Active Ingredient
Titanium Dioxide 8.86%
Atomy Derma Calming Sun Stick
FDA Label NDC 52257-1400
Full FDA labeling including Indications, Dosage, Usage, and Precautions
Structured Product Label
The following Structured Product Label (SPL) was submitted to the FDA by Atomy Co., Ltd. for the product Atomy Derma Calming Sun (NDC 52257-1400). 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 ingredient, inactive ingredients, purpose, warnings, description, package label.principal display panel, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.
Label Section Quick Index
Inactive Ingredients
ISOPROPYL PALMITATE, ETHYLHEXYL PALMITATE, POLYETHYLENE, SYNTHETIC FLUORPHLOGOPITE, C12-15 ALKYL BENZOATE, METHYL METHACRYLATE CROSSPOLYMER, POLYMETHYLSILSESQUIOXANE, BUTYLENE GLYCOL DICAPRYLATE/DICAPRATE, PHENYL TRIMETHICONE, CAPRYLIC/CAPRIC TRIGLYCERIDE, CAPRYLYL METHICONE, OZOKERITE, VINYL DIMETHICONE, POLYHYDROXYSTEARIC ACID, CALAMINE, ALUMINUM STEARATE, ALUMINA, CITRUS AURANTIUM DULCIS (ORANGE) OIL, POLYGLYCERYL-4 DIISOSTEARATE/POLYHYDR OXYSTEARATE/SEBACATE, TRIETHOXYCAPRYLYLSILANE, STEARIC ACID, CITRUS NOBILIS (MANDARIN ORANGE) PEEL OIL, DEHYDROACETIC ACID, LITSEA CUBEBA FRUIT OIL, OCTYLDODECANOL, DIOSPYROS KAKI LEAF EXTRACT, ECHIUM PLANTAGINEUM SEED OIL, GLYCERIN, AQUA/WATER/EAU, CARDIOSPERMUM HALICACABUM FLOWER/LEAF/VINE EXTRACT, HELIANTHUS ANNUUS (SUNFLOWER) SEED OIL UNSAPONIFIABLES, PANCRATIUM MARITIMUM EXTRACT
Purpose
Sunscreen
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 product is swallowed, get medical help or contact a Poison Control Center right away.
Description
Directions:
• Apply liberally 15 minutes before sun exposure
• Reapply at least every 2 hours
• Use a water-resistant sunscreen if swimming or sweating
• Children under 6 months: 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 10 a.m. ‒ 2 p.m.
• Wear long-sleeved shirts, pants, hats, and sunglasses
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
Other Information:
Protect this product from excessive heat and direct sun
* Please review the disclaimer below.
