COOLA CLASSIC BODY SUNSCREEN FRAGRANCE-FREE SPF 50- avobenzone homosalate octisalate octocrylene lotion 
Bentley Laboratories, LLC

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COOLA CLASSIC BODY SUNSCREEN Fragrance-Free SPF 50

DRUG FACTS

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

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
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 rash occurs.

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 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 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 Information

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

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)

Revised: 12/2023
Document Id: 5368324e-9b83-48dc-8ab3-88146d9423f8
Set id: 57f2fdeb-2abc-4ad3-bb89-5faee883c0e5
Version: 6
Effective Time: 20231219
 
Bentley Laboratories, LLC