FDA.reportPublic FDA data

COOLA BARE REPUBLIC CLEARSCREEN SPF100 LOTION

Manufacturer
COOLA, LLC
Effective date
2025-12-15
Label type
HUMAN OTC DRUG LABEL
Version
3
Source
full-release
Hydrated at
2026-06-01 01:25:47

Label at a glance#

ProductCOOLA BARE REPUBLIC CLEARSCREEN SPF100
Active ingredientHOMOSALATE, AVOBENZONE, OCTOCRYLENE, OCTISALATE
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

Avobenzone 3.0%

Homosalate 15.0%

Octisalate 5.0%

Octocrylene 10.0%

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

Water, Butyloctyl Salicylate, Tridecyl Salicylate, Isodecyl Neopentanoate, Acrylates/Dimethicone Copolymer, Behenyl Alcohol, Diisopropyl Sebacate, Lauryl Lactate, Glyceryl Behenatae,Vitis Vinifera (Grape) Seed Extract, Daucus Carota Sativa (Carrot) Extract, Rubus Idaeus (Raspberry) Seed Extract, Sodium Hyaluronate, Glycerin, Ethylhexylglycerin, Chlorphenesin, Polyurethane-62, Silica, Ammonium Acryloyldimethyltaurate/VP Copolymer, Trideceth-6, Tocopherol, Arachidyl Alcohol, Arachidyl Glucoside, Lecithin, Sodium Phytate

Label

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

BR10223_v03BR10223_v03

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
79753-021-01COOLA BARE REPUBLIC CLEARSCREEN SPF10059 mL in 1 TUBELOTION593

Products#

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

DailyMed product names page 1 of 1 · 31 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
79753-02179753-021-01

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 29 matching rows.

Name, UNII, Kind table
NameUNIIKind
WATER059QF0KO0RIACT
RASPBERRY SEED OIL9S8867952AIACT
CHLORPHENESINI670DAL4SZIACT
HYALURONATE SODIUMYSE9PPT4THIACT
CARROT SEED OIL595AO13F11IACT
.ALPHA.-TOCOPHEROL, DL-7QWA1RIO01IACT
GRAPE SEED OIL930MLC8XGGIACT
ARACHIDYL ALCOHOL1QR1QRA9BUIACT
GLYCERINPDC6A3C0OXIACT
BUTYLOCTYL SALICYLATE2EH13UN8D3IACT
ETHYLHEXYLGLYCERIN147D247K3PIACT
TRIDECYL SALICYLATEAZQ08K38Z1IACT
DOCOSANOL9G1OE216XYIACT
GLYCERYL MONOBEHENATEA626UU0W2AIACT
TRIDECETH-63T5PCR2H0CIACT
PHYTATE SODIUM88496G1ERLIACT
POLYURETHANE-62TBK645J3J8IACT
LAURYL LACTATEG5SU0BFK7OIACT
LECITHIN, SOYBEAN1DI56QDM62IACT
ARACHIDYL GLUCOSIDE6JVW35JOOJIACT
SILICON DIOXIDEETJ7Z6XBU4IACT
AMMONIUM ACRYLOYLDIMETHYLTAURATE/VP COPOLYMERW59H9296ZGIACT
ISODECYL NEOPENTANOATEW60VYE24XCIACT
DIISOPROPYL SEBACATEJ8T3X564IHIACT
2-ETHYLHEXYL ACRYLATE, METHACRYLATE, METHYL METHACRYLATE, OR BUTYL METHACRYLATE/HYDROXYPROPYL DIMETHICONE COPOLYMER (30000-300000 MW)S7ZA3CCJ4MIACT
HOMOSALATEV06SV4M95SACTIB
AVOBENZONEG63QQF2NOXACTIB
OCTOCRYLENE5A68WGF6WMACTIB
OCTISALATE4X49Y0596WACTIB

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 BARE REPUBLIC CLEARSCREEN SPF100AVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENECOOLA, LLCf14cf2b8-b110-1210-e053-2995a90a01022025-12-15WarningsExact identifier
ndc (package): 79753-021-01
ndc (product): 79753-021
ndc11 (package): 79753002101
spl id: 46069245-ad40-caf7-e063-6394a90ab0c9
spl set id: f14cf2b8-b110-1210-e053-2995a90a0102

Reported adverse events (FAERS/openFDA)#

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