FDA.reportPublic FDA data

Mineral Sunscreen Stick SPF 50

Manufacturer
COOLA LLC
Effective date
2025-12-14
Label type
HUMAN OTC DRUG LABEL
Version
5
Source
full-release
Hydrated at
2026-06-01 01:23:02

Label at a glance#

ProductMineral Sunscreen Stick SPF 50 Fragrance-Free
Active ingredientZINC OXIDE
Label structure9 sections

Label contents#

Full prescribing information#

OTC - ACTIVE INGREDIENT SECTION

Drug Facts

Active Ingredients

Zinc Oxide 13.63%

OTC - PURPOSE SECTION

Purpose

Suncreen

INDICATIONS & USAGE SECTION

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 SECTION

Warnings

For external use only

Do not useon damaged or broken skin

When using this productkeep out of eyes. Rinse with water to remove.

OTC - STOP USE SECTION

Stop use and ask doctorif 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.

DOSAGE & ADMINISTRATION SECTION

Directions
• 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 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-sleeve shirts, pants, hats, and sunglasses
●Children under 6 months: Ask a doctor

INACTIVE INGREDIENT SECTION

Inactive Ingredients
Helianthus Annus (Sunflower) Seed Oil (ORGANIC), caprylic/Capric Triglyceride
(ORGANIC), Copernicia Cerifera (Carnauba) Wax (ORGANIC), Ozokerite,
Polymethylsilsesquioxane, Capryloyl Glycerin/Sebacic Acid Copolymer, Silica,
Trimethoxybenzylidene Pentanedione, Butyrospermum Parkii (Shea) Butter (ORGANIC),
1,2-Heanediol Dimethicone, Ethyl Ferulate, Triethoxycaprylylsilane, Polyhydroxystearic
Acid, Limnanthese Alba (Meadowfoam) Seed Oil, Mauritia Flexuosa Fruit Oil (ORGANIC),
Rubus Idaeus (Raspberry) Seed Oil (ORGANIC), Optuntia Ficus-Indica Seed Oil (ORGANIC)

OTHER SAFETY INFORMATION

Other information

  • may stain fabrics
  • protect this product from excessive heat and direct sun

OTC - QUESTIONS SECTION

Questions or comments?
Call 760-940-2125

COOLA Label

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

SPF

50

70%+

Organic

COOLA ​®

Classic

Sunscreen Stick

Fragrance-Free

Broad Spectrum SPF 50

Water-Resistant (80 Minutes)

+Plant Protection ®

Net Wt. 0.6 OZ / 17.0 g

©2022 COOLA. Manufactured in the USA for COOLA, located in

Sunny & Cool San Diego, CA 92010.  All Rights Reserved.  Questions or

Comments?  Call 760-940-2125. www.coola.com

COOLA 032-OuterCOOLA 032-Outer

COOLA 032 InnerCOOLA 032 Inner

res

DailyMed Pharmacologic Classes#

Class, Version, Type table
ClassVersionTypeEffective
ZINC CATION Pharmacologic Class Indexing2Indexing - Pharmacologic Class20180813

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
79753-032-01Mineral Sunscreen Stick SPF 50Fragrance-Free17 g in 1 CANISTERSTICK175
79753-032-01Mineral Sunscreen Stick SPF 50Fragrance-Free1 in 1 CARTONSTICK15

Products#

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

DailyMed product names page 1 of 1 · 21 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
79753-03279753-032-01

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 19 matching rows.

Name, UNII, Kind table
NameUNIIKind
SUNFLOWER OIL3W1JG795YIIACT
MEDIUM-CHAIN TRIGLYCERIDESC9H2L21V7UIACT
CARNAUBA WAXR12CBM0EIZIACT
CERESINQ1LS2UJO3AIACT
POLYMETHYLSILSESQUIOXANE (11 MICRONS)Z570VEV8XKIACT
CAPRYLOYL GLYCERIN/SEBACIC ACID COPOLYMER (2000 MPA.S)N7YC58165TIACT
SILICON DIOXIDEETJ7Z6XBU4IACT
TRIMETHOXYBENZYLIDENE PENTANEDIONE322V0ACF25IACT
SHEA BUTTERK49155WL9YIACT
1,2-HEXANEDIOLTR046Y3K1GIACT
DIMETHICONE92RU3N3Y1OIACT
ETHYL FERULATE5B8915UELWIACT
TRIETHOXYCAPRYLYLSILANELDC331P08EIACT
POLYHYDROXYSTEARIC ACID (2300 MW)YXH47AOU0FIACT
MEADOWFOAM SEED OIL412ZHA4T4YIACT
MAURITIA FLEXUOSA FRUIT OIL48H19MS04LIACT
RASPBERRY SEED OIL9S8867952AIACT
OPUNTIA FICUS-INDICA WHOLE23Z87HTQ6PIACT
ZINC OXIDESOI2LOH54ZACTIM

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
Mineral Sunscreen Stick SPF 50 Fragrance-FreeZINC OXIDECOOLA LLCee8706b0-ad42-403a-be7c-b660f040a2442025-12-14WarningsExact identifier
ndc (package): 79753-032-01
ndc (product): 79753-032
ndc11 (package): 79753003201
spl id: 45edd8cc-b74a-0dae-e063-6394a90a3cf2
spl set id: ee8706b0-ad42-403a-be7c-b660f040a244

Reported adverse events (FAERS/openFDA)#

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