COOLA Classic Body Sunscreen Guava Mango

Manufacturer
Gordon Laboratories, Inc. | GORDON LABORATORIES,INC
Effective date
2019-01-31
Label type
HUMAN OTC DRUG LABEL
Version
1
Source
full-release
Hydrated at
2026-05-31 23:02:23

Label at a glance#

ProductCOOLA Classic Body Sunscreen Guava Mango SPF 50
Active ingredientAVOBENZONE, OCTISALATE, OCTOCRYLENE, HOMOSALATE
Label structure9 sections

Label contents#

Full prescribing information#

OTC - ACTIVE INGREDIENT SECTION

Active Ingredients

AVOBENZONE 1.75%, HOMOSALATE 5.0%, OCTISALATE 2.0%, OCTOCRYLENE 5.0%

OTC - PURPOSE SECTION

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

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 prodcut is swallowed, get medical help or contact Poison Control Center right away.

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

Directions

* apply liberally 15 minutes before sun exposure

* reapply:

* after 80 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 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-sleve shirts, pants, hats, and sunglasses



* children under 6 months: Ask a doctor

INACTIVE INGREDIENT SECTION

Inactive ingredients

Aloe Barbadensis Leaf Juice (ORGANIC), Brassica Campestris (Rapeseed) Seed Oil, Butylene Glycol, Camelina Sativa Seed Oil, Caprylyl Glycol, Carthamus Tinctorius (Safflower) Oleosomes, Carthamus Tinctorius (Safflower) Seed Oil (ORGANIC), Carthamus Tinctorius (Safflower) Seedcake Extract, Decyl Glucoside, Didecyldimonium Chloride, Dimethicone, Flavor, Glycerin (ORGANIC), Hydrogenated Methyl Abietata, Hydrolyzed Jojoba Esters, Jojoba Esters, Limnanthes Alba (Meadowfoam) Seed Oil, Mauritia Flexuosa Fruit Oil, Methylpropanediol, Opuntia Ficus-Indica Flower Extract, Polyacrylate Crosspolymer-6, Polyquaternium-80, Polysilicone-11, Rubus Idaeus (Raspberry) Seed Oil, Silica, Sodium Phytate, Squalane, Xanthan Gum

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

Classic Body Sunscreen Guava Mango Tube 148 mLClassic Body Sunscreen Guava Mango Tube 148 mLClassic Body Sunscreen Guava Mango carton 148 mLClassic Body Sunscreen Guava Mango carton 148 mL

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
21839-450-022021-01-29C16284748780-1ba0f9c33-213e-a910-e053-dadaa90a0b85COOLA Classic Body Sunscreen Guava Mango SPF 50

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
21839-450-01COOLA Classic Body Sunscreen Guava MangoSPF 50148 mL in 1 TUBELOTION1481
21839-450-02COOLA Classic Body Sunscreen Guava MangoSPF 501 in 1 CARTONLOTION11

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
21839-450COOLA CLASSIC BODY SUNSCREEN GUAVA MANGO SPF 50 (AVOBENZONE,HOMOSALATE, OCTISALATE,OCTOCRYLENE) LOTION [GORDON LABORATORIES, INC.]1Legacy NDC, 2 package rows20191227_9aa24411-fdad-c256-e053-2a95a90a3649.zip

Products#

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

DailyMed product names page 1 of 1 · 38 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
21839-45021839-450-01, 21839-450-02

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 36 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
9aa24411-fdae-c256-e053-2a95a90a36499aa24411-fdad-c256-e053-2a95a90a36492019-01-31WarningsExact identifier
spl id: 9aa24411-fdae-c256-e053-2a95a90a3649
spl set id: 9aa24411-fdad-c256-e053-2a95a90a3649

Reported adverse events (FAERS/openFDA)#

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