Label: COOLA REFRESHING WATER MIST SUNSCREEN SPF 30- avobenzone,homosalate, octisalate,octocrylene liquid

  • 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 December 26, 2019

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  • ACTIVE INGREDIENT

    Active Ingredients - Avobenzone 2.0%, Homosalate 10.0%, Octisalate 5.0%, Octocrylene 5.5%

  • QUESTIONS

    Questions or comments? Call 760-940-2125

  • INDICATIONS & USAGE

    Directions: SHAKE WELL before use. With your eyes completely closed, mist face evenly, holding bottle 6-10 inces away from face. Allow to fully dry.

  • DESCRIPTION

    * Featuring Plant Cell Cultures, Coconut Water & hyaluronic Acid

    * Alcohol Free

    * Anti-Pollution

    * UVA/UVB/IR/HEV

    * Broad Spectrum SPF 30

    * Dermatologist tested

    * Gluten Free

    * Non-GMO

  • NOT FOR SALE .34 FL OZ / 10 mL

    Refreshing Water Mist 10 mL Sample

  • INGREDIENTS AND APPEARANCE
    COOLA REFRESHING WATER MIST SUNSCREEN  SPF 30
    avobenzone,homosalate, octisalate,octocrylene liquid
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:21839-590
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    AVOBENZONE (UNII: G63QQF2NOX) (AVOBENZONE - UNII:G63QQF2NOX) AVOBENZONE20 mg  in 1 mL
    HOMOSALATE (UNII: V06SV4M95S) (HOMOSALATE - UNII:V06SV4M95S) HOMOSALATE100 mg  in 1 mL
    OCTISALATE (UNII: 4X49Y0596W) (OCTISALATE - UNII:4X49Y0596W) OCTISALATE50 mg  in 1 mL
    OCTOCRYLENE (UNII: 5A68WGF6WM) (OCTOCRYLENE - UNII:5A68WGF6WM) OCTOCRYLENE55 mg  in 1 mL
    Inactive Ingredients
    Ingredient NameStrength
    ETHYL OLIVATE (UNII: KKJ108Y20W)  
    CETYL PALMITATE (UNII: 5ZA2S6B08X)  
    POLYOXYL 20 CETOSTEARYL ETHER (UNII: YRC528SWUY)  
    TROPOLONE (UNII: 7L6DL16P1T)  
    LAURYL GLUCOSIDE (UNII: 76LN7P7UCU)  
    GLYCERYL STEARATE SE (UNII: FCZ5MH785I)  
    CAPRYLYL GLYCOL (UNII: 00YIU5438U)  
    CETEARYL ISONONANOATE (UNII: P5O01U99NI)  
    COCONUT WATER (UNII: 267F5Y81NT)  
    CETEARETH-12 (UNII: 7V4MR24V5P)  
    BUTYLENE GLYCOL (UNII: 3XUS85K0RA)  
    PHYTATE SODIUM (UNII: 88496G1ERL)  
    PROPANEDIOL (UNII: 5965N8W85T)  
    JASMINUM SAMBAC FLOWER (UNII: 2S686I937F)  
    MEDIUM-CHAIN TRIGLYCERIDES (UNII: C9H2L21V7U)  
    BENZOIC ACID (UNII: 8SKN0B0MIM)  
    ALCOHOL (UNII: 3K9958V90M)  
    1,2-HEXANEDIOL (UNII: TR046Y3K1G)  
    COCOA (UNII: D9108TZ9KG)  
    SODIUM STEAROYL GLUTAMATE (UNII: 65A9F4P024)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    CETOSTEARYL ALCOHOL (UNII: 2DMT128M1S)  
    ALOE VERA LEAF (UNII: ZY81Z83H0X)  
    SOYBEAN (UNII: L7HT8F1ZOD)  
    WATER (UNII: 059QF0KO0R)  
    HYALURONATE SODIUM (UNII: YSE9PPT4TH)  
    SCHINUS MOLLE FRUITING TOP (UNII: T8L6O1KSB4)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:21839-590-0310 mL in 1 BOTTLE; Type 0: Not a Combination Product12/31/2018
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph finalpart35212/31/2018
    Labeler - Gordon Laboratories, Inc. (008328619)
    Registrant - Gordon Laboratories, Inc. (008328619)
    Establishment
    NameAddressID/FEIBusiness Operations
    GORDON LABORATORIES,INC008328619manufacture(21839-590)
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