COOLA CLASSIC FACE SUNSCREEN White Tea Broad Spectrum

Manufacturer
Bentley Laboratories, LLC
Effective date
2023-12-19
Label type
HUMAN OTC DRUG LABEL
Version
3
Source
full-release
Hydrated at
2026-06-01 00:04:55

Label at a glance#

ProductCOOLA CLASSIC FACE SUNSCREEN White Tea Broad Spectrum SPF 50
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 5.0%
Octisalate 2.0%        Octocrylene 5.0%

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 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 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 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),
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, Decyl
Glucoside, Dimethicone, Flavor*, Glycerin
(ORGANIC), 1,2-Hexanediol, Limnanthes
Alba (Meadowfoam) Seed Oil, Mauritia
Flexuosa (Buriti) Fruit Oil, Methyl
Dihydroabietate, Opuntia Ficus-Indica
Flower Extract, Polyacrylate
Crosspolymer-6, Polysilicone-11, Rubus
Idaeus (Raspberry) Seed Oil, Silica, Sodium
Hydroxide, Sodium Phytate, Sorbitan
Oleate, Sorbitan Palmitate, Squalane,
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
                                          50

                                        70% +
                                       Organic

                                       COOLA​®

                                        Classic
                                   Face Sunscreen
                                       White Tea

                                        Non-Greasy
                                Lightweight Hydration
                                   +Plant Protection®

                               Broad Spectrum SPF 50
                           Water Resistant (80 Minutes)

                                 1.7 FL OZ/ 50 mL

  Hawaii Reef Friendly Sunscreen Oxybenzone & Octinoxate Free

                               *Naturally Derived

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.
                            www.coola.com

Box

COOLA 143-50 BoxCOOLA 143-50 Box

Tube

COOLA 143-50 TubeCOOLA 143-50 Tube

res

FDA-Initiated Inactive NDC Indexing#

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
54111-143-50COOLA CLASSIC FACE SUNSCREEN White Tea Broad SpectrumSPF 5050 mL in 1 TUBELOTION503
54111-143-50COOLA CLASSIC FACE SUNSCREEN White Tea Broad SpectrumSPF 501 in 1 CARTONLOTION13

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
54111-143COOLA CLASSIC FACE SUNSCREEN WHITE TEA BROAD SPECTRUM SPF 50 (AVOBENZONE HOMOSALATE OCTISALATE OCTOCRYLENE) LOTION [BENTLEY LABORATORIES, LLC]3Current NDC, Legacy NDC, 2 package rows20231220_4e0e426d-f037-428f-98f2-2d3e945bd040.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
54111-14354111-143-50

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
COOLA CLASSIC FACE SUNSCREEN White Tea Broad Spectrum SPF 50AVOBENZONE HOMOSALATE OCTISALATE OCTOCRYLENEBentley Laboratories, LLC4e0e426d-f037-428f-98f2-2d3e945bd0402023-12-19WarningsExact identifier
ndc (package): 54111-143-50
ndc (product): 54111-143
ndc11 (package): 54111014350
spl id: 1d1f3d4a-c17a-42b2-af85-54167ab7921f
spl set id: 4e0e426d-f037-428f-98f2-2d3e945bd040

Reported adverse events (FAERS/openFDA)#

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