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 133 of 357 · 7,139 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Tinted Mineral Matte CE SunscreenTITANIUM DIOXIDE, ZINC OXIDEThe Maui Medical Group, Inc34b72d14-b69b-e9dd-e063-6394a90a748e2025-12-11Exact identifier
application number: M020
Tinted Mineral SunscreenTITANIUM DIOXIDE, ZINC OXIDESCIENCE CEUTICALS, LLC369b20e2-2cad-e047-e063-6294a90a1bba2025-12-11Exact identifier
application number: M020
Tinted Mineral Matte CE SunscreenTITANIUM DIOXIDE, ZINC OXIDEThe Maui Medical Group, Inc34b60880-5fe1-b78f-e063-6294a90a748d2025-12-11Exact identifier
application number: M020
Sheer Mineral SunscreenTITANIUM DIOXIDE, ZINC OXIDEThe Maui Medical Group, Inc34b51190-6a6d-c5e0-e063-6394a90ae8752025-12-11Exact identifier
application number: M020
Tinted Ultra Zinc Face and BodyZINC OXIDELIV BODY AND BEAUTY LLC374fae34-41b9-4cab-e063-6394a90a9b1d2025-12-11Exact identifier
application number: M020
Z BlocZINC OXIDEThe Maui Medical Group, Inc34b64eb5-a91f-de43-e063-6294a90a80432025-12-11Exact identifier
application number: M020
Sheer Tinted Sunscreen StickTITANIUM DIOXIDE, ZINC OXIDEThe Maui Medical Group, Inc34b6e8d0-6235-dac2-e063-6394a90afefd2025-12-11Exact identifier
application number: M020
Tinted Sunscreen Face PrimerTITANIUM DIOXIDE, ZINC OXIDELIV BODY AND BEAUTY374f6b79-2ac4-61cf-e063-6394a90a699b2025-12-11Exact identifier
application number: M020
Non Tinted Ultra Zinc Face and BodyZINC OXIDELIV BODY AND BEAUTY LLC375008f2-8dd4-aa31-e063-6394a90a5be82025-12-11Exact identifier
application number: M020
Replenishing Daily ProtectionZINC OXIDEThe Maui Medical Group, Inc34b96d82-7fcf-e452-e063-6394a90a781b2025-12-11Exact identifier
application number: M020
Daily Sun DefenseTITANIUM DIOXIDE, ZINC OXIDELIV BODY AND BEAUTY LLC3750c2fd-c5cc-fd00-e063-6394a90aeb892025-12-11Exact identifier
application number: M020
Non Tinted Ultra Zinc Face and BodyZINC OXIDELIV BODY AND BEAUTY LLC3750ffbf-a82d-b4b9-e063-6294a90a7d682025-12-11Exact identifier
application number: M020
The BlockZINC OXIDEELITE ESTHETICS BY NICOLE CAROLINE LLC34a6b17e-6e9e-3f2c-e063-6294a90a1c322025-12-11Exact identifier
application number: M020
SPF 40 Broad Spectrum Non-TintedZINC OXIDETeton Dermatology Holdings, Inc.35093797-008b-b265-e063-6294a90a99492025-12-11Exact identifier
application number: M020
Tinted Zinc ProtectionZINC OXIDETeton Dermatology Holdings, Inc.3508d5a8-9d3c-51d1-e063-6394a90abc8e2025-12-11Exact identifier
application number: M020
SPF 40 Broad SpectrumTITANIUM DIOXIDE, ZINC OXIDETeton Dermatology Holdings, Inc.35081ce0-2203-ab86-e063-6294a90aefd52025-12-11Exact identifier
application number: M020
Antioxidant SPFZINC OXIDETeton Dermatology Holdings, Inc.3509a916-f3e1-9c53-e063-6394a90a5bff2025-12-11Exact identifier
application number: M020
Ultimate Physical Sunscreen TintedZINC OXIDEHALEM DERMATOLOGY PLLC35bb4953-ca8c-e927-e063-6394a90a1a312025-12-11Exact identifier
application number: M020
Lip ProtectionTITANIUM DIOXIDE, ZINC OXIDETeton Dermatology Holdings, Inc.3509eea7-f966-2080-e063-6294a90aeeb52025-12-11Exact identifier
application number: M020
Mineral Lip SunscreenTITANIUM DIOXIDE, ZINC OXIDEHALEM DERMATOLOGY PLLC35bce44e-d9f4-9279-e063-6394a90a64532025-12-11Exact 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