Label: COOLA CLASSIC BODY SUNSCREEN SPF 70 - PEACH BLOSSOM- avobenzone, homosalate, octisalate, octocrylene cream

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

Drug Label Information

Updated December 20, 2023

If you are a consumer or patient please visit this version.

  • ACTIVE INGREDIENT

    Drug Facts

    Active Ingredients

    Avobenzone 3.0%, Homosalate 5.0%, Octisalate 4.9%, Octocrylene 7.5%

    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.

    Rinse with water to remove.

    Do not use on damaged or broken skin

    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.
    • 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
    spection 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

    Inactive Ingredients
    1,2-Hexanediol, Acrylates/C12-22 Alkyl Methacrylate Copolymer, Aloe Barbadensis Leaf Juice (ORGANIC), Benzyl Alcohol, Bisabolol (ORGANIC), Brassica Campestris (Rapeseed) Seed Oil, Butyloctyl Salicylate, Camelina Sativa Seed Oil, Caprylyl Glycol, Carthamus Tinctorius (Safflower) Oleosomes (ORGANIC), Carthamus Tinctorius (Safflower) Seed Oil (ORGANIC), Citric Acid, Cocos Nucifera (Coconut) Oil*, Decanal*, Dimethyl Heptenal*, Ethyl Acetoacetate*, Ethyl Butyrate*, Ethyl Caproate*, Gamma-Nonalactone*, Gamma Undecalactone*, Gluconolactone, Glycerin (ORGANIC), Hexenyl Acetate*, Hexyl Acetate*, Hydroxyacetophenone, Isoamyl Acetate*, Limnanthes Alba (Meadowfoam) Seed Oil, Mauritia Flexuosa (Buriti) Fruit Oil, Opuntia Ficus-Indica Flower Extract, Pentylene Glycol, Polyacrylate Crosspolymer-6, Prunus Persica (Peach) Flower Extract, Raspberry Ketone*, Rubus Idaeus (Raspberry) Seed Oil, Sodium Benzoate, Sodium Hydroxide, Sodium Phytate, Triethyl Citrate*, Xanthan Gum

  • 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

    70

    70%+

    Organic

    COOLA​®

    Classic

    Body Sunscreen

    Peach Blossom

    Ultra Lightweight

    Hydrates & Nourishes

    +Plant Protection®

    Broad Spectrum SPF 70

    Water Resistant (80 Minutes)

    5.0 FL OZ / 148 mL

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

    Sunny & Cool San Diego, CA 92010.  All Rights Reserved.

    Hawaii Reef Friendly Sunscreen Oxybenzone & Octinoxate Free
    *Plant-derived scent constituent. See coola.com for additional detail.

    Carton

    015-01 Box

    Bottle

    015-01 Btl

    res

  • INGREDIENTS AND APPEARANCE
    COOLA CLASSIC BODY SUNSCREEN SPF 70 - PEACH BLOSSOM 
    avobenzone, homosalate, octisalate, octocrylene cream
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:79753-015
    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) HOMOSALATE5.0 g  in 100 mL
    OCTISALATE (UNII: 4X49Y0596W) (OCTISALATE - UNII:4X49Y0596W) OCTISALATE4.9 g  in 100 mL
    OCTOCRYLENE (UNII: 5A68WGF6WM) (OCTOCRYLENE - UNII:5A68WGF6WM) OCTOCRYLENE7.5 g  in 100 mL
    Inactive Ingredients
    Ingredient NameStrength
    1,2-HEXANEDIOL (UNII: TR046Y3K1G)  
    BUTYL ACRYLATE/C16-C20 ALKYL METHACRYLATE/METHACRYLIC ACID/METHYL METHACRYLATE COPOLYMER (UNII: 7K68DGG29P)  
    ALOE VERA LEAF (UNII: ZY81Z83H0X)  
    BENZYL ALCOHOL (UNII: LKG8494WBH)  
    LEVOMENOL (UNII: 24WE03BX2T)  
    BRASSICA RAPA SUBSP. OLEIFERA OIL (UNII: N4G8379626)  
    BUTYLOCTYL SALICYLATE (UNII: 2EH13UN8D3)  
    CAMELINA SATIVA SEED OIL (UNII: 12824X01L0)  
    CAPRYLYL GLYCOL (UNII: 00YIU5438U)  
    CARTHAMUS TINCTORIUS (SAFFLOWER) OLEOSOMES (UNII: 9S60Q72309)  
    SAFFLOWER OIL (UNII: 65UEH262IS)  
    CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP)  
    COCONUT OIL (UNII: Q9L0O73W7L)  
    DECANAL (UNII: 31Z90Q7KQJ)  
    2,6-DIMETHYL-5-HEPTENAL (UNII: Z331YX9EL9)  
    ETHYL ACETOACETATE (UNII: IZP61H3TB1)  
    ETHYL BUTYRATE (UNII: UFD2LZ005D)  
    ETHYL CAPROATE (UNII: FLO6YR1SHT)  
    .GAMMA.-NONALACTONE (UNII: I1XGH66S8P)  
    .GAMMA.-UNDECALACTONE (UNII: QB1T0AG2YL)  
    GLUCONOLACTONE (UNII: WQ29KQ9POT)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    HEXENYL ACETATE, (2Z)- (UNII: PT792BQ57D)  
    HEXYL ACETATE (UNII: 7U7KU3MWT0)  
    HYDROXYACETOPHENONE (UNII: G1L3HT4CMH)  
    ISOAMYL ACETATE (UNII: Z135787824)  
    MEADOWFOAM SEED OIL (UNII: 412ZHA4T4Y)  
    MAURITIA FLEXUOSA FRUIT OIL (UNII: 48H19MS04L)  
    OPUNTIA FICUS-INDICA LEAF (UNII: 5VM709H93V)  
    PENTYLENE GLYCOL (UNII: 50C1307PZG)  
    AMMONIUM ACRYLOYLDIMETHYLTAURATE, DIMETHYLACRYLAMIDE, LAURYL METHACRYLATE AND LAURETH-4 METHACRYLATE COPOLYMER, TRIMETHYLOLPROPANE TRIACRYLATE CROSSLINKED (45000 MPA.S) (UNII: Q7UI015FF9)  
    PRUNUS PERSICA FLOWER (UNII: 19GWB0JENH)  
    4-(P-HYDROXYPHENYL)-2-BUTANONE (UNII: 7QY1MH15BG)  
    RASPBERRY SEED OIL (UNII: 9S8867952A)  
    SODIUM BENZOATE (UNII: OJ245FE5EU)  
    SODIUM HYDROXIDE (UNII: 55X04QC32I)  
    PHYTATE SODIUM (UNII: 88496G1ERL)  
    TRIETHYL CITRATE (UNII: 8Z96QXD6UM)  
    XANTHAN GUM (UNII: TTV12P4NEE)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:79753-015-011 in 1 CARTON02/08/2021
    1148 mL in 1 TUBE; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC Monograph DrugM02002/08/2021
    Labeler - COOLA LLC (956990290)