COOLA Full Spectrum 360 Refreshing Water Cream SPF 50

Manufacturer
COOLA LLC
Effective date
2023-12-20
Label type
HUMAN OTC DRUG LABEL
Version
2
Source
full-release
Hydrated at
2026-06-01 00:05:17

Label at a glance#

ProductCOOLA Full Spectrum 360 Refreshing Water Cream SPF 50
Active ingredientAVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENE
Label structure9 sections

Label contents#

Full prescribing information#

OTC - ACTIVE INGREDIENT SECTION

Drug Facts

Active Ingredients

Avobenzone 3.0%, Homosalate 5.0%, Octisalate 3.0%, 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 after 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 spection 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
Adipic Acid/Diglycol Crosspolymer, Aloe Barbadensis Flower Extract, Aloe Barbadensis Leaf Juice, (ORGANIC)
Anisaldehyde*, Argania Spinosa Kernel Oil, Benzyl Acetate*, Bisabolol, Butylene Glycol, Caprylhydroxamic Acid,
Carthamus Tinctorius (Safflower) Oleosomes (ORGANIC), Citric Acid, Coccinia Indica Fruit Extract, Cocos Nucifera
(Coconut) Water (ORGANIC), Corallina Officinalis Extract, Curcuma Longa (Turmeric) Root Extract, Delta-Decalactone*,
Ethyl Butyrate*, Gamma-Nonalactone*, Gamma-Octalactone*, Gluconolactone, Glycerin (ORGANIC), Glyceryl Caprylate,
Glyceryl Stearate, Heliotropine*, Hyaluronic Acid, Isododecane, Jasminum Sambac (Jasmine) Leaf Cell Extract, Juniperus
Mexicana, Lecithin, Leuconostoc/Radish Root Ferment Filtrate, Leuconostoc Ferment Filtrate, Melia Azadirachta Flower
Extract, Melia Azadirachta Leaf Extract, Methyl Anthranilate*, Methyl Benzoate*, Methyl Benzyl Acetate*, Mimosa
Tenuiflora Bark Extract, Neopentyl Glycol Diheptanoate, Nerolidol, Ocimum Basilicum (Basil) Flower/Leaf Extract, Ocimum
Sanctum Leaf Extract, Phenethyl Alcohol*, Propanediol, Schinus Molle Extract, Sodium Acrylates Copolymer, Sodium
Benzoate, Sodium Hydroxide, Sodium Stearoyl Glutamate, Solanum Melongena (Eggplant) Fruit Extract, Theobroma
Cacao (Cocoa) Seed Extract, Tocopheryl Acetate, Triethyl Citrate*, Vanillin, Water, 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

COOLA Label

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

SPF

50

70%+

Organic

COOLA​®

Refreshing Water Cream

Sunscreen

1.5 FL OZ / 44 mL

Broad Spectrum SPF 70

Water Resistant (80 Minutes)

5.0 FL OZ / 148 mL

©2021 COOLA. Distributed by: COOLA LLC, located in

Sunny & Cool San Diego, CA 92010.  All Rights Reserved.

†Hawaii Reef Friendly Sunscreen Oxybenzone & Octinoxate Free
*Plant-derived scent constituent. See coola.com for additional detail.

Carton

020 Box 1.5 OZ020 Box 1.5 OZ

Bottle

020 Box 1.5 OZ020 Box 1.5 OZ

res

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
79753-020-01COOLA Full Spectrum 360 Refreshing Water Cream SPF 501 in 1 CARTONCREAM12
79753-020-01COOLA Full Spectrum 360 Refreshing Water Cream SPF 5044 mL in 1 JARCREAM442
79753-020-02COOLA Full Spectrum 360 Refreshing Water Cream SPF 5015 mL in 1 JARCREAM152
79753-020-02COOLA Full Spectrum 360 Refreshing Water Cream SPF 501 in 1 CARTONCREAM12

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
79753-020COOLA FULL SPECTRUM 360 REFRESHING WATER CREAM SPF 50 (AVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENE) CREAM [COOLA LLC]2Current NDC, Legacy NDC, 4 package rows20231221_d12e30bd-88ee-4e34-ae63-c34766aed3a8.zip

Products#

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

DailyMed product names page 1 of 2 · 60 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
79753-02079753-020-01, 79753-020-02

Ingredients#

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

DailyMed ingredient rows page 1 of 2 · 58 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
COOLA Full Spectrum 360 Refreshing Water Cream SPF 50AVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENECOOLA LLCd12e30bd-88ee-4e34-ae63-c34766aed3a82023-12-20WarningsExact identifier
ndc (package): 79753-020-02
ndc (package): 79753-020-01
ndc (product): 79753-020
ndc11 (package): 79753002001
ndc11 (package): 79753002002
spl id: 1cc9aa13-9722-40c4-b356-c18a20fd432d
spl set id: d12e30bd-88ee-4e34-ae63-c34766aed3a8

Reported adverse events (FAERS/openFDA)#

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