Label: COOLA CLASSIC SUNSCREEN STICK SPF 30 - TROPICAL COCONUT- avobenzone 3.0%, octisalate 4.0%, octocrytene 7.0% stick

  • 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 January 6, 2021

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  • ACTIVE INGREDIENT

    Drug Facts

    Active Ingredients

    Avobenzone 3.0%, Octisalate 4.0%, Octocrylene 7.0%

    Purpose

    Suncreen

  • INDICATIONS & USAGE

    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

    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.

    Do not use on damaged or broken skin

    Stop use and ask doctor if skin 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.

  • DOSAGE & ADMINISTRATION

    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
    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 spection
    SPF 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-sleeve shirts, pants, hats, and sunglasses
    ●Children under 6 months: Ask a doctor

  • INACTIVE INGREDIENT

    Inactive Ingredients
    1,2-Hexanediol, Bisabolol, Bis-Octyldodecyl Dimer Dilinoleate/Propanediol Copolymer,
    Brassica Campestris (Rapeseed) Seed Oil, Camelina Sativa Seed Oil, Camellia Oleifera
    Seed Oil (ORGANIC), Caprylic/Capric Triglyceride (ORGANIC), Carthamus Tinctorius
    (Safflower) Seed Oil (ORGANIC), Dimethyl Heptenal*, Gamma-Nonalactone*,
    Gamma-Octalactone*, Hydroxystearic Acid, Limnanthes Alba (Meadowfoam) Seed Oil,
    Maltol*, Mauritia Flexuosa (Buriti) Fruit Oil (ORGANIC), Opuntia Ficus-Indica Flower Extract,
    Polyester-8, Rubus Idaeus (Raspberry) Seed Oil (ORGANIC), Silica Dimethyl Silylate,
    Trans-2-Hexenal*, Triethyl Citrate*, VANILLIN* OR VANADIUM*???*

  • OTHER SAFETY INFORMATION

    Other information

    • may stain fabrics
    • protect this product from excessive heat and direct sun
  • SPL UNCLASSIFIED SECTION

    Questions or comments?
    Call 760-940-2125

  • COOLA Label

    SPF

    30

    70%+

    Organic

    COOLA​®

    Classic

    Sunscreen Stick

    Tropical Coconut

    Broad Spectrum SPF 30

    Water Resistant (80 Minutes)

    +Plant Protection®

    0.6 OZ / 17.0 g

    ©2021 COOLA. Distributed by: COOLA LLC, located in Sunny &

    Cool San Diego, CA 92010.  All Rights Reserved.  www.coola.com

    Hawaii Reef Friendly Sunscreen Oxybenzone & Octinoxate Free
    *Plant-derived scent constituent. See coola.com for additional detail.

    Carton

    016 Box

    Canister

    016 Tube

    res

  • INGREDIENTS AND APPEARANCE
    COOLA CLASSIC SUNSCREEN STICK SPF 30 - TROPICAL COCONUT 
    avobenzone 3.0%, octisalate 4.0%, octocrytene 7.0% stick
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:79753-016
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    AVOBENZONE (UNII: G63QQF2NOX) (AVOBENZONE - UNII:G63QQF2NOX) AVOBENZONE3.0 g  in 100 g
    OCTISALATE (UNII: 4X49Y0596W) (OCTISALATE - UNII:4X49Y0596W) OCTISALATE4.0 g  in 100 g
    OCTOCRYLENE (UNII: 5A68WGF6WM) (OCTOCRYLENE - UNII:5A68WGF6WM) OCTOCRYLENE7.0 g  in 100 g
    Inactive Ingredients
    Ingredient NameStrength
    1,2-HEXANEDIOL (UNII: TR046Y3K1G)  
    LEVOMENOL (UNII: 24WE03BX2T)  
    BIS-OCTYLDODECYL DIMER DILINOLEATE/PROPANEDIOL COPOLYMER (UNII: TY3J98ZR7R)  
    BRASSICA RAPA SUBSP. OLEIFERA OIL (UNII: N4G8379626)  
    CAMELINA SATIVA SEED OIL (UNII: 12824X01L0)  
    CAMELLIA OIL (UNII: T1PE06G0VE)  
    MEDIUM-CHAIN TRIGLYCERIDES (UNII: C9H2L21V7U)  
    SAFFLOWER OIL (UNII: 65UEH262IS)  
    2,6-DIMETHYL-5-HEPTENAL (UNII: Z331YX9EL9)  
    .GAMMA.-NONALACTONE (UNII: I1XGH66S8P)  
    .GAMMA.-OCTALACTONE (UNII: UHD6M52X0K)  
    10-HYDROXYSTEARIC ACID (UNII: 384M5B7IFL)  
    MEADOWFOAM SEED OIL (UNII: 412ZHA4T4Y)  
    MALTOL (UNII: 3A9RD92BS4)  
    MAURITIA FLEXUOSA FRUIT OIL (UNII: 48H19MS04L)  
    OPUNTIA FICUS-INDICA LEAF (UNII: 5VM709H93V)  
    POLYESTER-8 (1400 MW, CYANODIPHENYLPROPENOYL CAPPED) (UNII: T9296U138P)  
    RASPBERRY SEED OIL (UNII: 9S8867952A)  
    SILICA DIMETHYL SILYLATE (UNII: EU2PSP0G0W)  
    2-HEXENAL, (2E)- (UNII: 69JX3AIR1I)  
    TRIETHYL CITRATE (UNII: 8Z96QXD6UM)  
    VANILLIN (UNII: CHI530446X)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:79753-016-011 in 1 CARTON02/08/2021
    117 g in 1 CANISTER; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph not finalpart35202/08/2021
    Labeler - COOLA LLC (956990290)
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