Atomy Sunscreen White Broad Spectrum Spf 50 Plus Cream
FDA Label NDC 52257-1450

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 Sunscreen White Broad Spectrum Spf 50 Plus (NDC 52257-1450). 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, keep out of reach of children, uses, directions, other information, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.

Active Ingredients

HOMOSALATE 7.50%
OCTISALATE 4.50%
TITANIUM DIOXIDE 2.20%
ZINC OXIDE 12.70%

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, 1,2-Hexanediol, Vinyl Dimethicone/Methicone Silsesquioxane Crosspolymer, Triethoxycaprylylsilane, Aluminum Hydroxide, Stearic Acid, Sorbitan Caprylate, Dimethicone/Peg-10/15 Crosspolymer, Fragrance(Parfum), Dimethicone/Vinyl Dimethicone Crosspolymer, Glyceryl Caprylate, Ethylhexylglycerin, Adenosine, Tocopherol, Camellia Sinensis Leaf Extract, Melissa Officinalis Extract, Centella Asiatica Extract, Perilla Ocymoides Leaf 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

Keep out of reach of children. If product is swallowed, get medical help or contact a Poison Control Center right away.

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

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

Other Information

Protect this product from excessive heat and direct sun

* Please review the disclaimer below.