FDA.reportPublic FDA data

COOLA Classic Body Sunscreen Fragrance-Free

Manufacturer
Gordon Laboratories, Inc. | GORDON LABORATORIES,INC
Effective date
2019-12-16
Label type
HUMAN OTC DRUG LABEL
Version
1
Source
full-release
Hydrated at
2026-05-31 23:02:04

Label at a glance#

ProductCOOLA Classic Body Sunscreen Fragrance-Free SPF 50
Active ingredientAVOBENZONE, OCTISALATE, OCTOCRYLENE, HOMOSALATE
Label structure9 sections

Label contents#

Full prescribing information#

OTC - ACTIVE INGREDIENT SECTION

Active Ingredients

AVOBENZONE 1.75%, HOMOSALATE 5.0%, OCTISALATE 2.0%, OCTOCRYLENE 5.0%

OTC - PURPOSE SECTION

Sunscreen

INDICATIONS & USAGE SECTION

Uses


* helps prevent sunburn

* if used as directed with other sun protection measures (see Directions), decreases the rise of skin cancer and early skin aging caused by the sun

WARNINGS AND PRECAUTIONS 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.

Stop use and ask doctor if skin rash occurs

Keep out of reach of children. If prodcut is swallowed, get medical help or contact Poison Control Center right away.

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 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 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 aging. To decrease this risk, regularly use a sunscreen with a broad spectrum 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-sleve shirts, pants, hats, and sunglasses


* children under 6 months: Ask a doctor

INACTIVE INGREDIENT SECTION

Inactive ingredients

Aloe Barbadensis Leaf Juice (ORGANIC), Blue-Green (Algae) Extract (ORGANIC), Butyloctyl Salicylate, C30-38 Olefin/Isopropyl Maleate/MA Copolymer, Caprylic/Capric Triglyceride, Carthamus Tinctorius (Safflower) Oleosomes (ORGANIC), Chlorphenesin, Cocos Nucifera (Coconut) Oil (ORGANIC), Ethylhexylglycerin, Glycerin (ORGANIC), Glyceryl Stearate, Limnanthes Alba (Meadowfoam) Seed Oil, Magnesium Sulfate, Mauritia Flexuosa (Buriti) Fruit Oil (ORGANIC), Neopentyl Glycol Diheptanoate, Olive Oil Polyglyceryl-6 Esters, Opuntia Ficus-Indica Flower Extract, Polyglyceryl-6 Pentaoleate, Polymethyl Methacrylate, Rubus Idaeus (Raspberry) Seed Oil, Silica, Simmondsia Chinensis (Jojoba) Seed Oil (ORGANIC), Stearyl/Octyldodecyl Citrate Crosspolymer, Tocopherol, VP/Hexadecene Copolymer.

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.PRINCIPAL DISPLAY PANEL

COOLA Classic Body Sunscreen Fragrance-Free SPF 50 TubeCOOLA Classic Body Sunscreen Fragrance-Free SPF 50 TubeCOOLA Classic Body Sunscreen Fragrance-Free SPF 50 CartonCOOLA Classic Body Sunscreen Fragrance-Free SPF 50 Carton

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
21839-430-022021-01-29C16284748780-1ba0f9c33-355b-a910-e053-dadaa90a0b85COOLA Classic Body Sunscreen Fragrance-Free SPF 50

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
21839-430-01COOLA Classic Body Sunscreen Fragrance-FreeSPF 50148 mL in 1 TUBELOTION1481
21839-430-02COOLA Classic Body Sunscreen Fragrance-FreeSPF 501 in 1 CARTONLOTION11

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
21839-430COOLA CLASSIC BODY SUNSCREEN FRAGRANCE-FREE SPF 50 (AVOBENZONE,HOMOSALATE, OCTISALATE,OCTOCRYLENE) LOTION [GORDON LABORATORIES, INC.]1Legacy NDC, 2 package rows20191218_99db1eb6-9886-0781-e053-2a95a90a5e8f.zip

Products#

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

DailyMed product names page 1 of 2 · 41 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
21839-43021839-430-01, 21839-430-02

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 39 matching rows.

Name, UNII, Kind table
NameUNIIKind
AVOBENZONEG63QQF2NOXACTIB
SODIUM HYDROXIDE55X04QC32IIACT
OCTISALATE4X49Y0596WACTIB
XANTHAN GUMTTV12P4NEEIACT
WATER059QF0KO0RIACT
TROPOLONE7L6DL16P1TIACT
PHYTATE SODIUM88496G1ERLIACT
ALOE VERA LEAFZY81Z83H0XIACT
DECYL GLUCOSIDEZ17H97EA6YIACT
CITRIC ACID MONOHYDRATE2968PHW8QPIACT
OCTOCRYLENE5A68WGF6WMACTIB
BUTYLENE GLYCOL3XUS85K0RAIACT
CANOLA OIL331KBJ17RKIACT
ALCOHOL3K9958V90MIACT
1,2-HEXANEDIOLTR046Y3K1GIACT
PHENOXYETHANOLHIE492ZZ3TIACT
METHYL DIHYDROABIETATE7666FJ0J9FIACT
SODIUM BENZOATEOJ245FE5EUIACT
RASPBERRY SEED OIL9S8867952AIACT
DIMETHICONE/VINYL DIMETHICONE CROSSPOLYMER (SOFT PARTICLE)9E4CO0W6C5IACT
TOCOPHEROLR0ZB2556P8IACT
TERT-BUTYL ALCOHOLMD83SFE959IACT
SODIUM CHLORIDE451W47IQ8XIACT
SILICON DIOXIDEETJ7Z6XBU4IACT
AMMONIUM ACRYLOYLDIMETHYLTAURATE, DIMETHYLACRYLAMIDE, LAURYL METHACRYLATE AND LAURETH-4 METHACRYLATE COPOLYMER, TRIMETHYLOLPROPANE TRIACRYLATE CROSSLINKED (45000 MPA.S)Q7UI015FF9IACT
OPUNTIA FICUS-INDICA23Z87HTQ6PIACT
JOJOBA OIL, RANDOMIZED7F0EV20QYLIACT
HYDROGENATED JOJOBA OIL, RANDOMIZEDQ47ST02F58IACT
HEXYLENE GLYCOLKEH0A3F75JIACT
GLUCONOLACTONEWQ29KQ9POTIACT
CARTHAMUS TINCTORIUS SEEDCAKEDHQ13F4N2WIACT
DIMETHICONE92RU3N3Y1OIACT
MAURITIA FLEXUOSA FRUIT OIL48H19MS04LIACT
MEADOWFOAM SEED OIL412ZHA4T4YIACT
GLYCERINPDC6A3C0OXIACT
SAFFLOWER OIL65UEH262ISIACT
CAPRYLYL GLYCOL00YIU5438UIACT
CAMELINA SATIVA SEED OIL12824X01L0IACT
HOMOSALATEV06SV4M95SACTIB

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
99db1eb6-9887-0781-e053-2a95a90a5e8f99db1eb6-9886-0781-e053-2a95a90a5e8f2019-12-16WarningsExact identifier
spl id: 99db1eb6-9887-0781-e053-2a95a90a5e8f
spl set id: 99db1eb6-9886-0781-e053-2a95a90a5e8f

Reported adverse events (FAERS/openFDA)#

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