FDA.reportPublic FDA data

Kinesys

Product NDC
61481-3003
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 340 of 346 · 6,912 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
REPAIRWEAR LASER FOCUS LINE SMOOTHING BROAD SPECTRUM SPF 15 -VERY DRY TO DRY COMBINATIONOCTINOXATE, OCTISALATE, AND TITANIUM DIOXIDECLINIQUE LABORATORIES LLC4c40047b-01d6-4221-a044-9f884519bdd52023-10-05WarningsExact identifier
application number: M020
CLINIQUE SMART CUSTOM REPAIR MOISTURIZER BROAD SPECTRUM SPF 15 - COMBINATION/OILY TO OILYAVOBENZONE AND OCTISALATECLINIQUE LABORATORIES LLC9c9a0fa4-b440-4d7f-805e-d997e120024d2023-10-05WarningsExact identifier
application number: M020
EVEN BETTER GLOW LIGHT REFLECTING MAKEUP BROAD SPECTRUM SPF 15OCTINOXATE, TITANIUM DIOXIDE, AND ZINC OXIDECLINIQUE LABORATORIES LLC756cb656-2f79-4e7f-b4b3-18d6e89309212023-10-05WarningsExact identifier
application number: M020
bareMinerals ORIGINAL Liquid Mineral Foundation Broad Spectrum SPF 20 Sunscreen FAIR 01TITANIUM DIOXIDEOrveon Global US, LLCf083af9e-e235-5f03-e053-2a95a90a53252023-10-04WarningsExact identifier
application number: M020
Fair Foundation SPF 15ZINC OXIDE, TITANIUM DIOXIDEOrveon Global US, LLC491a5768-1aad-458e-b4d6-72ea085d1d9f2023-10-04WarningsExact identifier
application number: M020
BAREMINERALS SPF 20 CORRECTING CONCEALER Dark 2TITANIUM DIOXIDEOrveon Global US LLC6845acee-5a3f-4c8d-9386-8823b30373f32023-10-04WarningsExact identifier
application number: M020
bareMinerals Complexion Rescue Broad Spectrum SPF 30 Opal 01TITANIUM DIOXIDEOrveon Global US, LLC798934af-f011-4a95-bdb6-b577154713c42023-10-04WarningsExact identifier
application number: M020
bareMinerals Complexion Rescue Brightening Concealer SPF 25 Deep MahoganyTITANIUM DIOXIDEOrveon Global US LLCf03b4fa3-4da9-5e44-e053-2a95a90af3442023-10-04WarningsExact identifier
application number: M020
bareMinerals Complexion Rescue Tinted Hydrating Broad Spectrum SPF 30 Cashew 3.5TITANIUM DIOXIDEOrveon Global US LLC2de76f3c-b438-47ca-84e5-e871e9d995a42023-10-04WarningsExact identifier
application number: M020
bareMinerals Original Foundation Broad Spectrum SPF 15 Fair IvoryTITANIUM DIOXIDEOrveon Global US LLC15c92bce-75f4-40e3-ae28-9bcbc241c8e92023-10-04WarningsExact identifier
application number: M020
bareMinerals Complexion Rescue Defense Radiant Protective Veil Broad Spectrum SPF 30 Soft RadianceTITANIUM DIOXIDE AND ZINC OXIDEOrveon Global US LLC0c2db44d-8604-4883-ab01-f14bc441e4e42023-10-04WarningsExact identifier
application number: M020
bareMinerals Original Foundation Broad Spectrum SPF 15 Medium Beige 12TITANIUM DIOXIDE AND ZINC OXIDEOrveon Global US LLC3c35fd13-1a4b-4acf-ada4-16ee2e52dd942023-10-04WarningsExact identifier
application number: M020
bareMinerals Prime Time BB Primer-Cream Broad Spectrum SPF 30 MediumTITANIUM DIOXIDE AND ZINC OXIDEOrveon Global US LLC3cc5b952-4619-4395-97c0-5b68efa9af6d2023-10-04WarningsExact identifier
application number: M020
bareMinerals Skinlongevity Vital Power Moisturizer Broad Spectrum SPF 30TITANIUM DIOXIDE AND ZINC OXIDEOrveon Global US LLC29c25bc3-902a-41af-996a-8c7e8a4bf5742023-10-04WarningsExact identifier
application number: M020
bareMinerals Original Foundation Broad Spectrum SPF 15 Fairly Light 03TITANIUM DIOXIDEOrveon Global US LLCb2909888-5a98-4894-a895-230aa53f64d92023-10-04WarningsExact identifier
application number: M020
bareMinerals Original Foundation Broad Spectrum SPF 15 Tan 19TITANIUM DIOXIDE AND ZINC OXIDEOrveon Global US LLCa5888955-f381-4209-9589-bd2e79a84f592023-10-04WarningsExact identifier
application number: M020
bareMinerals Original Foundation Broad Spectrum SPF 15 Light 08TITANIUM DIOXIDE AND ZINC OXIDEOrveon Global US LLCad15bdee-67e6-4281-8144-e84b7c478a342023-10-04WarningsExact identifier
application number: M020
bareMinerals Original Foundation Broad Spectrum SPF 15 Medium Tan 18TITANIUM DIOXIDE AND ZINC OXIDEOrveon Global US LLCaa4d7945-6cc9-4f20-b588-a5588e57d30a2023-10-04WarningsExact identifier
application number: M020
bareMinerals Original Foundation Broad Spectrum SPF 15 Golden Tan 20TITANIUM DIOXIDE AND ZINC OXIDEOrveon Global US LLC2f8b6c57-dcae-408e-898d-d5630deeb0902023-10-04WarningsExact identifier
application number: M020
bareMinerals Original Foundation Broad Spectrum SPF 15 Neutral Dark 24ZINC OXIDEOrveon Global US LLCbeaf1ff7-4942-4ba5-ba25-3287cc409e932023-10-04WarningsExact identifier
application number: M020

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
61481-3003-16148130030130 mL in 1 BOTTLE, SPRAY (61481-3003-1) 30 ml2017-06-010000-00-00NoNoCurrent
61481-3003-461481300304120 mL in 1 BOTTLE, SPRAY (61481-3003-4) 120 ml2017-06-010000-00-00NoNoCurrent