GESGEP ONE DROP PERFECTION TRUE- titanium dioxide, octinoxate, octisalate, zinc oxide cream

gesgep ONE DROP PERFECTION TRUE by

Drug Labeling and Warnings

gesgep ONE DROP PERFECTION TRUE by is a Otc medication manufactured, distributed, or labeled by Daesik and Taeyoon Co., Ltd., Cosmecca Korea Co., Ltd.. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

ACTIVE INGREDIENT

Titanium Dioxide 21.49%

Octinoxate 7.00%

Octisalate 3.00%

Zinc Oxide 2.91%

PURPOSE

Sunscreen

INDICATIONS & USAGE

Helps prevent sunburn

DOSAGE & ADMINISTRATION

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

WARNINGS

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

Keep out of reach of the children. If product is swallowed, get medical help or contact a poison control center right away.

INACTIVE INGREDIENT

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

PRINCIPAL DISPLAY PANEL

INGREDIENTS AND APPEARANCE

GESGEP ONE DROP PERFECTION TRUE 
titanium dioxide, octinoxate, octisalate, zinc oxide cream

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 71407-002
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
TITANIUM DIOXIDE (UNII: 15FIX9V2JP) (TITANIUM DIOXIDE - UNII:15FIX9V2JP)	TITANIUM DIOXIDE	6.438 mg  in 30 mL
OCTINOXATE (UNII: 4Y5P7MUD51) (OCTINOXATE - UNII:4Y5P7MUD51)	OCTINOXATE	2.1 mg  in 30 mL
OCTISALATE (UNII: 4X49Y0596W) (OCTISALATE - UNII:4X49Y0596W)	OCTISALATE	0.9 mg  in 30 mL
ZINC OXIDE (UNII: SOI2LOH54Z) (ZINC CATION - UNII:13S1S8SF37)	ZINC CATION	0.873 mg  in 30 mL

Inactive Ingredients
Ingredient Name	Strength
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 Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 71407-002-02	1 in 1 CARTON	05/15/2017
1	NDC: 71407-002-01	30 mL in 1 CONTAINER; Type 0: Not a Combination Product

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph not final	part352	05/15/2017

Labeler - Daesik and Taeyoon Co., Ltd. (694818974)

Registrant - Daesik and Taeyoon Co., Ltd. (694818974)

Establishment
Name	Address	ID/FEI	Business Operations
Cosmecca Korea Co., Ltd.		688830827	manufacture(71407-002)