MedPath

TOCOBO Bio Watery Sun Screen

TOCOBO Bio Watery Sun Screen

Approved
Approval ID

2f7eb413-ff49-711d-e063-6394a90ad6dc

Product Type

HUMAN OTC DRUG LABEL

Effective Date

Sep 1, 2025

Manufacturers
FDA

PICTON CO., Ltd.

DUNS: 695418404

Products 1

Detailed information about drug products covered under this FDA approval, including NDC codes, dosage forms, ingredients, and administration routes.

Avobenzone, Homosalate, Octisalate, Octocrylene

Product Details

FDA regulatory identification and product classification information

FDA Identifiers
NDC Product Code85287-040
Application NumberM020
Product Classification
M
Marketing Category
C200263
G
Generic Name
Avobenzone, Homosalate, Octisalate, Octocrylene
Product Specifications
Route of AdministrationTOPICAL
Effective DateSeptember 1, 2025
FDA Product Classification

INGREDIENTS (23)

WATERInactive
Code: 059QF0KO0R
Classification: IACT
CENTELLA ASIATICA TRITERPENOIDSInactive
Code: 4YS74Q4G4J
Classification: IACT
1,2-HEXANEDIOLInactive
Code: TR046Y3K1G
Classification: IACT
TROMETHAMINEInactive
Code: 023C2WHX2V
Classification: IACT
ETHYLHEXYLGLYCERINInactive
Code: 147D247K3P
Classification: IACT
TOCOPHEROLInactive
Code: R0ZB2556P8
Classification: IACT
POLYACRYLATE CROSSPOLYMER-6Inactive
Code: Q7UI015FF9
Classification: IACT
BUTYLOCTYL SALICYLATEInactive
Code: 2EH13UN8D3
Classification: IACT
DIPROPYLENE GLYCOLInactive
Code: E107L85C40
Classification: IACT
PANTHENOLInactive
Code: WV9CM0O67Z
Classification: IACT
C20-22 ALCOHOLSInactive
Code: O4M0347C6A
Classification: IACT
AMMONIUM ACRYLOYLDIMETHYLTAURATE/VP COPOLYMERInactive
Code: W59H9296ZG
Classification: IACT
PENTYLENE GLYCOLInactive
Code: 50C1307PZG
Classification: IACT
DIETHYLHEXYL 2,6-NAPHTHALATEInactive
Code: I0DQJ7YGXM
Classification: IACT
SILICAInactive
Code: ETJ7Z6XBU4
Classification: IACT
CETYL ALCOHOLInactive
Code: 936JST6JCN
Classification: IACT
C20-22 ALKYL PHOSPHATEInactive
Code: L4VKP0Y7RP
Classification: IACT
CAPRYLYL METHICONEInactive
Code: Q95M2P1KJL
Classification: IACT
GLYCERYL STEARATEInactive
Code: 230OU9XXE4
Classification: IACT
OCTISALATEActive
Quantity: 1.8 g in 40 mL
Code: 4X49Y0596W
Classification: ACTIB
OCTOCRYLENEActive
Quantity: 3.6 g in 40 mL
Code: 5A68WGF6WM
Classification: ACTIB
HOMOSALATEActive
Quantity: 5.4 g in 40 mL
Code: V06SV4M95S
Classification: ACTIB
AVOBENZONEActive
Quantity: 1.08 g in 40 mL
Code: G63QQF2NOX
Classification: ACTIB

Drug Labeling Information

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

LOINC: 51945-4Updated: 3/12/2025

TOCOBO Bio Watery Sun Screen

INDICATIONS & USAGE SECTION

LOINC: 34067-9Updated: 3/12/2025

Uses

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

OTHER SAFETY INFORMATION

LOINC: 60561-8Updated: 3/12/2025

Other 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.

OTC - ACTIVE INGREDIENT SECTION

LOINC: 55106-9Updated: 3/12/2025

Active Ingredients

Avobenzone 2.7 %

Homosalate 13.5 %

Octisalate 4.5 %

Octocrylene 9 %

OTC - PURPOSE SECTION

LOINC: 55105-1Updated: 3/12/2025

Purpose

Sunscreen

WARNINGS SECTION

LOINC: 34071-1Updated: 3/12/2025

Warnings

For external use only

OTC - DO NOT USE SECTION

LOINC: 50570-1Updated: 3/12/2025

Do not use

• on damaged or broken skin

OTC - WHEN USING SECTION

LOINC: 50567-7Updated: 3/12/2025

When using this product

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

OTC - STOP USE SECTION

LOINC: 50566-9Updated: 3/12/2025

Stop use and ask a doctor

• if rash occurs

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

LOINC: 50565-1Updated: 3/12/2025

Keep out of reach of children.

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

DOSAGE & ADMINISTRATION SECTION

LOINC: 34068-7Updated: 3/12/2025

Directions

• 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

INACTIVE INGREDIENT SECTION

LOINC: 51727-6Updated: 3/12/2025

Inactive Ingredients

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

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