Active Ingredients
Avobenzone 2.8 %, Homosalate 7.3 %, Octisalate 4.8 %, Octocrylene 8.7 %
Some By Mi Truecica Aqua Calming Sunscreen Cream
FDA Label NDC 74472-501
Full FDA labeling including Indications, Dosage, Usage, and Precautions
Structured Product Label
The following Structured Product Label (SPL) was submitted to the FDA by Perennebell Co., Ltd. for the product Some By Mi Truecica Aqua Calming Sunscreen (NDC 74472-501). 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 active ingredients, purpose, uses, warnings, do not use, when using this product, stop use and ask a doctor, 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
Purpose
sunscreen
Uses
■ Helps prevent sun burn. ■ 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.
■ 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 Information
■ Protect the product in this container 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, Butylene Glycol, Polyglyceryl-6 Stearate, Dibutyl Adipate, Isohexadecane, Niacinamide, Pentylene Glycol, Glyceryl Stearate SE, Arginine, Cetearyl Olivate, Acrylates/C10-30 Alkyl Acrylate Crosspolymer, Polyglyceryl-6 Behenate, Sorbitan Olivate, Carbomer, 1,2-Hexanediol, Vinyl Dimethicone/Methicone Silsesquioxane Crosspolymer, Ammonium Acryloyldimethyltaurate/VP Copolymer, Methylpropanediol, Adenosine, Ethylhexylglycerin, Caprylyl Glycol, Rosmarinus Officinalis (Rosemary) Leaf Oil, Mentha Arvensis Extract, Ethyl Hexanediol, Tocopherol, Trehalose, Melaleuca Alternifolia (Tea Tree) Leaf Water, Centella Asiatica Extract, Hydrolyzed Hyaluronic Acid, Panthenol, Cymbopogon Nardus (Citronella) Oil, Dipropylene Glycol, Lavandula Angustifolia (Lavender) Oil, Aloe Barbadensis Leaf Extract, Ocimum Basilicum (Basil) Oil, Litsea Cubeba Fruit Oil, Propanediol, Sodium Palmitoyl Proline, Steareth-30, Artemisia Capillaris Extract, Glycerin, Saussurea Involucrata Extract, Portulaca Oleracea Extract, Madecassoside, Asiaticoside, Thymus Vulgaris (Thyme) Extract, Madecassic Acid, Asiatic Acid, Nymphaea Alba Flower Extract
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Artwork
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