FDA.reportPublic FDA data

KINESYS

Manufacturer
Wilc Healthcare Inc | Cosmaceutical Research Laboratory Inc
Effective date
2019-09-19
Label type
HUMAN OTC DRUG LABEL
Version
2
Source
legacy-cache
Hydrated at
2026-08-02 00:09:31

Label at a glance#

ProductKINESYS SPF 30 SOLID SUNSCREEN
Active ingredientOCTINOXATE, OCTISALATE, OXYBENZONE, TITANIUM DIOXIDE
Label structure5 sections

Dosage and administration

Apply liberally 20 minutes prior to exposure to sun and wind. Re-apply every two hours to maximize protection. Re-apply to lips after eating or drinking. Store product below 30°C.

Label contents#

Full prescribing information#

Directions

DOSAGE & ADMINISTRATION SECTION

Apply liberally 20 minutes prior to exposure to sun and wind. Re-apply every two hours to maximize protection. Re-apply to lips after eating or drinking. Store product below 30°C.

Warning

WARNINGS SECTION

For external use only.

OTC - STOP USE SECTION

Discontinue use if signs of irritation or rash appear. Avoid contact with eyes.

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

Keep out of reach of children.

OTC - DO NOT USE SECTION

Do not use on infants less than six months of age.

Active Ingredients

OTC - ACTIVE INGREDIENT SECTION

Octinoxate 7.5%, Octisalate 5%, Oxybenzone 4.5%, Titanium Dioxide 1%.

Inactive Ingredients

INACTIVE INGREDIENT SECTION

PPG-2 Myristyl Ether Propionate, Stearyl Alcohol, Pentaerythrityl Tetracaprylate/Caprate, Candelilla Wax, Synthetic Beeswax, C10-30 Cholesterol/Lanosterol Esters, Tribehenin.

PRINCIPAL DISPLAY PANEL - 7.3 g Tube Label

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

SPF 30
sun protection stick

solid sunscreen for
LIPS, FACE AND BODY

Protects age spots, freckles,
wrinkles and scars

  • non-comedogenic
  • hypoallergenic
  • fragrance-free
  • UVA/UVB protection

KINeSYS®

7.3g (0.26 OZ)
DIN 02237002

EarthKind™

PRINCIPAL DISPLAY PANEL - 7.3 g Tube Label
PRINCIPAL DISPLAY PANEL - 7.3 g Tube Label

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIISPL versionUploaded
OCTINOXATEACTIVE INGREDIENT4Y5P7MUD511
OCTISALATEACTIVE INGREDIENT4X49Y0596W1
OXYBENZONEACTIVE INGREDIENT95OOS7VE0Y1
TITANIUM DIOXIDEACTIVE INGREDIENT15FIX9V2JP1
OCTINOXATEACTIVE MOIETY4Y5P7MUD511
OCTISALATEACTIVE MOIETY4X49Y0596W1
OXYBENZONEACTIVE MOIETY95OOS7VE0Y1
TITANIUM DIOXIDEACTIVE MOIETY15FIX9V2JP1
C10-30 CHOLESTEROL/LANOSTEROL ESTERSINACTIVE INGREDIENT137SL7IL0Y1
CANDELILLA WAXINACTIVE INGREDIENTWL0328HX191
PENTAERYTHRITYL TETRACAPRYLATE/TETRACAPRATEINACTIVE INGREDIENT832C4KF14X1
PPG-2 MYRISTYL ETHER PROPIONATEINACTIVE INGREDIENT88R97D8U8A1
STEARYL ALCOHOLINACTIVE INGREDIENT2KR89I4H1Y1
TRIBEHENININACTIVE INGREDIENT8OC9U7TQZ01

Products#

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

DailyMed product names page 1 of 1 · 12 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
61481-004561481-0045-1, 61481-0045-2, 61481-0045-3

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 10 matching rows.

Name, UNII, Kind table
NameUNIIKind
OCTINOXATE4Y5P7MUD51ACTIB
OCTISALATE4X49Y0596WACTIB
OXYBENZONE95OOS7VE0YACTIB
TITANIUM DIOXIDE15FIX9V2JPACTIB
PPG-2 MYRISTYL ETHER PROPIONATE88R97D8U8AIACT
STEARYL ALCOHOL2KR89I4H1YIACT
PENTAERYTHRITYL TETRACAPRYLATE/TETRACAPRATE832C4KF14XIACT
CANDELILLA WAXWL0328HX19IACT
C10-30 CHOLESTEROL/LANOSTEROL ESTERS137SL7IL0YIACT
TRIBEHENIN8OC9U7TQZ0IACT

Source Document#

Source XML

Inactive ingredient matches#

Inactive Ingredient Database values describe FDA-listed use contexts. The match method and ambiguity count are shown because ingredient names, routes, and dosage forms are not always unique. Browse recovered IID releases and source provenance.

Inactive ingredient links page 1 of 1 · 16 matching rows.

DailyMed ingredient, IID ingredient, UNII table
DailyMed ingredientIID ingredientUNIIDosage form / routePotencyMaximum daily exposureMatch
STEARYL ALCOHOLSTEARYL ALCOHOL2KR89I4H1YCREAM / TOPICAL162000 mgExact identifier — unii candidate
12 equally ranked IID candidates
CANDELILLA WAXCANDELILLA WAXWL0328HX19TABLET, DELAYED RELEASE / ORAL1 mgExact identifier — unii candidate
4 equally ranked IID candidates
STEARYL ALCOHOLSTEARYL ALCOHOL2KR89I4H1YTABLET / ORAL20 mgExact identifier — unii candidate
12 equally ranked IID candidates
STEARYL ALCOHOLSTEARYL ALCOHOL2KR89I4H1YAEROSOL, FOAM / TOPICAL37 mgExact identifier — unii candidate
12 equally ranked IID candidates
STEARYL ALCOHOLSTEARYL ALCOHOL2KR89I4H1YSUSPENSION / TOPICAL2.01 %w/wExact identifier — unii candidate
12 equally ranked IID candidates
STEARYL ALCOHOLSTEARYL ALCOHOL2KR89I4H1YTABLET, FILM COATED, EXTENDED RELEASE / ORAL120 mgExact identifier — unii candidate
12 equally ranked IID candidates
STEARYL ALCOHOLSTEARYL ALCOHOL2KR89I4H1YSUPPOSITORY / VAGINAL8.5 mgExact identifier — unii candidate
12 equally ranked IID candidates
STEARYL ALCOHOLSTEARYL ALCOHOL2KR89I4H1YPOWDER / ORAL0.11 mgExact identifier — unii candidate
12 equally ranked IID candidates
STEARYL ALCOHOLSTEARYL ALCOHOL2KR89I4H1YCREAM / VAGINAL425 mgExact identifier — unii candidate
12 equally ranked IID candidates
CANDELILLA WAXCANDELILLA WAXWL0328HX19TABLET, EXTENDED RELEASE / ORAL3 mgExact identifier — unii candidate
4 equally ranked IID candidates
STEARYL ALCOHOLSTEARYL ALCOHOL2KR89I4H1YLOTION / TOPICAL1140 mgExact identifier — unii candidate
12 equally ranked IID candidates
CANDELILLA WAXCANDELILLA WAXWL0328HX19TABLET / ORAL4 mgExact identifier — unii candidate
4 equally ranked IID candidates
STEARYL ALCOHOLSTEARYL ALCOHOL2KR89I4H1YOINTMENT / TOPICAL569 mgExact identifier — unii candidate
12 equally ranked IID candidates
STEARYL ALCOHOLSTEARYL ALCOHOL2KR89I4H1YCAPSULE, EXTENDED RELEASE / ORAL72 mgExact identifier — unii candidate
12 equally ranked IID candidates
CANDELILLA WAXCANDELILLA WAXWL0328HX19TABLET, FILM COATED / ORAL0.8 mgExact identifier — unii candidate
4 equally ranked IID candidates
STEARYL ALCOHOLSTEARYL ALCOHOL2KR89I4H1YTABLET, EXTENDED RELEASE / ORAL244 mgExact identifier — unii candidate
12 equally ranked IID candidates

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
2bc04165-5e77-8478-e063-6294a90ae879e7a6941a-2ee1-4128-afac-c9349bac10962025-01-15WarningsExact identifier
spl set id: e7a6941a-2ee1-4128-afac-c9349bac1096

Reported adverse events (FAERS/openFDA)#

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