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 323 of 346 · 6,912 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
DERMAKA Broad Spectrum SPF-42 SunscreenTITANIUM DIOXIDE, ZINC OXIDEDERMAKA SKIN PRODUCTS32b892fd-c68f-4670-bbaa-0b3de57128492023-11-11WarningsExact identifier
application number: M020
WILMA SCHUMANN Moisture Protektiv Day Cream SPF-20OCTINOXATE, OXYBENZONE, TITANIUM DIOXIDESKINMETICS INC4a719986-d1d0-4156-b803-04004b7215042023-11-11WarningsExact identifier
application number: M020
DERMAKA Broad Spectrum SPF-42 Sunscreen UntintedTITANIUM DIOXIDE, ZINC OXIDEDERMAKA SKIN PRODUCTS9aa24e1f-e338-4947-a437-554fb6b227a22023-11-11WarningsExact identifier
application number: M020
TIGER BABY Baby Sunscreen SPF-50ZINC OXIDEBRICKELL BRANDS LLCf2aa0e03-e8b6-42d0-8fa0-2e96ca486b5c2023-11-11WarningsExact identifier
application number: M020
Brickell Mens Products Daily Defense Face Moisturizer SPF-20OCTISALATE, ZINC OXIDEBRICKELL BRANDS LLCa61e20e4-d5c9-4dc4-a18a-cc88b358d15c2023-11-11WarningsExact identifier
application number: M020
EIGHT SAINTS Chase The Sun SPF-30OCTOCRYLENE, OCTISALATE, ZINC OXIDEBRICKELL BRANDS LLC9b19b2b4-d8b9-415d-a217-4a5ef3d75a8c2023-11-11WarningsExact identifier
application number: M020
LUCKY 13s ALL NATURAL TATTOO SUNSCREEN SPF-30ZINC OXIDESALES BRAIN HOLDINGS LLCec06bc4b-90d6-4b41-9086-f57737a34d912023-11-11WarningsExact identifier
application number: M020
TRENDY JOHN SPF-32 Sheer Mineral SunscreenTITANIUM DIOXIDE, ZINC OXIDETRENDY JOHN LLC80dccecb-fbb3-4af6-9cb4-6acea733e9962023-11-11WarningsExact identifier
application number: M020
CARIBBEAN SOL Natural Sunscreen SPF-30ZINC OXIDECaribbean Sol International, LLC19117321-c37b-4b37-9bd6-7c5c973e2f312023-11-11WarningsExact identifier
application number: M020
MIAMI BEACH BUM Blocked SPF-30 SunscreenZINC OXIDEMIAMI BEACH BUM669443a1-7b54-454f-b22f-8cfa9df38bbb2023-11-11WarningsExact identifier
application number: M020
STRYX Daily Moisturizer SPF-30OCTISALATE, ENSULIZOLESTRYX MEN, INC.2bac4348-5b5d-41cc-893e-b9d5c1215ab02023-11-11WarningsExact identifier
application number: M020
SIMPLI DAY All In One SmartCream SPF 42ZINC OXIDE, OCTISALATE, OCTOCRYLENE, ENSULIZOLESIMPLI SKIN MD LLCe5aab0ec-eda2-4073-998a-966202dc22332023-11-11WarningsExact identifier
application number: M020
HAWAIIAN SOL Natural Sunscreen SPF-30ZINC OXIDECaribbean Sol International, LLC3c43fe36-2c24-4859-a262-8af4d3420e472023-11-11WarningsExact identifier
application number: M020
JOYSPRING Kids Mineral Sunscreen SPF-30ZINC OXIDEJOYSPRING HOLDINGS LLC3ca50033-5bcb-4a6d-8aba-a797c5b8d0e92023-11-11WarningsExact identifier
application number: M020
TANCEUTICALS SPF DROPS Broad Spectrum SPF-30AVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENETANCEUTICALS, LLC8640b971-7c99-4c8f-ac5c-ecdd88b99fe02023-11-11WarningsExact identifier
application number: M020
PROTEKT SPF-50 Sheer Mineral SunscreenZINC OXIDEProtekt Products, Inc.806b4e40-0e02-424b-80e7-026a211b4dfe2023-11-11WarningsExact identifier
application number: M020
KOVR All-Natural SPF-30 Moisturizing Sunscreen for WomenTITANIUM DIOXIDE, ZINC OXIDEACTIVE LIFE INC0ddc3bb9-595e-4ebd-ad3e-df4d94fd34ed2023-11-11WarningsExact identifier
application number: M020
Personalized Day Moisturizer with SPF 50ZINC OXIDEProven Skincarebb921e91-9faf-4210-9091-ab511af9012a2023-11-10WarningsExact identifier
application number: M020
Personalized Day Moisturizer with SPFZINC OXIDEProven Skincaref4d682bc-825f-494c-8528-3d328dc639942023-11-10WarningsExact identifier
application number: M020
Ultra Replenishing Sunscreen SPF 40HOMOSALATE, OCTISALATE, OCTOCRYLENE, ZINC OXYIDE CREAMCosMedical Technologies, LLC92ad5d7a-9adb-7d55-e053-2995a90a80e72023-11-10WarningsExact 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