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 327 of 346 · 6,912 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
RADIANCE Silky Mineral Primer Sunscreen SPF-42 HONEYTITANIUM DIOXIDE, ZINC OXIDESANTO REMEDIO LLC867a88df-9a18-447f-8301-2ec91566302e2023-11-06WarningsExact identifier
application number: M020
CALIFORNIA MANGO SPF-30 SUNSCREENAVOBENZONE, OCTISALATE, OCTOCRYLENECALMANGO, INCe0de0504-763d-4518-8a9c-67724077701d2023-11-06WarningsExact identifier
application number: M020
KOVR All-Natural SPF-30 Moisturizing Sunscreen for MenTITANIUM DIOXIDE, ZINC OXIDEACTIVE LIFE INCbf766aab-a52d-41e8-a06a-f2e536d2219b2023-11-06WarningsExact identifier
application number: M020
PROJECT REEF SPF-50ZINC OXIDE, TITANIUM DIOXIDEProject Reef LLC6bcd470c-6994-4d28-8370-4cc9d68e1e782023-11-06WarningsExact identifier
application number: M020
BB OSKIN Broad Spectrum SPF-30TITANIUM DIOXIDE, OCTOCRYLENE, ZINC OXIDEO'Skin Studio NYd84cca38-b673-484e-aa25-df58d904d4d32023-11-06WarningsExact identifier
application number: M020
MIAMI MD SUN SHIELD Broad Spectrum SPF 40AVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENEBRAND BOLT LLC3a53d53a-129a-41c3-a8e7-c1b1bb98d8bd2023-11-06WarningsExact identifier
application number: M020
JOY SPRING Kids Mineral Sunscreen SPF-30ZINC OXIDEJOYSPRING HOLDINGS LLC76613a3d-f4a8-4961-b36a-d84b4e10dea02023-11-06WarningsExact identifier
application number: M020
Aruba Aloe Sport Line Lip Balm Broad Spectrum SPF 30TITANIUM DIOXIDE, ZINC OXIDEAruba Aloe Balm NV80461b6d-b1b7-4220-894d-8bd4259094742023-11-06WarningsExact identifier
application number: M020
Sport Broad Spectrum SPF50 Water Resistant 80 minutes Mineral Sunscreen UVA UVB Protection StickZINC OXIDEAruba Aloe Balm NV3201cc8b-5fee-4f3b-a826-e349786d1b322023-11-06WarningsExact identifier
application number: M020
Broad Spectrum SPF50 Water Resistant (80 minutes) Mineral Sunscreen UVA UVB Protection Stick for KidsZINC OXIDEAruba Aloe Balm NV25f060eb-628c-4a11-b1d7-06922ee86b242023-11-06WarningsExact identifier
application number: M020
SPF30 SunscreenAVOBENZONE, HOMOSALATE, OCTOCRYLENE, OCITSALATEZhejiang Ayan Biotech Co., Ltd.44321dff-1a61-452f-8324-6de2a196db512023-11-06WarningsExact identifier
application number: M020
SPF30 SunscreenAVOBENZONE, HOMOSALATE, OCTOCRYLENE, OCITSALATEZhejiang Ayan Biotech Co., Ltd.cac6f5e5-91c2-4978-bffd-5ca2a75906372023-11-06WarningsExact identifier
application number: M020
SPF15 SunscreenAVOBENZONE, HOMOSALATE, OCTOCRYLENE, OCTISALATEZhejiang Ayan Biotech Co.,Ltd.68035415-47c3-4eed-93f4-bb6b26c9149a2023-11-06WarningsExact identifier
application number: M020
SPF30 Sunscreen and Antibacterial Hand SanitizerALCOHOL, AVOBENZONE, HOMOSALATE, OCTOCRYLENE, OCTISALATEZhejiang Ayan Biotech Co., Ltd.b5e2458f-8e84-4e57-b6f7-e428a94c97a42023-11-06WarningsExact identifier
application number: M020
SPF30 Sunscreen and SPF15AVOBENZONE, HOMOSALATE, OCTOCRYLENE, OCTISALATEZhejiang Ayan Biotech Co.,Ltd.6c40259b-565a-46d0-90d0-ccc1867645522023-11-06WarningsExact identifier
application number: M020
Image Skincare Prevention Plus Daily Ultimate ProtectionHOMOSALATE, OCTISALATE, OCTOCRYLENE, ZINC OXIDE SUNSCREENSwiss-American CDMO, LLC3473f94c-5faf-4415-9605-f58ec93cd2682023-11-06WarningsExact identifier
application number: M020
Image MD Restoring Lip Enhancer SPF15SUNSCREENSwiss-American CDMO, LLCe296579e-ba30-4a29-afe0-bb51f863369c2023-11-06WarningsExact identifier
application number: M020
Image Prevention Refiner Primer SPF50ZINC OXIDE, TITANIUM DIOXIDE SUNSCREENSwiss-American CDMO, LLC0e490f11-666c-420c-8c12-b45cd238ce472023-11-06WarningsExact identifier
application number: M020
Image Prevention Plus Professional Ultimate Protection Moisturizer SPF50HOMOSALATE, OCTISALATE, OCTOCRYLENE, ZINC OXIDE SUNSCREENSwiss-American CDMO, LLCd807f94a-f933-47d9-938f-b91f663af0782023-11-06WarningsExact identifier
application number: M020
Farmasi BB Beauty Balm Cream SPF 15- 01 LightTITANIUM DIOXIDEFarmasi US LLC97c1da03-b79c-46a3-a9f0-7aeb94ed66da2023-11-05WarningsExact 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