Label: COOLA SPF 50 CLASSIC- sunscreen face mist spray

  • 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 April 4, 2023

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

  • Active Ingredients

    Avobenzone 2.9%, Octisalate 4.9%, Octocrylene 9.5%

  • 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.

    Flammable: 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 out of eyes. Rinse with water to remove.

    Stop use and ask doctor if skin rash occurs.

    Keep out of reach of children.

    If product is swallowed, get medical help or contact a Poison Control Center right away.

  • Directions

    SHAKE WELL before use.

    With your eyes completely closed, mist face evenly, holding bottle 10-12 inches away from face.

    Wait until dry.

    Apply liberally 15 minutes before sun exposure.

    Reapply:

    -After 80 minutes 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 the risk, regularly use a sunscreen with a broad-spectrum SPF of 15 or higher and other protection measures including:

    -Limit time in the sun, especially from 10 a.m. – 2 p.m.

    -Wear long sleeves shirts, pants, hats, and sunglasses.

    Children under 6 months: Ask a doctor.

  • Inactive Ingredients

    Alcohol (ORGANIC), Butyloctyl Salicylate, Ethylhexyl Methoxycrylene, Polyester-8, Fragrance (Natural), VA/Butyl Maleate/Isobornyl Acrylate Copolymer, Carthamus Tinctorius (Safflower) Seed Oil (ORGANIC), Rubus Idaeus (Raspberry) Seed Oil (ORGANIC), Mauritia Flexuosa (Buriti) Fruit Oil (ORGANIC), Limnanthes Alba (Meadowfoam) Seed Oil, Brassica Campestris (Rapeseed) Seed Oil, Camellia Sinensis Leaf Extract (ORGANIC),Glycyrrhiza Glabra (Licorice) Root Extract (ORGANIC), Opuntia Ficus-Indica Flower Extract, Camelina Sativa Seed Oil, Bisabolol (ORGANIC), Glycerin (ORGANIC), Water, Ethyl Ferulate, Diisooctyl Succinate

  • Other Information

    Protect this product from excessive heat and direct sun

  • Questions or Comments

    Call 760-940-2125

  • Package Label

    CLA SPF 50 Facial Sunscreen Mist

  • INGREDIENTS AND APPEARANCE
    COOLA  SPF 50 CLASSIC
    sunscreen face mist spray
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:79753-033
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    AVOBENZONE (UNII: G63QQF2NOX) (AVOBENZONE - UNII:G63QQF2NOX) AVOBENZONE2.9 g  in 100 mL
    OCTISALATE (UNII: 4X49Y0596W) (OCTISALATE - UNII:4X49Y0596W) OCTISALATE4.9 g  in 100 mL
    OCTOCRYLENE (UNII: 5A68WGF6WM) (OCTOCRYLENE - UNII:5A68WGF6WM) OCTOCRYLENE9.5 g  in 100 mL
    Inactive Ingredients
    Ingredient NameStrength
    ALCOHOL (UNII: 3K9958V90M)  
    POLYESTER-8 (1400 MW, CYANODIPHENYLPROPENOYL CAPPED) (UNII: T9296U138P)  
    SAFFLOWER OIL (UNII: 65UEH262IS)  
    ETHYLHEXYL METHOXYCRYLENE (UNII: S3KFG6Q5X8)  
    VINYL ACETATE (UNII: L9MK238N77)  
    ISOBORNYL ACRYLATE (UNII: IX0PRH184P)  
    DIBUTYL MALEATE (UNII: 4X371TMK9K)  
    CAMELINA SATIVA SEED OIL (UNII: 12824X01L0)  
    DICAPRYL SUCCINATE (UNII: 8XD1ZF2M1M)  
    BRASSICA RAPA SUBSP. OLEIFERA OIL (UNII: N4G8379626)  
    GREEN TEA LEAF (UNII: W2ZU1RY8B0)  
    MAURITIA FLEXUOSA FRUIT OIL (UNII: 48H19MS04L)  
    LEVOMENOL (UNII: 24WE03BX2T)  
    ETHYL FERULATE (UNII: 5B8915UELW)  
    MEADOWFOAM SEED OIL (UNII: 412ZHA4T4Y)  
    OPUNTIA FICUS-INDICA FLOWER (UNII: 83YSP51SMA)  
    RASPBERRY SEED OIL (UNII: 9S8867952A)  
    GLYCYRRHIZA GLABRA (UNII: 2788Z9758H)  
    WATER (UNII: 059QF0KO0R)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    BUTYLOCTYL SALICYLATE (UNII: 2EH13UN8D3)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:79753-033-01100 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product11/02/2021
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph not finalpart35211/02/2021
    Labeler - COOLA LLC (956990290)