ATOMY DERMA CALMING SUN- titanium dioxide stick

ATOMY DERMA CALMING SUN by

Drug Labeling and Warnings

ATOMY DERMA CALMING SUN by is a Otc medication manufactured, distributed, or labeled by ATOMY CO., LTD., Kolmar Korea Co.,Ltd. Bucheon Factory. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

ACTIVE INGREDIENT

Titanium Dioxide 8.86%

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.

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

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

INGREDIENTS AND APPEARANCE

ATOMY DERMA CALMING SUN 
titanium dioxide stick

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 52257-1400
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
Titanium Dioxide (UNII: 15FIX9V2JP) (TITANIUM DIOXIDE - UNII:15FIX9V2JP)	Titanium Dioxide	1.41 g  in 16 g

Inactive Ingredients
Ingredient Name	Strength
ISOPROPYL PALMITATE (UNII: 8CRQ2TH63M)
ETHYLHEXYL PALMITATE (UNII: 2865993309)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 52257-1400-1	16 g in 1 CARTON; Type 0: Not a Combination Product	05/01/2021

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC Monograph Drug	M020	05/01/2021

Labeler - ATOMY CO., LTD. (631154601)

Registrant - ATOMY CO., LTD. (631154601)

Establishment
Name	Address	ID/FEI	Business Operations
Kolmar Korea Co.,Ltd. Bucheon Factory		963271763	manufacture(52257-1400)