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NDC 61481-0036-02 Kinesys 25 g/100g Details

Kinesys 25 g/100g

Kinesys is a TOPICAL CREAM in the HUMAN OTC DRUG category. It is labeled and distributed by Wilc Healthcare Inc. The primary component is ZINC OXIDE.

Product Information

NDC	61481-0036
Product ID	61481-0036_7a4116fe-20cf-465c-a44c-858d8e898752
Associated GPIs
GCN Sequence Number	n/a
GCN Sequence Number Description	n/a
HIC3	n/a
HIC3 Description	n/a
GCN	n/a
HICL Sequence Number	n/a
HICL Sequence Number Description	n/a
Brand/Generic	n/a
Proprietary Name	Kinesys
Proprietary Name Suffix	n/a
Non-Proprietary Name	Zinc Oxide
Product Type	HUMAN OTC DRUG
Dosage Form	CREAM
Route	TOPICAL
Active Ingredient Strength	25
Active Ingredient Units	g/100g
Substance Name	ZINC OXIDE
Labeler Name	Wilc Healthcare Inc
Pharmaceutical Class	Copper Absorption Inhibitor [EPC], Decreased Copper Ion Absorption [PE]
DEA Schedule	n/a
Marketing Category	OTC MONOGRAPH NOT FINAL
Application Number	part348
Listing Certified Through	2024-12-31

Package

Package Images

NDC 61481-0036-02 (61481003602)

Pricing Information	N/A
NDC Package Code	61481-0036-2
Billing NDC	61481003602
Package	60 g in 1 JAR (61481-0036-2)
Marketing Start Date	2018-09-26
NDC Exclude Flag	N

Standard Product Labeling (SPL)/Prescribing Information SPL a32b44c3-eda0-48ea-95fc-250a2c2396ca Details

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

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

Ingredient Name	Strength
Inactive Ingredients
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)

#	Item Code	Package Description	Marketing Start Date	Marketing End Date
Packaging
1	NDC:61481-0036-2	60 g in 1 JAR; Type 0: Not a Combination Product	09/26/2018

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

Labeler - Wilc Healthcare Inc (203499140)

Registrant - Wilc Healthcare Inc (203499140)

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

Revised: 9/2018

Document Id: 7a4116fe-20cf-465c-a44c-858d8e898752

Set id: a32b44c3-eda0-48ea-95fc-250a2c2396ca

Version: 1

Effective Time: 20180926