3FUNCTION CC CREAM- octinoxate, titanium dioxide, zinc oxide, octisalate 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 CC CREAM

Titanium Dioxide (6.00%)
Ethylhexyl Methoxycinnamate (6.00%)
Ethylhexyl Salicylate (4.00%)
Zinc Oxide (2.50%)

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, 1,2-Hexanediol, Adenosine, Allantoin, BHT, Butylene Glycol, Butylene Glycol Dicaprylate/Dicaprate, Caprylhydroxamic Acid, Centella Asiatica Extract, Ceramide 3, Cetyl PEG/PPG-10/1 Dimethicone, Cyclopentasiloxane, Disodium EDTA, 4-Methylbenzylidene Camphor, Erythritol, CI 77491, CI 77492, CI 77499, Glycerin, Polyethylene, Houttuynia Cordata Extract, Sodium Hyaluronate, Hydrogenated Polyisobutene, Saccharomyces/Imperata Cylindrica Root Ferment Extract, Isopropyl Myristate, Lauryl PEG/PPG-18/18 Methicone, Lavandula Angustifolia (Lavender) Extract, Magnesium Aluminum Silicate, Magnesium Stearate, Mannitol, Caprylic/Capric Triglyceride, Naiacinamide, Origanum Vulgare Flower/Leaf/Stem Extract, Phenoxyethanol, Polymethyl Methacrylate, Rosmarinus Officinalis (Rosemary) Extract, Royal Jelly Extract, Scutellaria Baicalensis Root Extract, Silica, Sorbitan Sesquioleate, Illicium Verum (Anise) Fruit Extract, Zea Mays (Corn) Starch, Stearyl Dimethicone, Talc, Thymus Vulgaris (Thyme) Extract, Triethoxycaprylylsilane, Ubiquinone, Saccharomyces/Viscum Album (Mistletoe) Ferment Extract, Xanthan Gum, Beeswax, Dimethicone/Vinyl Dimethicone Crosspolymer, Ozokerite, Fragrance, Lactobacillus/Soybean Ferment Extract, Hydrolyzed Collagen

Enesti 3Function CC Cream

3FUNCTION CC CREAM 
octinoxate, titanium dioxide, zinc oxide, octisalate cream
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:69858-002
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
TITANIUM DIOXIDE (UNII: 15FIX9V2JP) (TITANIUM DIOXIDE - UNII:15FIX9V2JP) TITANIUM DIOXIDE1.8 g  in 30 g
OCTINOXATE (UNII: 4Y5P7MUD51) (OCTINOXATE - UNII:4Y5P7MUD51) OCTINOXATE1.8 g  in 30 g
OCTISALATE (UNII: 4X49Y0596W) (OCTISALATE - UNII:4X49Y0596W) OCTISALATE1.2 g  in 30 g
ZINC OXIDE (UNII: SOI2LOH54Z) (ZINC OXIDE - UNII:SOI2LOH54Z) ZINC OXIDE0.75 g  in 30 g
Inactive Ingredients
Ingredient NameStrength
WATER (UNII: 059QF0KO0R)  
.ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)  
1,2-HEXANEDIOL (UNII: TR046Y3K1G)  
ADENOSINE (UNII: K72T3FS567)  
ALLANTOIN (UNII: 344S277G0Z)  
BUTYLATED HYDROXYTOLUENE (UNII: 1P9D0Z171K)  
BUTYLENE GLYCOL (UNII: 3XUS85K0RA)  
BUTYLENE GLYCOL DICAPRYLATE/DICAPRATE (UNII: 75D21FL1PI)  
CAPRYLHYDROXAMIC ACID (UNII: UPY805K99W)  
CENTELLA ASIATICA (UNII: 7M867G6T1U)  
CERAMIDE 3 (UNII: 4370DF050B)  
CETYL PEG/PPG-10/1 DIMETHICONE (HLB 2) (UNII: V2W71V8T0X)  
CYCLOMETHICONE 5 (UNII: 0THT5PCI0R)  
EDETATE DISODIUM (UNII: 7FLD91C86K)  
ENZACAMENE (UNII: 8I3XWY40L9)  
ERYTHRITOL (UNII: RA96B954X6)  
FERRIC OXIDE RED (UNII: 1K09F3G675)  
FERRIC OXIDE YELLOW (UNII: EX438O2MRT)  
FERROSOFERRIC OXIDE (UNII: XM0M87F357)  
GLYCERIN (UNII: PDC6A3C0OX)  
HIGH DENSITY POLYETHYLENE (UNII: UG00KM4WR7)  
HOUTTUYNIA CORDATA FLOWERING TOP (UNII: RH041UUZ22)  
HYALURONATE SODIUM (UNII: YSE9PPT4TH)  
HYDROGENATED POLYBUTENE (1300 MW) (UNII: 7D1YQ9Y5EZ)  
IMPERATA CYLINDRICA ROOT (UNII: VYT2JA85NH)  
ISOPROPYL MYRISTATE (UNII: 0RE8K4LNJS)  
LAURYL PEG/PPG-18/18 METHICONE (UNII: ZJ5S27D9NX)  
LAVANDULA ANGUSTIFOLIA FLOWERING TOP (UNII: 9YT4B71U8P)  
MAGNESIUM ALUMINUM SILICATE (UNII: 6M3P64V0NC)  
MAGNESIUM STEARATE (UNII: 70097M6I30)  
MANNITOL (UNII: 3OWL53L36A)  
MEDIUM-CHAIN TRIGLYCERIDES (UNII: C9H2L21V7U)  
NIACINAMIDE (UNII: 25X51I8RD4)  
ORIGANUM VULGARE SUBSP. HIRTUM FLOWER (UNII: 3799SP11NY)  
PHENOXYETHANOL (UNII: HIE492ZZ3T)  
POLY(METHYL METHACRYLATE; 450000 MW) (UNII: Z47NNT4J11)  
ROSEMARY (UNII: IJ67X351P9)  
ROYAL JELLY (UNII: L497I37F0C)  
SCUTELLARIA BAICALENSIS ROOT (UNII: 7J95K7ID2S)  
SILICON DIOXIDE (UNII: ETJ7Z6XBU4)  
SORBITAN SESQUIOLEATE (UNII: 0W8RRI5W5A)  
STAR ANISE FRUIT (UNII: CK15HA8438)  
STARCH, CORN (UNII: O8232NY3SJ)  
STEARYL DIMETHICONE (400 MPA.S AT 50C) (UNII: R327X197HY)  
TALC (UNII: 7SEV7J4R1U)  
THYME (UNII: CW657OBU4N)  
TRIETHOXYCAPRYLYLSILANE (UNII: LDC331P08E)  
UBIDECARENONE (UNII: EJ27X76M46)  
VISCUM ALBUM FRUITING TOP (UNII: BK9092J5MP)  
XANTHAN GUM (UNII: TTV12P4NEE)  
YELLOW WAX (UNII: 2ZA36H0S2V)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:69858-002-021 in 1 CARTON05/21/201507/31/2017
1NDC:69858-002-0130 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.