Label: COOLA LIPLUX HYDRATING OIL SPF 30- avobenzone, homosalate, octisalate, octocrylene oil

  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None

Drug Label Information

Updated December 20, 2023

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  • ACTIVE INGREDIENT

    Drug Facts

    Active Ingredients

    Avobenzone 3.0%, Homosalate 4.0%, Octisalate 4.0%, Octocrylene 10.0%

    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.

    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 & again after swimming or sweating. Apply at least every 2 hours.
    Sun Protection Measures - To decrease your risk of cancer and early skin aging. 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. and wear
    long-sleeve shirts, pants, hats, and sunglasses.  Children under 6 months: Ask a doctor

  • INACTIVE INGREDIENT

    Inactive Ingredients-​​Adipic Acid/Diglycol Crosspolymer,Camellia Oleifera Seed Oil (ORGANIC),Caprylic/Capric Triglyceride,Ethylhexylmethoxycrylene,Flavor,Glyceryl Caprylate,Helianthus Annus (Sunflower) Seed Oil (ORGANIC),Polyglyceryl-3 Diisostearate,Polyurethane-79,Punica Granatum Flower Extract,Simmondsia Chinensis (Jojoba) Seed Oil (ORGANIC),Sodium Saccharin,Tocopheryl Acetate

  • OTHER SAFETY INFORMATION

    Other information

    • protect this product from excessive heat and direct sun
  • QUESTIONS

    Questions or comments?
    Call 760-940-2125

  • COOLA Label

    SPF

    30

    70%+

    Organic

    COOLA​®

    Liplux®

    Hydrating Oil

    ​Golden Glow

    Nourishes & Protects​​

    Broad Spectrum SPF 30

    0.11 FL OZ / 3.2 mL

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

    Sunny & Cool San Diego, CA 92010.

    Carton

    COOLA BENTLY

    Bottle

    coola bottle

    res

  • INGREDIENTS AND APPEARANCE
    COOLA LIPLUX HYDRATING OIL SPF 30 
    avobenzone, homosalate, octisalate, octocrylene oil
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:79753-018
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    AVOBENZONE (UNII: G63QQF2NOX) (AVOBENZONE - UNII:G63QQF2NOX) AVOBENZONE3.0 g  in 100 mL
    HOMOSALATE (UNII: V06SV4M95S) (HOMOSALATE - UNII:V06SV4M95S) HOMOSALATE4.0 g  in 100 mL
    OCTISALATE (UNII: 4X49Y0596W) (OCTISALATE - UNII:4X49Y0596W) OCTISALATE4.0 g  in 100 mL
    OCTOCRYLENE (UNII: 5A68WGF6WM) (OCTOCRYLENE - UNII:5A68WGF6WM) OCTOCRYLENE10.0 g  in 100 mL
    Inactive Ingredients
    Ingredient NameStrength
    ADIPIC ACID/DIGLYCOL CROSSPOLYMER (20000 MPA.S) (UNII: R9TPS68K19)  
    CAMELLIA OIL (UNII: T1PE06G0VE)  
    CAPRYLIC/CAPRIC/LAURIC TRIGLYCERIDE (UNII: FJ1H6M2JG9)  
    ETHYLHEXYL METHOXYCRYLENE (UNII: S3KFG6Q5X8)  
    GLYCERYL CAPRYLATE (UNII: TM2TZD4G4A)  
    SUNFLOWER OIL (UNII: 3W1JG795YI)  
    POLYGLYCERYL-3 DIISOSTEARATE (UNII: 46P231IQV8)  
    MEDIUM-CHAIN TRIGLYCERIDES (UNII: C9H2L21V7U)  
    PUNICA GRANATUM FLOWER (UNII: D9B634V4GP)  
    JOJOBA OIL (UNII: 724GKU717M)  
    SACCHARIN SODIUM (UNII: SB8ZUX40TY)  
    .ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:79753-018-011 in 1 CARTON12/22/2020
    13.2 mL in 1 BOTTLE; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC Monograph DrugM02012/22/2020
    Labeler - COOLA LLC (956990290)
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