FDA.reportPublic FDA data

Kinesys

Product NDC
61481-3003
Requested package NDC
61481-3003-4
11-digit product format
614813003
Labeler code
61481
Product ID
61481-3003_5dcf37ca-5a8a-3db7-e063-6294a90a01fb
Type
HUMAN OTC DRUG
Nonproprietary name
OCTINOXATE, OCTOCRYLENE, OCTISALATE, and AVOBENZONE
Dosage form
SPRAY
Route
TOPICAL
Labeler
Wilc Healthcare Inc
Application
M020
Marketing category
OTC MONOGRAPH DRUG
Marketing start
2017-06-01
Substance
OCTINOXATE; OCTOCRYLENE; OCTISALATE; AVOBENZONE
Active strength
7.5; 7.5; 5; 2.5 g/100mL; g/100mL; g/100mL; g/100mL
NDC exclude flag
No
Listing certified through
2027-12-31
Current FDA listing
Yes

Reported adverse events (FAERS/openFDA)#

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

Additional Listing Data#

Finished product
Yes
Brand name base
Kinesys
Brand name suffix
Broad Spectrum SPF 30 Alcohol-Free Sunscreen - Mango Scent
Listing expiration
2027-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
OCTINOXATE7.5 g/100mL
OCTOCRYLENE7.5 g/100mL
OCTISALATE5 g/100mL
AVOBENZONE2.5 g/100mL

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
61481-3003-1KinesysBroad Spectrum SPF 30 Alcohol-Free Sunscreen - Mango Scent30 mL in 1 BOTTLE, SPRAYSPRAY308
61481-3003-4KinesysBroad Spectrum SPF 30 Alcohol-Free Sunscreen - Mango Scent120 mL in 1 BOTTLE, SPRAYSPRAY1208

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
AVOBENZONEACTIVE INGREDIENTG63QQF2NOXKINESYS BROAD SPECTRUM SPF 30 ALCOHOL-FREE SUNSCREEN - MANGO SCENT (OCTINOXATE, OCTOCRYLENE, OCTISALATE, AND AVOBENZONE) SPRAY [KINESYS PHARMACEUTICALS INC.]1
OCTINOXATEACTIVE INGREDIENT4Y5P7MUD51KINESYS BROAD SPECTRUM SPF 30 ALCOHOL-FREE SUNSCREEN - MANGO SCENT (OCTINOXATE, OCTOCRYLENE, OCTISALATE, AND AVOBENZONE) SPRAY [KINESYS PHARMACEUTICALS INC.]1
OCTISALATEACTIVE INGREDIENT4X49Y0596WKINESYS BROAD SPECTRUM SPF 30 ALCOHOL-FREE SUNSCREEN - MANGO SCENT (OCTINOXATE, OCTOCRYLENE, OCTISALATE, AND AVOBENZONE) SPRAY [KINESYS PHARMACEUTICALS INC.]1
OCTOCRYLENEACTIVE INGREDIENT5A68WGF6WMKINESYS BROAD SPECTRUM SPF 30 ALCOHOL-FREE SUNSCREEN - MANGO SCENT (OCTINOXATE, OCTOCRYLENE, OCTISALATE, AND AVOBENZONE) SPRAY [KINESYS PHARMACEUTICALS INC.]1
AVOBENZONEACTIVE MOIETYG63QQF2NOXKINESYS BROAD SPECTRUM SPF 30 ALCOHOL-FREE SUNSCREEN - MANGO SCENT (OCTINOXATE, OCTOCRYLENE, OCTISALATE, AND AVOBENZONE) SPRAY [KINESYS PHARMACEUTICALS INC.]1
OCTINOXATEACTIVE MOIETY4Y5P7MUD51KINESYS BROAD SPECTRUM SPF 30 ALCOHOL-FREE SUNSCREEN - MANGO SCENT (OCTINOXATE, OCTOCRYLENE, OCTISALATE, AND AVOBENZONE) SPRAY [KINESYS PHARMACEUTICALS INC.]1
OCTISALATEACTIVE MOIETY4X49Y0596WKINESYS BROAD SPECTRUM SPF 30 ALCOHOL-FREE SUNSCREEN - MANGO SCENT (OCTINOXATE, OCTOCRYLENE, OCTISALATE, AND AVOBENZONE) SPRAY [KINESYS PHARMACEUTICALS INC.]1
OCTOCRYLENEACTIVE MOIETY5A68WGF6WMKINESYS BROAD SPECTRUM SPF 30 ALCOHOL-FREE SUNSCREEN - MANGO SCENT (OCTINOXATE, OCTOCRYLENE, OCTISALATE, AND AVOBENZONE) SPRAY [KINESYS PHARMACEUTICALS INC.]1
.ALPHA.-TOCOPHEROL ACETATE, DL-INACTIVE INGREDIENTWR1WPI7EW8KINESYS BROAD SPECTRUM SPF 30 ALCOHOL-FREE SUNSCREEN - MANGO SCENT (OCTINOXATE, OCTOCRYLENE, OCTISALATE, AND AVOBENZONE) SPRAY [KINESYS PHARMACEUTICALS INC.]1
BUTYLOCTYL SALICYLATEINACTIVE INGREDIENT2EH13UN8D3KINESYS BROAD SPECTRUM SPF 30 ALCOHOL-FREE SUNSCREEN - MANGO SCENT (OCTINOXATE, OCTOCRYLENE, OCTISALATE, AND AVOBENZONE) SPRAY [KINESYS PHARMACEUTICALS INC.]1
CYCLOMETHICONE 5INACTIVE INGREDIENT0THT5PCI0RKINESYS BROAD SPECTRUM SPF 30 ALCOHOL-FREE SUNSCREEN - MANGO SCENT (OCTINOXATE, OCTOCRYLENE, OCTISALATE, AND AVOBENZONE) SPRAY [KINESYS PHARMACEUTICALS INC.]1
DIPHENYLSILOXY PHENYL TRIMETHICONEINACTIVE INGREDIENTI445L28B12KINESYS BROAD SPECTRUM SPF 30 ALCOHOL-FREE SUNSCREEN - MANGO SCENT (OCTINOXATE, OCTOCRYLENE, OCTISALATE, AND AVOBENZONE) SPRAY [KINESYS PHARMACEUTICALS INC.]1
ETHYLHEXYL PALMITATEINACTIVE INGREDIENT2865993309KINESYS BROAD SPECTRUM SPF 30 ALCOHOL-FREE SUNSCREEN - MANGO SCENT (OCTINOXATE, OCTOCRYLENE, OCTISALATE, AND AVOBENZONE) SPRAY [KINESYS PHARMACEUTICALS INC.]1
HEXADECYL POVIDONE (4 HEXADECYL BRANCHES/REPEAT)INACTIVE INGREDIENTAG75W62QYUKINESYS BROAD SPECTRUM SPF 30 ALCOHOL-FREE SUNSCREEN - MANGO SCENT (OCTINOXATE, OCTOCRYLENE, OCTISALATE, AND AVOBENZONE) SPRAY [KINESYS PHARMACEUTICALS INC.]1
LEVOMENOLINACTIVE INGREDIENT24WE03BX2TKINESYS BROAD SPECTRUM SPF 30 ALCOHOL-FREE SUNSCREEN - MANGO SCENT (OCTINOXATE, OCTOCRYLENE, OCTISALATE, AND AVOBENZONE) SPRAY [KINESYS PHARMACEUTICALS INC.]1

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
61481-3003KINESYS BROAD SPECTRUM SPF 30 ALCOHOL-FREE SUNSCREEN - MANGO SCENT (OCTINOXATE, OCTOCRYLENE, OCTISALATE, AND AVOBENZONE) SPRAY [WILC HEALTHCARE INC]7Current NDC, Legacy NDC, 2 package rows20241101_60e7ed8e-f421-4e08-97a8-af647200e4ae.zip

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 198 of 353 · 7,041 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Dolce and Gabbana Everlast Foundation SPF 20 27N Medium DeepOCTISALATE, OCTOCRYLENE, TITANIUM DIOXIDE, ZINC OXIDEDolce & Gabbana Beauty S.R.La9068dc0-bc48-498b-adc9-57ff810384af2025-08-11WarningsExact identifier
application number: M020
Dolce and Gabbana Everlast Foundation SPF 20 28W Medium DeepOCTISALATE, OCTOCRYLENE, TITANIUM DIOXIDE, ZINC OXIDEDolce & Gabbana Beauty S.R.L37f01f66-c604-4fc3-a263-2089db91283f2025-08-11WarningsExact identifier
application number: M020
Dolce and Gabbana Everlast Foundation SPF 20 29W Medium DeepOCTISALATE, OCTOCRYLENE, TITANIUM DIOXIDE, ZINC OXIDEDolce & Gabbana Beauty S.R.Lbca57893-bd2d-44ac-a503-2f11c3b62bf22025-08-11WarningsExact identifier
application number: M020
Dolce and Gabbana Everlast Foundation SPF 20 30N Medium DeepOCTISALATE, OCTOCRYLENE, TITANIUM DIOXIDE, ZINC OXIDEDolce & Gabbana Beauty S.R.L37188b77-ab0b-4bea-b839-99e589600a2b2025-08-11WarningsExact identifier
application number: M020
Dolce and Gabbana Everlast Foundation SPF 20 31N Medium DeepOCTISALATE, OCTOCRYLENE, TITANIUM DIOXIDE, ZINC OXIDEDolce & Gabbana Beauty S.R.Lc89e45d6-2322-4913-a557-e1780a86fd632025-08-11WarningsExact identifier
application number: M020
Sun Bum Face 70 Premium SunscreenAVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENESun Bum, LLC3c1ed89c-6d50-6400-e063-6294a90a14332025-08-11WarningsExact identifier
application number: M020
NAKED SUNDAYS CABANA GLOW MINERAL GLOW SERUM DROPS Illuminating 15mL with Pink Algae SPF 50ZINC OXIDENAKED SUNDAYS PTY LTD24e9ea4d-3073-c126-e063-6394a90a7c6e2025-08-10WarningsExact identifier
application number: M020
GOLDEN ROSE GLOW KISS TINTED LIP BALM PEACH SHAKEAVOBENZONE, OCTINOXATEERKUL KOZMETIK SANAYI VE TICARET ANONIM SIRKETId1c5b7a5-73f9-4df6-9469-ce42e4f33ae82025-08-08WarningsExact identifier
application number: M020
GOLDEN ROSE GLOW KISS TINTED LIP BALM VANILLA LATTEAVOBENZONE, OCTINOXATEERKUL KOZMETIK SANAYI VE TICARET ANONIM SIRKETI96efeb92-a276-4ac9-b30a-11b4fa3672632025-08-08WarningsExact identifier
application number: M020
GR LIP BUTTER PEACH SPF 15AVOBENZONE, OCTINOXATEERKUL KOZMETIK SANAYI VE TICARET ANONIM SIRKETIedeb2ee1-cc84-4254-80c1-6410cd77c4222025-08-08WarningsExact identifier
application number: M020
GR LIP BUTTER STRAWBERRY SPF 15AVOBENZONE, OCTINOXATEERKUL KOZMETIK SANAYI VE TICARET ANONIM SIRKETI7abe936b-a4d5-457c-9cdd-761b201bb0462025-08-08WarningsExact identifier
application number: M020
GR LIP BUTTER BLUEBERRY SPF 15AVOBENZONE, OCTINOXATEERKUL KOZMETIK SANAYI VE TICARET ANONIM SIRKETIe4eb80d8-e75c-4bb7-b3bc-9f05a0f23bab2025-08-08WarningsExact identifier
application number: M020
GOLDEN ROSE GLOW KISS TINTED LIP BALM CHOCO CAKEAVOBENZONE, OCTINOXATEERKUL KOZMETIK SANAYI VE TICARET ANONIM SIRKETI8be1c27c-7988-47c4-b613-3bc86f53981e2025-08-08WarningsExact identifier
application number: M020
GOLDEN ROSE GLOW KISS TINTED LIP BALM STRAWBERRYAVOBENZONE, OCTINOXATEERKUL KOZMETIK SANAYI VE TICARET ANONIM SIRKETIa3c8d778-ce9c-46eb-a0c3-6886eb1d39342025-08-08WarningsExact identifier
application number: M020
GOLDEN ROSE glow kiss TINTED LIP BALM CHERRY JUICEAVOBENZONE, OCTINOXATEERKUL KOZMETIK SANAYI VE TICARET ANONIM SIRKETI6cdb0b61-a9c2-4a78-9752-8e7aedaeef452025-08-08WarningsExact identifier
application number: M020
GOLDEN ROSE GLOW KISS TINTED LIP BALM BERRY PINKAVOBENZONE, OCTINOXATEERKUL KOZMETIK SANAYI VE TICARET ANONIM SIRKETIf1b6c068-06d2-4a44-8199-7111d1b6a0d62025-08-08WarningsExact identifier
application number: M020
GR LIP BUTTER COOKIE SPF 15AVOBENZONE, OCTINOXATEERKUL KOZMETIK SANAYI VE TICARET ANONIM SIRKETI0274f5f1-1ee1-48a5-af7a-deb3aa3a34d72025-08-08WarningsExact identifier
application number: M020
GR LIP BUTTER ICE MINT SPF 15AVOBENZONE, OCTINOXATEERKUL KOZMETIK SANAYI VE TICARET ANONIM SIRKETIa355777b-2cce-48ce-acc6-2aa7f154c4ba2025-08-08WarningsExact identifier
application number: M020
GR LIP BUTTER RASPBERRY SPF 15AVOBENZONE, OCTINOXATEERKUL KOZMETIK SANAYI VE TICARET ANONIM SIRKETI5443202c-4f88-4063-a227-c50abbd480d62025-08-08WarningsExact identifier
application number: M020
SUNSCREEN SPF50ETHYLHEXYL METHOXYCINNAMATE, OCTOCRYLENE, TITANIUM DIOXIDEGuangzhou Tinsun Biotechnology Company Limited3bc1c6e9-1dd5-d7c6-e063-6394a90ad89e2025-08-07WarningsExact identifier
application number: M020

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
61481-3003-461481300304120 mL in 1 BOTTLE, SPRAY (61481-3003-4) 120 ml2017-06-010000-00-00NoNoCurrent