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

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.

----------

COOLA CLASSIC BODY SUNSCREEN Guava Mango Broad Spectrum 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,
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 Information

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

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)

Revised: 4/2023
Document Id: 07213063-d2ae-49fc-af7a-73f741395e31
Set id: 9a397a2c-4734-4dae-93dd-15c68e6c297d
Version: 2
Effective Time: 20230405
 
COOLA LLC