Otc - Active Ingredient
Active ingredients
Avobenzone 2.7%
Homosalate 13.5%
Octisalate 4.5%
Octocrylene 9.5%
Tonefitsun Sebum Control Vegan Sunscreen Stick
FDA Label NDC 58544-160
Full FDA labeling including Indications, Dosage, Usage, and Precautions
Structured Product Label
The following Structured Product Label (SPL) was submitted to the FDA by Hankook Cosmetics Manufacturing Co.,ltd_eumseong Factory for the product Tonefitsun Sebum Control Vegan Sunscreen (NDC 58544-160). This document serves as the official prescribing information, containing essential scientific data and clinical materials required for healthcare providers and patients.
This specific version of the label includes detailed information regarding otc - active ingredient, otc - purpose, indications & usage, warnings, dosage & administration, other safety information, otc - keep out of reach of children, inactive ingredient, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.
Label Section Quick Index
Otc - 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
Otc - 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
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