KINESYS- zinc oxide cream

Kinesys by

Drug Labeling and Warnings

Kinesys by is a Otc medication manufactured, distributed, or labeled by Wilc Healthcare Inc, Cosmaceutical Research Laboratory Inc. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

Active Ingredient

Zinc Oxide 25% w/w

Purpose

Sunscreen

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

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

• Apply generously and spread evenly to all exposed skin 20 minutes before sun exposure

Reapply:

• after 80 minutes of swimming or sweating
• immediately after towel drying
• at least every 2 hours

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:

• limit time in the sun, especially from 10 a.m. – 2 p.m.
• wear long-sleeve shirts, pants, hats, and sunglasses

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

• protect the product in this container from excessive heat and direct sun.

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)

INGREDIENTS AND APPEARANCE

KINESYS 
zinc oxide cream

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 61481-0036
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
ZINC OXIDE (UNII: SOI2LOH54Z) (ZINC CATION - UNII:13S1S8SF37)	ZINC CATION	25 g  in 100 g

Inactive Ingredients
Ingredient Name	Strength
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 Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 61481-0036-2	60 g in 1 JAR; Type 0: Not a Combination Product	09/26/2018

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC MONOGRAPH NOT FINAL	part348	09/26/2018

Labeler - Wilc Healthcare Inc (203499140)

Registrant - Wilc Healthcare Inc (203499140)

Establishment
Name	Address	ID/FEI	Business Operations
Cosmaceutical Research Laboratory Inc		256797309	manufacture(61481-0036)