FDA.reportPublic FDA data

COOLA Refreshing Water Mist Sunscreen

Manufacturer
Gordon Laboratories, Inc. | GORDON LABORATORIES,INC
Effective date
2019-12-26
Label type
HUMAN OTC DRUG LABEL
Version
1
Source
full-release
Hydrated at
2026-05-31 23:02:23

Label at a glance#

ProductCOOLA Refreshing Water Mist Sunscreen SPF 30
Active ingredientAVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENE
Label structure5 sections

Label contents#

Full prescribing information#

OTC - ACTIVE INGREDIENT SECTION

Active Ingredients - Avobenzone 2.0%, Homosalate 10.0%, Octisalate 5.0%, Octocrylene 5.5%

OTC - QUESTIONS SECTION

Questions or comments? Call 760-940-2125

INDICATIONS & USAGE SECTION

Directions: SHAKE WELL before use. With your eyes completely closed, mist face evenly, holding bottle 6-10 inces away from face. Allow to fully dry.

DESCRIPTION SECTION

* Featuring Plant Cell Cultures, Coconut Water & hyaluronic Acid

* Alcohol Free

* Anti-Pollution

* UVA/UVB/IR/HEV

* Broad Spectrum SPF 30

* Dermatologist tested

* Gluten Free

* Non-GMO

NOT FOR SALE .34 FL OZ / 10 mL

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Refreshing Water Mist 10 mL SampleRefreshing Water Mist 10 mL Sample

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
c6f86816-7da6-43ea-8c25-ac9758311cc5Product name120220118
252e11b6-1a9a-4283-a242-df2c129c496dProduct name320170717

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
21839-590-032021-01-29C16284748780-1ba0f9c33-4a01-a910-e053-dadaa90a0b85COOLA Refreshing Water Mist Sunscreen SPF 30

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
21839-590-03COOLA Refreshing Water Mist SunscreenSPF 3010 mL in 1 BOTTLELIQUID101

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
21839-590COOLA REFRESHING WATER MIST SUNSCREEN SPF 30 (AVOBENZONE,HOMOSALATE, OCTISALATE,OCTOCRYLENE) LIQUID [GORDON LABORATORIES, INC.]1Legacy NDC, 1 package rows20191227_9aa12daf-d287-1bcf-e053-2a95a90a512c.zip

Products#

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

DailyMed product names page 1 of 1 · 33 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
21839-59021839-590-03

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 31 matching rows.

Name, UNII, Kind table
NameUNIIKind
ETHYL OLIVATEKKJ108Y20WIACT
CETYL PALMITATE5ZA2S6B08XIACT
POLYOXYL 20 CETOSTEARYL ETHERYRC528SWUYIACT
TROPOLONE7L6DL16P1TIACT
LAURYL GLUCOSIDE76LN7P7UCUIACT
GLYCERYL STEARATE SEFCZ5MH785IIACT
CAPRYLYL GLYCOL00YIU5438UIACT
CETEARYL ISONONANOATEP5O01U99NIIACT
COCONUT WATER267F5Y81NTIACT
CETEARETH-127V4MR24V5PIACT
BUTYLENE GLYCOL3XUS85K0RAIACT
PHYTATE SODIUM88496G1ERLIACT
PROPANEDIOL5965N8W85TIACT
JASMINUM SAMBAC FLOWER2S686I937FIACT
MEDIUM-CHAIN TRIGLYCERIDESC9H2L21V7UIACT
BENZOIC ACID8SKN0B0MIMIACT
ALCOHOL3K9958V90MIACT
1,2-HEXANEDIOLTR046Y3K1GIACT
COCOAD9108TZ9KGIACT
SODIUM STEAROYL GLUTAMATE65A9F4P024IACT
GLYCERINPDC6A3C0OXIACT
AVOBENZONEG63QQF2NOXACTIB
HOMOSALATEV06SV4M95SACTIB
OCTISALATE4X49Y0596WACTIB
OCTOCRYLENE5A68WGF6WMACTIB
CETOSTEARYL ALCOHOL2DMT128M1SIACT
ALOE VERA LEAFZY81Z83H0XIACT
SOYBEANL7HT8F1ZODIACT
WATER059QF0KO0RIACT
HYALURONATE SODIUMYSE9PPT4THIACT
SCHINUS MOLLE FRUITING TOPT8L6O1KSB4IACT

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
9aa12daf-d286-1bcf-e053-2a95a90a512c9aa12daf-d287-1bcf-e053-2a95a90a512c2019-12-26Exact identifier
spl id: 9aa12daf-d286-1bcf-e053-2a95a90a512c
spl set id: 9aa12daf-d287-1bcf-e053-2a95a90a512c

Reported adverse events (FAERS/openFDA)#

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