COOLA CLASSIC BODY SUNSCREEN Guava Mango 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 21:17:37

Label at a glance#

ProductCOOLA CLASSIC BODY SUNSCREEN Guava Mango 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 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 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, 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
                                Body Sunscreen
                                  Guava Mango

                                Ultra Lightweight
                             Hydrates & Nourishes
                              +Plant Protection®

                          Broad Spectrum SPF 50
                      Water Resistant (80 Minutes)

                             5 FL OZ / 148 mL

Hawaii Reef Friendly Sunscreen Oxybenzone & Octinoxate Free
   *Naturally derived. See coola.com for additional detail.

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

COOLa Box 142-50COOLa Box 142-50

Tube

COOLa Tube 142 50COOLa Tube 142 50

res

FDA-Initiated Inactive NDC Indexing#

Products#

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

DailyMed product names page 1 of 1 · 34 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
54111-14254111-142-50

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 32 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
16edacf6-e5a2-4196-a202-b52f98f723b1c0cedf12-9530-4466-bba9-7b682a6f5d702023-12-19WarningsExact identifier
spl id: 16edacf6-e5a2-4196-a202-b52f98f723b1
spl set id: c0cedf12-9530-4466-bba9-7b682a6f5d70

Reported adverse events (FAERS/openFDA)#

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