COOLA - Mineral Body Lotion SPF 30 - Tropical Coconut

Manufacturer
COOLA, LLC
Effective date
2024-12-20
Label type
HUMAN OTC DRUG LABEL
Version
4
Source
full-release
Hydrated at
2026-06-01 00:48:03

Label at a glance#

ProductCOOLA Mineral Body SPF 30 Tropical Coconut
Active ingredientZINC OXIDE
Label structure10 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 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 Measure : 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...

Label contents#

Full prescribing information#

OTC - ACTIVE INGREDIENT SECTION

Zinc Oxide - 14.2%

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 SECTION

  • 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 a 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

DOSAGE & ADMINISTRATION SECTION

  • Shake well
  • 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 Measure: 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. to 2 p.m. • Wear long-sleeved shirts, pants, hats, and sun glasses.

INACTIVE INGREDIENT SECTION

Citrus Aurantium Dulcis (Orange) Fruit Water (ORGANIC), Cocos Nucifera (Coconut) Oil (ORGANIC), Butyloctyl Salicylate, Cetearyl Alcohol, Carthamus Tinctorius (Safflower) Seed Oil (ORGANIC), Methyl Dihydroabietate, Sodium Stearoyl Glutamate, Coco-Glucoside, Acacia Senegal Gum (ORGANIC), Caesalpinia Spinosa Gum (ORGANIC), Sodium Hyaluronate, Glycerin, Laminaria Digitata Extract (ORGANIC), Butyrospermum Parkii (Shea) Butter (ORGANIC), Theobroma Cacao (Cocoa) Seed Butter (ORGANIC), Bisabolol (ORGANIC), Rosmarinus Officinalis (Rosemary) Leaf Extract (ORGANIC), Helianthus Annuus (Sunflower) Seed Oil (ORGANIC), Mauritia Flexuosa Fruit Oil (ORGANIC), Limnanthes Alba (Meadowfoam) Seed Oil, Persea Gratissima (Avocado) Oil (ORGANIC), Rubus Idaeus (Raspberry) Seed Oil (ORGANIC), Brassica Campestris (Rapeseed) Seed Oil, Camelina Sativa Seed Oil, Opuntia Ficus-Indica Flower Extract, Carthamus Tinctorius (Safflower) Oleosomes, Caprylhydroxamic Acid, Caprylyl Glycol, Sodium Gluconate, Arachidyl Alcohol, Arachidyl Glucoside, Behenyl Alcohol, Capryloyl Glycerin/Sebacic Acid Copolymer, Water, Citric Acid, Gamma-Nonalactone, Gamma-Octalactone, Caprylic/Capric Triglyceride, Trans-2-hexenal, Vanillin, Maltol, Dimethyl Heptenal

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

2211

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
6bd95106-a412-1dad-b9cc-4cb74bfb27ceProduct name220230315
290f523a-f9db-9774-b5a9-e1f908ac1782Product name120150828
c6b65c52-69c7-df49-550a-a50c137f6218Product name120140508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
79753-053-01COOLA Mineral Body SPF 30 Tropical Coconut1 in 1 CARTONLOTION14
79753-053-01COOLA Mineral Body SPF 30 Tropical Coconut148 mL in 1 TUBELOTION1484
79753-053-02COOLA Mineral Body SPF 30 Tropical Coconut100 mL in 1 TUBELOTION1004
79753-053-02COOLA Mineral Body SPF 30 Tropical Coconut1 in 1 CARTONLOTION14

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
79753-053COOLA MINERAL BODY SPF 30 TROPICAL COCONUT (ZINC OXIDE) LOTION [COOLA, LLC]4Current NDC, Legacy NDC, 4 package rows20241222_eeb5d4f1-8cba-9ef6-e053-2a95a90a823f.zip

Products#

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

DailyMed product names page 1 of 2 · 44 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
79753-05379753-053-01, 79753-053-02

Ingredients#

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

DailyMed ingredient rows page 1 of 2 · 43 matching rows.

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 Mineral Body SPF 30 Tropical CoconutZINC OXIDECOOLA, LLCeeb5d4f1-8cba-9ef6-e053-2a95a90a823f2024-12-20WarningsExact identifier
ndc (package): 79753-053-01
ndc (package): 79753-053-02
ndc (product): 79753-053
ndc11 (package): 79753005302
ndc11 (package): 79753005301
spl id: 29b70f22-a6e3-4c0b-e063-6294a90a8d1d
spl set id: eeb5d4f1-8cba-9ef6-e053-2a95a90a823f

Reported adverse events (FAERS/openFDA)#

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