FDA.reportPublic FDA data

COOLA BARE REPUBLIC MINERAL SPORT SPF50 LOTION NON-NANO

Manufacturer
COOLA, LLC
Effective date
2021-03-03
Label type
HUMAN OTC DRUG LABEL
Version
1
Source
legacy-cache
Hydrated at
2026-08-01 22:49:37

Label at a glance#

ProductCOOLA BARE REPUBLIC MINERAL SPORT SPF50 NON-NANO
Active ingredientZINC OXIDE, TITANIUM DIOXIDE
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 children under 6 months of age: ask a doctor 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 ...

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 2.9%, Zinc Oxide 7.8

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 if

OTC - STOP USE SECTION

  • 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

  • children under 6 months of age: ask a doctor
  • 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

Other information

STORAGE AND HANDLING SECTION

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

Inactive Ingredients

INACTIVE INGREDIENT SECTION

Allyl Heptoate, Aloe Barbadensis Leaf Juice, Arachidyl Alcohol, Arachidyl Glucoside, Behenyl Alcohol, Butyloctyl Salicylate, C30-38 Olefin/Isopropyl Maleate/MA Copolymer, Caprylic/Capric Triglyceride, Daucus Carota Sativa (Carrot) Seed Oil, Ethylhexylglycerin, Gamma Decalactone, Gamma Nonalactone, Gamma Octalactone, Gluconolacetone, Glycerin, Glyceryl Caprylate, Glyceryl Stearate, Helianthus Annuus (Sunflower) Seed Oil, Heliotropine, Magnesium Sulfate, Maranta Arundinacea Root Powder, Neopentyl Glycol Diheptanoate, Phenethyl Alcohol, Raspberry Ketone, Rubus Idaeus (Raspberry) Seed Oil, Silica, Simmondsia Chinensis (Jojoba) Seed Oil, Sodium Benzoate, Sodium Hydroxide, Sodium Phytate, Sorbitan Sesquioleate, Sorbitan Tristearate, Stearyl/Octyldodecyl Citrate Crosspolymer, Stearyl Alcohol, Tocopheryl, Triethyl Citrate, Vanillin, Vitis Vinifera (Grape) Seed Oil, VP/Hexadecene Copolymer, Water

Label

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

CA00704CA00704

Products#

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

DailyMed product names page 1 of 2 · 42 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
79753-01179753-011-71

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 40 matching rows.

Name, UNII, Kind table
NameUNIIKind
SODIUM BENZOATEOJ245FE5EUIACT
VINYLPYRROLIDONE/HEXADECENE COPOLYMERKFR5QEN0N9IACT
ARACHIDYL GLUCOSIDE6JVW35JOOJIACT
DOCOSANOL9G1OE216XYIACT
CARROT SEED OIL595AO13F11IACT
GLYCERYL 1-STEARATE258491E1RZIACT
SORBITAN SESQUIOLEATE0W8RRI5W5AIACT
SORBITAN TRISTEARATE6LUM696811IACT
.ALPHA.-TOCOPHEROL, DL-7QWA1RIO01IACT
GRAPE SEED OIL930MLC8XGGIACT
JOJOBA OIL724GKU717MIACT
SODIUM HYDROXIDE55X04QC32IIACT
PHYTATE SODIUM88496G1ERLIACT
ARACHIDYL ALCOHOL1QR1QRA9BUIACT
SUNFLOWER OIL3W1JG795YIIACT
ETHYLHEXYLGLYCERIN147D247K3PIACT
MAGNESIUM SULFATE HEPTAHYDRATESK47B8698TIACT
GLYCERINPDC6A3C0OXIACT
ALLYL HEPTANOATEAU4CYG9V68IACT
STEARYL/OCTYLDODECYL CITRATE CROSSPOLYMERPN88NW0KPKIACT
SILICON DIOXIDEETJ7Z6XBU4IACT
MARANTA ARUNDINACEA ROOTFVN346W31AIACT
BUTYLOCTYL SALICYLATE2EH13UN8D3IACT
ZINC OXIDESOI2LOH54ZACTIB
MEDIUM-CHAIN TRIGLYCERIDESC9H2L21V7UIACT
.GAMMA.-DECALACTONE7HLS05KP9OIACT
.GAMMA.-NONALACTONEI1XGH66S8PIACT
PIPERONALKE109YAK00IACT
TITANIUM DIOXIDE15FIX9V2JPACTIB
.GAMMA.-OCTALACTONEUHD6M52X0KIACT
TRIETHYL CITRATE8Z96QXD6UMIACT
ALOE VERA LEAFZY81Z83H0XIACT
4-(P-HYDROXYPHENYL)-2-BUTANONE7QY1MH15BGIACT
VANILLINCHI530446XIACT
WATER059QF0KO0RIACT
GLUCONOLACTONEWQ29KQ9POTIACT
GLYCERYL CAPRYLATETM2TZD4G4AIACT
RASPBERRY SEED OIL9S8867952AIACT
NEOPENTYL GLYCOL DIHEPTANOATE5LKW3C543XIACT
PHENYLETHYL ALCOHOLML9LGA7468IACT

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
f4d84c2a-7b56-3ce4-e053-2a95a90a263ebca539b8-08b1-0aae-e053-2a95a90a9d122023-02-16WarningsExact identifier
spl set id: bca539b8-08b1-0aae-e053-2a95a90a9d12

Reported adverse events (FAERS/openFDA)#

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