FDA.reportPublic FDA data

Refreshing Water Hydration Stick

Manufacturer
COOLA LLC
Effective date
2024-12-27
Label type
HUMAN OTC DRUG LABEL
Version
3
Source
full-release
Hydrated at
2026-06-01 00:49:06

Label at a glance#

ProductRefreshing Water Hydration Stick SPF 50
Active ingredientAVOBENZONE, OCTISALATE, HOMOSALATE, OCTOCRYLENE
Label structure9 sections

Label contents#

Full prescribing information#

OTC - ACTIVE INGREDIENT SECTION

Drug Facts

Active Ingredients

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

OTC - PURPOSE SECTION

Purpose

Suncreen

INDICATIONS & USAGE SECTION

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 SECTION

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.

OTC - STOP USE SECTION

Stop use and ask doctor if skin rash occurs

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

Keep out of reach of children. If product is swallowed, get

medical help or contact a Poison Control Center right away.

DOSAGE & ADMINISTRATION SECTION

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 INGREDIENT SECTION

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 SAFETY INFORMATION

Other information

  • may stain fabrics
  • protect this product from excessive heat and direct sun

OTC - QUESTIONS SECTION

Questions or comments?
Call 760-940-2125

COOLA Label

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

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 BoxCOOLA Refresh2O 035 Box

COOLA Refresh2O 035 InnerCOOLA Refresh2O 035 Inner

res

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
79753-035-01Refreshing Water Hydration StickSPF 501 in 1 CARTONSTICK13
79753-035-01Refreshing Water Hydration StickSPF 5022.0 g in 1 CANISTERSTICK22.03

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
79753-035REFRESHING WATER HYDRATION STICK SPF 50 (AVOBENZONE OCTISALATE HOMOSALATE OCTOCRYLENE) STICK [COOLA LLC]3Current NDC, 2 package rows20241228_6da037f8-bedb-467a-b534-e44752120f2c.zip

Products#

Every source-derived product name is available through these pages.

DailyMed product names page 1 of 1 · 37 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
79753-03579753-035-01

Ingredients#

Every source-derived ingredient row is available through these pages.

DailyMed ingredient rows page 1 of 1 · 35 matching rows.

Name, UNII, Kind table
NameUNIIKind
AVOBENZONEG63QQF2NOXACTIB
OCTISALATE4X49Y0596WACTIB
HOMOSALATEV06SV4M95SACTIB
OCTOCRYLENE5A68WGF6WMACTIB
ALOE VERA LEAFZY81Z83H0XIACT
GLYCERINPDC6A3C0OXIACT
SODIUM STEARATEQU7E2XA9TGIACT
CARTHAMUS TINCTORIUS (SAFFLOWER) OLEOSOMES9S60Q72309IACT
POLYGLYCERYL-10 CAPRYLATEYS396CQX5CIACT
POLYGLYCERYL-10 CAPRATETL8V5BW2HCIACT
BUTYLOCTYL SALICYLATE2EH13UN8D3IACT
CARNAUBA WAXR12CBM0EIZIACT
SORBITAN OLIVATEMDL271E3GRIACT
VINYLPYRROLIDONE/HEXADECENE COPOLYMERKFR5QEN0N9IACT
PROPANEDIOL5965N8W85TIACT
BUTYLENE GLYCOL3XUS85K0RAIACT
1,2-HEXANEDIOLTR046Y3K1GIACT
CAPRYLYL GLYCOL00YIU5438UIACT
WATER059QF0KO0RIACT
JASMINUM OFFICINALE LEAF6OG06384IDIACT
AZADIRACHTA INDICA LEAFHKY915780TIACT
AZADIRACHTA INDICA FLOWER3TE8A92UPMIACT
CORALLINA OFFICINALIS4004498D06IACT
COCCINIA GRANDIS FRUITVLJ6WOT3K5IACT
TROPOLONE7L6DL16P1TIACT
EGGPLANTW5K7RAS4VKIACT
COCOAD9108TZ9KGIACT
ALOE VERA FLOWER575DY8C1ERIACT
COCONUT WATER267F5Y81NTIACT
JOJOBA OIL724GKU717MIACT
TURMERIC856YO1Z64FIACT
OCIMUM BASILICUM FLOWERING TOP7SAB275FP2IACT
HOLY BASIL LEAFSCJ765569PIACT
SCHINUS MOLLE FRUITING TOPT8L6O1KSB4IACT
HYALURONIC ACIDS270N0TRQYIACT

Source Document#

Source XML

openFDA label cross-check#

OpenFDA label data provides additional search and identifier links. DailyMed’s Structured Product Label is the canonical label on FDA.report. Matching records are deduplicated before they are shown below.

Matched openFDA labels page 1 of 1 · 1 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Refreshing Water Hydration Stick SPF 50AVOBENZONE OCTISALATE HOMOSALATE OCTOCRYLENECOOLA LLC6da037f8-bedb-467a-b534-e44752120f2c2024-12-27WarningsExact identifier
ndc (package): 79753-035-01
ndc (product): 79753-035
ndc11 (package): 79753003501
spl id: 5d3512a9-18c9-440c-9ce2-c1d13c647645
spl set id: 6da037f8-bedb-467a-b534-e44752120f2c

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.