FDA.reportPublic FDA data

ATOMY DERMA CALMING SUN

Manufacturer
ATOMY CO., LTD. | Kolmar Korea Co.,Ltd. Bucheon Factory
Effective date
2024-01-30
Label type
HUMAN OTC DRUG LABEL
Version
2
Source
full-release
Hydrated at
2026-06-01 00:08:06

Label at a glance#

ProductATOMY DERMA CALMING SUN
Active ingredientTitanium Dioxide
Label structure9 sections

Indications and 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

Dosage and administration

• 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 measur...

Label contents#

Full prescribing information#

ACTIVE INGREDIENT

OTC - ACTIVE INGREDIENT SECTION

Titanium Dioxide 8.86%

INACTIVE INGREDIENTS

INACTIVE INGREDIENT SECTION

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

OTC - PURPOSE SECTION

Sunscreen

WARNINGS

WARNINGS SECTION

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.

KEEP OUT OF REACH OF CHILDREN

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

If product is swallowed, get medical help or contact a Poison Control Center right away.

Uses

INDICATIONS & USAGE SECTION

• 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

DOSAGE & ADMINISTRATION SECTION

• 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

OTHER SAFETY INFORMATION

Protect this product from excessive heat and direct sun

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Image of cartonImage of cartonImage of cartonImage of carton

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
52257-1400-1ATOMY DERMA CALMING SUN16 g in 1 CARTONSTICK162

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
52257-1400ATOMY DERMA CALMING SUN (TITANIUM DIOXIDE) STICK [ATOMY CO., LTD.]2Current NDC, Legacy NDC, 1 package rows20240131_fd5fc3ba-6e7c-4e48-8e65-47c03141df45.zip

Products#

Every source-derived product name is available through these pages.

DailyMed product names page 1 of 1 · 4 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
52257-140052257-1400-1

Ingredients#

Every source-derived ingredient row is available through these pages.

DailyMed ingredient rows page 1 of 1 · 3 matching rows.

Name, UNII, Kind table
NameUNIIKind
Titanium Dioxide15FIX9V2JPACTIB
ISOPROPYL PALMITATE8CRQ2TH63MIACT
ETHYLHEXYL PALMITATE2865993309IACT

Source Document#

Source XML

openFDA label cross-check#

OpenFDA label data provides additional search and identifier links. DailyMed’s Structured Product Label is the canonical label on FDA.report. Matching records are deduplicated before they are shown below.

Matched openFDA labels page 1 of 1 · 1 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
ATOMY DERMA CALMING SUNTITANIUM DIOXIDEATOMY CO., LTD.fd5fc3ba-6e7c-4e48-8e65-47c03141df452024-01-30WarningsExact identifier
ndc (package): 52257-1400-1
ndc (product): 52257-1400
ndc11 (package): 52257140001
spl id: d9c210b4-3004-44e0-a417-0394f5af6302
spl set id: fd5fc3ba-6e7c-4e48-8e65-47c03141df45

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.