Otc - Active Ingredient
Avobenzone 3.0%
Homosalate 10.0%
Octisalate 5.0%
Octocrylene 8.7%
Tone Blur Essence Sunscreen Cream
FDA Label NDC 84326-124
Full FDA labeling including Indications, Dosage, Usage, and Precautions
Structured Product Label
The following Structured Product Label (SPL) was submitted to the FDA by Rbgroup Co., Ltd for the product Tone Blur Essence Sunscreen (NDC 84326-124). 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, otc - do not use, otc - when using, otc - stop use, otc - keep out of reach of children, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.
Label Section Quick Index
Otc - Purpose
Sunscreen
Indications & Usage
■ 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
Otc - Do Not Use
■ on damaged skin or broken skin
Otc - When Using
this product ■ keep out of eyes. Rinse with water to remove.
Otc - Stop Use
and ask a doctor if rash occurs.
Otc - Keep Out Of Reach Of Children
If swallowed, get medical help or contact a Poison Control Center right away.
Other Safety Information
■ Protect this product from excessive heat and direct sun.
Dosage & Administration
Directions
■ Apply liberally 15 minutes before sun exposure.
■ Use a water resistant sunscreen if swimming or swating.
■ Reapply at least every 2 hours.
■ Children under 6 months of age: Ask a doctor.
■ 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 10a.m. - 2 p.m. ■ Wear long-sleeve shirts, pants, hats, and sunglasses.
Inactive Ingredient
Water, Butyloctyl Salicylate, Dicaprylyl Carbonate, Cetearyl Alcohol, Cetearyl Glucosidde, Dipropylene Glycol, Sorbitan Olivate, Poly C10-30 Alkyl Acrylate, Polymethylsilsesquioxane, Niacinamide, Benzyl Glycol, Glyceryl Stearate SE, Panthenol, Arginine, Carbomer, Tocopherol, Butylene Glycol, Xanthan Gum, Hydroxypropyl Methylcellulose Stearoxy Ether, Ethylhexylglycerin, Glycerin, Adenosine, Ethyl Hexanediol, 1,2-Hexanediol, Centella Asiatica Extract, Madecassic Acid, Asiaticoside, Asiatic Acid, Aloe Barbadensis Leaf Juice, Sodium Hyaluronate
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