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.
Coola
- Manufacturer
- COOLA LLC
- Effective date
- 2024-12-20
- Label type
- HUMAN OTC DRUG LABEL
- Version
- 3
- Source
- full-release
- Hydrated at
- 2026-06-01 00:47:54
Label at a glance#
ProductCoola SPF 50 Classic
Active ingredientAVOBENZONE, OCTISALATE, OCTOCRYLENE
Label structure10 sections
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 ...
Contacts and useful links#
Label contents#
Full prescribing information#
Active Ingredients
Avobenzone 2.9%, Octisalate 4.9%, Octocrylene 9.5%
Purpose
Sunscreen
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
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.
.
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
Directions
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
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
Protect this product from excessive heat and direct sun
Questions or Comments
Call 760-940-2125
Package Label
FDA-Initiated Inactive NDC Indexing#
| NDC | Effective | Action | Document | Indexing SPL | Related label |
|---|---|---|---|---|---|
| 79753-033-01 | 2023-04-04 | C162847 | 48780-1 | f386c649-a0a0-0266-e053-dadaa90a7c1a | Coola Classic Face Sunscreen Mist SPF 50 (07-OC-013) |
| 79753-033-01 | 2023-01-30 | C162847 | 48780-1 | f386c649-a0a0-0266-e053-dadaa90a7c1a | Coola Classic Face Sunscreen Mist SPF 50 (07-OC-013) |
DailyMed Package Descriptions#
| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|---|---|---|---|---|---|
| 79753-033-01 | CoolaSPF 50 Classic | 100 mL in 1 BOTTLE, PLASTIC | SPRAY | 100 | 3 |
DailyMed Dashboard NDC Coverage#
Products#
Every source-derived product name is available through these pages.
- Coola SPF 50 Classic
- Sunscreen Face Mist
- ALCOHOL
- POLYESTER-8 (1400 MW, CYANODIPHENYLPROPENOYL CAPPED)
- SAFFLOWER OIL
- ETHYLHEXYL METHOXYCRYLENE
- VINYL ACETATE
- ISOBORNYL ACRYLATE
- DIBUTYL MALEATE
- CAMELINA SATIVA SEED OIL
- DICAPRYL SUCCINATE
- BRASSICA RAPA SUBSP. OLEIFERA OIL
- GREEN TEA LEAF
- MAURITIA FLEXUOSA FRUIT OIL
- LEVOMENOL
- ETHYL FERULATE
- MEADOWFOAM SEED OIL
- OPUNTIA FICUS-INDICA FLOWER
- RASPBERRY SEED OIL
- GLYCYRRHIZA GLABRA
- WATER
- GLYCERIN
- BUTYLOCTYL SALICYLATE
- AVOBENZONE
- OCTISALATE
- OCTOCRYLENE
NDC Codes#
| Product NDC | Package NDC |
|---|---|
| 79753-033 | 79753-033-01 |
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 |
|---|---|---|---|---|---|---|
| Coola SPF 50 Classic | SUNSCREEN FACE MIST | COOLA LLC | d18d0dac-5690-436e-e053-2995a90a0254 | 2024-12-20 | Warnings | 79753-033-01 79753-033 79753003301 29b70f22-a6e1-4c0b-e063-6294a90a8d1d d18d0dac-5690-436e-e053-2995a90a0254 |
Reported adverse events (FAERS/openFDA)#
Adverse event summaries are temporarily unavailable. Other product information remains available.