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 160 of 354 · 7,077 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
AGE20S SIGNATURE ESSENCE PACT INTENSE COVER MINI 27WOCTINOXATE, OCTOCRYLENE, TITANIUM DIOXIDEAekyung Industrial Co., Ltd.43c6252f-56b8-9e3c-e063-6294a90aa12c2025-11-17WarningsExact identifier
application number: M020
AGE20S SIGNATURE ESSENCE PACT INTENSE COVER MINI 28NOCTINOXATE, OCTOCRYLENE, TITANIUM DIOXIDEAekyung Industrial Co., Ltd.43c62e80-9ace-c1f2-e063-6294a90a5bfa2025-11-17WarningsExact identifier
application number: M020
AGE20S SIGNATURE ESSENCE PACT INTENSE COVER MINI 29WOCTINOXATE, OCTOCRYLENE, TITANIUM DIOXIDEAekyung Industrial Co., Ltd.43c6864c-bc8e-e900-e063-6294a90a7a142025-11-17WarningsExact identifier
application number: M020
AGE20S SIGNATURE ESSENCE PACT INTENSE COVER MINI 31NOCTINOXATE, OCTOCRYLENE, TITANIUM DIOXIDEAekyung Industrial Co., Ltd.43c77b48-18fb-3efe-e063-6294a90ade4b2025-11-17WarningsExact identifier
application number: M020
AGE20S SIGNATURE ESSENCE PACT INTENSE COVER MINI 33NOCTINOXATE, OCTOCRYLENE, TITANIUM DIOXIDEAekyung Industrial Co., Ltd.43c784ce-3a54-5416-e063-6294a90ac9a22025-11-17WarningsExact identifier
application number: M020
Daily Essential Face MoisturizerZINC OXIDESolarium Brands LLC2a92edc1-04ac-3eda-e063-6294a90ad46d2025-11-17WarningsExact identifier
application number: M020
Daily Essential Eye CreamTITANIUM DIOXIDE, ZINC OXIDESolarium Brands LLC2a931d9f-4ba8-e3a5-e063-6294a90af7802025-11-17WarningsExact identifier
application number: M020
Daily Essential Lip Oil Blushing NudeZINC OXIDESolarium Brands LLC2a93998c-185b-9207-e063-6294a90ab0e92025-11-17WarningsExact identifier
application number: M020
Solarium Daily Essentials Skin Perfecting PrimerZINC OXIDESolarium Brands LLC302a02d1-3dc5-2745-e063-6394a90ab6d22025-11-17WarningsExact identifier
application number: M020
Solarium Daily Essentials Luminizing Glow DropsZINC OXIDESolarium Brands LLC302a4efe-d429-b1c4-e063-6294a90a073d2025-11-17WarningsExact identifier
application number: M020
Daily Essential Lip Oil Dusty RoseZINC OXIDESolarium Brands LLC2a934860-02a7-a463-e063-6294a90aa4462025-11-17WarningsExact identifier
application number: M020
Daily Essential Lip Oil Scarlet BloomZINC OXIDESolarium Brands LLC2a931e78-e58c-e216-e063-6294a90a3e492025-11-17WarningsExact identifier
application number: M020
Morning Person Daily Repair Protect MoisturizerZINC OXIDEMorning Person Beauty33a20264-9216-154e-e063-6294a90a3c8b2025-11-17WarningsExact identifier
application number: M020
Banana Boat Baby Mineral Enriched Sunscreen UVA/UVB Protection Broad Spectrum SPF 50PLUSHOMOSALATE,OCTISALATE,OCTOCRYLENE,ZINC OXIDEEdgewell Personal Care Brands LLCc780d5cf-8388-42e0-e053-2a95a90a7c042025-11-17WarningsExact identifier
application number: M020
Hell on Earth The Resistance Daily Face MoisturizerTITANIUM DIOXIDE, ZINC OXIDEHell on Earth38debebf-1e12-09f3-e063-6294a90a9a2a2025-11-17WarningsExact identifier
application number: M020
BANANA BOAT PROTECTION PLUS VITAMINS FACE SUNSCREEN UVA/UVB BROAD SPECTRUM SPF 50AVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENEEdgewell Personal Care Brands LLCe64de59e-b8db-522e-e053-2a95a90ac4582025-11-17WarningsExact identifier
application number: M020
Credo Skin Solar Limits SerumZINC OXIDEEco-Chic LLC395dc8eb-978b-a18f-e063-6294a90a22072025-11-17WarningsExact identifier
application number: M020
BANANA BOATAVOBENZONE,HOMOSALATE,OCTISALATE,OCTOCRYLENEEdgewell Personal Care Brands LLC05ce5223-3fb2-4c27-e063-6394a90a8a8f2025-11-17WarningsExact identifier
application number: M020
Credo Follain Daily Mineral SunscreenZINC OXIDEEco-Chic LLC395d6ad4-04ae-8945-e063-6294a90ad87c2025-11-17WarningsExact identifier
application number: M020
BANANA BOATAVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENEEdgewell Personal Care Brands LLC0c7b7571-7317-98bc-e063-6294a90aa29f2025-11-17WarningsExact 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