COOLA Refreshing Water Mist SPF 18

Manufacturer
COOLA LLC | Bentley Laboratories, LLC
Effective date
2023-04-09
Label type
HUMAN OTC DRUG LABEL
Version
1
Source
full-release
Hydrated at
2026-05-31 23:54:40

Label at a glance#

ProductCOOLA Refreshing Water Mist SPF 18
Active ingredientAVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENE
Label structure9 sections

Label contents#

Full prescribing information#

OTC - ACTIVE INGREDIENT SECTION

Drug Facts

Active Ingredients

Avobenzone 2.0%. Homosalate 10.0%

Octisalate 5.0%, Octocrylene 5.5%

OTC - PURPOSE SECTION

Purpose

Sunscreen

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.

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
• shake well • apply liberally 15 minutes before sun exposure
• reapply: •after 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 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-sleeved shirts, pants, hats, and sunglasses
• children under 6 months: Ask a doctor


INACTIVE INGREDIENT SECTION

Inactive Ingredients
Aloe Barbadensis Leaf Extract (ORGANIC), Undecane,
Tridecane, Water, Cocos Nucifera (Coconut) Water
(ORGANIC), Sodium Hyaluronate, Jasminum Sambac
(Jasmine) Leaf Cell Extract, Theobroma Cacao (Cocoa)
Seed Extract, Schinus Molle Extract, Heliotropine*,
Juniperus Mexicana*, Propanediol, Butylene Glycol,
Methlypropanediol, Caprylic/Capric Triglyceride, Caprylyl
Glycol, Polyquaternium-80, Sodium Phytate,
Didecyldimonium Chloride, Anisaldehyde*, Benzyl
acetate*, Delta-Decalactone*, Gamma-Nonalactone*,
Gamma Octalactone*, Methyl benzoate*, Nerolidol*, Ethyl
Butyrate*, Triethyl citrate*, Vanillin

* Plant-derived scent constituent.

OTHER SAFETY INFORMATION

Other information

• protect this product from excessive heat and direct sun

OTC - QUESTIONS SECTION

Questions or comments? Call 760-940-2125

Product Label - COOLA Refreshing Water Mist Sunscreen SPF 18

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

SPF

18

COOLA​®​

Refreshing Water Mist

Sunscreen

Broad Spectrum SPF 18

0.85 FL OZ / 25 mL

© 2022 COOLA. Manufactured in the USA for

COOLA LLC, located inSunny & Cool San

Diego, CA 92009.  All Rights Reserved.

www.coola.com

Carton

079-02 25mL Box079-02 25mL Box

Jar

079-02 25mL Botl079-02 25mL Botl

 res

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
79753-079-022025-01-30C16284748780-12cef2736-9d35-d83d-e063-dadaa90ab31fCOOLA Refreshing Water Mist Sunscreen SPF 18

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
79753-079-02COOLA Refreshing Water Mist SPF 181 in 1 CARTONSPRAY11
79753-079-02COOLA Refreshing Water Mist SPF 1825 mL in 1 BOTTLESPRAY251

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
79753-079COOLA REFRESHING WATER MIST SPF 18 (AVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENE) SPRAY [COOLA LLC]12 package rows20230410_627d6472-c637-431d-bde2-556b531a13ff.zip

Products#

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

DailyMed product names page 1 of 1 · 35 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
79753-07979753-079-02

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 33 matching rows.

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
4c6d2b61-9129-414e-b706-73b01a934e51627d6472-c637-431d-bde2-556b531a13ff2023-04-09WarningsExact identifier
spl id: 4c6d2b61-9129-414e-b706-73b01a934e51
spl set id: 627d6472-c637-431d-bde2-556b531a13ff

Reported adverse events (FAERS/openFDA)#

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