Label: COLA DEW GOOD ILLUMINATING BODY MELT SPF 40- avobenzone, octisalate, octocrylene cream

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

Drug Label Information

Updated June 22, 2024

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  • ACTIVE INGREDIENT

    Avobenzone – 3.0%
    Octisalate – 4.0%
    Octocrylene – 8.0%

  • PURPOSE

    Purpose

    Sunscreen

  • 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.

  • Directions

    • Apply liberally 15 minutes before sun exposure
    • Reapply: • After 40 minutes of swimming or sweating.
    • Immediately after towel drying. • Apply at least every 2 hours.
    • Sun Protection Measures. Spending time in the sun increases
    your risk of skin cancer and early skin aging. To decrease this risk
    regularly use a sunscreen with a broad spectrum SPF value of 15 or higher
    and other sun protection measures including: • Limit time in the sun,
    especially from 10 a.m. to 2 p.m. • Wear long-sleeved shirts, pants,
    hats, and sunglasses. • Children under 6 months: Ask a doctor.

  • OTHER SAFETY INFORMATION

    Other information • Protect this product from excesssive

    heat and direct sun • May stain fabrics

  • INACTIVE INGREDIENT

    Inactive ingredients
    Aloe Barbadensis Leaf Juice (ORGANIC), Carthamus Tinctorius (Safflower),
    Oleosomes (ORGANIC), Water, Caprylic/Capric Triglyceride (ORGANIC), Cocos
    Nucifera (Coconut) Oil (ORGANIC), Ethylhexyl Methoxycrylene, Methyl
    Dihydroabietate, Mica, Glycerin (ORGANIC), Glyceryl Stearate,
    Stearyl/Octyldodecyl Citrate Crosspolymer, Polyacrylate Crosspolymer-6,
    Butyrospermum Parkii (Shea) Butter (ORGANIC), Lactobacillus Ferment, Sodium
    Hyaluronate, Ammonium Acryloyldimethyltaurate/VP Copolymer, Ethyl Ferulate,
    Caprylyl Glycol, 1,2-Hexanediol, Titanium Dioxide, Stearic Acid, Sodium Stearoyl
    Glutamate, Dimethicone, Sodium Phytate, Xanthan Gum, Maltodextrin, Sodium
    Hydroxide, Polysilicone-11, Butylene Glycol, Tropolone,
    Decyl Glucoside, Fragrance (Natural)

  • QUESTIONS

    Questions or Comments? Call 760-940-2125

  • PRINCIPAL DISPLAY PANEL

    Dew Good

    Illuminating Body Melt

    Sunscreen Lotion

    Broad Spectrum SPF 40

    3.4 FL. OZ. / 100 mL

    2024 COOLA. Manufactured in the USA for COOLA LLC,

    located in sunny San Diego, CA 92009

    www.coola.com

    Dew Good 082

    reg

  • INGREDIENTS AND APPEARANCE
    COLA DEW GOOD ILLUMINATING BODY MELT SPF 40 
    avobenzone, octisalate, octocrylene cream
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:79753-082
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    AVOBENZONE (UNII: G63QQF2NOX) (AVOBENZONE - UNII:G63QQF2NOX) AVOBENZONE3.0 g  in 100 mL
    OCTISALATE (UNII: 4X49Y0596W) (OCTISALATE - UNII:4X49Y0596W) OCTISALATE4.0 g  in 100 mL
    OCTOCRYLENE (UNII: 5A68WGF6WM) (OCTOCRYLENE - UNII:5A68WGF6WM) OCTOCRYLENE8.0 g  in 100 mL
    Inactive Ingredients
    Ingredient NameStrength
    ALOE VERA LEAF (UNII: ZY81Z83H0X)  
    SAFFLOWER (UNII: 4VBL71TY4Y)  
    WATER (UNII: 059QF0KO0R)  
    MEDIUM-CHAIN TRIGLYCERIDES (UNII: C9H2L21V7U)  
    COCONUT OIL (UNII: Q9L0O73W7L)  
    ETHYLHEXYL METHOXYCRYLENE (UNII: S3KFG6Q5X8)  
    METHYL DIHYDROABIETATE (UNII: 7666FJ0J9F)  
    MICA (UNII: V8A1AW0880)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    GLYCERYL MONOSTEARATE (UNII: 230OU9XXE4)  
    STEARYL/OCTYLDODECYL CITRATE CROSSPOLYMER (UNII: PN88NW0KPK)  
    AMMONIUM ACRYLOYLDIMETHYLTAURATE, DIMETHYLACRYLAMIDE, LAURYL METHACRYLATE AND LAURETH-4 METHACRYLATE COPOLYMER, TRIMETHYLOLPROPANE TRIACRYLATE CROSSLINKED (45000 MPA.S) (UNII: Q7UI015FF9)  
    SHEA BUTTER (UNII: K49155WL9Y)  
    LIMOSILACTOBACILLUS FERMENTUM (UNII: 2C1F12C6AP)  
    HYALURONATE SODIUM (UNII: YSE9PPT4TH)  
    AMMONIUM ACRYLOYLDIMETHYLTAURATE/VP COPOLYMER (UNII: W59H9296ZG)  
    ETHYL FERULATE (UNII: 5B8915UELW)  
    CAPRYLYL GLYCOL (UNII: 00YIU5438U)  
    1,2-HEXANEDIOL (UNII: TR046Y3K1G)  
    TITANIUM DIOXIDE (UNII: 15FIX9V2JP)  
    STEARIC ACID (UNII: 4ELV7Z65AP)  
    SODIUM STEAROYL GLUTAMATE (UNII: 65A9F4P024)  
    PHYTATE SODIUM (UNII: 88496G1ERL)  
    DIMETHICONE (UNII: 92RU3N3Y1O)  
    XANTHAN GUM (UNII: TTV12P4NEE)  
    MALTODEXTRIN (UNII: 7CVR7L4A2D)  
    SODIUM HYDROXIDE (UNII: 55X04QC32I)  
    DIMETHICONE/VINYL DIMETHICONE CROSSPOLYMER (SOFT PARTICLE) (UNII: 9E4CO0W6C5)  
    BUTYLENE GLYCOL (UNII: 3XUS85K0RA)  
    TROPOLONE (UNII: 7L6DL16P1T)  
    DECYL GLUCOSIDE (UNII: Z17H97EA6Y)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:79753-082-01100 mL in 1 TUBE; Type 0: Not a Combination Product06/24/2024
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC Monograph DrugM02006/24/2024
    Labeler - COOLA LLC (956990290)
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