Label: GESGEP ONE DROP PERFECTION HEALTHY- titanium dioxide, octinoxate, octisalate, zinc oxide cream
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Contains inactivated NDC Code(s)
NDC Code(s): 71407-003-01, 71407-003-02 - Packager: Daesik and Taeyoon Co., Ltd.
- Category: HUMAN OTC DRUG LABEL
- DEA Schedule: None
- Marketing Status: OTC monograph not final
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.
Drug Label Information
Updated May 15, 2017
If you are a consumer or patient please visit this version.
- Download DRUG LABEL INFO: PDF XML
- Official Label (Printer Friendly)
- ACTIVE INGREDIENT
- PURPOSE
- INDICATIONS & USAGE
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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
- KEEP OUT OF REACH OF CHILDREN
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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
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INGREDIENTS AND APPEARANCE
GESGEP ONE DROP PERFECTION HEALTHY
titanium dioxide, octinoxate, octisalate, zinc oxide creamProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:71407-003 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:71407-003-02 1 in 1 CARTON 05/15/2017 1 NDC:71407-003-01 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(71407-003)
