
    • Reapply: After 80 minutes of swimming or sweating. Immediately after towel drying. At least every 2 hours.
    • 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.​
    • Children under six months: Ask a doctor.
  • INACTIVE INGREDIENT

    Alcohol (ORGANIC), Butyloctyl Salicylate, Methyl Dihydroabietate, Flavor (NATURAL), Aloe Barbadensis Leaf Juice, Carthamus Tinctorius (Safflower) Seed Oil (ORGANIC), Mauritia Flexuosa (Buriti) Fruit Oil (ORGANIC), Rubus Idaeus (Raspberry) Seed Oil (ORGANIC), , Opuntia Ficus-Indica Seed Oil, Limnanthes Alba (Meadowfoam) Seed Oil

  • OTHER SAFETY INFORMATION

    • May stain fabrics
    • Protect this product from excessive heat and direct sun
  • QUESTIONS

    Call 760-940-2125

  • PRINCIPAL DISPLAY PANEL

    1

  • INGREDIENTS AND APPEARANCE
    COOLA CLASSIC BODY SPF 30 PINA COLADA 
    avobenzone, octisalate, octocrylene spray
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:79753-061
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    AVOBENZONE (UNII: G63QQF2NOX) (AVOBENZONE - UNII:G63QQF2NOX) AVOBENZONE2.8 g  in 100 mL
    OCTISALATE (UNII: 4X49Y0596W) (OCTISALATE - UNII:4X49Y0596W) OCTISALATE4.9 g  in 100 mL
    OCTOCRYLENE (UNII: 5A68WGF6WM) (OCTOCRYLENE - UNII:5A68WGF6WM) OCTOCRYLENE7.6 g  in 100 mL
    Inactive Ingredients
    Ingredient NameStrength
    SAFFLOWER OIL (UNII: 65UEH262IS)  
    MEADOWFOAM SEED OIL (UNII: 412ZHA4T4Y)  
    MAURITIA FLEXUOSA FRUIT OIL (UNII: 48H19MS04L)  
    RASPBERRY SEED OIL (UNII: 9S8867952A)  
    OPUNTIA FICUS-INDICA SEED OIL (UNII: 1XGW49AK2J)  
    ALCOHOL (UNII: 3K9958V90M)  
    BUTYLOCTYL SALICYLATE (UNII: 2EH13UN8D3)  
    ALOE VERA LEAF (UNII: ZY81Z83H0X)  
    METHYL DIHYDROABIETATE (UNII: 7666FJ0J9F)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:79753-061-01177 mL in 1 CAN; Type 0: Not a Combination Product10/01/2019
    2NDC:79753-061-0260 mL in 1 CAN; Type 0: Not a Combination Product01/01/2020
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph finalM02010/01/2019
    Labeler - COOLA, LLC (956990290)