Label: COOLA FULL SPECTRUM 360 SUN SILK DROPS 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 18, 2019

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  • DRUG FACTS

    Active ingredients

    Avobenzone 2.0%, Homosalate 10.0%

    Octisalate 5.0%, Octocrylene 6.0%

  • 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 AND PRECAUTIONS

    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 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-sleeve shirts, pants, hats, and sunglasses
    * children under 6 months: Ask a doctor

  • INACTIVE INGREDIENT

    Aloe Barbadensis Leaf Extract (Organic), Anthemis Nobilis (Chamomile) Flower Oil, Butylene Glycol, Butyloctyl Salicylate, Calcium Gluconate, Caprylic/Capric Triglyceride, Carthamus Tinctorius (Organic Safflower) Seed Oil, Citrus Aurantium Amara (Bitter Orange) Flower Extract, Citrus Aurantium Amara (Bitter Orange) Leaf/Twig Extract, Dicaprylyl Carbonate, Glycerin (Organic), Glyceryl Stearate Se, Jasminum Sambac (Jasmine) Leaf Cell Extract, Nylon-12, Olea Europaea (Organic Olive) Fruit Oil, Plankton Leaf Extract, Propanediol, Schinus Molle Extract, Simmondsia Chinensis (Organic Jojoba) Seed Oil, Sodium Benzoate, Sodium Hyaluronate, Sodium Stearoyl Glutamate, Theobroma Cacao (Cocoa) Seed Extract, Tocopheryl Acetate, Water (Aqua), Xanthan Gum

  • OTHER SAFETY INFORMATION

    Other information
    * protect this product from excessive heat and direct sun

  • QUESTIONS

    Questions or comments? Call 760-940-2125

  • INSTRUCTIONS FOR USE

    How to use:

    Apply daily to cleansed skin. For best

    results, dispense several drops as needed

    into palm of hand and apply evenly across

    face and neck using upward strokes. Drops

    are perfect for use alone or blended with

    your everyday skincare and makeup.

  • PRINCIPAL DISPLAY PANEL

    SILK SUN DROPS 30 ML BOTTLESUN SILK DROPS 1 FL SPF 30

  • INGREDIENTS AND APPEARANCE
    COOLA FULL SPECTRUM 360 SUN SILK DROPS  SPF 30
    avobenzone,homosalate, octisalate,octocrylene liquid
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:21839-620
    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) OCTOCRYLENE60 mg  in 1 mL
    Inactive Ingredients
    Ingredient NameStrength
    WATER (UNII: 059QF0KO0R)  
    ALPHA-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)  
    SODIUM STEAROYL GLUTAMATE (UNII: 65A9F4P024)  
    HYALURONATE SODIUM (UNII: YSE9PPT4TH)  
    SODIUM BENZOATE (UNII: OJ245FE5EU)  
    PROPANEDIOL (UNII: 5965N8W85T)  
    OLIVE OIL (UNII: 6UYK2W1W1E)  
    GLUCONOLACTONE (UNII: WQ29KQ9POT)  
    ALOE VERA LEAF (UNII: ZY81Z83H0X)  
    COCOA (UNII: D9108TZ9KG)  
    SCHINUS MOLLE FRUITING TOP (UNII: T8L6O1KSB4)  
    JASMINUM SAMBAC FLOWER (UNII: 2S686I937F)  
    GLYCERYL STEARATE SE (UNII: FCZ5MH785I)  
    CITRUS AURANTIUM FLOWER OIL (UNII: D4BGE91OXH)  
    SAFFLOWER OIL (UNII: 65UEH262IS)  
    NYLON-12 (UNII: 446U8J075B)  
    BUTYLOCTYL SALICYLATE (UNII: 2EH13UN8D3)  
    CHAMAEMELUM NOBILE FLOWER OIL (UNII: UB27587839)  
    XANTHAN GUM (UNII: TTV12P4NEE)  
    JOJOBA OIL (UNII: 724GKU717M)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    DICAPRYLYL CARBONATE (UNII: 609A3V1SUA)  
    MEDIUM-CHAIN TRIGLYCERIDES (UNII: C9H2L21V7U)  
    BUTYLENE GLYCOL (UNII: 3XUS85K0RA)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:21839-620-021 in 1 NOT APPLICABLE12/20/2018
    1NDC:21839-620-015 mL in 1 BOTTLE; Type 0: Not a Combination Product
    2NDC:21839-620-041 in 1 CARTON12/20/2018
    2NDC:21839-620-0330 mL in 1 BOTTLE; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph finalpart35212/20/2018
    Labeler - Gordon Laboratories, Inc. (008328619)
    Registrant - Gordon Laboratories, Inc. (008328619)
    Establishment
    NameAddressID/FEIBusiness Operations
    GORDON LABORATORIES,INC008328619manufacture(21839-620)
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