FDA.reportPublic FDA data

Koru Performance Suncreen Lotion SPF 40

Manufacturer
Koru Performance LLC | TAKA USA Inc. dba Cosmetic Innovations
Effective date
2021-07-30
Label type
HUMAN OTC DRUG LABEL
Version
1
Source
legacy-cache
Hydrated at
2026-08-01 22:39:14

Label at a glance#

ProductKoru Performance Sunscreen SPF40
Active ingredientZINC OXIDE
Label structure8 sections

Indications and uses

• Helps prevent sunburn. • Higher SPF gives more sunburn protection. • Provides high protection against sunburn. • Retains SPF after 80 minutes of swimming or sweating.

Dosage and administration

• Apply liberally 15 minutes before sun exposure • Use a water-resistant sunscreen if swimming or sweating. • Reapply 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...

Label contents#

Full prescribing information#

Active Ingredient

OTC - ACTIVE INGREDIENT SECTION

Zinc Oxide 20%

Purpose

OTC - PURPOSE SECTION

Sunscreen

Uses

INDICATIONS & USAGE SECTION

• Helps prevent sunburn.

• Higher SPF gives more sunburn protection.

• Provides high protection against sunburn.

• Retains SPF after 80 minutes of swimming or sweating.

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 doxtor

OTC - STOP USE SECTION

if rash or irritation deveops and lasts

Keep out of reach of children

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

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

Directions

DOSAGE & ADMINISTRATION SECTION

• Apply liberally 15 minutes before sun exposure

• Use a water-resistant sunscreen if swimming or sweating.

• Reapply

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 am to 2 pm

• wear long-sleeved shirts, pants, hats and sunglasses

Other Information

OTHER SAFETY INFORMATION

Protect this prodxuct from excessive heat and direct sun.

Inactive Ingredients

INACTIVE INGREDIENT SECTION

Batilol, Butylene glycol, Ceresin, Cetyl alcohol, Cocoyl caprylocaprate, Dimethicone, Disteardimonium hectorite, Edetate disodium, Ethylhexylglycerin, Ethyl ferulate, Medium chain triglycerides, Neopentyl glycol dicaprate, Pentaerythrityl tetraethylhexanoate, Phenoxyethanol, Polyglyceryl-3 pentaricinoleate, Polyglyceryl-4 isostearate, Propanediol, Propanediol dicaprylate, Silicon dioxide, Sorbitan isostearate, Styrene/Acrylamide copolymer (MW 500000), Triethoxycaprylylsilane, Water

Bottle Label

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Bottle LabelBottle Label

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
81129-001-012024-01-30C16284748780-11030e365-4c41-111a-e063-dadaa90a10e2Koru Performance Suncreen Lotion SPF 40

Products#

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

DailyMed product names page 1 of 1 · 26 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
81129-00181129-001-01

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 24 matching rows.

Name, UNII, Kind table
NameUNIIKind
STYRENE/ACRYLAMIDE COPOLYMER (MW 500000)5Z4DPO246AIACT
PROPANEDIOL DICAPRYLATEC577OMC6UHIACT
ZINC OXIDESOI2LOH54ZACTIB
TRIETHOXYCAPRYLYLSILANELDC331P08EIACT
WATER059QF0KO0RIACT
SILICON DIOXIDEETJ7Z6XBU4IACT
BATILOL39YR661C4UIACT
BUTYLENE GLYCOL3XUS85K0RAIACT
COCOYL CAPRYLOCAPRATE8D9H4QU99HIACT
ETHYL FERULATE5B8915UELWIACT
MEDIUM-CHAIN TRIGLYCERIDESC9H2L21V7UIACT
PHENOXYETHANOLHIE492ZZ3TIACT
POLYGLYCERYL-3 PENTARICINOLEATE7Q0OK5DOT4IACT
SORBITAN ISOSTEARATE01S2G2C1E4IACT
POLYGLYCERYL-4 ISOSTEARATE820DPX33S7IACT
CETYL ALCOHOL936JST6JCNIACT
DISTEARDIMONIUM HECTORITEX687XDK09LIACT
ETHYLHEXYLGLYCERIN147D247K3PIACT
NEOPENTYL GLYCOL DICAPRATE77T908SE82IACT
CERESINQ1LS2UJO3AIACT
EDETATE DISODIUM7FLD91C86KIACT
PROPANEDIOL5965N8W85TIACT
DIMETHICONE92RU3N3Y1OIACT
PENTAERYTHRITYL TETRAETHYLHEXANOATEXJ7052W897IACT

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
c85a8e6a-6425-f710-e053-2995a90a1b13c85a8e6a-6424-f710-e053-2995a90a1b132021-07-30WarningsExact identifier
spl id: c85a8e6a-6425-f710-e053-2995a90a1b13
spl set id: c85a8e6a-6424-f710-e053-2995a90a1b13

Reported adverse events (FAERS/openFDA)#

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