KORU PERFORMANCE SUNSCREEN SPF40- sunscreen stick

Koru Performance Sunscreen SPF40 by

Drug Labeling and Warnings

Koru Performance Sunscreen SPF40 by is a Otc medication manufactured, distributed, or labeled by Koru Performance LLC, TAKA USA Inc. dba Cosmetic Innovations. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

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 doctor

if rash or irritation develops 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 product 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

Applicator Label

INGREDIENTS AND APPEARANCE

KORU PERFORMANCE SUNSCREEN SPF40 
sunscreen stick

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 81129-002
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
ZINC OXIDE (UNII: SOI2LOH54Z) (ZINC OXIDE - UNII:SOI2LOH54Z)	ZINC OXIDE	200 mg  in 1 g

Inactive Ingredients
Ingredient Name	Strength
DIMETHICONE (UNII: 92RU3N3Y1O)
DISTEARDIMONIUM HECTORITE (UNII: X687XDK09L)
EDETATE DISODIUM (UNII: 7FLD91C86K)
PROPANEDIOL DICAPRYLATE (UNII: C577OMC6UH)
SORBITAN ISOSTEARATE (UNII: 01S2G2C1E4)
COCOYL CAPRYLOCAPRATE (UNII: 8D9H4QU99H)
PENTAERYTHRITYL TETRAETHYLHEXANOATE (UNII: XJ7052W897)
POLYGLYCERYL-3 PENTARICINOLEATE (UNII: 7Q0OK5DOT4)
CERESIN (UNII: Q1LS2UJO3A)
NEOPENTYL GLYCOL DICAPRATE (UNII: 77T908SE82)
TRIETHOXYCAPRYLYLSILANE (UNII: LDC331P08E)
POLYGLYCERYL-4 ISOSTEARATE (UNII: 820DPX33S7)
PROPANEDIOL (UNII: 5965N8W85T)
SILICON DIOXIDE (UNII: ETJ7Z6XBU4)
STYRENE/ACRYLAMIDE COPOLYMER (MW 500000) (UNII: 5Z4DPO246A)
ETHYL FERULATE (UNII: 5B8915UELW)
MEDIUM-CHAIN TRIGLYCERIDES (UNII: C9H2L21V7U)
PHENOXYETHANOL (UNII: HIE492ZZ3T)
BATILOL (UNII: 39YR661C4U)
BUTYLENE GLYCOL (UNII: 3XUS85K0RA)
CETYL ALCOHOL (UNII: 936JST6JCN)
ETHYLHEXYLGLYCERIN (UNII: 147D247K3P)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 81129-002-01	62 g in 1 APPLICATOR; Type 0: Not a Combination Product	08/01/2021

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph final	part352	08/01/2021

Labeler - Koru Performance LLC (117749158)

Establishment
Name	Address	ID/FEI	Business Operations
TAKA USA Inc. dba Cosmetic Innovations		802860515	manufacture(81129-002)