GESGEP ONE DROP PERFECTION HEALTHY- titanium dioxide, octinoxate, octisalate, zinc oxide cream 
Daesik and Taeyoon 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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Drug Facts

Titanium Dioxide 21.49%

Octinoxate 7.00%

Octisalate 3.00%

Zinc Oxide 2.91%

Sunscreen

Helps prevent sunburn

Apply liberally 15 minutes before sun exposure.

Reapply at least every two hours

Sun protection measures. Spending time in the sun increases your risk of skin cancer and early skin aging. To decrease this risk, regularly use a sunscreen with a broad spectrum SPF of 15 of higher and other sun protection measures including: 1) Limited time in the sun, especially from 10 am to 2 pm. 2) Wear long-sleeve shirts, pants, hats, and sunglasses
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 the children. If product is swallowed, get medical help or contact a poison control center right away.

Water
Cyclopentasiloxane
Butylene Glycol
Phenyl Trimethicone
Isododecane
Dimethicone
Niacinamide
Lauryl PEG-9 Polydimethylsiloxyethyl Dimethicone
Trimethylsiloxysilicate
Sodium Chloride
Ethylene/Methacrylate Copolymer
CI 77492
PEG-10 Dimethicone
Cetyl PEG/PPG-10/1 Dimethicone
Dimethicone/Vinyl Dimethicone Crosspolymer
Triethoxycaprylylsilane
Polyglyceryl-4 Isostearate
Hexyl Laurate
Tribehenin
Panthenol
Disteardimonium Hectorite
Polyhydroxystearic Acid
Tocopheryl Acetate
Polymethylsilsesquioxane
CI 77491
Acrylates/Dimethicone Copolymer
Sodium Benzoate
Potassium Sorbate
Isostearic Acid
Lecithin
Fragrance
Propylene Carbonate
Isopropyl Palmitate
Ethylhexyl Palmitate
CI 77499
Polyglyceryl-3 Polyricinoleate
Disodium EDTA
Adenosine
Anthemis Nobilis Flower Water
Glycerin
Caprylic/Capric Triglyceride
Polyglyceryl-10 Diisostearate
Hydrogenated Lecithin
1,2-Hexanediol
Pistacia Lentiscus (Mastic) Gum
Citric Acid
Hydrolyzed Hyaluronic Acid

image description

GESGEP ONE DROP PERFECTION HEALTHY 
titanium dioxide, octinoxate, octisalate, zinc oxide cream
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:71407-003
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
TITANIUM DIOXIDE (UNII: 15FIX9V2JP) (TITANIUM DIOXIDE - UNII:15FIX9V2JP) TITANIUM DIOXIDE6.438 mg  in 30 mL
OCTINOXATE (UNII: 4Y5P7MUD51) (OCTINOXATE - UNII:4Y5P7MUD51) OCTINOXATE2.1 mg  in 30 mL
OCTISALATE (UNII: 4X49Y0596W) (OCTISALATE - UNII:4X49Y0596W) OCTISALATE0.9 mg  in 30 mL
ZINC OXIDE (UNII: SOI2LOH54Z) (ZINC CATION - UNII:13S1S8SF37) ZINC CATION0.873 mg  in 30 mL
Inactive Ingredients
Ingredient NameStrength
Water (UNII: 059QF0KO0R)  
CYCLOMETHICONE 5 (UNII: 0THT5PCI0R)  
BUTYLENE GLYCOL (UNII: 3XUS85K0RA)  
Phenyl Trimethicone (UNII: DR0K5NOJ4R)  
Isododecane (UNII: A8289P68Y2)  
Dimethicone (UNII: 92RU3N3Y1O)  
Niacinamide (UNII: 25X51I8RD4)  
LAURYL PEG-9 POLYDIMETHYLSILOXYETHYL DIMETHICONE (UNII: 25G622K2RA)  
TRIMETHYLSILOXYSILICATE (M/Q 0.6-0.8) (UNII: 5041RX63GN)  
SODIUM CHLORIDE (UNII: 451W47IQ8X)  
FERRIC OXIDE YELLOW (UNII: EX438O2MRT)  
PEG-10 DIMETHICONE (600 CST) (UNII: 8PR7V1SVM0)  
CETYL PEG/PPG-10/1 DIMETHICONE (HLB 2) (UNII: V2W71V8T0X)  
TRIETHOXYCAPRYLYLSILANE (UNII: LDC331P08E)  
Polyglyceryl-4 Isostearate (UNII: 820DPX33S7)  
Hexyl Laurate (UNII: 4CG9F9W01Q)  
Tribehenin (UNII: 8OC9U7TQZ0)  
Panthenol (UNII: WV9CM0O67Z)  
Disteardimonium Hectorite (UNII: X687XDK09L)  
POLYHYDROXYSTEARIC ACID (2300 MW) (UNII: YXH47AOU0F)  
.ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)  
POLYMETHYLSILSESQUIOXANE (4.5 MICRONS) (UNII: 59Z907ZB69)  
FERRIC OXIDE RED (UNII: 1K09F3G675)  
SODIUM BENZOATE (UNII: OJ245FE5EU)  
Potassium Sorbate (UNII: 1VPU26JZZ4)  
Isostearic Acid (UNII: X33R8U0062)  
Propylene Carbonate (UNII: 8D08K3S51E)  
Isopropyl Palmitate (UNII: 8CRQ2TH63M)  
Ethylhexyl Palmitate (UNII: 2865993309)  
FERROSOFERRIC OXIDE (UNII: XM0M87F357)  
EDETATE DISODIUM ANHYDROUS (UNII: 8NLQ36F6MM)  
ADENOSINE (UNII: K72T3FS567)  
CHAMAEMELUM NOBILE FLOWER OIL (UNII: UB27587839)  
GLYCERIN (UNII: PDC6A3C0OX)  
MEDIUM-CHAIN TRIGLYCERIDES (UNII: C9H2L21V7U)  
HYDROGENATED SOYBEAN LECITHIN (UNII: H1109Z9J4N)  
1,2-Hexanediol (UNII: TR046Y3K1G)  
PISTACIA LENTISCUS RESIN (UNII: 7446H202QW)  
CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:71407-003-021 in 1 CARTON05/15/2017
1NDC:71407-003-0130 mL in 1 CONTAINER; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph not finalpart35205/15/2017
Labeler - Daesik and Taeyoon Co., Ltd. (694818974)
Registrant - Daesik and Taeyoon Co., Ltd. (694818974)
Establishment
NameAddressID/FEIBusiness Operations
Cosmecca Korea Co., Ltd.688830827manufacture(71407-003)

Revised: 5/2017
Document Id: 5f0338a3-1f1a-4f3c-9b04-4526ca27bd82
Set id: b1a1fcf1-8ef2-4556-a377-f868ead61c89
Version: 1
Effective Time: 20170515
 
Daesik and Taeyoon Co., Ltd.