Label: COOLA CLASSIC BODY SUNSCREEN FRAGRANCE-FREE SPF 50- avobenzone homosalate octisalate octocrylene lotion

  • NDC Code(s): 54111-145-51
  • Packager: Bentley Laboratories, LLC
  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None

Drug Label Information

Updated December 19, 2023

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

View All Sections
  • 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, 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
  • QUESTIONS

    Questions or Comments? Call 760-940-2125

  • Package Label

                                          SPF
                                            50

                                         70% +
                                         Organic

                                         COOLA®

                                          Classic
                                    Body Sunscreen
                                     Fragrance-Free

                                    Ultra Lightweight
                                Hydrates & Nourishes
                                  +Plant Protection®

                                 Broad Spectrum SPF 50
                            Water Resistant (80 Minutes)

                                  5 FL OZ / 148 mL

    *Hawaii Reef Friendly Sunscreen Oxybenzone & Octinoxate Free

    2020 COOLA. Distributed by: COOLA LLC, located in Sunny
    & Cool San Diego, CA 92010. BIORUS / EU: 7170 Manage,
       Belgium / UK: London WC2H 9JQ. All Rights Reserved.
                                  www.coola.com

    Box

    COOLA 145-51 Box

    Tube

    COOLA 145-51 Tube

    res

  • INGREDIENTS AND APPEARANCE
    COOLA CLASSIC BODY SUNSCREEN FRAGRANCE-FREE  SPF 50
    avobenzone homosalate octisalate octocrylene lotion
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:54111-145
    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 WHOLE (UNII: 23Z87HTQ6P)  
    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)  
    DISODIUM PHTHALATE (UNII: QB14YV193C)  
    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:54111-145-511 in 1 BOX11/06/2019
    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 DrugM02011/06/2019
    Labeler - Bentley Laboratories, LLC (068351753)
View All Sections

Find additional resources

(also available in the left menu)

Safety

Report Adverse Events, FDA Safety Recalls, Presence in Breast Milk

Related Resources

Medline Plus, Clinical Trials, PubMed, Biochemical Data Summary

More Info on this Drug

View Labeling Archives, RxNorm, Get Label RSS Feed, View NDC Code(s)NEW!