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

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 4 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
4Y5P7MUD51Internal UNII lookup
5A68WGF6WMInternal UNII lookup
4X49Y0596WInternal UNII lookup
G63QQF2NOXInternal UNII lookup

Harmonized SPL set identifiers#

SPL set identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
60e7ed8e-f421-4e08-97a8-af647200e4aeAvailable on FDA.report

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 239 of 346 · 6,912 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Sheglam Dew and Done Skin Tint with SPF 20 NudeZINC OXIDEEVER FAME PTE. LTD.2abd8527-72a5-1564-e063-6294a90ad8d32025-01-02WarningsExact identifier
application number: M020
Sheglam Dew and Done Skin Tint with SPF 20 NutmegZINC OXIDEEVER FAME PTE. LTD.2abdda5e-0f52-ae46-e063-6394a90ae6f52025-01-02WarningsExact identifier
application number: M020
Sheglam Dew and Done Skin Tint with SPF 20 PorcelainZINC OXIDEEVER FAME PTE. LTD.2abdddbc-d891-7c4d-e063-6294a90a81622025-01-02WarningsExact identifier
application number: M020
Sheglam Dew and Done Skin Tint with SPF 20 RussetZINC OXIDEEVER FAME PTE. LTD.2abe084b-7478-e923-e063-6394a90ac9412025-01-02WarningsExact identifier
application number: M020
Sheglam Dew and Done Skin Tint with SPF 20 PeachZINC OXIDEEVER FAME PTE. LTD.2abdca50-ffc4-8c36-e063-6394a90af7662025-01-02WarningsExact identifier
application number: M020
Tender Moments Baby Sunscreen Broad Spectrum SPF 50 Water Resistant (40 minutes)AVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENEDistribuidora Comercial Jafra, S.A. de C.V.c3bacceb-63a8-098c-e053-2995a90acd642025-01-02WarningsExact identifier
application number: M020
Sheer Daily Wear Face Protection Mineral Based Sunscreen SPF 16ZINC OXIDEREJUVA MINERALS INC3d83c220-1801-4193-b6a8-c777f412c1732025-01-02WarningsExact identifier
application number: M020
Sheglam Dew and Done Skin Tint with SPF 20 SaddleZINC OXIDEEVER FAME PTE. LTD.2abf69c5-07d7-252d-e063-6394a90a292b2025-01-02WarningsExact identifier
application number: M020
Sheglam Dew and Done Skin Tint with SPF 20 SandZINC OXIDEEVER FAME PTE. LTD.2abf7869-4418-7738-e063-6394a90ae89d2025-01-02WarningsExact identifier
application number: M020
Good Weather Skin The One Daily Sun SPF 30ZINC OXIDEGood Weather Inc.2ac30544-5ece-18ed-e063-6394a90a6a0d2025-01-02WarningsExact identifier
application number: M020
Exel Clarifying Line Daily Fluid Sun Shield white color Broad Spectrum SPF 60 plusOCTOCRYLENE, OCTINOXATE, OCTISALATE, TITANIUM DIOXIDE, ENSULIZOLEExelencia importers Corp.283c2780-5ad5-38f1-e063-6294a90ac3362025-01-01WarningsExact identifier
application number: M020
EXEL CLARIFYING LINE DAILY FLUID SUN SHIELD WHITE COLOR BROAD SPECTRUM SPF 60 PLUSOCTOCRYLENE, OCTINOXATE, OCTISALATE, TITANIUM DIOXIDE, ENSULIZOLEBiocosmetica Exel Argentina SRL2aabf782-65f9-e894-e063-6394a90a1ea32025-01-01WarningsExact identifier
application number: M020
EXEL CLARIFYING LINE DAILY FLUID SUN SHIELD WALNUT BROWN COLOR BROAD SPECTRUM SPF 60 PLUSOCTOCRYLENE, OCTINOXATE, OCTISALATE, TITANIUM DIOXIDE, ENSULIZOLEBiocosmetica Exel Argentina SRL2aad5b97-e64b-c678-e063-6294a90aa8c62025-01-01WarningsExact identifier
application number: M020
TIBENA ALWAYS REAL SUN BLOCK UV SPF 45AVOBENZONE, ETHYLHEXYL SALICYLATE, HOMOSALATE, OCTOCRYLENEKONAD CO LTD2aafbd33-710a-201e-e063-6294a90ab1bb2025-01-01WarningsExact identifier
application number: M020
THEFACESHOP Cushion CC SPF 50 Apricot Beige Oil-FreeENSULIZOLE, TITANIUM DIOXIDEfmg Co.Ltdd30ac897-3a30-7bba-e053-2995a90ac3422025-01-01WarningsExact identifier
application number: M020
THEFACESHOP Cushion CC Total Cover SPF 50 Apricot BeigeENSULIZOLE, TITANIUM DIOXIDEfmg Co.Ltdd30b0588-b0f4-39a8-e053-2a95a90abb352025-01-01WarningsExact identifier
application number: M020
THEFACESHOP Cushion CC SPF 50 Natural Beige Oil-FreeENSULIZOLE, TITANIUM DIOXIDEfmg Co.Ltdd30aeaa6-3423-401c-e053-2a95a90a8fe92025-01-01WarningsExact identifier
application number: M020
THEFACESHOP Cushion CC Total Cover SPF 50 Natural BeigeENSULIZOLE, TITANIUM DIOXIDEfmg Co.Ltdd30afd94-8bcd-01bc-e053-2a95a90afb492025-01-01WarningsExact identifier
application number: M020
THEFACESHOP Natural Sun Oil-Free Sunscreen Broad Spectrum SPF 50ENSULIZOLE, OCTINOXATE, OCTISALATE, TITANIUM DIOXIDE, ZINC OXIDEfmg Co.Ltdd30b156a-b9b1-499b-e053-2a95a90ada6a2025-01-01WarningsExact identifier
application number: M020
THEFACESHOP Natural Sun Long Lasting Sunscreen Broad Spectrum SPF 50ENSULIZOLE, OCTINOXATE, OCTISALATE, TITANIUM DIOXIDE, ZINC OXIDEfmg Co.Ltdd30b183d-a54d-752c-e053-2a95a90a24fc2025-01-01WarningsExact 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