Gesgep ONE DROP PERFECTION TRUE: Package Insert and Label Information

GESGEP ONE DROP PERFECTION TRUE- titanium dioxide, octinoxate, octisalate and 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.

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 AcidHydrolyzed Hyaluronic Acid

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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 DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
TITANIUM DIOXIDE (TITANIUM DIOXIDE) TITANIUM DIOXIDE 6.438 mg in 30 mL
OCTINOXATE (OCTINOXATE) OCTINOXATE 2.1 mg in 30 mL
OCTISALATE (OCTISALATE) OCTISALATE 0.9 mg in 30 mL
ZINC OXIDE (ZINC CATION) ZINC CATION 0.873 mg in 30 mL
Inactive Ingredients
Ingredient Name Strength
Water
CYCLOMETHICONE 5
BUTYLENE GLYCOL
Phenyl Trimethicone
Isododecane
Dimethicone
Niacinamide
LAURYL PEG-9 POLYDIMETHYLSILOXYETHYL DIMETHICONE
TRIMETHYLSILOXYSILICATE (M/Q 0.6-0.8)
SODIUM CHLORIDE
FERRIC OXIDE YELLOW
PEG-10 DIMETHICONE (600 CST)
CETYL PEG/PPG-10/1 DIMETHICONE (HLB 2)
TRIETHOXYCAPRYLYLSILANE
Polyglyceryl-4 Isostearate
Hexyl Laurate
Tribehenin
Panthenol
Disteardimonium Hectorite
POLYHYDROXYSTEARIC ACID (2300 MW)
.ALPHA.-TOCOPHEROL ACETATE
POLYMETHYLSILSESQUIOXANE (4.5 MICRONS)
FERRIC OXIDE RED
SODIUM BENZOATE
Potassium Sorbate
Isostearic Acid
Propylene Carbonate
Isopropyl Palmitate
Ethylhexyl Palmitate
FERROSOFERRIC OXIDE
EDETATE DISODIUM ANHYDROUS
ADENOSINE
CHAMAEMELUM NOBILE FLOWER OIL
GLYCERIN
MEDIUM-CHAIN TRIGLYCERIDES
HYDROGENATED SOYBEAN LECITHIN
1,2-Hexanediol
PISTACIA LENTISCUS RESIN
CITRIC ACID MONOHYDRATE
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:71407-002-02 1 CONTAINER in 1 CARTON contains a CONTAINER (71407-002-01)
1 NDC:71407-002-01 30 mL in 1 CONTAINER This package is contained within the CARTON (71407-002-02)
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 Operations
Cosmecca Korea Co., Ltd. 688830827 manufacture (71407-002)

Revised: 05/2017 Daesik and Taeyoon Co., Ltd.

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