ENESTI UV-CUT SUNBLOCK- octinoxate, titanium dioxide, octisalate, zinc oxide 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 UV-Cut Sunblock

Titanium Dioxide 4.7%

Ethylhexyl Methoxycinnamate 7.5%

Ethylhexyl Salicylate 5.0%

Zinc Oxide 2%

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, Allantoin, Isoamyl p-Methoxycinnamate, Butylene Glycol, Cetearyl Alcohol, Diethylamino Hydroxybenzoyl Hexyl Benzoate, Dimethicone, Disodium EDTA, Ethylhexyl Triazone, Glyceryl Stearate, Lipophilic, Glyceryl Stearate SE, Camellia Sinensis Leaf Extract, Methylparaben, Octyldodecanol, PEG-40 Stearate, Phenoxyethanol, Polysorbate 60, Propylparaben, Rosmarinus Officinalis (Rosemary) Extract, Sodium Polyacrylate, Sorbitan Sesquioleate, Stearic Acid, Water, Beeswax, Fragrance

Enesti UV-Cut Sunblock

ENESTI UV-CUT SUNBLOCK 
octinoxate, titanium dioxide, octisalate, zinc oxide cream
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:69858-004
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
TITANIUM DIOXIDE (UNII: 15FIX9V2JP) (TITANIUM DIOXIDE - UNII:15FIX9V2JP) TITANIUM DIOXIDE1.79 g  in 38.27 g
OCTINOXATE (UNII: 4Y5P7MUD51) (OCTINOXATE - UNII:4Y5P7MUD51) OCTINOXATE2.87 g  in 38.27 g
OCTISALATE (UNII: 4X49Y0596W) (OCTISALATE - UNII:4X49Y0596W) OCTISALATE1.91 g  in 38.27 g
ZINC OXIDE (UNII: SOI2LOH54Z) (ZINC CATION - UNII:13S1S8SF37) ZINC CATION0.77 g  in 38.27 g
Inactive Ingredients
Ingredient NameStrength
.ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)  
ALLANTOIN (UNII: 344S277G0Z)  
AMILOXATE (UNII: 376KTP06K8)  
BUTYLENE GLYCOL (UNII: 3XUS85K0RA)  
CETOSTEARYL ALCOHOL (UNII: 2DMT128M1S)  
DIETHYLAMINO HYDROXYBENZOYL HEXYL BENZOATE (UNII: ANQ870JD20)  
DIMETHICONE (UNII: 92RU3N3Y1O)  
EDETATE DISODIUM (UNII: 7FLD91C86K)  
ETHYLHEXYL TRIAZONE (UNII: XQN8R9SAK4)  
GLYCERYL MONOSTEARATE (UNII: 230OU9XXE4)  
GLYCERYL STEARATE SE (UNII: FCZ5MH785I)  
GREEN TEA LEAF (UNII: W2ZU1RY8B0)  
METHYLPARABEN (UNII: A2I8C7HI9T)  
OCTYLDODECANOL (UNII: 461N1O614Y)  
PEG-40 STEARATE (UNII: ECU18C66Q7)  
PHENOXYETHANOL (UNII: HIE492ZZ3T)  
POLYSORBATE 60 (UNII: CAL22UVI4M)  
PROPYLPARABEN (UNII: Z8IX2SC1OH)  
ROSEMARY (UNII: IJ67X351P9)  
SODIUM POLYACRYLATE (8000 MW) (UNII: 285CYO341L)  
SORBITAN SESQUIOLEATE (UNII: 0W8RRI5W5A)  
STEARIC ACID (UNII: 4ELV7Z65AP)  
WATER (UNII: 059QF0KO0R)  
YELLOW WAX (UNII: 2ZA36H0S2V)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:69858-004-021 in 1 CARTON05/21/201507/31/2017
1NDC:69858-004-0138.27 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
Document Id: 55b8913b-47b3-453b-e054-00144ff88e88
Set id: e341ce19-eab0-4e89-988c-da4faec87a07
Version: 2
Effective Time: 20170801
 
Enesti Co., Ltd.