ENESTI MULTIPLE ESSENCE 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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ENESTI MULTIPLE ESSENCE 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.

Water, Tocopheryl Acetate, Euterpe Oleracea Fruit Extract, Adenosine, C12-15 Alkyl Benzoate, Allantoin, Sweet Almond Oil, Aloe Barbadensis Leaf Extract, Arbutin, Bentonite, Butylene Glycol, Centella Asiatica Extract, Ceresin, Cetyl Ethylhexanoate, Cetyl PEG/PPG-10/1 Dimethicone, Chrysanthellum Indicum Extract, Cyclomethicone, Cyclopentasiloxane, Cyclohexasiloxane, Dimethicone, Dimethicone/Vinyl Dimethicone Crosspolymer, Dipropylene Glycol, Disodium EDTA, 4-Methylbenzylidene Camphor, Ethylhexylglycerin, CI 77491, CI 77492, CI 77499, Glycerin, Jasminum Officinale (Jasmine) Flower Extract, Leontopodium Alpinum Extract, Cereus Grandiflorus (Cactus) Extract, Lilium Candidum Flower Extract, Lonicera Japonica (Honeysuckle) Flower Extract, Magnolia Biondii Flower Extract, Methylparaben, Mica, Narcissus Pseudo-Narcissus (Daffodil) Flower Extract, Pearl Powder, PEG/PPG-20/20 Dimethicone, PEG-10 Dimethicone, Phenoxyethanol, Phenyl Trimethicone, Polymethyl Methacrylate, Rosa Gallica Flower Extract, Silica, Sodium Chloride, Triethoxycaprylylsilane, Trifolium Pratense (Clover) Flower Extract, Trihydroxystearin, Ultramarines, Synthetic Fluorphlogopite, Vinyl Dimethicone/Methicone Silsesquioxane Crosspolymer, Coral Powder, Fragrance

Enesti Multiple Essence BB Cream

ENESTI MULTIPLE ESSENCE BB CREAM 
octinoxate, titanium dioxide cream
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:69858-005
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
TITANIUM DIOXIDE (UNII: 15FIX9V2JP) (TITANIUM DIOXIDE - UNII:15FIX9V2JP) TITANIUM DIOXIDE3.7 g  in 50 g
OCTINOXATE (UNII: 4Y5P7MUD51) (OCTINOXATE - UNII:4Y5P7MUD51) OCTINOXATE2 g  in 50 g
Inactive Ingredients
Ingredient NameStrength
WATER (UNII: 059QF0KO0R)  
.ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)  
ACAI (UNII: 46AM2VJ0AW)  
ADENOSINE (UNII: K72T3FS567)  
ALKYL (C12-15) BENZOATE (UNII: A9EJ3J61HQ)  
ALLANTOIN (UNII: 344S277G0Z)  
ALMOND OIL (UNII: 66YXD4DKO9)  
ALOE VERA LEAF (UNII: ZY81Z83H0X)  
ARBUTIN (UNII: C5INA23HXF)  
BENTONITE (UNII: A3N5ZCN45C)  
BUTYLENE GLYCOL (UNII: 3XUS85K0RA)  
CENTELLA ASIATICA (UNII: 7M867G6T1U)  
CERESIN (UNII: Q1LS2UJO3A)  
CETYL ETHYLHEXANOATE (UNII: 134647WMX4)  
CETYL PEG/PPG-10/1 DIMETHICONE (HLB 4) (UNII: 8INO2K35FA)  
CHRYSANTHELLUM INDICUM TOP (UNII: STJ856D1Z0)  
CYCLOMETHICONE (UNII: NMQ347994Z)  
CYCLOMETHICONE 5 (UNII: 0THT5PCI0R)  
CYCLOMETHICONE 6 (UNII: XHK3U310BA)  
DIMETHICONE (UNII: 92RU3N3Y1O)  
DIMETHICONE/VINYL DIMETHICONE CROSSPOLYMER (SOFT PARTICLE) (UNII: 9E4CO0W6C5)  
DIPROPYLENE GLYCOL (UNII: E107L85C40)  
EDETATE DISODIUM (UNII: 7FLD91C86K)  
ENZACAMENE (UNII: 8I3XWY40L9)  
ETHYLHEXYLGLYCERIN (UNII: 147D247K3P)  
FERRIC OXIDE RED (UNII: 1K09F3G675)  
FERRIC OXIDE YELLOW (UNII: EX438O2MRT)  
FERROSOFERRIC OXIDE (UNII: XM0M87F357)  
GLYCERIN (UNII: PDC6A3C0OX)  
JASMINUM OFFICINALE FLOWER (UNII: 0Q8K841432)  
LEONTOPODIUM NIVALE SUBSP. ALPINUM ROOT (UNII: SDW6SS1K6I)  
SELENICEREUS GRANDIFLORUS FLOWER (UNII: II877K4UNR)  
LILIUM CANDIDUM FLOWER (UNII: COV655U2CJ)  
LONICERA JAPONICA FLOWER (UNII: 4465L2WS4Y)  
MAGNOLIA BIONDII FLOWER (UNII: G1YA92798O)  
METHYLPARABEN (UNII: A2I8C7HI9T)  
MICA (UNII: V8A1AW0880)  
NARCISSUS PSEUDONARCISSUS FLOWER (UNII: L879RBF1WN)  
PEARL (HYRIOPSIS CUMINGII) (UNII: A75L5FZ40U)  
PEG/PPG-20/20 DIMETHICONE (UNII: BA94B7CK8K)  
PEG-10 DIMETHICONE (600 CST) (UNII: 8PR7V1SVM0)  
PHENOXYETHANOL (UNII: HIE492ZZ3T)  
PHENYL TRIMETHICONE (UNII: DR0K5NOJ4R)  
POLY(METHYL METHACRYLATE; 450000 MW) (UNII: Z47NNT4J11)  
ROSA GALLICA FLOWER (UNII: X8W61WUV70)  
SILICON DIOXIDE (UNII: ETJ7Z6XBU4)  
SODIUM CHLORIDE (UNII: 451W47IQ8X)  
TRIETHOXYCAPRYLYLSILANE (UNII: LDC331P08E)  
TRIFOLIUM PRATENSE FLOWER (UNII: 4JS0838828)  
TRIHYDROXYSTEARIN (UNII: 06YD7896S3)  
ULTRAMARINE BLUE (UNII: I39WR998BI)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:69858-005-021 in 1 CARTON05/21/201507/31/2017
1NDC:69858-005-0150 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.