Active Ingredients
HOMOSALATE 7.50%
OCTISALATE 4.50%
TITANIUM DIOXIDE 2.20%
ZINC OXIDE 12.70%
Atomy Sunscreen Beige Broad Spectrum Spf 50 Plus Cream
FDA Label NDC 52257-1420
7 label sections · Submitted to the FDA by Atomy Co., Ltd. · 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 Sunscreen Beige Broad Spectrum Spf 50 Plus (NDC 52257-1420). 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, inactive ingredients, purpose, warnings, otc - keep out of reach of children, indications & usage, dosage & administration, 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
Aqua/Water/Eau, Cyclopentasiloxane, Dipropylene Glycol, Disiloxane, Lauryl Peg-10 Tris(Trimethylsiloxy)Silylethyl Dimethicone, Glycerin, Niacinamide, Propylheptyl Caprylate, Portulaca Oleracea Extract, Silica, Dimethicone, Disteardimonium Hectorite, Magnesium Sulfate, Dicaprylyl Carbonate, 1,2-Hexanediol, Vinyl Dimethicone/Methicone Silsesquioxane Crosspolymer, Synthetic Fluorphlogopite, Triethoxycaprylylsilane, Aluminum Hydroxide, Stearic Acid, Sorbitan Caprylate, Dimethicone/Peg-10/15 Crosspolymer, Fragrance(Parfum), Iron Oxides(CI 77492), Dimethicone/Vinyl Dimethicone Crosspolymer, Glyceryl Caprylate, Ethylhexylglycerin, Adenosine, Iron Oxides(CI 77491), Iron Oxides(CI 77499), Tocopherol, Camellia Sinensis Leaf Extract, Melissa Officinalis Extract, Centella Asiatica Extract, Perilla Ocymoides Leaf Extract
Purpose
Sunscreen
Warnings
For external use only
Do not useon damaged or broken skin
When using this productkeep out of eyes. Rinse with water to remove.
Stop use and ask a doctorif rash occurs
Keep out of reach of children. If product is swallowed, get medical help or contact a Poison Control Center right away.
Otc - Keep Out Of Reach Of Children
Keep out of reach of children. If product is swallowed, get medical help or contact a Poison Control Center right away.
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
Other Information:
Protect this product from excessive heat and direct sun
Dosage & Administration
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
* Please review the disclaimer below.
