KINESYS- zinc oxide cream 
Wilc Healthcare Inc

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.

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KINeSYS Performance Sunscreen CLEAR ZINC

Active Ingredient

Zinc Oxide 25% w/w

Purpose

Sunscreen

Uses

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 occurs

Keep out of reach of children.

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

Directions

Reapply:

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 of 15 or higher and other sun protection measures including:

children under 6 months: Ask a doctor

Inactive Ingredients

Aloe Barbadensis Lead Extract, Bisabolol, Beeswax, Capric/Caprylic Triglyceride, Coconut Oil, Peppermint Oil, Polyhydroxystearic acid and Isostearic acid, Rosemary Leaf Oil, Sunflower seed oil, Tocopherols.

Other Information

Questions or Comments?

Call toll free 1.888.KINeSYS [546.3797] www.kinesysactive.com

PRINCIPAL DISPLAY PANEL

NDC 61481-0036-2

KINeSYS Performance SUNSCREEN

CLEAR ZINC WITH 25% NATURAL ZINC OXIDE

BROAD SPECTRUM SPF 30

UVA+UVB

PEPPERMINT AND ROSEMARY

80 MINS WATER AND SWEAT RESISTANT

2 OZ (60 g)

Label

KINESYS 
zinc oxide cream
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:61481-0036
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
ZINC OXIDE (UNII: SOI2LOH54Z) (ZINC CATION - UNII:13S1S8SF37) ZINC CATION25 g  in 100 g
Inactive Ingredients
Ingredient NameStrength
ALOE VERA LEAF (UNII: ZY81Z83H0X)  
LEVOMENOL (UNII: 24WE03BX2T)  
COCONUT OIL (UNII: Q9L0O73W7L)  
PEPPERMINT OIL (UNII: AV092KU4JH)  
ISOSTEARIC ACID (UNII: X33R8U0062)  
ROSEMARY OIL (UNII: 8LGU7VM393)  
SUNFLOWER OIL (UNII: 3W1JG795YI)  
TOCOPHEROL (UNII: R0ZB2556P8)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:61481-0036-260 g in 1 JAR; Type 0: Not a Combination Product09/26/2018
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC MONOGRAPH NOT FINALpart34809/26/2018
Labeler - Wilc Healthcare Inc (203499140)
Registrant - Wilc Healthcare Inc (203499140)
Establishment
NameAddressID/FEIBusiness Operations
Cosmaceutical Research Laboratory Inc256797309manufacture(61481-0036)

Revised: 9/2018
Document Id: 7a4116fe-20cf-465c-a44c-858d8e898752
Set id: a32b44c3-eda0-48ea-95fc-250a2c2396ca
Version: 1
Effective Time: 20180926
 
Wilc Healthcare Inc