FDA.reportPublic FDA data

TOCOBO Bio Watery Sun Screen

Manufacturer
PICTON CO., Ltd. | Kolmar Korea Co., Ltd
Effective date
2025-09-01
Label type
HUMAN OTC DRUG LABEL
Version
2
Source
full-release
Hydrated at
2026-06-01 01:12:20

Label at a glance#

ProductTOCOBO Bio Watery Sun Screen
Active ingredientOCTISALATE, OCTOCRYLENE, HOMOSALATE, AVOBENZONE
Label structure12 sections

Indications and uses

• Helps prevent sunburn • If used as directed with other sun protection measures (see Directions ), decreases the risk of skin cancer and early skin aging caused by the sun

Dosage and administration

• apply liberally 15 minutes before sun exposure. Sun Protection Measures. Spending time in the sun increases your risk of skin cancer and early skin aging. To decrease this risk, regularly use a sunscreen with a Broad Spectrum SPF value of 15 or higher and other sun protection measures including: ·limit time in the sun, especially from 10 a.m. - 2 p.m. ·wear long-sleeved shirts, pants, hats, and sunglasses • chil...

Label contents#

Full prescribing information#

Active Ingredients

OTC - ACTIVE INGREDIENT SECTION

Avobenzone 2.7 %

Homosalate 13.5 %

Octisalate 4.5 %

Octocrylene 9 %

Purpose

OTC - PURPOSE SECTION

Sunscreen

Uses

INDICATIONS & USAGE SECTION

• Helps prevent sunburn
• If used as directed with other sun protection measures (see Directions), decreases the risk of skin cancer and early skin aging caused by the sun

Warnings

WARNINGS SECTION

For external use only

Do not use

OTC - DO NOT USE SECTION

• on damaged or broken skin

When using this product

OTC - WHEN USING SECTION

• keep out of eyes. Rinse with water to remove.

Stop use and ask a doctor

OTC - STOP USE SECTION

• if rash occurs

Keep out of reach of children.

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

If swallowed, get medical help or contact a Poison Control Center right away.

Directions

DOSAGE & ADMINISTRATION SECTION

• apply liberally 15 minutes before sun exposure. Sun Protection Measures.Spending time in the sun increases your risk of skin cancer and early skin aging. To decrease this risk, regularly use a sunscreen with a Broad Spectrum SPF value of 15 or higher and other sun protection measures including:
·limit time in the sun, especially from 10 a.m. - 2 p.m.
·wear long-sleeved shirts, pants, hats, and sunglasses
• children under 6 months of age: Ask a doctor
• reapply at least every 2 hours
• use a water-resistant sunscreen if swimming or sweating

Other information

OTHER SAFETY INFORMATION

• protect the product from excessive heat and direct sun
• Sun alert: Limiting sun exposure, wearing protective clothing, and using sunscreens may reduce the risks of skin aging, skin cancer, and other harmful effects of the sun.

Inactive Ingredients

INACTIVE INGREDIENT SECTION

Water, Butyloctyl Salicylate, Dipropylene Glycol, Panthenol, Diethylhexyl 2, 6-Naphthalate, C20-22 Alkyl Phosphate, C20-22 Alcohols, 1,2-Hexanediol, Silica, Caprylyl Methicone, Pentylene Glycol, Cetyl Alcohol, Methyl Methacrylate Crosspolymer, Glyceryl Stearate, Tromethamine, Polyacrylate Crosspolymer6, Ammonium Acryloyldimethyltaurate/VP Copolymer, Fragrance, Ethylhexylglycerin, VP/Eicosene Copolymer, Centella Asiatica Extract, Tocopherol

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

TOCOBO Bio Watery Sun ScreenTOCOBO Bio Watery Sun Screen

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

Products#

Every source-derived product name is available through these pages.

DailyMed product names page 1 of 1 · 25 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
85287-04085287-040-01, 85287-040-02

Ingredients#

Every source-derived ingredient row is available through these pages.

DailyMed ingredient rows page 1 of 1 · 23 matching rows.

Name, UNII, Kind table
NameUNIIKind
CENTELLA ASIATICA TRITERPENOIDS4YS74Q4G4JIACT
1,2-HEXANEDIOLTR046Y3K1GIACT
TROMETHAMINE023C2WHX2VIACT
ETHYLHEXYLGLYCERIN147D247K3PIACT
TOCOPHEROLR0ZB2556P8IACT
POLYACRYLATE CROSSPOLYMER-6Q7UI015FF9IACT
BUTYLOCTYL SALICYLATE2EH13UN8D3IACT
DIPROPYLENE GLYCOLE107L85C40IACT
PANTHENOLWV9CM0O67ZIACT
C20-22 ALCOHOLSO4M0347C6AIACT
PENTYLENE GLYCOL50C1307PZGIACT
AMMONIUM ACRYLOYLDIMETHYLTAURATE/VP COPOLYMERW59H9296ZGIACT
SILICAETJ7Z6XBU4IACT
CETYL ALCOHOL936JST6JCNIACT
WATER059QF0KO0RIACT
DIETHYLHEXYL 2,6-NAPHTHALATEI0DQJ7YGXMIACT
C20-22 ALKYL PHOSPHATEL4VKP0Y7RPIACT
CAPRYLYL METHICONEQ95M2P1KJLIACT
GLYCERYL STEARATE230OU9XXE4IACT
OCTISALATE4X49Y0596WACTIB
OCTOCRYLENE5A68WGF6WMACTIB
HOMOSALATEV06SV4M95SACTIB
AVOBENZONEG63QQF2NOXACTIB

Source Document#

Source XML

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 1 of 1 · 1 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
TOCOBO Bio Watery Sun ScreenAVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENEPICTON CO., Ltd.2f7eb413-ff49-711d-e063-6394a90ad6dc2025-09-01WarningsExact identifier
ndc (package): 85287-040-02
ndc (package): 85287-040-01
ndc (product): 85287-040
ndc11 (package): 85287004002
ndc11 (package): 85287004001
spl id: 3dc7d053-c02d-8e36-e063-6394a90a8ace
spl set id: 2f7eb413-ff49-711d-e063-6394a90ad6dc

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.