BBCREAM- titanium dioxide, ethylhexyl methoxycinnamate cream

BBCREAM by

Drug Labeling and Warnings

BBCREAM by is a Otc medication manufactured, distributed, or labeled by E-House Korea Holdings International, Enbioscience Co Ltd. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

DOSAGE & ADMINISTRATION

Directions: Apply on a clean, toned face

ACTIVE INGREDIENT

Active Ingredients: Titanium Dioxide 10.14%, Ethyhexyl Methoxycinnamate 4.5%

WHEN USING

Uses: Apply prior to sun exposure.  Re-Apply as required

PURPOSE

Purpose: Sunscreen

INACTIVE INGREDIENT

Inactive Ingredients: Water, Cyclopentasiloxane, Dimethicone, Talc, Arbutin, Dimethyl Sulfone, Aloe Barbedensis Leaf Juice, Silica

STOP USE

Caution: Do not apply to broken skin.  Avoid using on pimples and irritated skin.  Discontinue use if sun irritation develops or increases.
             If irritation persists, consult a health care practitioner.  Avoid contact with eyes

KEEP OUT OF REACH OF CHILDREN

KEEP OUT OF REACH OF CHILDREN

STORAGE AND HANDLING

Store in a cool dry place

DO NOT USE

Do not use other than directed.  For external use only

WARNINGS

Sun alert warning: Sun may cause sunburn, premature aging of the skin and skin cancer.  Avoiding the sun, wearing protective clothing and regular use of sunscreens over the years may reduce the chance of these harmful effects

PRINCIPAL DISPLAY PANEL

INGREDIENTS AND APPEARANCE

BBCREAM 
titanium dioxide, ethylhexyl methoxycinnamate cream

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 50387-300
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
TITANIUM DIOXIDE (UNII: 15FIX9V2JP) (TITANIUM DIOXIDE - UNII:15FIX9V2JP)	TITANIUM DIOXIDE	3.04 mL  in 30 mL
OCTINOXATE (UNII: 4Y5P7MUD51) (OCTINOXATE - UNII:4Y5P7MUD51)	OCTINOXATE	1.35 mL  in 30 mL

Inactive Ingredients
Ingredient Name	Strength
WATER (UNII: 059QF0KO0R)
DIMETHICONE (UNII: 92RU3N3Y1O)
TALC (UNII: 7SEV7J4R1U)
CYCLOMETHICONE 5 (UNII: 0THT5PCI0R)
SQUALENE (UNII: 7QWM220FJH)
ARBUTIN (UNII: C5INA23HXF)
POLYSORBATE 60 (UNII: CAL22UVI4M)
LICORICE (UNII: 61ZBX54883)
HYALURONATE SODIUM (UNII: YSE9PPT4TH)
ALOE VERA LEAF (UNII: ZY81Z83H0X)
SILICON DIOXIDE (UNII: ETJ7Z6XBU4)
WHEAT (UNII: 4J2I0SN84Y)
ALUMINUM HYDROXIDE (UNII: 5QB0T2IUN0)
STEARIC ACID (UNII: 4ELV7Z65AP)
APRICOT (UNII: 269CJD5GZ9)
EDETATE DISODIUM (UNII: 7FLD91C86K)
ADENOSINE (UNII: K72T3FS567)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 50387-300-30	30 mL in 1 TUBE

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph final	part352	04/20/2011

Labeler - E-House Korea Holdings International (688527548)

Registrant - E-House Korea Holdings International (688527548)

Establishment
Name	Address	ID/FEI	Business Operations
E-House Korea Holdings International		688527548	relabel

Establishment
Name	Address	ID/FEI	Business Operations
Enbioscience Co Ltd		687650226	manufacture