FDA.reportPublic FDA data

Coola Classic Body Spray SPF 30 - Pina Colada

Manufacturer
COOLA, LLC
Effective date
2025-02-17
Label type
HUMAN OTC DRUG LABEL
Version
2
Source
full-release
Hydrated at
2026-06-01 00:55:37

Label at a glance#

ProductCOOLA Classic Body SPF 30 Pina Colada
Active ingredientAVOBENZONE, OCTISALATE, OCTOCRYLENE
Label structure10 sections

Indications and uses

Helps prevent sunburn If used as directed with other sun protection measures (see Directions), decreases the nsk of skin cancer and early skin aging caused by the sun

Dosage and administration

Shake Well Apply liberally 15 minutes before sun exposure. Hold container 4 to 6 inches from skin to apply. Rub in. Do not spray directly on face. Spray onto hands and apply to face. 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 skin aging. To decrease this ris...

Label contents#

Full prescribing information#

OTC - ACTIVE INGREDIENT SECTION

Avobenzone - 2.8%

Octisalate - 4.9%

Octocrylene - 7.6%

OTC - PURPOSE SECTION

Sunscreen

Uses

INDICATIONS & USAGE SECTION

  • Helps prevent sunburn
  • If used as directed with other sun protection measures (see Directions), decreases the nsk of skin cancer and early skin aging caused by the sun

WARNINGS SECTION

  • For external use only
  • Flammable: Contents under pressure. Do not puncture or incinerat. 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 away from face to avoid breathing. Keep out of eyes. Rinse with water to remove. Apply outdoors. Avoid overspray as it could cause surface to become slippery. Do not apply in windy conditions. Use in a well-ventilated area.
  • Stop use and ask a doctor if 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

DOSAGE & ADMINISTRATION SECTION

  • Shake Well
  • Apply liberally 15 minutes before sun exposure.
  • Hold container 4 to 6 inches from skin to apply.
  • Rub in. Do not spray directly on face.
  • Spray onto hands and apply to face.
  • 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 skin aging. To decrease this risk, regularly use a sunscreen with a Broad Spectrum SPF value 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-sleeved shirts, pants, hats, and sunglasses.​
  • Children under six months: Ask a doctor.

INACTIVE INGREDIENT SECTION

Alcohol (ORGANIC), Butyloctyl Salicylate, Methyl Dihydroabietate, Flavor (NATURAL), Aloe Barbadensis Leaf Juice, Carthamus Tinctorius (Safflower) Seed Oil (ORGANIC), Mauritia Flexuosa (Buriti) Fruit Oil (ORGANIC), Rubus Idaeus (Raspberry) Seed Oil (ORGANIC), , Opuntia Ficus-Indica Seed Oil, Limnanthes Alba (Meadowfoam) Seed Oil

OTHER SAFETY INFORMATION

  • May stain fabrics
  • Protect this product from excessive heat and direct sun

OTC - QUESTIONS SECTION

Call 760-940-2125

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

cancan

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
79753-061-012025-02-17C16284748780-11030e365-0d16-111a-e063-dadaa90a10e2Coola Classic Body Spray SPF 30 - Pina Colada
79753-061-022025-02-17C16284748780-11030e365-0d16-111a-e063-dadaa90a10e2Coola Classic Body Spray SPF 30 - Pina Colada
79753-061-012024-01-30C16284748780-11030e365-0d16-111a-e063-dadaa90a10e2Coola Classic Body Spray SPF 30 - Pina Colada
79753-061-022024-01-30C16284748780-11030e365-0d16-111a-e063-dadaa90a10e2Coola Classic Body Spray SPF 30 - Pina Colada

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
79753-061-01COOLA Classic Body SPF 30 Pina Colada177 mL in 1 CANSPRAY1772
79753-061-02COOLA Classic Body SPF 30 Pina Colada60 mL in 1 CANSPRAY602

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
79753-061COOLA CLASSIC BODY SPF 30 PINA COLADA (AVOBENZONE, OCTISALATE, OCTOCRYLENE) SPRAY [COOLA, LLC]2Current NDC, Legacy NDC, 2 package rows20250221_edc59de7-c817-1a59-e053-2995a90a3408.zip

Products#

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

DailyMed product names page 1 of 1 · 14 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
79753-06179753-061-01, 79753-061-02

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 12 matching rows.

Name, UNII, Kind table
NameUNIIKind
SAFFLOWER OIL65UEH262ISIACT
MEADOWFOAM SEED OIL412ZHA4T4YIACT
MAURITIA FLEXUOSA FRUIT OIL48H19MS04LIACT
RASPBERRY SEED OIL9S8867952AIACT
AVOBENZONEG63QQF2NOXACTIB
OCTISALATE4X49Y0596WACTIB
OCTOCRYLENE5A68WGF6WMACTIB
OPUNTIA FICUS-INDICA SEED OIL1XGW49AK2JIACT
ALCOHOL3K9958V90MIACT
BUTYLOCTYL SALICYLATE2EH13UN8D3IACT
ALOE VERA LEAFZY81Z83H0XIACT
METHYL DIHYDROABIETATE7666FJ0J9FIACT

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
COOLA Classic Body SPF 30 Pina ColadaAVOBENZONE, OCTISALATE, OCTOCRYLENECOOLA, LLCedc59de7-c817-1a59-e053-2995a90a34082025-02-17WarningsExact identifier
ndc (package): 79753-061-02
ndc (package): 79753-061-01
ndc (product): 79753-061
ndc11 (package): 79753006102
ndc11 (package): 79753006101
spl id: 2e57b811-a01d-a7e8-e063-6294a90ab495
spl set id: edc59de7-c817-1a59-e053-2995a90a3408

Reported adverse events (FAERS/openFDA)#

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