TONEFITSUN ULTRA MOISTURIZING VEGAN SUNSCREEN- avobenzone, homosalate, octisalate, octocrylene cream

Drug Labeling and Warnings

Drug Details [pdf]

ACTIVE INGREDIENT

Active ingredients
AVOBENZONE 2.7%
HOMOSALATE 13.5%
OCTISALATE 4.5%
OCTOCRYLENE 9%

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
Water(Aqua), Dibutyl Adipate, Butyloctyl Salicylate, Propanediol, VP/Hexadecene Copolymer, 1,2-Hexanediol, Polymethylsilsesquioxane, Coco-Caprylate/Caprate, Panthenol, Poly C10-30 Alkyl Acrylate, Cetearyl Alcohol, Polyglyceryl-3 Distearate, Methyl Methacrylate Crosspolymer, Glyceryl Stearate, Potassium Cetyl Phosphate, Ammonium Polyacryloyldimethyl Taurate, Carbomer, Tromethamine, Glyceryl Stearate Citrate, Sodium Polyacryloyldimethyl Taurate, Tocopheryl Acetate, Ethylhexylglycerin, t-Butyl Alcohol

PRINCIPAL DISPLAY PANEL

INGREDIENTS AND APPEARANCE

TONEFITSUN ULTRA MOISTURIZING VEGAN SUNSCREEN 
avobenzone, homosalate, octisalate, octocrylene cream

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 58544-150
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
OCTOCRYLENE (UNII: 5A68WGF6WM) (OCTOCRYLENE - UNII:5A68WGF6WM)	OCTOCRYLENE	9 g  in 100 mL
AVOBENZONE (UNII: G63QQF2NOX) (AVOBENZONE - UNII:G63QQF2NOX)	AVOBENZONE	2.7 g  in 100 mL
HOMOSALATE (UNII: V06SV4M95S) (HOMOSALATE - UNII:V06SV4M95S)	HOMOSALATE	13.5 g  in 100 mL
OCTISALATE (UNII: 4X49Y0596W) (OCTISALATE - UNII:4X49Y0596W)	OCTISALATE	4.5 g  in 100 mL

Inactive Ingredients
Ingredient Name	Strength
VP/HEXADECENE COPOLYMER (UNII: KFR5QEN0N9)
DIBUTYL ADIPATE (UNII: F4K100DXP3)
WATER (UNII: 059QF0KO0R)
BUTYLOCTYL SALICYLATE (UNII: 2EH13UN8D3)
PROPANEDIOL (UNII: 5965N8W85T)
1,2-HEXANEDIOL (UNII: TR046Y3K1G)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 58544-150-02	1 in 1 CARTON	03/01/2026
1	NDC: 58544-150-01	50 mL 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	03/01/2026

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(58544-150)