TOCOBO BIO WATERY SUN SCREEN- avobenzone, homosalate, octisalate, octocrylene cream

TOCOBO Bio Watery Sun Screen by

Drug Labeling and Warnings

TOCOBO Bio Watery Sun Screen by is a Otc medication manufactured, distributed, or labeled by PICTON CO., Ltd., Kolmar Korea Co., Ltd. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

Active Ingredients

Avobenzone 2.7 %

Homosalate 13.5 %

Octisalate 4.5 %

Octocrylene 9 %

Purpose

Sunscreen

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

Warnings

For external use only

Do not use

on damaged or broken skin

When using this product

keep out of eyes. Rinse with water to remove.

Stop use and ask a doctor

if rash occurs

Keep out of reach of children.

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

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 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

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

PRINCIPAL DISPLAY PANEL

INGREDIENTS AND APPEARANCE

TOCOBO BIO WATERY SUN SCREEN 
avobenzone, homosalate, octisalate, octocrylene cream

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 85287-040
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
OCTISALATE (UNII: 4X49Y0596W) (OCTISALATE - UNII:4X49Y0596W)	OCTISALATE	1.8 g  in 40 mL
OCTOCRYLENE (UNII: 5A68WGF6WM) (OCTOCRYLENE - UNII:5A68WGF6WM)	OCTOCRYLENE	3.6 g  in 40 mL
HOMOSALATE (UNII: V06SV4M95S) (HOMOSALATE - UNII:V06SV4M95S)	HOMOSALATE	5.4 g  in 40 mL
AVOBENZONE (UNII: G63QQF2NOX) (AVOBENZONE - UNII:G63QQF2NOX)	AVOBENZONE	1.08 g  in 40 mL

Inactive Ingredients
Ingredient Name	Strength
CENTELLA ASIATICA TRITERPENOIDS (UNII: 4YS74Q4G4J)
1,2-HEXANEDIOL (UNII: TR046Y3K1G)
TROMETHAMINE (UNII: 023C2WHX2V)
ETHYLHEXYLGLYCERIN (UNII: 147D247K3P)
TOCOPHEROL (UNII: R0ZB2556P8)
POLYACRYLATE CROSSPOLYMER-6 (UNII: Q7UI015FF9)
BUTYLOCTYL SALICYLATE (UNII: 2EH13UN8D3)
DIPROPYLENE GLYCOL (UNII: E107L85C40)
PANTHENOL (UNII: WV9CM0O67Z)
C20-22 ALCOHOLS (UNII: O4M0347C6A)
PENTYLENE GLYCOL (UNII: 50C1307PZG)
AMMONIUM ACRYLOYLDIMETHYLTAURATE/VP COPOLYMER (UNII: W59H9296ZG)
SILICA (UNII: ETJ7Z6XBU4)
CETYL ALCOHOL (UNII: 936JST6JCN)
WATER (UNII: 059QF0KO0R)
DIETHYLHEXYL 2,6-NAPHTHALATE (UNII: I0DQJ7YGXM)
C20-22 ALKYL PHOSPHATE (UNII: L4VKP0Y7RP)
CAPRYLYL METHICONE (UNII: Q95M2P1KJL)
GLYCERYL STEARATE (UNII: 230OU9XXE4)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 85287-040-02	1 in 1 BOX	03/12/2025
1	NDC: 85287-040-01	40 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC Monograph Drug	M020	03/12/2025

Labeler - PICTON CO., Ltd. (695418404)

Establishment
Name	Address	ID/FEI	Business Operations
Kolmar Korea Co., Ltd		963271745	manufacture(85287-040)