ATOMY BB BROAD SPECTRUM- titanium dioxide, octinoxate, zinc oxide cream

ATOMY BB Broad Spectrum by

Drug Labeling and Warnings

ATOMY BB Broad Spectrum 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 Ingredients: Titanium Dioxide 7.92%, Octinoxate 3.50%, Zinc Oxide 1.92%

INACTIVE INGREDIENT

Inactive Ingredients:

AQUA/WATER/EAU ,BUTYLENE GLYCOL, CYCLOMETHICONE,DIMETHICONE, ISOPROPYL PALMITATE,TALC, PRUNUS AMYGDALUS DULCIS (SWEET ALMOND) OIL, BUTYLENE GLYCOL DICAPRYLATE/DICAPRATE, HEXYLDECYL MYRISTOYL METHYLAMINOPROPIONATE, ARBUTIN,CETYL PEG/PPG-10/1 DIMETHICONE,DIPENTAERYTHRITYL HEXAHYDROXYSTEARATE/HEXASTEARATE/HEXAROSINATE, DIMETHICONE/VINYL DIMETHICONE CROSSPOLYMER, HYDROGENATED POLY (C6-14OLEFIN),MAGNESIUM SULFATE,SQUALANE,POLYGLYCERYL-4 ISOSTEARATE, PORTULACA OLERACEA EXTRACT,VINYL DIMETHICONE/METHICONE SILSESQUIOXANE CROSSPOLYMER,IRON OXIDES (CI77492), DISTEARDIMONIUM HECTORITE,CAPRYLYL GLYCOL, GLYCERYLCAPRYLATE,IRON OXIDES (CI77491),IRON OXIDES (CI77499),TRIHYDROXYSTEARIN, METHICONE,GLYCOSYL TREHALOSE,FRAGRANCE(PARFUM), HYDROGENATED STARCH HYDROLYSATE,CAMELLIA SINENSIS LEAF EXTRACT, SILICA,TOCOPHERYL ACETATE, ALUMINUM HYDROXIDE, ALUMINUM STEARATE, ALTHAEA OFFICINALIS LEAF/ROOT EXTRACT,BORAGO OFFICINALIS EXTRACT, MELISSA OFFICINALIS LEAF EXTRACT,ROSMARINUS OFFICINALIS (ROSEMARY) 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 before use if rash or irritation develops and lasts.
Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center.

DESCRIPTION

Directions: 1. Apply after basic skin care product. 2. Spread an appropriate amount over the entire face following the skin texture. 3. Reapply as required.

Uses: 1. Helps prevent sunburn. 2. Provides high protection against sunburn. 3. Higher SPF gives more sunburn protection.

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

INGREDIENTS AND APPEARANCE

ATOMY BB BROAD SPECTRUM 
titanium dioxide, octinoxate, zinc oxide cream

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 52257-1330
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
Titanium Dioxide (UNII: 15FIX9V2JP) (TITANIUM DIOXIDE - UNII:15FIX9V2JP)	Titanium Dioxide	3.16 g  in 40 mL
Octinoxate (UNII: 4Y5P7MUD51) (OCTINOXATE - UNII:4Y5P7MUD51)	Octinoxate	1.4 g  in 40 mL
Zinc Oxide (UNII: SOI2LOH54Z) (ZINC CATION - UNII:13S1S8SF37)	ZINC CATION	0.76 g  in 40 mL

Inactive Ingredients
Ingredient Name	Strength
WATER (UNII: 059QF0KO0R)
BUTYLENE GLYCOL (UNII: 3XUS85K0RA)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 52257-1330-1	40 mL in 1 CARTON; Type 0: Not a Combination Product	07/01/2013

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph not final	part352	07/01/2013

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(52257-1330)