Label: BBCREAM- titanium dioxide, ethylhexyl methoxycinnamate cream
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Contains inactivated NDC Code(s)
NDC Code(s): 50387-300-30 - Packager: E-House Korea Holdings International
- Category: HUMAN OTC DRUG LABEL
- DEA Schedule: None
- Marketing Status: OTC monograph final
DISCLAIMER: Most OTC drugs are not reviewed and approved by FDA, however they may be marketed if they comply with applicable regulations and policies. FDA has not evaluated whether this product complies.
Drug Label Information
Updated April 17, 2011
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- DOSAGE & ADMINISTRATION
- ACTIVE INGREDIENT
- WHEN USING
- PURPOSE
- INACTIVE INGREDIENT
- STOP USE
- KEEP OUT OF REACH OF CHILDREN
- STORAGE AND HANDLING
- DO NOT USE
- WARNINGS
- PRINCIPAL DISPLAY PANEL
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INGREDIENTS AND APPEARANCE
BBCREAM
titanium dioxide, ethylhexyl methoxycinnamate creamProduct 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