FDA.reportPublic FDA data

Kinesys

Manufacturer
Wilc Healthcare Inc | Cosmaceutical Research Laboratory Inc
Effective date
2025-10-10
Label type
HUMAN OTC DRUG LABEL
Version
4
Source
full-release
Hydrated at
2026-06-01 01:39:22

Label at a glance#

ProductKinesys
Active ingredientZINC OXIDE
Label structure9 sections

Indications and 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

Dosage and administration

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 mea...

Storage and handling

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

Label contents#

Full prescribing information#

Active Ingredient

OTC - ACTIVE INGREDIENT SECTION

Zinc Oxide 25% w/w

Purpose

OTC - PURPOSE SECTION

Sunscreen

Uses

INDICATIONS & USAGE SECTION

  • 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

WARNINGS SECTION

For external use only

Do not use

OTC - DO NOT USE SECTION

  • on damaged or broken skin

When using this product

OTC - WHEN USING SECTION

  • keep out of eyes. Rinse with water to remove.

Stop use and ask a doctor

OTC - STOP USE SECTION

  • if rash occurs

Keep out of reach of children.

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

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

Directions

DOSAGE & ADMINISTRATION SECTION

  • 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

INACTIVE INGREDIENT SECTION

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

STORAGE AND HANDLING SECTION

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

Questions or Comments?

OTC - QUESTIONS SECTION

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

PRINCIPAL DISPLAY PANEL

PACKAGE LABEL.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)

LabelLabel

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYSPL version
1125471zinc oxide 25 % Topical CreamPSN4
1125471zinc oxide 250 MG/ML Topical CreamSCD4
1125471zinc oxide 25 % Topical CreamSY4
1125471ZNO 250 MG/ML Topical CreamSY4

DailyMed Pharmacologic Classes#

Class, Version, Type table
ClassVersionTypeEffective
ZINC CATION Pharmacologic Class Indexing2Indexing - Pharmacologic Class20180813

Product Linked Resources#

Resource, Code type, Value table
ResourceCode typeValueEquivalent identifiersSource image
BarcodeEAN-130778817065115GTIN-13: 0778817065115
EAN-13: 0778817065115
GTIN-12: 778817065115
UPC-A: 778817065115
GTIN storage (14 digits): 00778817065115		2.jpg

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
f47a510b-6679-4664-b2d6-47b5c4afe7ccProduct name420260217
030ce964-9b2d-45aa-b5d3-f78ce03ef61cProduct name220250515
0306390c-dd77-4363-afe0-63c58088b2a1Product name120220120
503ea967-4b9c-48cf-9e87-c7975295849dProduct name220220120
190f2a5b-bbc8-65c7-fcb0-97891307b917Product name120140508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
61481-0036-2Kinesys60 g in 1 JARCREAM604

Products#

Every source-derived product name is available through these pages.

DailyMed product names page 1 of 1 · 11 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
61481-003661481-0036-2

Ingredients#

Every source-derived ingredient row is available through these pages.

DailyMed ingredient rows page 1 of 1 · 9 matching rows.

Name, UNII, Kind table
NameUNIIKind
ALOE VERA LEAFZY81Z83H0XIACT
LEVOMENOL24WE03BX2TIACT
COCONUT OILQ9L0O73W7LIACT
PEPPERMINT OILAV092KU4JHIACT
ISOSTEARIC ACIDX33R8U0062IACT
ROSEMARY OIL8LGU7VM393IACT
SUNFLOWER OIL3W1JG795YIIACT
TOCOPHEROLR0ZB2556P8IACT
ZINC OXIDESOI2LOH54ZACTIM

Source Document#

Source XML

Older Hydrated Versions#

Version, Effective date, Source table
VersionEffective dateSourceHydrated
32024-10-24full-release2026-06-01 00:32:18

openFDA label cross-check#

OpenFDA label data provides additional search and identifier links. DailyMed’s Structured Product Label is the canonical label on FDA.report. Matching records are deduplicated before they are shown below.

Matched openFDA labels page 1 of 1 · 1 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
KinesysZINC OXIDEWilc Healthcare Inca32b44c3-eda0-48ea-95fc-250a2c2396ca2025-10-10WarningsExact identifier
ndc (package): 61481-0036-2
ndc (product): 61481-0036
ndc11 (package): 61481003602
spl id: 40d002ec-dea0-9d7f-e063-6394a90a5224
spl set id: a32b44c3-eda0-48ea-95fc-250a2c2396ca

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.