Label: COOLA REFRESHING WATER MIST SPF 18- avobenzone, homosalate, octisalate, octocrylene spray

  • NDC Code(s): 54111-148-50
  • Packager: Bentley Laboratories, LLC
  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None

Drug Label Information

Updated December 19, 2023

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  • ACTIVE INGREDIENT

    Drug Facts

    Active Ingredients

    Avobenzone 2.0%. Homosalate 10.0%

    Octisalate 5.0%, Octocrylene 5.5%

    Purpose

    Sunscreen

  • 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.

    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
    • shake well • apply liberally 15 minutes before sun exposure
    • reapply: •after 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 aging. To
    decrease this risk, regularly use a sunscreen with a broad
    spectrum 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-sleeved shirts, pants, hats, and sunglasses
    • children under 6 months: Ask a doctor


  • INACTIVE INGREDIENT

    Inactive Ingredients
    Aloe Barbadensis Leaf Extract (ORGANIC), Undecane,
    Tridecane, Water, Cocos Nucifera (Coconut) Water
    (ORGANIC), Sodium Hyaluronate, Jasminum Sambac
    (Jasmine) Leaf Cell Extract, Theobroma Cacao (Cocoa)
    Seed Extract, Schinus Molle Extract, Heliotropine*,
    Juniperus Mexicana*, Propanediol, Butylene Glycol,
    Methlypropanediol, Caprylic/Capric Triglyceride, Caprylyl
    Glycol, Polyquaternium-80, Sodium Phytate,
    Didecyldimonium Chloride, Anisaldehyde*, Benzyl
    acetate*, Delta-Decalactone*, Gamma-Nonalactone*,
    Gamma Octalactone*, Methyl benzoate*, Nerolidol*, Ethyl
    Butyrate*, Triethyl citrate*, Vanillin

    * Plant-derived scent constituent.

  • OTHER SAFETY INFORMATION

    Other information

    • protect this product from excessive heat and direct sun

  • QUESTIONS

    Questions or comments? Call 760-940-2125

  • COOLA Label

    COOLA​®​

    Refreshing Water Mist

    Sunscreen

    SPF 18

    Alcohol-Free

    Broad Spectrum SPF 18

    1.7 FL OZ / 50 mL

    Distributed by: COOLA LLC, located in

    Sunny & Cool San Diego, CA 92009

    www.coola.com

    54111-148 Box

    148 jar

     res

  • INGREDIENTS AND APPEARANCE
    COOLA REFRESHING WATER MIST SPF 18 
    avobenzone, homosalate, octisalate, octocrylene spray
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:54111-148
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    AVOBENZONE (UNII: G63QQF2NOX) (AVOBENZONE - UNII:G63QQF2NOX) AVOBENZONE2.0 g  in 100 mL
    HOMOSALATE (UNII: V06SV4M95S) (HOMOSALATE - UNII:V06SV4M95S) HOMOSALATE10.0 g  in 100 mL
    OCTISALATE (UNII: 4X49Y0596W) (OCTISALATE - UNII:4X49Y0596W) OCTISALATE5.0 g  in 100 mL
    OCTOCRYLENE (UNII: 5A68WGF6WM) (OCTOCRYLENE - UNII:5A68WGF6WM) OCTOCRYLENE5.5 g  in 100 mL
    Inactive Ingredients
    Ingredient NameStrength
    ALOE VERA LEAF (UNII: ZY81Z83H0X)  
    UNDECANE (UNII: JV0QT00NUE)  
    TRIDECANE (UNII: A3LZF0L939)  
    WATER (UNII: 059QF0KO0R)  
    COCONUT WATER (UNII: 267F5Y81NT)  
    HYALURONATE SODIUM (UNII: YSE9PPT4TH)  
    JASMINUM OFFICINALE LEAF (UNII: 6OG06384ID)  
    COCOA (UNII: D9108TZ9KG)  
    SCHINUS MOLLE FRUITING TOP (UNII: T8L6O1KSB4)  
    PIPERONAL (UNII: KE109YAK00)  
    JUNIPERUS DEPPEANA WOOD OIL (UNII: 4739QA5686)  
    PROPANEDIOL (UNII: 5965N8W85T)  
    BUTYLENE GLYCOL (UNII: 3XUS85K0RA)  
    METHYLPROPANEDIOL (UNII: N8F53B3R4R)  
    MEDIUM-CHAIN TRIGLYCERIDES (UNII: C9H2L21V7U)  
    CAPRYLYL GLYCOL (UNII: 00YIU5438U)  
    POLYQUATERNIUM-80 (UNII: 3N8LGV97HR)  
    PHYTATE SODIUM (UNII: 88496G1ERL)  
    DIDECYLDIMONIUM CHLORIDE (UNII: JXN40O9Y9B)  
    P-ANISALDEHYDE (UNII: 9PA5V6656V)  
    BENZYL ACETATE (UNII: 0ECG3V79ZJ)  
    .DELTA.-DECALACTONE (UNII: CNA0S5T234)  
    .GAMMA.-NONALACTONE (UNII: I1XGH66S8P)  
    .GAMMA.-OCTALACTONE (UNII: UHD6M52X0K)  
    METHYL BENZOATE (UNII: 6618K1VJ9T)  
    NEROLIDOL (UNII: QR6IP857S6)  
    ETHYL BUTYRATE (UNII: UFD2LZ005D)  
    TRIETHYL CITRATE (UNII: 8Z96QXD6UM)  
    VANILLIN (UNII: CHI530446X)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:54111-148-501 in 1 CARTON07/30/2020
    150 mL in 1 BOTTLE; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC Monograph DrugM02007/30/2020
    Labeler - Bentley Laboratories, LLC (068351753)
    Registrant - Bentley Laboratories, LLC (068351753)
    Establishment
    NameAddressID/FEIBusiness Operations
    Bentley Laboratories, LLC068351753manufacture(54111-148)
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