SEOYOON HANBANG JA AN COVER BB CREAM- octinoxate, titanium dioxide cream 
Enesti Co., Ltd.

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.

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SEOYOON HANBANG JA AN COVER BB CREAM

Titanium Dioxide (7.40%)

 Ethylhexyl Methoxycinnamate (4.00%)

Sunscreen

Helps to prevent sunburn

Apply liberally 15 minutes before sun exposure. Reapply at least every two hours.

Ask a doctor to use for children under 6 months.

For external use only.
Do not use on damaged or broken skin.
When using this product, keep out of eyes. Rinse with water to remove
Stop using and ask a doctor if rash occurs.

Keep out of reach of children.

If product is swallowed, get medical help or contact a Poison Control Center right away.

Tocopheryl Acetate, Adenosine, C12-15 Alkyl Benzoate, Allantoin, Prunus Amygdalus Dulcis (Sweet Almond) Oil, Arbutin, Panax Ginseng Root Extract, Bentonite, Butylene Glycol, Cetyl PEG/PPG-10/1 Dimethicone, Coptis Chinensis Root Extract, Cyclopentasiloxane, Cyclohexasiloxane, Dimethicone, Dimethicone/Vinyl Dimethicone Crosspolymer, Dipropylene Glycol, Disodium EDTA, 4-Methylbenzylidene Camphor, Iron Oxides (CI 77491), Iron Oxides (CI 77492), Iron Oxides (CI 77499), Allium Sativum (Garlic) Bulb Extract, Glycerin, Dipotassium Glycyrrhizate, Camellia Sinensis Leaf Extract, Hydrogenated Lecithin, Indigofera Tinctoria Extract, Lauryl Methacrylate/Glycol Dimethacrylate Crosspolymer, Nelumbo Nucifera Flower Extract, Paeonia Suffruticosa Root Extract, PEG/PPG-20/20 Dimethicone, PEG-10 Dimethicone, Phellinus Linteus Extract, Phenyl Trimethicone, Polymethyl Methacrylate, Propylene Glycol Dicaprylate/Dicaprate, Punica Granatum Extract, Oryza Sativa (Rice) Extract, Carthamus Tinctorius (Safflower) Flower Extract, Carthamus Tinctorius (Safflower) Seed Oil, Scutellaria Baicalensis Root Extract, Scutellaria Galericulata Extract, Sesamum Indicum (Sesame) Seed Extract, Silica, Sodium Chloride, Triethoxycaprylylsilane, Trihydroxystearin, Ultramarine Blue, Water, Bees Wax, Fragrance (Ginseng), Fragrance (Sun Happy), Red Ginseng Extract, Synthetic Fluorphlogopite, Vinyl Dimethicone/Methicone Silsesquioxane Crosspolymer

image description

SEOYOON HANBANG JA AN COVER BB CREAM 
octinoxate, titanium dioxide cream
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:69858-001
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
OCTINOXATE (UNII: 4Y5P7MUD51) (OCTINOXATE - UNII:4Y5P7MUD51) OCTINOXATE1.6 g  in 40 g
TITANIUM DIOXIDE (UNII: 15FIX9V2JP) (TITANIUM DIOXIDE - UNII:15FIX9V2JP) TITANIUM DIOXIDE2.96 g  in 40 g
Inactive Ingredients
Ingredient NameStrength
ENZACAMENE (UNII: 8I3XWY40L9)  
ADENOSINE (UNII: K72T3FS567)  
ALLANTOIN (UNII: 344S277G0Z)  
GARLIC (UNII: V1V998DC17)  
ARBUTIN (UNII: C5INA23HXF)  
YELLOW WAX (UNII: 2ZA36H0S2V)  
BENTONITE (UNII: A3N5ZCN45C)  
BUTYLENE GLYCOL (UNII: 3XUS85K0RA)  
ALKYL (C12-15) BENZOATE (UNII: A9EJ3J61HQ)  
GREEN TEA LEAF (UNII: W2ZU1RY8B0)  
SAFFLOWER (UNII: 4VBL71TY4Y)  
SAFFLOWER OIL (UNII: 65UEH262IS)  
CETYL PEG/PPG-10/1 DIMETHICONE (HLB 4) (UNII: 8INO2K35FA)  
COPTIS CHINENSIS ROOT (UNII: CXS4LJR7EL)  
CYCLOMETHICONE 6 (UNII: XHK3U310BA)  
CYCLOMETHICONE 5 (UNII: 0THT5PCI0R)  
DIMETHICONE (UNII: 92RU3N3Y1O)  
DIMETHICONE/VINYL DIMETHICONE CROSSPOLYMER (SOFT PARTICLE) (UNII: 9E4CO0W6C5)  
GLYCYRRHIZINATE DIPOTASSIUM (UNII: CA2Y0FE3FX)  
DIPROPYLENE GLYCOL (UNII: E107L85C40)  
EDETATE DISODIUM (UNII: 7FLD91C86K)  
GLYCERIN (UNII: PDC6A3C0OX)  
HYDROGENATED SOYBEAN LECITHIN (UNII: H1109Z9J4N)  
INDIGOFERA TINCTORIA LEAF (UNII: 2K7DF8HZDM)  
FERRIC OXIDE RED (UNII: 1K09F3G675)  
FERRIC OXIDE YELLOW (UNII: EX438O2MRT)  
FERROSOFERRIC OXIDE (UNII: XM0M87F357)  
LAURYL METHACRYLATE/GLYCOL DIMETHACRYLATE CROSSPOLYMER (UNII: EX0F4CZ66H)  
NELUMBO NUCIFERA FLOWER (UNII: 61W322NLDV)  
RICE GERM (UNII: 7N2B70SFEZ)  
PAEONIA SUFFRUTICOSA ROOT (UNII: 7M7E9A2C8J)  
ASIAN GINSENG (UNII: CUQ3A77YXI)  
PEG/PPG-20/20 DIMETHICONE (UNII: BA94B7CK8K)  
PEG-10 DIMETHICONE (600 CST) (UNII: 8PR7V1SVM0)  
PHELLINUS LINTEUS MYCELIUM (UNII: 40K19XJV3C)  
PHENYL TRIMETHICONE (UNII: DR0K5NOJ4R)  
POLY(METHYL METHACRYLATE; 450000 MW) (UNII: Z47NNT4J11)  
PROPYLENE GLYCOL DICAPRYLATE/DICAPRATE (UNII: O4446S9CRA)  
ALMOND OIL (UNII: 66YXD4DKO9)  
PUNICA GRANATUM ROOT BARK (UNII: CLV24I3T1D)  
SCUTELLARIA BAICALENSIS ROOT (UNII: 7J95K7ID2S)  
SCUTELLARIA GALERICULATA LEAF (UNII: 08OTK3OU82)  
SESAME SEED (UNII: 7Y1255HVXR)  
SILICON DIOXIDE (UNII: ETJ7Z6XBU4)  
SODIUM CHLORIDE (UNII: 451W47IQ8X)  
.ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)  
TRIETHOXYCAPRYLYLSILANE (UNII: LDC331P08E)  
TRIHYDROXYSTEARIN (UNII: 06YD7896S3)  
ULTRAMARINE BLUE (UNII: I39WR998BI)  
WATER (UNII: 059QF0KO0R)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:69858-001-021 in 1 CARTON05/21/201507/31/2017
1NDC:69858-001-0140 g in 1 CONTAINER; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph not finalpart35205/21/201507/31/2017
Labeler - Enesti Co., Ltd. (688304598)
Registrant - Enesti Co., Ltd. (688304598)

Revised: 8/2017
 
Enesti Co., Ltd.