FDA.reportPublic FDA data

Kinesys

Product NDC
61481-3002
11-digit product format
614813002
Labeler code
61481
Product ID
61481-3002_5dcf370f-0457-09c4-e063-6394a90af9e7
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 Kids Alcohol-Free Sunscreen
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
61481-3002-1KinesysBroad Spectrum SPF 30 Kids Alcohol-Free Sunscreen30 mL in 1 BOTTLE, SPRAYSPRAY306
61481-3002-4KinesysBroad Spectrum SPF 30 Kids Alcohol-Free Sunscreen120 mL in 1 BOTTLE, SPRAYSPRAY1206

DailyMed Socrata Ingredients#

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

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
61481-3002KINESYS BROAD SPECTRUM SPF 30 KIDS ALCOHOL-FREE SUNSCREEN (OCTINOXATE, OCTOCRYLENE, OCTISALATE, AND AVOBENZONE) SPRAY [WILC HEALTHCARE INC]5Current NDC, Legacy NDC, 2 package rows20241101_9adea1a4-efa6-4fe1-85e8-ed69fa098a87.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 88 of 353 · 7,041 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Drs. pharmacy sunscreen SPF 30 (Physical Filters)SUNSCREEN SPF 30OL PHARMA TECH LLC. (Drs. Pharmacy)315a5b1f-9dc2-a243-e063-6394a90a5e082026-01-06WarningsExact identifier
application number: M020
SHISEIDO ULTIMATE SUN PROTECTORAVOBENZONE, HOMOSALATE, OCTISALATE, AND OCTOCRYLENESHISEIDO AMERICAS CORPORATION51f759b7-8c49-41d4-aaa3-f901d599cac52026-01-06WarningsExact identifier
application number: M020
cle de peau BEAUTE SYNACTIF DAYTIME MOISTURIZER ENRICHED n (Refill)AVOBENZONE, OCTINOXATE, AND OCTOCRYLENESHISEIDO AMERICAS CORPORATION463dc557-9743-4a38-969e-2c78fc10ee2a2026-01-06WarningsExact identifier
application number: M020
CLE DE PEAU BEAUTE PROTECTIVE FORTIFYING nAVOBENZONE, OCTINOXATE, OCTOCRYLENE, AND OXYBENZONESHISEIDO AMERICAS CORPORATION23bb4225-bfb5-47e2-80fe-733761ba40692026-01-06WarningsExact identifier
application number: M020
SHISEIDO WHITE LUCENT DAYAVOBENZONE, OCTINOXATE, AND OCTOCRYLENESHISEIDO AMERICAS CORPORATIONe881e637-e0f0-4c90-8343-2be6e74020b82026-01-06WarningsExact identifier
application number: M020
Hawaiian Tropic Lip Balm Sunscreen SPF 30AVOBENZONE,OCTISALATE,OCTOCRYLENEEdgewell Personal Care Brands LLCc7b71be3-f906-bd09-e053-2995a90adc612026-01-06WarningsExact identifier
application number: M020
SHISEIDO BENEFIANCE WRINKLERESIST24 DAYAVOBENZONE, OCTINOXATE, AND OCTOCRYLENESHISEIDO AMERICAS CORPORATIONd308d578-c881-4c10-8c79-9e3cd58b694c2026-01-06WarningsExact identifier
application number: M020
Coppertone Sport Sunscreen Lip Balm SPF 30AVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENE,Beiersdorf Inc47bc6776-1130-0162-e063-6294a90a2adc2026-01-06WarningsExact identifier
application number: M020
HAWAIIAN TROPICAVOBENZONE,HOMOSALATE,OCTISALATE,OCTOCRYLENEEdgewell Personal Care Brands LLC088fa3cd-b9b8-d10b-e063-6394a90a7fd62026-01-06WarningsExact identifier
application number: M020
SPF 50 Florida Sun Defense Broad Spectrum SPF 50 Sunscreen Body OilHOMOSALATE, OCTISALATE, OCTOCRYLENENaples Soap Company, Inc.47c147a9-c4f4-ab82-e063-6394a90aaa5c2026-01-06WarningsExact identifier
application number: M020
PoutScreen Lip Treatment Love LetterAVOBENZONE, OCTINOXATE, OCTOCRYLENENAKED SUNDAYS PTY LTD47d22c6d-49fd-f97c-e063-6294a90a6ba12026-01-06WarningsExact identifier
application number: M020
Moisturizing Antioxidant SPF 50OCTINOXATE, OCTISALATE, HOMOSALATE, OXYBENZONE, ZINC OXIDETopiderm, Inc.727c14d3-ad26-4e8b-91f6-b7a5f07e4e2f2026-01-05WarningsExact identifier
application number: M020
EVERYRAY SUNCARE SUNSHINE SERUMEVERYRAY SUNCARE SUNSHINE SERUMGuangzhou Fantesy Biotechnology Co.,Ltd062be336-2af4-10e2-e063-6294a90a480a2026-01-05WarningsExact identifier
application number: M020
sunscreen powderSUNSCREEN POWDERGuangzhou Fantesy Biotechnology Co.,Ltdfae8ecaf-7a9c-902b-e053-6394a90a5f312026-01-05WarningsExact identifier
application number: M020
ORLASKIN HYDRATING SUNSCREENORLASKIN HYDRATING SUNSCREENGuangzhou Fantesy Biotechnology Co.,Ltd0808b0cd-2cfb-8554-e063-6294a90ad6c42026-01-05WarningsExact identifier
application number: M020
DALLAS JAMES SKINCARE CO. SPF 50 SunscreenDALLAS JAMES SKINCARE CO. SPF 50 SUNSCREENGuangzhou Fantesy Biotechnology Co.,Ltd225faeec-4f96-e082-e063-6394a90a9a312026-01-05WarningsExact identifier
application number: M020
LING NEW YORK Save Face Broad Spectrum SPF 30LING NEW YORK SAVE FACE BROAD SPECTRUM SPF 30Guangzhou Fantesy Biotechnology Co.,Ltd1dfa80bd-495a-18fb-e063-6394a90a4d0d2026-01-05WarningsExact identifier
application number: M020
Sky and Sol Sunscreen SPF30SKY AND SOL SUNSCREEN SPF30Guangzhou Fantesy Biotechnology Co.,Ltd1d917329-dea2-e792-e063-6294a90a0a0d2026-01-05WarningsExact identifier
application number: M020
Sky and Sol Sunscreen SPF50SKY AND SOL SUNSCREEN SPF50Guangzhou Fantesy Biotechnology Co.,Ltd1c699b06-c156-b0da-e063-6294a90a947d2026-01-05WarningsExact identifier
application number: M020
HAWAIIAN TROPICAVOBENZONE,HOMOSALATE,OCTISALATE,OCTOCRYLENEEdgewell Personal Care Brands LLC228fab45-e0d2-f219-e063-6294a90a1ef62026-01-05WarningsExact identifier
application number: M020

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
61481-3002-16148130020130 mL in 1 BOTTLE, SPRAY (61481-3002-1) 30 ml2017-06-010000-00-00NoNoCurrent
61481-3002-461481300204120 mL in 1 BOTTLE, SPRAY (61481-3002-4) 120 ml2017-06-010000-00-00NoNoCurrent