TONEFITSUN SEBUM CONTROL VEGAN SUNSCREEN- avobenzone, homosalate, octisalate, octocrylene stick

Drug Labeling and Warnings

Drug Details [pdf]

ACTIVE INGREDIENT

Active ingredients

Avobenzone 2.7%
Homosalate 13.5%
Octisalate 4.5%
Octocrylene 9.5%

PURPOSE

Purpose
Sunscreen

INDICATIONS & USAGE

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

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.

DOSAGE & ADMINISTRATION

Directions
apply liberally 15 minutes before sun exposure
children under 6 months of age : Ask a doctor
reapply at least every 2 hours
use a water resistant sunscreen if swimming or sweating
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

OTHER SAFETY INFORMATION

Other Information
Protect this product from excessive heat and direct sun

KEEP OUT OF REACH OF CHILDREN

Keep out of reach of children.

INACTIVE INGREDIENT

Inactive Ingredients

Dibutyl Adipate, Butyloctyl Salicylate, Vinyl Dimethicone/Methicone Silsesquioxane Crosspolymer, Silica, Synthetic Wax, C12-15 Alkyl Benzoate, Polyester-8, Butylene Glycol Dicaprylate/Dicaprate, VP/Hexadecene Copolymer, Synthetic Fluorphlogopite, Microcrystalline Wax, 1,2-Hexanediol, Caprylic/Capric Glycerides, Fragrance(Parfum), Triethoxycaprylylsilane, Tocopheryl Acetate, Panthenol

PRINCIPAL DISPLAY PANEL

INGREDIENTS AND APPEARANCE

TONEFITSUN SEBUM CONTROL VEGAN SUNSCREEN 
avobenzone, homosalate, octisalate, octocrylene stick

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 58544-160
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
OCTOCRYLENE (UNII: 5A68WGF6WM) (OCTOCRYLENE - UNII:5A68WGF6WM)	OCTOCRYLENE	9.5 g  in 100 g
AVOBENZONE (UNII: G63QQF2NOX) (AVOBENZONE - UNII:G63QQF2NOX)	AVOBENZONE	2.7 g  in 100 g
HOMOSALATE (UNII: V06SV4M95S) (HOMOSALATE - UNII:V06SV4M95S)	HOMOSALATE	13.5 g  in 100 g
OCTISALATE (UNII: 4X49Y0596W) (OCTISALATE - UNII:4X49Y0596W)	OCTISALATE	4.5 g  in 100 g

Inactive Ingredients
Ingredient Name	Strength
C12-15 ALKYL BENZOATE (UNII: A9EJ3J61HQ)
MICROCRYSTALLINE WAX (UNII: XOF597Q3KY)
BUTYLENE GLYCOL DICAPRYLATE/DICAPRATE (UNII: 75D21FL1PI)
TRIETHOXYCAPRYLYLSILANE (UNII: LDC331P08E)
1,2-HEXANEDIOL (UNII: TR046Y3K1G)
DIBUTYL ADIPATE (UNII: F4K100DXP3)
BUTYLOCTYL SALICYLATE (UNII: 2EH13UN8D3)
VINYL DIMETHICONE/METHICONE SILSESQUIOXANE CROSSPOLYMER (UNII: 9NH1UDD2RR)
SILICON DIOXIDE (UNII: ETJ7Z6XBU4)
VP/HEXADECENE COPOLYMER (UNII: KFR5QEN0N9)
ALPHA-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)
PANTHENOL (UNII: WV9CM0O67Z)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 58544-160-02	1 in 1 CARTON	04/01/2026
1	NDC: 58544-160-01	20 g in 1 CONTAINER; 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	04/01/2026

Labeler - Hankook Cosmetics Manufacturing Co.,Ltd_Eumseong Factory (687772475)

Registrant - HANKOOK COSMETICS CO., LTD. (688270639)

Establishment
Name	Address	ID/FEI	Business Operations
Hankook Cosmetics Manufacturing Co.,Ltd_Eumseong Factory		688235645	manufacture(58544-160)