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 16, 2019

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  • ACTIVE INGREDIENT

    Active ingredients

    Avobenzone 2.0%, Homosalate 10.0%, Octisalate 5.0%, Octocrylene 5.5%

  • PURPOSE

    Purpose

    Sunscreen

  • INDICATIONS & USAGE

    Uses

    * helps prevent sunburn

    * if used as directed with other sun protection measures (see Directions), decreases the rise 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. If prodcut is swallowed, get medical help or contact Poison Control Center right away.

    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.

  • 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 rise, 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-sleve shirts, pants, hats, and sunglasses

    * children under 6 months: Ask a doctor

  • INACTIVE INGREDIENT

    Inactive ingredients

    Aloe Barbadensis Leaf Juice (ORGANIC), Butylene Glycol, Caprylyl Glycol, Ceteareth-12, Ceteareth-20, Cetearyl Alcohol, Cetearyl Isononanoate, Cetyl Palmitate, Citronellyl Acetate, Cocos Nucifera (ORGANIC Coconut) Water, Cyclamen Aldehyde, Ethylene Brassylate, Glycerin (ORGANIC), Glyceryl Stearate, Glycine Soja (Soybean) Extract, Hyaluronic Acid, Jasminum Sambac Leaf Cell Extract, Lauryl Glucoside, Methyl Dihydrojasmonate, Methylenedioxyphenyl Methylpropanal, Olive Oil Polyglyceryl-6 Esters, 1,2-Hexanediol, Propanediol, Schinus Molle Extract, Sodium Phytate, Sodium Stearoyl Glutamate, Theobroma Cacao (Cocoa) Seed Extract, Tropolone

  • OTHER SAFETY INFORMATION

    Other information

    * protect this product from excessive heat and direct sun

  • QUESTIONS

    Questions or comments? Call 760-940-2125

  • PRINCIPAL DISPLAY PANEL

    Refreshing Water Mist sunscreen bottle image

    Refreshing Water Mist sunscreen carton image

  • INGREDIENTS AND APPEARANCE
    COOLA REFRESHING WATER MIST SUNSCREEN  SPF 30
    avobenzone, homosalate, octisalate, octocrylene liquid
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:21839-570
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    AVOBENZONE (UNII: G63QQF2NOX) (AVOBENZONE - UNII:G63QQF2NOX) AVOBENZONE20 mg  in 1 mL
    OCTISALATE (UNII: 4X49Y0596W) (OCTISALATE - UNII:4X49Y0596W) OCTISALATE50 mg  in 1 mL
    HOMOSALATE (UNII: V06SV4M95S) (HOMOSALATE - UNII:V06SV4M95S) HOMOSALATE100 mg  in 1 mL
    OCTOCRYLENE (UNII: 5A68WGF6WM) (OCTOCRYLENE - UNII:5A68WGF6WM) OCTOCRYLENE55 mg  in 1 mL
    Inactive Ingredients
    Ingredient NameStrength
    WATER (UNII: 059QF0KO0R)  
    JASMINUM SAMBAC FLOWER (UNII: 2S686I937F)  
    SOYBEAN (UNII: L7HT8F1ZOD)  
    GLYCERYL STEARATE SE (UNII: FCZ5MH785I)  
    CETEARETH-12 (UNII: 7V4MR24V5P)  
    BENZOIC ACID (UNII: 8SKN0B0MIM)  
    ALCOHOL (UNII: 3K9958V90M)  
    ALOE VERA LEAF (UNII: ZY81Z83H0X)  
    PHYTATE SODIUM (UNII: 88496G1ERL)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    MEDIUM-CHAIN TRIGLYCERIDES (UNII: C9H2L21V7U)  
    1,2-HEXANEDIOL (UNII: TR046Y3K1G)  
    TROPOLONE (UNII: 7L6DL16P1T)  
    HYALURONATE SODIUM (UNII: YSE9PPT4TH)  
    BUTYLENE GLYCOL (UNII: 3XUS85K0RA)  
    CAPRYLYL GLYCOL (UNII: 00YIU5438U)  
    COCOA (UNII: D9108TZ9KG)  
    SODIUM STEAROYL GLUTAMATE (UNII: 65A9F4P024)  
    SCHINUS MOLLE FRUITING TOP (UNII: T8L6O1KSB4)  
    ETHYL OLIVATE (UNII: KKJ108Y20W)  
    COCONUT WATER (UNII: 267F5Y81NT)  
    CETOSTEARYL ALCOHOL (UNII: 2DMT128M1S)  
    PROPANEDIOL (UNII: 5965N8W85T)  
    LAURYL GLUCOSIDE (UNII: 76LN7P7UCU)  
    CETEARYL ISONONANOATE (UNII: P5O01U99NI)  
    CETYL PALMITATE (UNII: 5ZA2S6B08X)  
    POLYOXYL 20 CETOSTEARYL ETHER (UNII: YRC528SWUY)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:21839-570-111 in 1 CARTON12/31/2018
    1NDC:21839-570-1260 mL in 1 BOTTLE; Type 0: Not a Combination Product
    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(21839-570)
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