FDA.reportPublic FDA data

TOCOBO Bio Watery Sun Screen

Product NDC
85287-041
11-digit product format
852870041
Labeler code
85287
Product ID
85287-041_3dc7cede-9771-9373-e063-6394a90ad331
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
2025-07-22
Substance
OCTISALATE; AVOBENZONE; OCTOCRYLENE; HOMOSALATE
Active strength
.45; .27; .9; 1.35 g/10mL; g/10mL; g/10mL; g/10mL
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
OCTISALATE.45 g/10mL
AVOBENZONE.27 g/10mL
OCTOCRYLENE.9 g/10mL
HOMOSALATE1.35 g/10mL

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 4 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
4X49Y0596WInternal UNII lookup
G63QQF2NOXInternal UNII lookup
5A68WGF6WMInternal UNII lookup
V06SV4M95SInternal UNII lookup

Harmonized SPL set identifiers#

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

Identifier, FDA.report destination table
IdentifierFDA.report destination
3a7db6f4-66fd-4473-e063-6394a90a886eAvailable 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
85287-041-01TOCOBO Bio Watery Sun Screen10 mL in 1 BOTTLE, PLASTICCREAM102
85287-041-02TOCOBO Bio Watery Sun Screen1 in 1 BOXCREAM12

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 98 of 354 · 7,077 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Eucerin Daily HydrationAVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENEBeiersdorf Inc798cbf7f-b93d-49c8-b1c1-216486e57ea52025-12-31WarningsExact identifier
application number: M020
Eucerin Face immersive HydrationAVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENEBeiersdorf Incfe0b3717-f472-3a61-e053-6394a90a44fb2025-12-31WarningsExact identifier
application number: M020
NIVEA MEN Age Defense Face MoisturizerAVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENEBeiersdorf Inc27cbec3e-e811-6498-e063-6394a90ada492025-12-31WarningsExact identifier
application number: M020
Nivea Men Maximum Hydration FaceAVOBENZONE, OCTISALATE, OCTOCRYLENEBeiersdorf Incf1276b11-6683-e982-e053-2a95a90a78032025-12-31WarningsExact identifier
application number: M020
Nivea Men Sensitive ProtectiveAVOBENZONE, OCTISALATE, OCTOCRYLENEBeiersdorf Incf6cff3d1-cca5-4b3e-a481-0c4def90684c2025-12-31WarningsExact identifier
application number: M020
Nivea Smoothness Lip CareAVOBENZONE,OCTOCRYLENEBeiersdorf Incc28e327d-ad39-9bd6-e053-2a95a90a04eb2025-12-31WarningsExact identifier
application number: M020
BOTANICAL SOOTHING SPF-30OCTINOXATE, OCTISALATE, ZINC OXIDECONTROL CORRECTIVE SKINCARE INC00a923fe-e6da-420e-a705-4773ecc2176b2025-12-31WarningsExact identifier
application number: M020
AROMA MATTE DAY SUNSCREEN SPF-30OCTINOXATE, OCTISALATE, ZINC OXIDECONTROL CORRECTIVE SKINCARE INCf822f3ec-3c57-100a-e053-6294a90ab0ec2025-12-31WarningsExact identifier
application number: M020
CONTROL CORRECTIVE TINTED MOISTURIZER SPF-30 SUNSCREENTITANIUM DIOXIDE, ZINC OXIDECONTROL CORRECTIVE SKINCARE INC8ac09149-f7e7-40a8-b306-98964d0cd6e32025-12-31WarningsExact identifier
application number: M020
CONTROL CORRECTIVE SUNSCREEN SPF-30OCTINOXATE, OCTISALATE, ZINC OXIDECONTROL CORRECTIVE SKINCARE INCe389b2bc-bb1c-443a-9bf6-c6d96380f3782025-12-31WarningsExact identifier
application number: M020
CONTROL CORRECTIVE INTENSIVE SKIN BRIGHTENING SPF-30 SUNSCREENOCTINOXATE, OCTISALATE, ZINC OXIDECONTROL CORRECTIVE SKINCARE INC61b6dab9-3378-4206-bf1f-6f385a9c882c2025-12-31WarningsExact identifier
application number: M020
Blue Lizard Sensitive SPF 50 SunscreenTITANIUM DIOXIDE AND ZINC OXIDECrown Laboratories32d78048-d281-1d80-e063-6394a90aec192025-12-31WarningsExact identifier
application number: M020
DAYWEAR ANTI OXIDANT 72H-HYDRATION SORBET CREME BROAD SPECTRUM SPF 15AVOBENZONE, HOMOSALATE, OCTISALATE, AND OCTOCRYLENEESTEE LAUDER INCdf535004-c94c-4a28-ad20-78bd1741e39f2025-12-31WarningsExact identifier
application number: M020
FUTURIST SKIN TINT SERUMOCTINOXATE,OCTISALATE,ZINC OXIDEESTEE LAUDER INCea21e5a5-69d6-2de4-e053-2995a90a93b42025-12-31WarningsExact identifier
application number: M020
Dr.Jart Cicapair Tiger Grass Color Correcting TreatmentZINC OXIDE, TITANIUM DIOXIDEHave & Be Co., Ltd.40f96baf-0359-4d68-801f-68562c9094462025-12-31WarningsExact identifier
application number: M020
Dr.Jart Premium Beauty Balm Fair-LightZINC OXIDE, TITANIUM DIOXIDE, OCTINOXATE, OCTISALATEHave & Be Co., Ltd.b38b1b64-b433-4e11-9cf6-2108a552d1392025-12-31WarningsExact identifier
application number: M020
Dr.Jart Premium Beauty Balm Light Medium-MediumZINC OXIDE, TITANIUM DIOXIDE, OCTINOXATE, OCTISALATEHave & Be Co., Ltd.45b1c2c6-a45b-4a45-bec9-e5341079c0a12025-12-31WarningsExact identifier
application number: M020
Dr.Jart Premium Beauty Balm Medium-TanZINC OXIDE, TITANIUM DIOXIDE, OCTINOXATE, OCTISALATEHave & Be Co., Ltd.28a2ba45-1eff-488c-aae4-362b9f78b8df2025-12-31WarningsExact identifier
application number: M020
Dr.Jart Premium Beauty Balm Deep Tan-DeepZINC OXIDE, TITANIUM DIOXIDE, OCTINOXATE, OCTISALATEHave & Be Co., Ltd.3c346960-b76b-4241-a188-8ee6948530782025-12-31WarningsExact identifier
application number: M020
DR.JART CICAPAIR TIGER GRASS CAMO DROPSZINC OXIDE, TITANIUM DIOXIDEHave & Be Co., Ltd.f06348f5-4ebc-325b-e053-2a95a90ada522025-12-31WarningsExact identifier
application number: M020

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
85287-041-018528700410110 mL in 1 BOTTLE, PLASTIC10 mlHistorical
85287-041-02852870041021 BOTTLE, PLASTIC in 1 BOX (85287-041-02) / 10 mL in 1 BOTTLE, PLASTIC (85287-041-01) 2025-07-22NoNoCurrent