FDA.reportPublic FDA data

Coola

Manufacturer
Bell International Laboratories, Inc
Effective date
2021-11-02
Label type
HUMAN OTC DRUG LABEL
Version
1
Source
legacy-cache
Hydrated at
2026-08-01 22:25:57

Label at a glance#

ProductCoola SPF 50 Classic
Active ingredientAVOBENZONE, OCTISALATE, OCTOCRYLENE
Label structure9 sections

Indications and 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.

Dosage and administration

SHAKE WELL before use. With your eyes completely closed, mist face evenly, holding bottle 10-12 inches away from face. Wait until dry. Apply liberally 15 minutes before sun exposure. Reapply: -After 80 minutes 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 ...

Label contents#

Full prescribing information#

Active Ingredients

OTC - ACTIVE INGREDIENT SECTION

Avobenzone 2.9%, Octisalate 4.9%, Octocrylene 9.5%

Purpose

OTC - PURPOSE SECTION

Sunscreen

Uses

INDICATIONS & USAGE SECTION

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

WARNINGS SECTION

For external use only.

Flammable: Do not store at temperatures above 120 F.

Do not use in the presence of a flame or spark, or while smoking.

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 product is swallowed, get medical help or contact a Poison Control Center right away.

Directions

DOSAGE & ADMINISTRATION SECTION

SHAKE WELL before use.

With your eyes completely closed, mist face evenly, holding bottle 10-12 inches away from face.

Wait until dry.

Apply liberally 15 minutes before sun exposure.

Reapply:

-After 80 minutes 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 the risk, regularly use a sunscreen with a broad-spectrum SPF of 15 or higher and other protection measures including:

-Limit time in the sun, especially from 10 a.m. – 2 p.m.

-Wear long sleeves shirts, pants, hats, and sunglasses.

Children under 6 months: Ask a doctor.

Inactive Ingredients

INACTIVE INGREDIENT SECTION

Alcohol (ORGANIC), Butyloctyl Salicylate, Ethylhexyl Methoxycrylene, Polyester-8, Fragrance (Natural), VA/Butyl Maleate/Isobornyl Acrylate Copolymer, Carthamus Tinctorius (Safflower) Seed Oil (ORGANIC), Rubus Idaeus (Raspberry) Seed Oil (ORGANIC), Mauritia Flexuosa (Buriti) Fruit Oil (ORGANIC), Limnanthes Alba (Meadowfoam) Seed Oil, Brassica Campestris (Rapeseed) Seed Oil, Camellia Sinensis Leaf Extract (ORGANIC),Glycyrrhiza Glabra (Licorice) Root Extract (ORGANIC), Opuntia Ficus-Indica Flower Extract, Camelina Sativa Seed Oil, Bisabolol (ORGANIC), Glycerin (ORGANIC), Water, Ethyl Ferulate, Diisooctyl Succinate

Other Information

OTHER SAFETY INFORMATION

Protect this product from excessive heat and direct sun

Questions or Comments

OTC - QUESTIONS SECTION

Call 760-940-2125

Package Label

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

CLA SPF 50 Facial Sunscreen MistCLA SPF 50 Facial Sunscreen Mist

Products#

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

DailyMed product names page 1 of 1 · 26 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
76150-33076150-330-67

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 24 matching rows.

Name, UNII, Kind table
NameUNIIKind
ALCOHOL3K9958V90MIACT
POLYESTER-8 (1400 MW, CYANODIPHENYLPROPENOYL CAPPED)T9296U138PIACT
SAFFLOWER OIL65UEH262ISIACT
ETHYLHEXYL METHOXYCRYLENES3KFG6Q5X8IACT
VINYL ACETATEL9MK238N77IACT
ISOBORNYL ACRYLATEIX0PRH184PIACT
DIBUTYL MALEATE4X371TMK9KIACT
CAMELINA SATIVA SEED OIL12824X01L0IACT
DICAPRYL SUCCINATE8XD1ZF2M1MIACT
AVOBENZONEG63QQF2NOXACTIB
OCTISALATE4X49Y0596WACTIB
OCTOCRYLENE5A68WGF6WMACTIB
BRASSICA RAPA SUBSP. OLEIFERA OILN4G8379626IACT
GREEN TEA LEAFW2ZU1RY8B0IACT
MAURITIA FLEXUOSA FRUIT OIL48H19MS04LIACT
LEVOMENOL24WE03BX2TIACT
ETHYL FERULATE5B8915UELWIACT
MEADOWFOAM SEED OIL412ZHA4T4YIACT
OPUNTIA FICUS-INDICA FLOWER83YSP51SMAIACT
RASPBERRY SEED OIL9S8867952AIACT
GLYCYRRHIZA GLABRA2788Z9758HIACT
WATER059QF0KO0RIACT
GLYCERINPDC6A3C0OXIACT
BUTYLOCTYL SALICYLATE2EH13UN8D3IACT

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
d101d792-a1bc-ecd7-e053-2a95a90a715fd101d792-a1bb-ecd7-e053-2a95a90a715f2021-11-02WarningsExact identifier
spl id: d101d792-a1bc-ecd7-e053-2a95a90a715f
spl set id: d101d792-a1bb-ecd7-e053-2a95a90a715f

Reported adverse events (FAERS/openFDA)#

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