FDA.reportPublic FDA data

TOCOBO Bio Watery Sun Screen

Product NDC
85287-040
11-digit product format
852870040
Labeler code
85287
Product ID
85287-040_3dc7d053-c02d-8e36-e063-6394a90a8ace
Type
HUMAN OTC DRUG
Nonproprietary name
Avobenzone, Homosalate, Octisalate, Octocrylene
Dosage form
CREAM
Route
TOPICAL
Labeler
PICTON CO., Ltd.
Application
M020
Marketing category
OTC MONOGRAPH DRUG
Marketing start
2025-03-12
Substance
OCTISALATE; OCTOCRYLENE; HOMOSALATE; AVOBENZONE
Active strength
1.8; 3.6; 5.4; 1.08 g/40mL; g/40mL; g/40mL; g/40mL
NDC exclude flag
No
Listing certified through
2026-12-31
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
TOCOBO Bio Watery Sun Screen
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
OCTISALATE1.8 g/40mL
OCTOCRYLENE3.6 g/40mL
HOMOSALATE5.4 g/40mL
AVOBENZONE1.08 g/40mL

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 4 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
4X49Y0596WInternal UNII lookup
5A68WGF6WMInternal UNII lookup
V06SV4M95SInternal 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
2f7eb413-ff49-711d-e063-6394a90ad6dcAvailable on FDA.report

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
77dc03a4-fbfc-e6a3-fe95-285bbae40d75Product name220250814

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
85287-040-01TOCOBO Bio Watery Sun Screen40 mL in 1 BOTTLE, PLASTICCREAM402
85287-040-02TOCOBO Bio Watery Sun Screen1 in 1 BOXCREAM12

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
85287-040TOCOBO BIO WATERY SUN SCREEN (AVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENE) CREAM [PICTON CO., LTD.]1Current NDC, 2 package rows20250315_2f7eb413-ff49-711d-e063-6394a90ad6dc.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 62 of 357 · 7,139 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
e.l.f. Wake the E.L.F. Up Skincare SetAVOBENZONE, OCTISALATE, OCTOCRYLENE, HOMOSALATEe.l.f. Cosmetics, Inc4b20c56a-3e91-3419-e063-6294a90ad3612026-02-18WarningsExact identifier
application number: M020
Dermatone Mineral SPF 30ZINC OXIDE 20%Dermatone Labs LLC26e3209f-cb5c-484e-9b2e-74dc397d47902026-02-18WarningsExact identifier
application number: M020
SHISEIDO ESSENTIAL ENERGY HYDRATING DAYHOMOSALATE, OCTOCRYLENE, OCTISALATE, AND AVOBENZONESHISEIDO AMERICAS CORPORATION8b88039a-09fe-458b-b80f-49cde49b65952026-02-17WarningsExact identifier
application number: M020
cle de peau BEAUTE SYNACTIF DAYTIME MOISTURIZER ENRICHED nAVOBENZONE, OCTINOXATE, AND OCTOCRYLENESHISEIDO AMERICAS CORPORATIONf3729d0b-e601-48bb-9907-1d6e3ab319962026-02-17WarningsExact identifier
application number: M020
Luminesce Daily Moisturizing ComplexAVOBENZONE, OCTINOXATE, OCTISALATE, OCTOCRYLENEVelovita Inc.4b0c2213-8667-be6f-e063-6394a90a5e862026-02-17WarningsExact identifier
application number: M020
Sport Sunscreen SPF 30AVOBENZONE, HOMOSALATE, OCTISALATEValu Merchandisers Companye168f8e8-22d0-4a60-b9f9-dec9d0fab3f12026-02-16Warnings, Adverse reactionsExact identifier
application number: M020
Sunscreen for Kids SPF 50AVOBENZONE, HOMOSALATE, OCTISALATEValu Merchandisers Companycfc3b202-6511-450a-b3c1-2d8e8ebc070d2026-02-16Warnings, Adverse reactionsExact identifier
application number: M020
Sport Sunscreen SPF 70AVOBENZONE, HOMOSALATE, OCTISALATEValu Merchandisers Company5a8af0ea-b31c-456a-bc23-31e2473ca75a2026-02-16Warnings, Adverse reactionsExact identifier
application number: M020
Sparms 100% Organic Face SunscreenZINC OXIDE SUNSCREENVEGANIC SKN LIMITED4ae6b187-142b-e4a6-e063-6294a90af3652026-02-15WarningsExact identifier
application number: M020
Lotus Harmony - Quinn Shield Sunscreen SPF50ZINC OXIDE SUNSCREENVEGANIC SKN LIMITED4ae73d23-1118-716c-e063-6394a90a68c72026-02-15WarningsExact identifier
application number: M020
Avebonzone, Homosalate, OctisalateAVEBONZONE, HOMOSALATE, OCTISALATEAmazon.com Services LLC4ab542aa-bd05-ba7a-e063-6294a90ae5842026-02-13Warnings, Adverse reactionsExact identifier
application number: M020
Beauty HydratingHOMOSALATE, ZINC OXIDETopco Associates LLC6e88ccc8-8576-4573-8a5b-28e64008a3492026-02-13Warnings, Adverse reactionsExact identifier
application number: M020
Wotnot Naturals Natural Zinc Sunscreen SPF 30ZINC OXIDEECOdirect Pty Ltd (Trading as Wotnot Naturals)4ab759ae-0c1c-bddc-e063-6394a90a1d092026-02-13WarningsExact identifier
application number: M020
Wotnot Naturals Natural Zinc Sunscreen SPF 30ZINC OXIDEECOdirect Pty Ltd (Trading as Wotnot Naturals)4ab83b34-9376-d169-e063-6394a90a18cd2026-02-13WarningsExact identifier
application number: M020
Homosalate, Octisalate, Zinc oxideHOMOSALATE, OCTISALATE, ZINC OXIDETopco Associates LLC48fb9a3c-c058-ce71-e063-6294a90aaf1e2026-02-13Warnings, Adverse reactionsExact identifier
application number: M020
Ambi Even and Clear Facial MoisturizerHOMOSALATE 15%, OCTISALATE 5%, OCTOCRYLENE 3%, AVOBENZONE 3%73453-112469440e9-bf47-bebd-e063-6294a90acca22026-02-12WarningsExact identifier
application number: M020
Intelligent Defense Mineral SunscreenZINC OXIDEGLO PHARMA4ab664aa-5f0c-7ddb-e063-6294a90a97532026-02-12WarningsExact identifier
application number: M020
Sky and Sol Sports SunscreenZINC OXIDEDelta Ecommerce LLC4dd054cd-8f53-4210-e063-6394a90ade272026-02-12WarningsExact identifier
application number: M020
Sky and Sol Kids and Babies SunscreenZINC OXIDEDelta Ecommerce LLC4de67653-ab31-c6b2-e063-6394a90a7e8c2026-02-12WarningsExact identifier
application number: M020
Eva Claire Natural Professional SunscreenAVOBENZONE, HOMOSALATE, OCTOCRYLENE, OCTISALATEEva Claire Cosmetics Co., Ltd.4a870452-cac2-4d2c-e063-6294a90abb072026-02-11WarningsExact identifier
application number: M020

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
85287-040-018528700400140 mL in 1 BOTTLE, PLASTIC40 mlHistorical
85287-040-02852870040021 BOTTLE, PLASTIC in 1 BOX (85287-040-02) / 40 mL in 1 BOTTLE, PLASTIC (85287-040-01) 2025-03-12NoNoCurrent