COOLA Refreshing Water Mist Sunscreen

Manufacturer
Gordon Laboratories, Inc. | GORDON LABORATORIES,INC
Effective date
2019-12-16
Label type
HUMAN OTC DRUG LABEL
Version
1
Source
full-release
Hydrated at
2026-05-31 23:02:02

Label at a glance#

ProductCOOLA Refreshing Water Mist Sunscreen SPF 30
Active ingredientAVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENE
Label structure9 sections

Label contents#

Full prescribing information#

OTC - ACTIVE INGREDIENT SECTION

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 rise of skin cancer and early skin aging caused by the sun

WARNINGS AND PRECAUTIONS SECTION

Warnings


For external use only

OTC - DO NOT USE SECTION

Do not use on damaged or broken skin

OTC - WHEN USING SECTION

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

* 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 othersunprotection measures including: limit time in the sun, especially from: 10 a.m. – 2 p.m. * wear long-sleve shirts, pants, hats, and sunglasses * children under 6 months: Ask a doctor

INACTIVE INGREDIENT SECTION

Inactive ingredients

Aloe Barbadensis Leaf Juice (ORGANIC), Butylene Glycol, Caprylyl Glycol, Ceteareth-12, Ceteareth-20, Cetearyl Alcohol, Cetearyl lsononanoate, Cetyl Palmitate, Citronellyl Acetate, Cocos Nucifera (ORGANIC Coconut) Water, Cyclamen Aldehyde, Ethylene Brassylate, Glycerin (ORGANIC), Glyceryl Stearate, Glycine Soja (Soybean) Extract, Hyaluronic Acid, Jasminum Sambac Leaf Cell Extract, Lauryl Glucoside, Methyl Dihydrojasmonate, Methylenedioxyphenyl Methylpropanal, Olive Oil Polyglyceryl-6 Esters, 1,2-Hexanediol, Propanediol, Schinus Molle Extract, Sodium Phytate, Sodium Stearoyl Glutamate, Theobroma Cacao Cocoa Seed Extract, Tropolone

OTHER SAFETY INFORMATION

Other information


* protect this product from excessive heat and direct sun

OTC - QUESTIONS SECTION

Questions or comments? Call 760-940-2125

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

COOLA Refreshing Water Mist Sunscreen SPF 30 25 ml cartonCOOLA Refreshing Water Mist Sunscreen SPF 30 25 ml cartonCOOLA Refreshing Water Mist Sunscreen SPF 30 25 ml bottleCOOLA Refreshing Water Mist Sunscreen SPF 30 25 ml bottle

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
c6f86816-7da6-43ea-8c25-ac9758311cc5Product name120220118
252e11b6-1a9a-4283-a242-df2c129c496dProduct name320170717

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
21839-590-022021-01-29C16284748780-1ba0f9c33-20e7-a910-e053-dadaa90a0b85COOLA Refreshing Water Mist Sunscreen SPF 30

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
21839-590-01COOLA Refreshing Water Mist SunscreenSPF 3025 mL in 1 BOTTLELIQUID251
21839-590-02COOLA Refreshing Water Mist SunscreenSPF 301 in 1 CARTONLIQUID11

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
21839-590COOLA REFRESHING WATER MIST SUNSCREEN SPF 30 (AVOBENZONE,HOMOSALATE, OCTISALATE,OCTOCRYLENE) LIQUID [GORDON LABORATORIES, INC.]1Legacy NDC, 2 package rows20191217_99d86e48-3c0e-4dec-e053-2995a90a7d05.zip

Products#

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

DailyMed product names page 1 of 1 · 33 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
21839-59021839-590-01, 21839-590-02

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 31 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
99d86e48-3c0f-4dec-e053-2995a90a7d0599d86e48-3c0e-4dec-e053-2995a90a7d052019-12-16WarningsExact identifier
spl id: 99d86e48-3c0f-4dec-e053-2995a90a7d05
spl set id: 99d86e48-3c0e-4dec-e053-2995a90a7d05

Reported adverse events (FAERS/openFDA)#

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