COOLA CLASSIC FACE SUNSCREEN CUCUMBER BROAD SPECTRUM SPF 30- 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.

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COOLA CLASSIC FACE SUNSCREEN Cucumber Broad Spectrum SPF 30

DRUG FACTS

Active Ingredients
Avobenzone 1.75%    Homosalate 2.5%
Octisalate 1.5%        Octocrylene 3.75%

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 40 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), Amyris
Balsamifera Bark Oil*, 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, Citric Acid,
Citronellyl Acetate*, Citrus Aurantium Dulcis
(Orange) Peel Oil*, Decanal*, Decyl Glucoside,
Dimethicone, Dimethyl Heptenal*, Glycerin
(ORGANIC), 1,2-Hexanediol, 3-Hexenol*,
Hexenyl Acetate*, Hexyl Acetate*, Hydrolyzed
Jojoba Esters, Jojoba Esters, Limnanthes Alba
(Meadowfoam) Seed Oil, Linalyl Acetate*,
Mauritia Flexuosa (Buriti) Fruit Oil, Methyl
Dihydroabietate, Nerol*, Opuntia Ficus-Indica
Flower Extract, Polyacrylate, Crosspolymer-6,
Polysilicone-11, Rubus Idaeus (Raspberry) Seed
Oil, Silica, Sodium Phytate, Sorbitan Oleate,
Sorbitan Palmitate, Squalane, Triethyl Citrate*,
Tropolone, Water, Xanthan Gum

Other Information

Questions or Comments? Call 760-940-2125

Package Label - COOLA CLASSIC FACE SUNSCREEN Cucumber Broad Spectrum SPF 30

  NEEDS OUTER BOX LABELING INSERTED    

                                    SPF
                                       30

                                    70% +
                                    Organic

                                    COOLA®

                                    Classic
                              Face Sunscreen
                                  Cucumbar

                               Non-Greasy
                           Ultralight Hydration
                             +Plant Protection®

                          Broad Spectrum SPF 30
                     Water Resistant (40 Minutes)

                          .85 FL OZ / 25 mL

2021 COOLA. Distributed by: COOLA LLC,
located in Sunny & Cool San Diego, CA 92010. ,
   All Rights Reserved.  www.coola.com

Box TO DELETE OLD!!!!!!

Tube

073-02 25mL Tube

res

COOLA CLASSIC FACE SUNSCREEN CUCUMBER BROAD SPECTRUM  SPF 30
avobenzone homosalate octisalate octocrylene lotion
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:79753-073
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) HOMOSALATE2.5 g  in 100 mL
OCTISALATE (UNII: 4X49Y0596W) (OCTISALATE - UNII:4X49Y0596W) OCTISALATE1.5 g  in 100 mL
OCTOCRYLENE (UNII: 5A68WGF6WM) (OCTOCRYLENE - UNII:5A68WGF6WM) OCTOCRYLENE3.75 g  in 100 mL
Inactive Ingredients
Ingredient NameStrength
ALOE VERA LEAF (UNII: ZY81Z83H0X)  
AMYRIS BALSAMIFERA OIL (UNII: I1BJ961J2E)  
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)  
CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP)  
CITRONELLYL ACETATE (UNII: IZ420RT3OY)  
ORANGE OIL (UNII: AKN3KSD11B)  
DECANAL (UNII: 31Z90Q7KQJ)  
DECYL GLUCOSIDE (UNII: Z17H97EA6Y)  
DIMETHICONE (UNII: 92RU3N3Y1O)  
2,6-DIMETHYL-5-HEPTENAL (UNII: Z331YX9EL9)  
GLYCERIN (UNII: PDC6A3C0OX)  
1,2-HEXANEDIOL (UNII: TR046Y3K1G)  
3-HEXEN-1-OL, (3Z)- (UNII: V14F8G75P4)  
HEXENYL ACETATE, (2Z)- (UNII: PT792BQ57D)  
HEXYL ACETATE (UNII: 7U7KU3MWT0)  
HYDROLYZED JOJOBA ESTERS (ACID FORM) (UNII: UDR641JW8W)  
JOJOBA OIL, RANDOMIZED (UNII: 7F0EV20QYL)  
MEADOWFOAM SEED OIL (UNII: 412ZHA4T4Y)  
LINALYL ACETATE (UNII: 5K47SSQ51G)  
MAURITIA FLEXUOSA FRUIT OIL (UNII: 48H19MS04L)  
METHYL DIHYDROABIETATE (UNII: 7666FJ0J9F)  
NEROL (UNII: 38G5P53250)  
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)  
DISODIUM PHTHALATE (UNII: QB14YV193C)  
SORBITAN MONOOLEATE (UNII: 06XEA2VD56)  
SORBITAN MONOPALMITATE (UNII: 77K6Z421KU)  
SQUALANE (UNII: GW89575KF9)  
TRIETHYL CITRATE (UNII: 8Z96QXD6UM)  
TROPOLONE (UNII: 7L6DL16P1T)  
WATER (UNII: 059QF0KO0R)  
XANTHAN GUM (UNII: TTV12P4NEE)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:79753-073-021 in 1 CARTON02/01/2023
125 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: c2df38eb-16ee-4f72-9ba5-4d9579c590a2
Set id: dec3b0d1-f06e-4acf-8ba2-64167e774abc
Version: 1
Effective Time: 20230407
 
COOLA LLC