ATOMY MINERAL COMPACT NO.25- titanium dioxide, zinc oxide powder

ATOMY MINERAL COMPACT NO.25 by

Drug Labeling and Warnings

ATOMY MINERAL COMPACT NO.25 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

Active Ingredient: TITANIUM DIOXIDE 18.32%, ZINC OXIDE 1.92%

INACTIVE INGREDIENT

Inactive Ingredients:

MICA, TALC, SILICA, DIMETHICONE, BORON NITRIDE ,DIISOSTEARYL MALATE, TRIFLUOROMETHYL C1-4 ALKYL DIMETHICONE, TRIETHOXYCAPRYLYLSILANE, NYLON-12, DIPHENYLSILOXY PHENYL TRIMETHICONE, TRIETHYLHEXANOIN, POLYMETHYL METHACRYLATE, TOCOPHERYL ACETATE, ROYAL JELLY EXTRACT, DIPENTAERYTHRITYL HEXAHYDROXYSTEARATE/HEXASTEARATE/HEXAROSINATE, METHICONE, GLYCERYL CAPRYLATE, DIMETHICONE/VINYL DIMETHICONE CROSSPOLYMER, SILICA DIMETHYL SILYLATE, POLYGLYCERYL-2 TETRAISOSTEARATE, CAPRYLYL GLYCOL, ALUMINUM MYRISTATE, ALUMINUM HYDROXIDE, DISODIUM STEAROYL GLUTAMATE, TRIMETHYLSILOXYSILICATE, MYRISTIC ACID, PHYTOSTERYL/OCTYLDODECYL LAUROYL GLUTAMATE, ALUMINUM DIMYRISTATE, ALUMINA, MINERAL WATER, ZEA MAYS (CORN) STARCH, CALCIUM CARBONATE, HYDROXYAPATITE, PISTACIA LENTISCUS (MASTIC) GUM, PROPOLIS WAX, AQUA/WATER/EAU, ACETYL HEXAPEPTIDE-8, FRAGRANCE(PARFUM), IRON OXIDES(CI 77492), IRON OXIDES(CI 77491), IRON OXIDES(CI 77499)

PURPOSE

Purpose: Sunscreen

WARNINGS

Warnings:

For external use only. UV exposure from the sun increases the risk of skin cancer, premature skin aging and other skin damage. It is important to decrease UV exposure by limiting time in the sun, wearing protective clothing, and using a sunscreen. When using this product, keep out of eyes. Rinse water to remove. Stop use and ask a doctor, if rash or irritation develops and lasts.

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

DESCRIPTION

Uses: Provides moderate protection against adverse effects of the sun. Higher SPF gives more sunburn protection. Helps prevent sunburn. Effective for the skin highly sensitive to sunburn.

Indication and usage: Children under 6months of age: ask a doctor. Reapply as needed or after towel drying, swimming or perspiring. Not intended for protection while sunbathing.

Dosage and administration: Apply liberally before sun exposure.

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

INGREDIENTS AND APPEARANCE

ATOMY MINERAL COMPACT NO.25 
titanium dioxide, zinc oxide powder

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 52257-1300
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
TITANIUM DIOXIDE (UNII: 15FIX9V2JP) (TITANIUM DIOXIDE - UNII:15FIX9V2JP)	TITANIUM DIOXIDE	2.19 g  in 12 g
ZINC OXIDE (UNII: SOI2LOH54Z) (ZINC CATION - UNII:13S1S8SF37)	ZINC CATION	0.23 g  in 12 g

Inactive Ingredients
Ingredient Name	Strength
MICA (UNII: V8A1AW0880)
TALC (UNII: 7SEV7J4R1U)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 52257-1300-1	12 g in 1 CARTON; Type 0: Not a Combination Product	02/01/2015

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph not final	part352	02/01/2015

Labeler - ATOMY CO., LTD. (631154601)

Registrant - ATOMY CO., LTD. (631154601)

Establishment
Name	Address	ID/FEI	Business Operations
Kolmar Korea Co.,Ltd. Bucheon Factory		689847167	manufacture(52257-1300)