COOLA CLASSIC FACE SUNSCREEN Cucumber Broad Spectrum

Manufacturer
Bentley Laboratories, LLC
Effective date
2023-12-19
Label type
HUMAN OTC DRUG LABEL
Version
3
Source
legacy-cache
Hydrated at
2026-08-01 21:17:39

Label at a glance#

ProductCOOLA CLASSIC FACE SUNSCREEN Cucumber Broad Spectrum SPF 30
Active ingredientAVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENE
Label structure14 sections

Label contents#

Full prescribing information#

SPL UNCLASSIFIED SECTION

DRUG FACTS

OTC - ACTIVE INGREDIENT SECTION

Active Ingredients
Avobenzone 1.75%    Homosalate 2.5%
Octisalate 1.5%        Octocrylene 3.75%

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.

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 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 40 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 skin aging. To
decrease this risk, regularly use a sunscreen with a broad
spectrum SPF of 15 or higher and after 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), Amyris
Balsamifera Bark Oil*, Brassica Campestris
(Rapeseed) Seed Oil, Butylene Glycol, Camelina
Sativa Seed Oil, Caprylyl Glycol, Carthamus
Tinctorius (Safflower) Oleosomes, Carthamus
Tinctorius (Safflower) Seed Oil (ORGANIC),
Cetearyl Alcohol, Cetyl Palmitate, Citric Acid,
Citronellyl Acetate*, Citrus Aurantium Dulcis
(Orange) Peel Oil*, Decanal*, Decyl Glucoside,
Dimethicone, Dimethyl Heptenal*, Glycerin
(ORGANIC), 1,2-Hexanediol, 3-Hexenol*,
Hexenyl Acetate*, Hexyl Acetate*, Hydrolyzed
Jojoba Esters, Jojoba Esters, Limnanthes Alba
(Meadowfoam) Seed Oil, Linalyl Acetate*,
Mauritia Flexuosa (Buriti) Fruit Oil, Methyl
Dihydroabietate, Nerol*, Opuntia Ficus-Indica
Flower Extract, Polyacrylate, Crosspolymer-6,
Polysilicone-11, Rubus Idaeus (Raspberry) Seed
Oil, Silica, Sodium Phytate, Sorbitan Oleate,
Sorbitan Palmitate, Squalane, Triethyl Citrate*,
Tropolone, 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

Package Label

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

                                     SPF
                                       30

                                    70% +
                                    Organic

                                    COOLA®

                                    Classic
                              Face Sunscreen
                                  Cucumbar

                               Non-Greasy
                           Ultralight Hydration
                             +Plant Protection®

                          Broad Spectrum SPF 30
                     Water Resistant (40 Minutes)

                          1.7 FL OZ/ 50 mL

Hawaii Reef Friendly Sunscreen Oxybenzone & Octinoxate Free

2020 COOLA. Distributed by: COOLA LLC, located in Sunny
& Cool San Diego, CA 92010. BIORUS / EU: 7170 Manage,
   Belgium / UK: London WC2H 9JQ. All Rights Reserved.
          Questions or Comments? Call 760-940-2125
                                 www.coola.com

Box

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Tube

COOLA 144-50 TubeCOOLA 144-50 Tube

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FDA-Initiated Inactive NDC Indexing#

Products#

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

DailyMed product names page 1 of 2 · 48 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
54111-14454111-144-50

Ingredients#

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

DailyMed ingredient rows page 1 of 2 · 46 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
bd043c97-c73c-4179-be23-3cadd34f56c2e8ee3634-44c9-41fa-bc0a-01c88de6e3742023-12-19WarningsExact identifier
spl id: bd043c97-c73c-4179-be23-3cadd34f56c2
spl set id: e8ee3634-44c9-41fa-bc0a-01c88de6e374

Reported adverse events (FAERS/openFDA)#

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