3FUNCTION PEARL 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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3FUNCTION PEARL BB CREAM

Titanium Dioxide  6.88%

Ethylhexyl Methoxycinnamate  7.40%

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, Allantoin, Aloe Barbadensis Leaf Extract , Bentonite, Butylene Glycol, Caprylyl Glycol, Caprylyl Methicone, Cetyl PEG/PPG-10/1 Dimethicone, Chrysanthellum Indicum Extract, Cyclopentasiloxane, Cyclohexasiloxane, Dimethicone, Dipropylene Glycol, Disteardimonium Hectorite, Disodium EDTA, 4-Methylbenzylidene Camphor, Ethylhexylglycerin, CI 77491, CI 77492, CI 77499, Sodium Hyaluronate, Jasminum Officinale (Jasmine) Flower Extract, Leontopodium Alpinum Extract, Lilium Candidum Flower Extract, Lonicera Japonica (Honeysuckle) Flower Extract, Magnolia Biondii Flower Extract, Mica, Narcissus Pseudo-Narcissus(Daffodil)Flower Extract, Opuntia Ficus-Indica Extract, PEG-10 Dimethicone, Phenoxyethanol, Propylene Carbonate, Rosa Gallica Flower Extract, Carthamus Tinctorius (Safflower) Seed Oil, Sodium Chloride, Tin Oxide, Triethoxycaprylylsilane, Trifolium Pratense (Clover) Flower Extract, Tropolone, Ultramarine, Synthetic Fluorphlogopite, Fragrance

Enesti 3Funtion Pearl BB Cream

3FUNCTION PEARL BB CREAM 
octinoxate, titanium dioxide cream
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:69858-003
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
TITANIUM DIOXIDE (UNII: 15FIX9V2JP) (TITANIUM DIOXIDE - UNII:15FIX9V2JP) TITANIUM DIOXIDE3.1 g  in 45 g
OCTINOXATE (UNII: 4Y5P7MUD51) (OCTINOXATE - UNII:4Y5P7MUD51) OCTINOXATE3.33 g  in 45 g
Inactive Ingredients
Ingredient NameStrength
WATER (UNII: 059QF0KO0R)  
ALLANTOIN (UNII: 344S277G0Z)  
ALOE VERA LEAF (UNII: ZY81Z83H0X)  
BENTONITE (UNII: A3N5ZCN45C)  
BUTYLENE GLYCOL (UNII: 3XUS85K0RA)  
CAPRYLYL GLYCOL (UNII: 00YIU5438U)  
CAPRYLYL TRISILOXANE (UNII: Q95M2P1KJL)  
CETYL PEG/PPG-10/1 DIMETHICONE (HLB 4) (UNII: 8INO2K35FA)  
CHRYSANTHELLUM INDICUM TOP (UNII: STJ856D1Z0)  
COPTIS CHINENSIS ROOT (UNII: CXS4LJR7EL)  
CYCLOMETHICONE 5 (UNII: 0THT5PCI0R)  
CYCLOMETHICONE 6 (UNII: XHK3U310BA)  
DIMETHICONE (UNII: 92RU3N3Y1O)  
DIPROPYLENE GLYCOL CAPRYLATE (UNII: CJ981S4H3T)  
DISTEARDIMONIUM HECTORITE (UNII: X687XDK09L)  
EDETATE DISODIUM (UNII: 7FLD91C86K)  
ENZACAMENE (UNII: 8I3XWY40L9)  
ETHYLHEXYLGLYCERIN (UNII: 147D247K3P)  
FERRIC OXIDE RED (UNII: 1K09F3G675)  
FERRIC OXIDE YELLOW (UNII: EX438O2MRT)  
FERROSOFERRIC OXIDE (UNII: XM0M87F357)  
HYALURONATE SODIUM (UNII: YSE9PPT4TH)  
JASMINUM OFFICINALE FLOWER (UNII: 0Q8K841432)  
LEONTOPODIUM NIVALE SUBSP. ALPINUM ROOT (UNII: SDW6SS1K6I)  
LILIUM CANDIDUM FLOWER (UNII: COV655U2CJ)  
LONICERA JAPONICA FLOWER (UNII: 4465L2WS4Y)  
MAGNOLIA BIONDII FLOWER (UNII: G1YA92798O)  
MICA (UNII: V8A1AW0880)  
NARCISSUS PSEUDONARCISSUS FLOWER (UNII: L879RBF1WN)  
OPUNTIA FICUS-INDICA (UNII: 23Z87HTQ6P)  
PEG-10 DIMETHICONE (600 CST) (UNII: 8PR7V1SVM0)  
PHENOXYETHANOL (UNII: HIE492ZZ3T)  
PROPYLENE CARBONATE (UNII: 8D08K3S51E)  
ROSA GALLICA FLOWER (UNII: X8W61WUV70)  
SAFFLOWER OIL (UNII: 65UEH262IS)  
SODIUM CHLORIDE (UNII: 451W47IQ8X)  
STANNIC OXIDE (UNII: KM7N50LOS6)  
TRIETHOXYCAPRYLYLSILANE (UNII: LDC331P08E)  
TRIFOLIUM PRATENSE FLOWER (UNII: 4JS0838828)  
TROPOLONE (UNII: 7L6DL16P1T)  
ULTRAMARINE BLUE (UNII: I39WR998BI)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:69858-003-021 in 1 CARTON05/21/201507/31/2017
1NDC:69858-003-0145 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.