Label: COOLA CLASSIC BODY SUNSCREEN GUAVA MANGO BROAD SPECTRUM SPF 50- avobenzone homosalate octisalate octocrylene lotion

  • 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 April 5, 2023

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  • SPL UNCLASSIFIED SECTION

    DRUG FACTS

  • ACTIVE INGREDIENT

    Active Ingredients
    Avobenzone 1.75%    Homosalate 5.0%
    Octisalate 2.0%          Octocrylene 5.0%

  • PURPOSE

    Purpose
    Sunscreen

  • 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

    Do not use on damaged or broken skin.

  • WHEN USING

    When using this product keep out of eyes.
    Rinse with water to remove.

  • STOP USE

    Stop use and ask doctor if 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
    • reapply:
      • after 80 minutes of 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 skin aging. To
    decrease this risk, regularly use a sunscreen with a broad
    spectrum SPF of 15 or higher and after 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

    Inactive Ingredients
    Aloe Barbadensis Leaf Juice (ORGANIC), Brassica
    Campestris (Rapeseed) Seed Oil, Butylene Glycol,
    Camelina Sativa Seed Oil, Caprylyl Glycol, Carthamus
    Tinctorius (Safflower) Oleosomes, Carthamus
    Tinctorius (Safflower) Seed Oil (ORGANIC), Cetearyl
    Alcohol, Cetyl Palmitate, Decyl Glucoside, Dimethicone,
    Flavor*, Glycerin (ORGANIC), 1,2-Hexanediol,
    Limnanthes Alba (Meadowfoam) Seed Oil, Mauritia
    Flexuosa (Buriti) Fruit Oil, Methyl Dihydroabietate,
    Opuntia Ficus-Indica Flower Extract, Polyacrylate
    Crosspolymer-6, Polysilicone-11, Rubus Idaeus
    (Raspberry) Seed Oil, Silica, Sodium Hydroxide, Sodium
    Phytate, Sorbitan Oleate, Sorbitan Palmitate, Tropolone,
    Water, Xanthan Gum

  • OTHER SAFETY INFORMATION

    Other Information

    • protect this product from excessive heat and direct sun
    • may stain fabrics
  • QUESTIONS

    Questions or Comments? Call 760-940-2125

  • Package Label

                                          SPF
                                           50

                                          70% +
                                         Organic

                                         COOLA

                                         Classic
                                    Body Sunscreen
                                      Guava Mango

                                    Ultra Lightweight
                                 Hydrates & Nourishes
                                  +Plant Protection®

                              Broad Spectrum SPF 50
                          Water Resistant (80 Minutes)

                                 3.4 FL OZ / 100 mL

    2020 COOLA. Distributed by: COOLA LLC,

    located in Sunny& Cool San Diego, CA 92009.

    All Rights Reserved. ww.coola.com

    Box

    075-02 3.4 Oz Box

    Tube

    075-02 3.4 Oz Tube

    res

  • INGREDIENTS AND APPEARANCE
    COOLA CLASSIC BODY SUNSCREEN GUAVA MANGO BROAD SPECTRUM  SPF 50
    avobenzone homosalate octisalate octocrylene lotion
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:79753-075
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    AVOBENZONE (UNII: G63QQF2NOX) (AVOBENZONE - UNII:G63QQF2NOX) AVOBENZONE1.75 g  in 100 mL
    HOMOSALATE (UNII: V06SV4M95S) (HOMOSALATE - UNII:V06SV4M95S) HOMOSALATE5.0 g  in 100 mL
    OCTISALATE (UNII: 4X49Y0596W) (OCTISALATE - UNII:4X49Y0596W) OCTISALATE2.0 g  in 100 mL
    OCTOCRYLENE (UNII: 5A68WGF6WM) (OCTOCRYLENE - UNII:5A68WGF6WM) OCTOCRYLENE5.0 g  in 100 mL
    Inactive Ingredients
    Ingredient NameStrength
    ALOE VERA LEAF (UNII: ZY81Z83H0X)  
    BRASSICA RAPA SUBSP. OLEIFERA OIL (UNII: N4G8379626)  
    BUTYLENE GLYCOL (UNII: 3XUS85K0RA)  
    CAMELINA SATIVA SEED OIL (UNII: 12824X01L0)  
    CAPRYLYL GLYCOL (UNII: 00YIU5438U)  
    CARTHAMUS TINCTORIUS SEED OLEOSOMES (UNII: 9S60Q72309)  
    SAFFLOWER OIL (UNII: 65UEH262IS)  
    CETOSTEARYL ALCOHOL (UNII: 2DMT128M1S)  
    CETYL PALMITATE (UNII: 5ZA2S6B08X)  
    DECYL GLUCOSIDE (UNII: Z17H97EA6Y)  
    DIMETHICONE (UNII: 92RU3N3Y1O)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    1,2-HEXANEDIOL (UNII: TR046Y3K1G)  
    MEADOWFOAM SEED OIL (UNII: 412ZHA4T4Y)  
    MAURITIA FLEXUOSA FRUIT OIL (UNII: 48H19MS04L)  
    METHYL DIHYDROABIETATE (UNII: 7666FJ0J9F)  
    OPUNTIA FICUS-INDICA FLOWER (UNII: 83YSP51SMA)  
    AMMONIUM ACRYLOYLDIMETHYLTAURATE, DIMETHYLACRYLAMIDE, LAURYL METHACRYLATE AND LAURETH-4 METHACRYLATE COPOLYMER, TRIMETHYLOLPROPANE TRIACRYLATE CROSSLINKED (45000 MPA.S) (UNII: Q7UI015FF9)  
    DIMETHICONE/VINYL DIMETHICONE CROSSPOLYMER (SOFT PARTICLE) (UNII: 9E4CO0W6C5)  
    RASPBERRY SEED OIL (UNII: 9S8867952A)  
    SILICON DIOXIDE (UNII: ETJ7Z6XBU4)  
    SODIUM HYDROXIDE (UNII: 55X04QC32I)  
    PHYTATE SODIUM (UNII: 88496G1ERL)  
    SORBITAN MONOOLEATE (UNII: 06XEA2VD56)  
    SORBITAN MONOPALMITATE (UNII: 77K6Z421KU)  
    TROPOLONE (UNII: 7L6DL16P1T)  
    WATER (UNII: 059QF0KO0R)  
    XANTHAN GUM (UNII: TTV12P4NEE)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:79753-075-021 in 1 CARTON02/01/2023
    1100 mL in 1 TUBE; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph finalpart35202/01/2023
    Labeler - COOLA LLC (956990290)
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