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 248 of 346 · 6,912 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Buildable BlurHOMOSALATE, OCTISALATE, ZINC OXIDECOSMAX USA, CORPORATION06b1f8bc-8b2b-451a-e063-6294a90a34bd2024-12-25WarningsExact identifier
application number: M020
Buildable BlurHOMOSALATE, OCTISALATE, ZINC OXIDECOSMAX USA, CORPORATION06b26dd0-44cb-91a7-e063-6394a90a603a2024-12-25WarningsExact identifier
application number: M020
Buildable BlurHOMOSALATE, OCTISALATE, ZINC OXIDECOSMAX USA, CORPORATION06b2b996-e02c-e40a-e063-6394a90aa0d92024-12-25WarningsExact identifier
application number: M020
Buildable BlurHOMOSALATE, OCTISALATE, ZINC OXIDECOSMAX USA, CORPORATION06c5efde-42e1-e4fc-e063-6394a90a491d2024-12-25WarningsExact identifier
application number: M020
Buildable BlurHOMOSALATE, OCTISALATE, ZINC OXIDECOSMAX USA, CORPORATION06c5efde-42d0-e4fc-e063-6394a90a491d2024-12-25WarningsExact identifier
application number: M020
Buildable BlurHOMOSALATE, OCTISALATE, ZINC OXIDECOSMAX USA, CORPORATION06c61c42-edc9-1ebd-e063-6294a90aee132024-12-25WarningsExact identifier
application number: M020
Invisible Sunscreen SPF 40HOMOSALATE, OCTISALATE, AVOBENZONE, OCTOCRYLENECOSMAX USA, CORPORATION29fe531e-2ade-170f-e063-6394a90a13962024-12-24WarningsExact identifier
application number: M020
SOLAR MILK SPF50AVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENECOSMAX USA, CORPORATION29fe4dad-d1fb-e750-e063-6294a90ab3072024-12-24WarningsExact identifier
application number: M020
CHANTECAILLE Ultra Sun Protection Sunscreen Broad Spectrum SPF 45AVOBENZONE, OCTINOXATE, OCTISALATE, OCTOCRYLENEChantecaille Beaute Incd30cc344-846d-416e-ac57-4a29d4ed82632024-12-24WarningsExact identifier
application number: M020
Almay Age Smart Shade CC Luminous Primer SPF 15ZINC OXIDE, TITANIUM DIOXIDE MAKE-UPAlmay, Inc.281557c0-e668-4436-86a7-3f583091e4e42024-12-24WarningsExact identifier
application number: M020
EIGHT HOUR LIP PROTECTANT SPF 15PETROLATUM, OXYBENZONE, OCTINOXATE, AVOBENZONEREVLON2a0ac6aa-0315-d79e-e063-6294a90a9c532024-12-24WarningsExact identifier
application number: M020
RV Illuminance Serum Tint Broad Spectrum 15 AmberFACE FOUNDATION WITH SPFREVLON CONSUMER PR Consumer Products Corp2a0b311f-9dcc-9b26-e063-6394a90a29a82024-12-24WarningsExact identifier
application number: M020
RV Illuminance Serum Tint Broad Spectrum 15 Buff BeigeFACE FOUNDATION WITH SPFREVLON CONSUMER PR Consumer Products Corp2a0b3b8b-d38b-cd4d-e063-6294a90a919a2024-12-24WarningsExact identifier
application number: M020
RV Illuminance Serum Tint Broad Spectrum 15 HazelFACE FOUNDATION WITH SPFREVLON CONSUMER PR Consumer Products Corp2a0b3b8b-d38c-cd4d-e063-6294a90a919a2024-12-24WarningsExact identifier
application number: M020
RV Illuminance Serum Tint Broad Spectrum 15 Cool BeigeFACE FOUNDATION WITH SPFREVLON CONSUMER PR Consumer Products Corp2a0b48b8-5953-9ab7-e063-6394a90a6b242024-12-24WarningsExact identifier
application number: M020
RV Illuminance Serum Tint Broad Spectrum 15 Creamy NaturalFACE FOUNDATION WITH SPFREVLON CONSUMER PR Consumer Products Corp2a0b311f-9dcd-9b26-e063-6394a90a29a82024-12-24WarningsExact identifier
application number: M020
RV Illuminance Serum Tint Broad Spectrum 15 Rich MahoganyFACE FOUNDATION WITH SPFREVLON CONSUMER PR Consumer Products Corp2a0b6b99-883b-ffd4-e063-6294a90a7f4b2024-12-24WarningsExact identifier
application number: M020
RV Illuminance Serum Tint Broad Spectrum 15 Light TanFACE FOUNDATION WITH SPFREVLON CONSUMER PR Consumer Products Corp2a0b557a-ff60-f33f-e063-6394a90ac66f2024-12-24WarningsExact identifier
application number: M020
RV Illuminance Serum Tint Broad Spectrum 15 Light BeigeFACE FOUNDATION WITH SPFREVLON CONSUMER PR Consumer Products Corp2a0b6b99-8839-ffd4-e063-6294a90a7f4b2024-12-24WarningsExact identifier
application number: M020
RV Illuminance Serum Tint Broad Spectrum 15 Light NaturalFACE FOUNDATION WITH SPFREVLON CONSUMER PR Consumer Products Corp2a0b668d-036e-893e-e063-6294a90a82af2024-12-24WarningsExact 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