FDA.reportPublic FDA data

COOLA 70 PERCENT PLUS ORGANIC MINERAL BODY SUNSCREEN SPF50

Manufacturer
COOLA, LLC | Bentley Laboratories, LLC
Effective date
2024-12-27
Label type
HUMAN OTC DRUG LABEL
Version
4
Source
legacy-cache
Hydrated at
2026-08-01 20:44:15

Label at a glance#

ProductCOOLA 70 PERCENT PLUS ORGANIC MINERAL BODY SUNSCREEN SPF50
Active ingredientTITANIUM DIOXIDE, ZINC OXIDE
Label structure12 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

apply liberally 15 minutes before sun exposure 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...

Storage and handling

protect this product from excessive heat and direct sun may stain or damage some fabrics, materials or surfaces

Label contents#

Full prescribing information#

Active ingredients

OTC - ACTIVE INGREDIENT SECTION

Titanium Dioxide 3.5%, Zinc Oxide 7.25%

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

Do not use

OTC - DO NOT USE SECTION

  • on damaged or broken skin.

When using this product

OTC - WHEN USING SECTION

  • keep out of eyes. Rinse with water to remove.

Stop use and ask a doctor

OTC - STOP USE SECTION

  • if skin rash occurs.

Keep out of the reach of children

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

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

Directions

DOSAGE & ADMINISTRATION SECTION

  • apply liberally 15 minutes before sun exposure
  • 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 6 months of age: Ask a doctor

Inactive Ingredients

INACTIVE INGREDIENT SECTION

Aloe Barbadensis Leaf Juice (ORGANIC), Amyris Balsamifera Bark Oil, Blue-Green (Algae) Extract (ORGANIC), Butyloctyl Salicylate, C30-38 Olefin/Isopropyl Maleate/MA Copolymer, Cananga Odorata Flower Oil, Caprylic/Capric Triglyceride, Carthamus Tinctorius (Safflower) Oleosomes (ORGANIC), Chlorphenesin, Citrus Paradisi (Grapefruit) Peel Oil, Cocos Nucifera (Coconut) Oil (ORGANIC), Ethylhexylglycerin, Glycerin (ORGANIC), Glyceryl Stearate, Limnanthes Alba (Meadowfoam) Seed Oil, Magnesium Sulfate, Mauritia Flexuosa (Buriti) Fruit Oil (ORGANIC), Neopentyl Glycol Diheptanoate, Olive Oil Polyglyceryl-6 Esters, Opuntia Ficus-Indica Flower Extract, Pelargonium Graveolens Flower Oil, Polyglyceryl-6 Pentaoleate, Polymethyl Methacrylate, Rubus Idaeus (Raspberry) Seed Oil, Silica, Simmondsia Chinensis (Jojoba) Seed Oil (ORGANIC), Stearyl/Octyldodecyl Citrate Crosspolymer, Tocopherol, Triethyl Citrate, VP/Hexadecene Copolymer., Water

Other information

STORAGE AND HANDLING SECTION

  • protect this product from excessive heat and direct sun
  • may stain or damage some fabrics, materials or surfaces

Label

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

CA52394ACA52394A

CA52372 tubeCA52372 tube

CA00792 cartonCA00792 carton

CA00792 tubeCA00792 tube

CA00889 cartonCA00889 carton

CA00889 tubeCA00889 tube

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
79753-040COOLA 70 PERCENT PLUS ORGANIC MINERAL BODY SUNSCREEN SPF50 (TITANIUM DIOXIDE, ZINC OXIDE) LOTION [COOLA, LLC]4Legacy NDC20241228_cb95c712-1680-4040-e053-2995a90af004.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
79753-04079753-040-01, 79753-040-02, 79753-040-72, 79753-040-03

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
OLIVE OIL POLYGLYCERYL-6 ESTERS4KDO9AFM9IIACT
POLY(METHYL METHACRYLATE; 450000 MW)Z47NNT4J11IACT
COCONUT OILQ9L0O73W7LIACT
AMYRIS BALSAMIFERA OILI1BJ961J2EIACT
PELARGONIUM GRAVEOLENS FLOWER OIL3K0J1S7QGCIACT
GRAPEFRUIT OILYR377U58W9IACT
NEOPENTYL GLYCOL DIHEPTANOATE5LKW3C543XIACT
CANANGA OIL8YOY78GNNXIACT
CHLORPHENESINI670DAL4SZIACT
APHANIZOMENON FLOSAQUAE49VG1X560XIACT
TRIETHYL CITRATE8Z96QXD6UMIACT
TITANIUM DIOXIDE15FIX9V2JPACTIB
ALOE VERA LEAFZY81Z83H0XIACT
WATER059QF0KO0RIACT
RASPBERRY SEED OIL9S8867952AIACT
JOJOBA OIL724GKU717MIACT
VINYLPYRROLIDONE/HEXADECENE COPOLYMERKFR5QEN0N9IACT
GLYCERYL 1-STEARATE258491E1RZIACT
.ALPHA.-TOCOPHEROL, DL-7QWA1RIO01IACT
MAGNESIUM SULFATE HEPTAHYDRATESK47B8698TIACT
GLYCERINPDC6A3C0OXIACT
STEARYL/OCTYLDODECYL CITRATE CROSSPOLYMERPN88NW0KPKIACT
SAFFLOWER OIL65UEH262ISIACT
SILICON DIOXIDEETJ7Z6XBU4IACT
MAURITIA FLEXUOSA FRUIT OIL48H19MS04LIACT
BUTYLOCTYL SALICYLATE2EH13UN8D3IACT
ZINC OXIDESOI2LOH54ZACTIB
MEDIUM-CHAIN TRIGLYCERIDESC9H2L21V7UIACT
ETHYLHEXYLGLYCERIN147D247K3PIACT
MEADOWFOAM SEED OIL412ZHA4T4YIACT
OPUNTIA TUNA FLOWERING TOPR4AS8333O2IACT

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
45f281ae-2b28-71cf-e063-6294a90a24b5cb95c712-1680-4040-e053-2995a90af0042025-12-14WarningsExact identifier
spl set id: cb95c712-1680-4040-e053-2995a90af004

Reported adverse events (FAERS/openFDA)#

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