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 250 of 346 · 6,912 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Walgreens SPF 50 HydratingAVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENEWALGREEN COMPANYf347588d-8225-45a7-e053-2995a90ab6882024-12-22WarningsExact identifier
application number: M020
Mineral SunstickZINC SPF STICKTubby Todd29e41fe8-4e17-dbaa-e063-6294a90a4a102024-12-22WarningsExact identifier
application number: M020
Mineral SunscreenZINC OXIDE SPF 50Tubby Todd29e487da-5312-8192-e063-6294a90ad8092024-12-22WarningsExact identifier
application number: M020
EcoStick Sunscreen SPF 35ZINC OXIDE, TITANIUM DIOXIDEStream2Sea, LLCeba17b7a-5e96-4462-9b71-44c2bc577dce2024-12-21WarningsExact identifier
application number: M020
Planet Protecting Sunscreen 30TITANIUM DIOXIDEStream2Sea, LLC89e44c5f-121e-4fdd-b9e0-023909ea32f52024-12-21WarningsExact identifier
application number: M020
BABYGANICS SPF 50 Plus SUNSCREENZINC OXIDE, OCTISALATE, AND OCTOCRYLENEKAS Direct LLC dba Babyganics4075f9dc-c25f-434f-a3fc-a7f896295c3d2024-12-20WarningsExact identifier
application number: M020
SunscreenHOMOSALATE, OCTINOXATE, OCTISALATE, OXYBENZONETotal Resources International7d4f820d-e154-428e-89c2-2e26e088ceef2024-12-20WarningsExact identifier
application number: M020
Babyganics Sheer Blend SPF50 Mineral SunscreenZINC OXIDEKAS Direct LLC dba BabyGanicsedced0dc-dd43-4ac9-b816-f4edb45fc87b2024-12-20WarningsExact identifier
application number: M020
NARS Radiance Primer Broad Spectrum SPF 35 SunscreenOCTISALATE, OCTOCRYLENE, AVOBENZONE, HOMOSALATECOSMAX USA, CORPORATION29ad7391-d932-3549-e063-6394a90ab2b22024-12-20WarningsExact identifier
application number: M020
Face Reality daily spf 30 plus Sunscreen SPF 30HOMOSALATE, OCTISALATE, AVOBENZONEFace Reality,LLC45a3ce12-15fe-4040-95da-ac8513a39fb92024-12-20WarningsExact identifier
application number: M020
Face Reality mineral matte spf 28 Sunscreen SPF 28ZINC OXIDE, TITANIUM DIOXIDEFace Reality, LLC29b70afe-cf9d-d0ba-e063-6394a90a1cc42024-12-20WarningsExact identifier
application number: M020
Sonage Roux Tinted Day Creme with SPF 30 Sheer Tinted MoisturizerZINC OXIDEASA Universal Inc. dba: Sonagefd14d70c-6cd0-5de6-e053-6294a90a7add2024-12-20WarningsExact identifier
application number: M020
Coola SPF 50 ClassicSUNSCREEN FACE MISTCOOLA LLCd18d0dac-5690-436e-e053-2995a90a02542024-12-20WarningsExact identifier
application number: M020
COOLA Mineral Body SPF 30 Tropical CoconutZINC OXIDECOOLA, LLCeeb5d4f1-8cba-9ef6-e053-2a95a90a823f2024-12-20WarningsExact identifier
application number: M020
Oars and Alps SPF 50 100% Mineral Antioxidant SunscreenTITANIUM DIOXIDE, ZINC OXIDEOars and Alps LLCf3971b85-a13e-4195-e053-2995a90a73cb2024-12-20WarningsExact identifier
application number: M020
Vacation SPF 30 MineralZINC OXIDEVacation Inc.f69513ae-f210-075f-e053-2a95a90a9b2e2024-12-20WarningsExact identifier
application number: M020
Vacation SPF 30 Chardonnay OilAVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENEVacation Inc.f694752d-4839-3768-e053-2995a90a5d3e2024-12-20WarningsExact identifier
application number: M020
Oars and Alps SPF 50 Hydrating Antioxidant SunscreenSprayAVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENEOars and Alps LLCec5b82f5-b36c-fbc5-e053-2995a90afa0c2024-12-20WarningsExact identifier
application number: M020
Oars and Alps SPF 70 Hydrating Antioxidant SunscreenAVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENEOars and Alps LLCf39673a7-0b62-bdf7-e053-2995a90aa2b72024-12-20WarningsExact identifier
application number: M020
Carpe SPF 30 Face PrimerTITANIUM DIOXIDE, ZINC OXIDEClutch, Inc. DBA Carpefeac5ee2-faa5-fd17-e053-6394a90a7f992024-12-20WarningsExact 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