KORU PERFORMANCE SUNSCREEN SPF40- sunscreen lotion 
Koru Performance LLC

Disclaimer: Most OTC drugs are not reviewed and approved by FDA, however they may be marketed if they comply with applicable regulations and policies. FDA has not evaluated whether this product complies.

----------

Koru Performance Suncreen Lotion SPF 40

Active Ingredient

Zinc Oxide 20%

Purpose

Sunscreen

Uses

• Helps prevent sunburn.

• Higher SPF gives more sunburn protection.

• Provides high protection against sunburn.

• Retains SPF after 80 minutes of swimming or sweating.

Warnings

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 doxtor

if rash or irritation deveops and lasts

Keep out of reach of children

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

Directions

• 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

Protect this prodxuct from excessive heat and direct sun.

Inactive Ingredients

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

Bottle Label

KORU PERFORMANCE SUNSCREEN SPF40 
sunscreen lotion
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:81129-001
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
ZINC OXIDE (UNII: SOI2LOH54Z) (ZINC OXIDE - UNII:SOI2LOH54Z) ZINC OXIDE200 mg  in 1 mL
Inactive Ingredients
Ingredient NameStrength
STYRENE/ACRYLAMIDE COPOLYMER (MW 500000) (UNII: 5Z4DPO246A)  
PROPANEDIOL DICAPRYLATE (UNII: C577OMC6UH)  
TRIETHOXYCAPRYLYLSILANE (UNII: LDC331P08E)  
WATER (UNII: 059QF0KO0R)  
SILICON DIOXIDE (UNII: ETJ7Z6XBU4)  
BATILOL (UNII: 39YR661C4U)  
BUTYLENE GLYCOL (UNII: 3XUS85K0RA)  
COCOYL CAPRYLOCAPRATE (UNII: 8D9H4QU99H)  
ETHYL FERULATE (UNII: 5B8915UELW)  
MEDIUM-CHAIN TRIGLYCERIDES (UNII: C9H2L21V7U)  
PHENOXYETHANOL (UNII: HIE492ZZ3T)  
POLYGLYCERYL-3 PENTARICINOLEATE (UNII: 7Q0OK5DOT4)  
SORBITAN ISOSTEARATE (UNII: 01S2G2C1E4)  
POLYGLYCERYL-4 ISOSTEARATE (UNII: 820DPX33S7)  
CETYL ALCOHOL (UNII: 936JST6JCN)  
DISTEARDIMONIUM HECTORITE (UNII: X687XDK09L)  
ETHYLHEXYLGLYCERIN (UNII: 147D247K3P)  
NEOPENTYL GLYCOL DICAPRATE (UNII: 77T908SE82)  
CERESIN (UNII: Q1LS2UJO3A)  
EDETATE DISODIUM (UNII: 7FLD91C86K)  
PROPANEDIOL (UNII: 5965N8W85T)  
DIMETHICONE (UNII: 92RU3N3Y1O)  
PENTAERYTHRITYL TETRAETHYLHEXANOATE (UNII: XJ7052W897)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:81129-001-01100 mL in 1 BOTTLE; Type 0: Not a Combination Product08/01/2021
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph finalpart35208/01/2021
Labeler - Koru Performance LLC (117749158)
Establishment
NameAddressID/FEIBusiness Operations
TAKA USA Inc. dba Cosmetic Innovations802860515manufacture(81129-001)

Revised: 7/2021
Document Id: c85a8e6a-6425-f710-e053-2995a90a1b13
Set id: c85a8e6a-6424-f710-e053-2995a90a1b13
Version: 1
Effective Time: 20210730
 
Koru Performance LLC