MedPath

TOCOBO Cotton Airy Sun Stick

TOCOBO Cotton Airy Sun Stick

Approved
Approval ID

2f7e7ef4-c3ac-4c26-e063-6394a90a9e42

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 Code85287-019
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 (18)

CAPRYLYL METHICONEInactive
Code: Q95M2P1KJL
Classification: IACT
CAPRYLYL GLYCOLInactive
Code: 00YIU5438U
Classification: IACT
VINYL DIMETHICONE/METHICONE SILSESQUIOXANE CROSSPOLYMERInactive
Code: 9NH1UDD2RR
Classification: IACT
CENTELLA ASIATICA TRITERPENOIDSInactive
Code: 4YS74Q4G4J
Classification: IACT
PANTHENOLInactive
Code: WV9CM0O67Z
Classification: IACT
DIETHYLHEXYL 2,6-NAPHTHALATEInactive
Code: I0DQJ7YGXM
Classification: IACT
SILICAInactive
Code: ETJ7Z6XBU4
Classification: IACT
WATERInactive
Code: 059QF0KO0R
Classification: IACT
DICAPRYLYL CARBONATEInactive
Code: 609A3V1SUA
Classification: IACT
TOCOPHEROLInactive
Code: R0ZB2556P8
Classification: IACT
TRIETHOXYCAPRYLYLSILANEInactive
Code: LDC331P08E
Classification: IACT
ETHYLHEXYLGLYCERINInactive
Code: 147D247K3P
Classification: IACT
1,2-HEXANEDIOLInactive
Code: TR046Y3K1G
Classification: IACT
HOMOSALATEActive
Quantity: 2.584 g in 19 g
Code: V06SV4M95S
Classification: ACTIB
BUTYLENE GLYCOL DICAPRYLATE/DICAPRATEInactive
Code: 75D21FL1PI
Classification: IACT
OCTOCRYLENEActive
Quantity: 1.71 g in 19 g
Code: 5A68WGF6WM
Classification: ACTIB
OCTISALATEActive
Quantity: 0.855 g in 19 g
Code: 4X49Y0596W
Classification: ACTIB
AVOBENZONEActive
Quantity: 0.513 g in 19 g
Code: G63QQF2NOX
Classification: ACTIB

Drug Labeling Information

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

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

TOCOBO Cotton Airy Sun Stick

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

OTC - WHEN USING SECTION

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

When using this product

keep out of eyes. Rinse with water to remove.

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 - 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.

OTC - ACTIVE INGREDIENT SECTION

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

Active Ingredients

Avobenzone 2.7 %

Homosalate 13.6 %

Octisalate 4.5 %

Octocrylene 9 %

OTC - PURPOSE SECTION

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

Purpose

Sunscreen

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

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.

INACTIVE INGREDIENT SECTION

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

Inactive Ingredients

Synthetic Wax, Dicaprylyl Carbonate, Butylene Glycol Dicaprylate/Dicaprate, Methyl Methacrylate Crosspolymer, Vinyl Dimethicone/Methicone Silsesquioxane Crosspolymer, Butyloctyl Salicylate, Silica, Acrylates Copolymer, Diethylhexyl 2,6-Naphthalate, Caprylyl Methicone, Ozokerite, Vinyl Dimethicone, Lauryl Polyglyceryl-3 Polydimethylsiloxyethyl Dimethicone, Caprylyl Glycol, Triethoxycaprylylsilane, Fragrance, Ethylhexylglycerin, Tocopherol, Panthenol, Water, 1,2-Hexanediol, Centella Asiatica Extract

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