REFRESHING WATER HYDRATION STICK SPF 50- avobenzone octisalate homosalate octocrylene stick 
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 Refreshing Water Hydration Stick SPF 50

Drug Facts

Active Ingredients

Avobenzone 2.5%, Homosalate 3.5%, Octisalate 2.15%, Octocrylene 5.0%

Purpose

Suncreen

Uses

  (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 skin 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 swimming or sweating ● immediately afte
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 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 Ingredients

Aloe Barbadensis Leaf Juice (ORGANIC), Glycerin (ORGANIC), Sodium Stearate, Carthamus Tinctorius (Safflower) Oleosomes (ORGANIC), Polyglyceryl-10 Caprylate/Caprate, Butyloctyl Salicylate, Copernicia Cerifera (Carnauba) Wax (ORGANIC), Sorbitan Olivate, VP/Hexadecene Copolymer, Cocos Nucifera (Coconut) Fruit Water (ORGANIC), Jasminum Sambac (Jasmine) Leaf Cell Extract, Melia Azadirachta Leaf Extract, Melia Azadirachta Flower Extract, Coralline Officinalis Extract, Solanum Melongena (Eggplant) Fruit Extract, Theobroma Cacao (Cocoa) Seed Extract, Aloe Barbadensis Flower Extract, Simmondsia Chinensis (Jojoba) Seed Oil, Hyaluronic Acid, Coccinia Indica Fruit Extract, Curcuma Longa (Turmeric) Root Extract, Ocimum Basilicum (Basil) Flower/Leaf Extract, Ocimum Sanctum Leaf Extract, Schinus Molle Extract, Propanediol, Butylene Glycol, 1,2-Hexanediol, Caprylyl Glycol, Water, Tropolone, Fragrance (Natural)

Other information

Questions or comments?
Call 760-940-2125

COOLA Label

SPF

50

70%+

Organic

COOLA​®

Refreshing Water

Hydration Stick

Sunscreen

Net Wt. 0.8 OZ / 22.0 g

©2023 COOLA. Manufactured in the USA for COOLA

LLC, located in Sunny & Cool San Diego, CA 92010. 

All Rights Reserved.  www.coola.com

COOLA Refresh2O 035 Box

COOLA Refresh2O 035 Inner

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REFRESHING WATER HYDRATION STICK  SPF 50
avobenzone octisalate homosalate octocrylene stick
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:79753-035
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
AVOBENZONE (UNII: G63QQF2NOX) (AVOBENZONE - UNII:G63QQF2NOX) AVOBENZONE2.5 g  in 100 g
OCTISALATE (UNII: 4X49Y0596W) (OCTISALATE - UNII:4X49Y0596W) OCTISALATE2.15 g  in 100 g
HOMOSALATE (UNII: V06SV4M95S) (HOMOSALATE - UNII:V06SV4M95S) HOMOSALATE3.5 g  in 100 g
OCTOCRYLENE (UNII: 5A68WGF6WM) (OCTOCRYLENE - UNII:5A68WGF6WM) OCTOCRYLENE5.0 g  in 100 g
Inactive Ingredients
Ingredient NameStrength
ALOE VERA LEAF (UNII: ZY81Z83H0X)  
GLYCERIN (UNII: PDC6A3C0OX)  
SODIUM STEARATE (UNII: QU7E2XA9TG)  
CARTHAMUS TINCTORIUS (SAFFLOWER) OLEOSOMES (UNII: 9S60Q72309)  
POLYGLYCERYL-10 CAPRYLATE (UNII: YS396CQX5C)  
POLYGLYCERYL-10 CAPRATE (UNII: TL8V5BW2HC)  
BUTYLOCTYL SALICYLATE (UNII: 2EH13UN8D3)  
CARNAUBA WAX (UNII: R12CBM0EIZ)  
SORBITAN OLIVATE (UNII: MDL271E3GR)  
VINYLPYRROLIDONE/HEXADECENE COPOLYMER (UNII: KFR5QEN0N9)  
PROPANEDIOL (UNII: 5965N8W85T)  
BUTYLENE GLYCOL (UNII: 3XUS85K0RA)  
1,2-HEXANEDIOL (UNII: TR046Y3K1G)  
CAPRYLYL GLYCOL (UNII: 00YIU5438U)  
WATER (UNII: 059QF0KO0R)  
JASMINUM OFFICINALE LEAF (UNII: 6OG06384ID)  
AZADIRACHTA INDICA LEAF (UNII: HKY915780T)  
AZADIRACHTA INDICA FLOWER (UNII: 3TE8A92UPM)  
CORALLINA OFFICINALIS (UNII: 4004498D06)  
COCCINIA GRANDIS FRUIT (UNII: VLJ6WOT3K5)  
TROPOLONE (UNII: 7L6DL16P1T)  
EGGPLANT (UNII: W5K7RAS4VK)  
COCOA (UNII: D9108TZ9KG)  
ALOE VERA FLOWER (UNII: 575DY8C1ER)  
COCONUT WATER (UNII: 267F5Y81NT)  
JOJOBA OIL (UNII: 724GKU717M)  
TURMERIC (UNII: 856YO1Z64F)  
OCIMUM BASILICUM FLOWERING TOP (UNII: 7SAB275FP2)  
HOLY BASIL LEAF (UNII: SCJ765569P)  
SCHINUS MOLLE FRUITING TOP (UNII: T8L6O1KSB4)  
HYALURONIC ACID (UNII: S270N0TRQY)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:79753-035-011 in 1 CARTON01/16/2023
122.0 g in 1 CANISTER; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph finalpart35201/16/2023
Labeler - COOLA LLC (956990290)

Revised: 1/2023
Document Id: 391c57fe-bf3f-4af1-9130-2e1559e443e8
Set id: 6da037f8-bedb-467a-b534-e44752120f2c
Version: 2
Effective Time: 20230125
 
COOLA LLC