ATOMY SUNSCREEN WHITE BROAD SPECTRUM SPF50 PLUS- octinoxate, octisalate, zinc oxide, titanium dioxide cream

ATOMY SUNSCREEN by

Drug Labeling and Warnings

ATOMY SUNSCREEN by is a Otc medication manufactured, distributed, or labeled by ATOMY CO., LTD., Kolmar Korea Co.,LTD. Gwanjeong Factory. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

ACTIVE INGREDIENT

Active Ingredient: Octinoxate 6.8%, Octisalate 4.5%, Zinc Oxide 13.44%, Titanium Dioxide 4.88%

INACTIVE INGREDIENT

Inactive Ingredients:

AQUA/WATER/EAU , CYCLOPENTASILOXANE, BUTYLENE GLYCOL, DIPROPYLENE GLYCOL, BUTYLOCTYL SALICYLATE, DICAPRYLYL CARBONATE, PEG-10 DIMETHICONE, DISTEARDIMONIUM HECTORITE, PORTULACA OLERACEA EXTRACT, MAGNESIUM SULFATE, DIMETHICONE, ALUMINUM HYDROXIDE, PHENOXYETHANOL, ALUMINUM STEARATE, FRAGRANCE(PARFUM), TRIETHOXYCAPRYLYLSILANE, METHICONE, CAPRYLYL GLYCOL, GLYCERYL CAPRYLATE, STEARIC ACID, POLYGLYCERYL-6 POLYRICINOLEATE, DIMETHICONE/VINYL DIMETHICONE CROSSPOLYMER, CAMELLIA SINENSIS LEAF EXTRACT, THYMUS VULGARIS (THYME) OIL, ALTHAEA OFFICINALIS LEAF/ROOT EXTRACT, MELISSA OFFICINALIS EXTRACT, BORAGO OFFICINALIS EXTRACT, CENTELLA ASIATICA EXTRACT, JASMINUM OFFICINALE (JASMINE) EXTRACT, PERILLA OCYMOIDES LEAF EXTRACT

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 with 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: Helps prevent sunburn. Effective for sensitive skin easily prone to sun burns.

Directions: Apply liberally before sun exposure. Children under 6 months of age: ask a doctor Reapply as needed or after swimming, perspiring, or towel drying.

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

INGREDIENTS AND APPEARANCE

ATOMY SUNSCREEN  WHITE BROAD SPECTRUM SPF50 PLUS
octinoxate, octisalate, zinc oxide, titanium dioxide cream

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 52257-1240
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
Octinoxate (UNII: 4Y5P7MUD51) (OCTINOXATE - UNII:4Y5P7MUD51)	Octinoxate	4.08 mg  in 60 mL
Octisalate (UNII: 4X49Y0596W) (OCTISALATE - UNII:4X49Y0596W)	Octisalate	2.70 mg  in 60 mL
Zinc Oxide (UNII: SOI2LOH54Z) (ZINC CATION - UNII:13S1S8SF37)	ZINC CATION	8.06 mg  in 60 mL
Titanium Dioxide (UNII: 15FIX9V2JP) (TITANIUM DIOXIDE - UNII:15FIX9V2JP)	Titanium Dioxide	2.92 mg  in 60 mL

Inactive Ingredients
Ingredient Name	Strength
WATER (UNII: 059QF0KO0R)
BUTYLOCTYL SALICYLATE (UNII: 2EH13UN8D3)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 52257-1240-1	60 mL in 1 CARTON; Type 0: Not a Combination Product	02/01/2013

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph not final	part352	02/01/2013

Labeler - ATOMY CO., LTD. (631154601)

Registrant - ATOMY CO., LTD. (631154601)

Establishment
Name	Address	ID/FEI	Business Operations
Kolmar Korea Co.,LTD. Gwanjeong Factory		689512611	manufacture(52257-1240)