COOLA Refreshing Water Mist Sunscreen
- Manufacturer
- GORDON LABORATORIES,INC
- Effective date
- 2019-12-16
- Label type
- HUMAN OTC DRUG LABEL
- Version
- 2
- Source
- full-release
- Hydrated at
- 2026-05-31 23:02:01
Label at a glance#
ProductCOOLA Refreshing Water Mist Sunscreen SPF 30
Active ingredientAVOBENZONE, OCTISALATE, HOMOSALATE, OCTOCRYLENE
Label structure9 sections
Contacts and useful links#
Label contents#
Full prescribing information#
OTC - ACTIVE INGREDIENT SECTION
Active ingredients
Avobenzone 2.0%, Homosalate 10.0%, Octisalate 5.0%, Octocrylene 5.5%
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 rise of skin cancer and early skin aging caused by the sun
WARNINGS 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
* shake well * apply liberally 15 minutes before sun exposure
* reapply: * after 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 rise, 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), Butylene Glycol, Caprylyl Glycol, Ceteareth-12, Ceteareth-20, Cetearyl Alcohol, Cetearyl Isononanoate, Cetyl Palmitate, Citronellyl Acetate, Cocos Nucifera (ORGANIC Coconut) Water, Cyclamen Aldehyde, Ethylene Brassylate, Glycerin (ORGANIC), Glyceryl Stearate, Glycine Soja (Soybean) Extract, Hyaluronic Acid, Jasminum Sambac Leaf Cell Extract, Lauryl Glucoside, Methyl Dihydrojasmonate, Methylenedioxyphenyl Methylpropanal, Olive Oil Polyglyceryl-6 Esters, 1,2-Hexanediol, Propanediol, Schinus Molle Extract, Sodium Phytate, Sodium Stearoyl Glutamate, Theobroma Cacao (Cocoa) Seed Extract, Tropolone
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
DailyMed Product Concepts#
| Product concept | Relation | Version | Effective |
|---|---|---|---|
| c6f86816-7da6-43ea-8c25-ac9758311cc5 | Product name | 1 | 20220118 |
| 252e11b6-1a9a-4283-a242-df2c129c496d | Product name | 3 | 20170717 |
FDA-Initiated Inactive NDC Indexing#
| NDC | Effective | Action | Document | Indexing SPL | Related label |
|---|---|---|---|---|---|
| 21839-570-11 | 2021-01-29 | C162847 | 48780-1 | ba0f9c33-53ea-a910-e053-dadaa90a0b85 | COOLA Refreshing Water Mist Sunscreen SPF 30 |
DailyMed Package Descriptions#
| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|---|---|---|---|---|---|
| 21839-570-11 | COOLA Refreshing Water Mist SunscreenSPF 30 | 1 in 1 CARTON | LIQUID | 1 | 2 | |
| 21839-570-12 | COOLA Refreshing Water Mist SunscreenSPF 30 | 60 mL in 1 BOTTLE | LIQUID | 60 | 2 |
DailyMed Dashboard NDC Coverage#
| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|---|---|---|---|
| 21839-570 | COOLA REFRESHING WATER MIST SUNSCREEN SPF 30 (AVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENE) LIQUID [GORDON LABORATORIES,INC] | 2 | Legacy NDC, 2 package rows | 20191217_998b6c00-1211-37b9-e053-2a95a90abed5.zip |
Products#
Every source-derived product name is available through these pages.
- COOLA Refreshing Water Mist Sunscreen SPF 30
- Avobenzone, Homosalate, Octisalate, Octocrylene
- WATER
- JASMINUM SAMBAC FLOWER
- SOYBEAN
- GLYCERYL STEARATE SE
- CETEARETH-12
- BENZOIC ACID
- ALCOHOL
- AVOBENZONE
- OCTISALATE
- ALOE VERA LEAF
- PHYTATE SODIUM
- GLYCERIN
- MEDIUM-CHAIN TRIGLYCERIDES
- 1,2-HEXANEDIOL
- TROPOLONE
- HYALURONATE SODIUM
- BUTYLENE GLYCOL
- CAPRYLYL GLYCOL
- COCOA
- SODIUM STEAROYL GLUTAMATE
- SCHINUS MOLLE FRUITING TOP
- ETHYL OLIVATE
- COCONUT WATER
- CETOSTEARYL ALCOHOL
- PROPANEDIOL
- LAURYL GLUCOSIDE
- CETEARYL ISONONANOATE
- CETYL PALMITATE
- POLYOXYL 20 CETOSTEARYL ETHER
- HOMOSALATE
- OCTOCRYLENE
NDC Codes#
| Product NDC | Package NDC |
|---|---|
| 21839-570 | 21839-570-12, 21839-570-11 |
Ingredients#
Every source-derived ingredient row is available through these pages.
Source Document#
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.
| Brand | Generic | Manufacturer | SPL set ID | Effective date | Available safety fields | Join |
|---|---|---|---|---|---|---|
| 99d9daba-c194-a16b-e053-2a95a90ab3be | 998b6c00-1211-37b9-e053-2a95a90abed5 | 2019-12-16 | Warnings | 99d9daba-c194-a16b-e053-2a95a90ab3be 998b6c00-1211-37b9-e053-2a95a90abed5 |
Reported adverse events (FAERS/openFDA)#
Adverse event summaries are temporarily unavailable. Other product information remains available.