FDA.reportPublic FDA data

COOLA Classic Body Sunscreen Fragrance-Free

Manufacturer
Bentley Laboratories, LLC
Effective date
2023-12-19
Label type
HUMAN OTC DRUG LABEL
Version
6
Source
full-release
Hydrated at
2026-06-01 00:05:05

Label at a glance#

ProductCOOLA Classic Body Sunscreen Fragrance-Free 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, 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
                                 Fragrance-Free

                                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

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 145-51 BoxCOOLA 145-51 Box

Tube

COOLA 145-51 TubeCOOLA 145-51 Tube

res

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
54111-145-512023-01-06C16284748780-1d6a99b39-6d3f-a426-e053-dadaa90af4c2COOLA CLASSIC BODY SUNSCREEN Fragrance-Free SPF 50
54111-145-512022-01-28C16284748780-1d6a99b39-6d3f-a426-e053-dadaa90af4c2COOLA CLASSIC BODY SUNSCREEN Fragrance-Free SPF 50

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
54111-145-51COOLA Classic Body Sunscreen Fragrance-FreeSPF 50148 mL in 1 TUBELOTION1486
54111-145-51COOLA Classic Body Sunscreen Fragrance-FreeSPF 501 in 1 BOXLOTION16

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
54111-145COOLA CLASSIC BODY SUNSCREEN FRAGRANCE-FREE SPF 50 (AVOBENZONE HOMOSALATE OCTISALATE OCTOCRYLENE) LOTION [BENTLEY LABORATORIES, LLC]6Current NDC, Legacy NDC, 2 package rows20231221_57f2fdeb-2abc-4ad3-bb89-5faee883c0e5.zip

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
54111-14554111-145-51

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 32 matching rows.

Name, UNII, Kind table
NameUNIIKind
AVOBENZONEG63QQF2NOXACTIB
HOMOSALATEV06SV4M95SACTIB
OCTISALATE4X49Y0596WACTIB
OCTOCRYLENE5A68WGF6WMACTIB
ALOE VERA LEAFZY81Z83H0XIACT
BRASSICA RAPA SUBSP. OLEIFERA OILN4G8379626IACT
BUTYLENE GLYCOL3XUS85K0RAIACT
CAMELINA SATIVA SEED OIL12824X01L0IACT
CAPRYLYL GLYCOL00YIU5438UIACT
CARTHAMUS TINCTORIUS SEED OLEOSOMES9S60Q72309IACT
SAFFLOWER OIL65UEH262ISIACT
CETOSTEARYL ALCOHOL2DMT128M1SIACT
CETYL PALMITATE5ZA2S6B08XIACT
DECYL GLUCOSIDEZ17H97EA6YIACT
DIMETHICONE92RU3N3Y1OIACT
GLYCERINPDC6A3C0OXIACT
1,2-HEXANEDIOLTR046Y3K1GIACT
MEADOWFOAM SEED OIL412ZHA4T4YIACT
MAURITIA FLEXUOSA FRUIT OIL48H19MS04LIACT
METHYL DIHYDROABIETATE7666FJ0J9FIACT
OPUNTIA FICUS-INDICA WHOLE23Z87HTQ6PIACT
AMMONIUM ACRYLOYLDIMETHYLTAURATE, DIMETHYLACRYLAMIDE, LAURYL METHACRYLATE AND LAURETH-4 METHACRYLATE COPOLYMER, TRIMETHYLOLPROPANE TRIACRYLATE CROSSLINKED (45000 MPA.S)Q7UI015FF9IACT
DIMETHICONE/VINYL DIMETHICONE CROSSPOLYMER (SOFT PARTICLE)9E4CO0W6C5IACT
RASPBERRY SEED OIL9S8867952AIACT
SILICON DIOXIDEETJ7Z6XBU4IACT
SODIUM HYDROXIDE55X04QC32IIACT
DISODIUM PHTHALATEQB14YV193CIACT
SORBITAN MONOOLEATE06XEA2VD56IACT
SORBITAN MONOPALMITATE77K6Z421KUIACT
TROPOLONE7L6DL16P1TIACT
WATER059QF0KO0RIACT
XANTHAN GUMTTV12P4NEEIACT

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 Body Sunscreen Fragrance-Free SPF 50AVOBENZONE HOMOSALATE OCTISALATE OCTOCRYLENEBentley Laboratories, LLC57f2fdeb-2abc-4ad3-bb89-5faee883c0e52023-12-19WarningsExact identifier
ndc (package): 54111-145-51
ndc (product): 54111-145
ndc11 (package): 54111014551
spl id: 5368324e-9b83-48dc-8ab3-88146d9423f8
spl set id: 57f2fdeb-2abc-4ad3-bb89-5faee883c0e5

Reported adverse events (FAERS/openFDA)#

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