FDA.reportPublic FDA data

Kinesys ® Broad Spectrum SPF 30 Girl Alcohol-Free Spray Sunscreen

Manufacturer
Wilc Healthcare Inc | Cosmaceutical Research Laboratory Inc
Effective date
2017-07-12
Label type
HUMAN OTC DRUG LABEL
Version
2
Source
full-release
Hydrated at
2026-05-31 22:51:55

Label at a glance#

ProductKinesys Broad Spectrum SPF 30 Girl Alcohol-Free Sunscreen
Active ingredientOCTINOXATE, OCTOCRYLENE, OCTISALATE, AVOBENZONE
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

Hold container 4 to 6 inches from the skin to apply apply generously and spread evenly by hand 15 minutes before sun exposure reapply: after 80 minutes of swimming or sweating immediately after towel drying at least every 2 hours Do not spray directly onto the face. Spray into hands, and apply to the face. Do not apply in windy condition Use in well-ventilated area Sun Protection Measures. Spending time in the sun...

Storage and handling

protect this product from excessive heat and direct sun

Label contents#

Full prescribing information#

Active Ingredients

OTC - ACTIVE INGREDIENT SECTION

Avobenzone 2.5%
Octinoxate 7.5%
Octisalate 5.0%
Octocrylene 7.5%

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.

Do not use

OTC - DO NOT USE SECTION

near flame or while smoking

Directions

DOSAGE & ADMINISTRATION SECTION

  • Hold container 4 to 6 inches from the skin to apply
  • apply generously and spread evenly by hand 15 minutes before sun exposure
  • reapply:
    • after 80 minutes of swimming or sweating
    • immediately after towel drying
    • at least every 2 hours
  • Do not spray directly onto the face. Spray into hands, and apply to the face.
  • Do not apply in windy condition
  • Use in well-ventilated area
  • 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

Bisabolol, Butyloctyl Salicylate, Cyclopentasiloxane, Diphenylsioxy Phenyl Trimethicone, Fragrance, Octyl Palmitate, Tocopherols, VP/ Hexadecene Copolymer.

Other Information

STORAGE AND HANDLING SECTION

  • protect this product from excessive heat and direct sun

PRINCIPAL DISPLAY PANEL - 30 mL Bottle Label

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

NDC 61481-3004-1

BROAD SPECTRUM SPF 30

Girl

Alcohol-Free Performance SUNSCREEN

KINeSYS®

Vanilla-Green Tea // Oil-Free

  • Clear Spray
  • Preservative-Free

BROAD SPECTRUM SPF 30

WATER RESISTANT (80 MINUTES)

1.0 FL OZ (30 mL)

LabelLabel

NDC 61481-3004-4

BROAD SPECTRUM SPF 30

Girl

Alcohol-Free Performance SUNSCREEN

KINeSYS®

Vanilla-Green Tea // Oil-Free

Clear Spray
Preservative-Free

BROAD SPECTRUM SPF 30

WATER RESISTANT (80 MINUTES)

4.0 FL OZ (120 mL)

Label 1Label 1

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
61481-3004-12020-01-31C16284748780-19d75b9d0-b7ca-f424-e053-dadaa90a57ceKinesys ® Broad Spectrum SPF 30 Girl Alcohol-Free Spray Sunscreen
61481-3004-42020-01-31C16284748780-19d75b9d0-b7ca-f424-e053-dadaa90a57ceKinesys ® Broad Spectrum SPF 30 Girl Alcohol-Free Spray Sunscreen

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
61481-3004-1KinesysBroad Spectrum SPF 30 Girl Alcohol-Free Sunscreen30 mL in 1 BOTTLE, SPRAYSPRAY302
61481-3004-4KinesysBroad Spectrum SPF 30 Girl Alcohol-Free Sunscreen120 mL in 1 BOTTLE, SPRAYSPRAY1202

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
61481-3004KINESYS BROAD SPECTRUM SPF 30 GIRL ALCOHOL-FREE SUNSCREEN (OCTINOXATE, OCTOCRYLENE, OCTISALATE, AND AVOBENZONE) SPRAY [WILC HEALTHCARE INC]2Legacy NDC, 2 package rows20170713_3f42f0b8-dbd0-424e-bfe6-587391716101.zip

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIISPL versionUploaded
AvobenzoneACTIVE INGREDIENTG63QQF2NOX1
OCTINOXATEACTIVE INGREDIENT4Y5P7MUD511
OCTISALATEACTIVE INGREDIENT4X49Y0596W1
OCTOCRYLENEACTIVE INGREDIENT5A68WGF6WM1
AvobenzoneACTIVE MOIETYG63QQF2NOX1
OCTINOXATEACTIVE MOIETY4Y5P7MUD511
OCTISALATEACTIVE MOIETY4X49Y0596W1
OCTOCRYLENEACTIVE MOIETY5A68WGF6WM1
.ALPHA.-TOCOPHEROL ACETATE, DL-INACTIVE INGREDIENTWR1WPI7EW81
BUTYLOCTYL SALICYLATEINACTIVE INGREDIENT2EH13UN8D31
CYCLOMETHICONE 5INACTIVE INGREDIENT0THT5PCI0R1
DIPHENYLSILOXY PHENYL TRIMETHICONEINACTIVE INGREDIENTI445L28B121
ETHYLHEXYL PALMITATEINACTIVE INGREDIENT28659933091
HEXADECYL POVIDONE (4 HEXADECYL BRANCHES/REPEAT)INACTIVE INGREDIENTAG75W62QYU1
LEVOMENOLINACTIVE INGREDIENT24WE03BX2T1

Products#

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

DailyMed product names page 1 of 1 · 13 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
61481-300461481-3004-4, 61481-3004-1

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 11 matching rows.

Name, UNII, Kind table
NameUNIIKind
OCTINOXATE4Y5P7MUD51ACTIB
OCTOCRYLENE5A68WGF6WMACTIB
OCTISALATE4X49Y0596WACTIB
AVOBENZONEG63QQF2NOXACTIB
CYCLOMETHICONE 50THT5PCI0RIACT
ETHYLHEXYL PALMITATE2865993309IACT
BUTYLOCTYL SALICYLATE2EH13UN8D3IACT
DIPHENYLSILOXY PHENYL TRIMETHICONEI445L28B12IACT
VINYLPYRROLIDONE/HEXADECENE COPOLYMERKFR5QEN0N9IACT
TOCOPHEROLR0ZB2556P8IACT
LEVOMENOL24WE03BX2TIACT

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 · 5 matching rows.

DailyMed ingredient, IID ingredient, UNII table
DailyMed ingredientIID ingredientUNIIDosage form / routePotencyMaximum daily exposureMatch
CYCLOMETHICONE 5CYCLOMETHICONE 50THT5PCI0RCREAM, AUGMENTED / TOPICAL260 mgExact identifier — unii candidate
3 equally ranked IID candidates
.ALPHA.-TOCOPHEROL ACETATE, DL-.ALPHA.-TOCOPHEROL ACETATE, DL-WR1WPI7EW8AEROSOL, FOAM / TOPICALNAExact identifier — unii candidate
2 equally ranked IID candidates
.ALPHA.-TOCOPHEROL ACETATE, DL-.ALPHA.-TOCOPHEROL ACETATE, DL-WR1WPI7EW8OINTMENT / TOPICALNAExact identifier — unii candidate
2 equally ranked IID candidates
CYCLOMETHICONE 5CYCLOMETHICONE 50THT5PCI0RAEROSOL / TOPICAL2.5 %w/wExact identifier — unii candidate
3 equally ranked IID candidates
CYCLOMETHICONE 5CYCLOMETHICONE 50THT5PCI0RAEROSOL, FOAM / TOPICAL144 mgExact identifier — unii candidate
3 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
357d069b-73d6-4559-9cc8-153ad123ab163f42f0b8-dbd0-424e-bfe6-5873917161012017-07-12WarningsExact identifier
spl id: 357d069b-73d6-4559-9cc8-153ad123ab16
spl set id: 3f42f0b8-dbd0-424e-bfe6-587391716101

Reported adverse events (FAERS/openFDA)#

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