WIKLAR UV COVER SHIELD: Package Insert and Label Information

WIKLAR UV COVER SHIELD- octinoxate, zinc oxide, octisalate and titanium dioxide cream
Fanipinkorea 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.

Octinoxate 7.00%

Zinc Oxide 4.6%
Octisalate 4.50%
Titanium Dioxide 1.00%

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, C12-15 Alkyl Benzoate, Glycerin, Dicaprylyl Carbonate, Bis-Ethylhexyloxyphenol, Methoxyphenyl Triazine, Cetyl PEG/PPG-10/1 Dimethicone, Isoamyl p-Methoxycinnamate, Niacinamide, Glyceryl Behenate/Eicosadioate, Disteardimonium Hectorite, Nylon-12, Cyclohexasiloxane, Ozokerite, Sodium Chloride, Polyhydroxystearic Acid, Sorbitan Isostearate, Hydrogen Dimethicone, Triethyl Citrate, Phenoxyethanol
Dimethicone Crosspolymer, Aluminum Stearate, Trimethylsiloxysilicate, Butylene Glycol, Alumina, Ethylhexylglycerin, Snail Secretion Filtrate, Tocopheryl Acetate, Sodium Hyaluronate, Silkworm Cocoon Extract, Propolis Extract, Beta-Glucan, Adenosine, Disodium EDTA, Ethyl Hexanediol, 1,2-Hexanediol, Fragrance

WIKLAR UV COVER SHIELD octinoxate, zinc oxide, octisalate, titanium dioxide cream

Product Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:71460-001 Route of Administration TOPICAL DEA Schedule

Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength OCTINOXATE (OCTINOXATE) OCTINOXATE 3.5 g in 50 g ZINC OXIDE (ZINC CATION) ZINC CATION 2.3 g in 50 g OCTISALATE (OCTISALATE) OCTISALATE 2.25 g in 50 g TITANIUM DIOXIDE (TITANIUM DIOXIDE) TITANIUM DIOXIDE 0.5 g in 50 g

Inactive Ingredients Ingredient Name Strength WATER CYCLOMETHICONE 5 ALKYL (C12-15) BENZOATE GLYCERIN DICAPRYLYL CARBONATE BEMOTRIZINOL CETYL PEG/PPG-10/1 DIMETHICONE (HLB 3) AMILOXATE NIACINAMIDE GLYCERYL BEHENATE/EICOSADIOATE DISTEARDIMONIUM HECTORITE NYLON-12 CYCLOMETHICONE 6 CERESIN SODIUM CHLORIDE POLYHYDROXYSTEARIC ACID (2300 MW) SORBITAN ISOSTEARATE HYDROGEN DIMETHICONE (20 CST) TRIETHYL CITRATE PHENOXYETHANOL DIMETHICONE CROSSPOLYMER (450000 MPA.S AT 12% IN CYCLOPENTASILOXANE) ALUMINUM STEARATE TRIMETHYLSILOXYSILICATE (M/Q 0.6-0.8) BUTYLENE GLYCOL ALUMINUM OXIDE ETHYLHEXYLGLYCERIN .ALPHA.-TOCOPHEROL ACETATE HYALURONATE SODIUM BOMBYX MORI FIBER PROPOLIS WAX ADENOSINE EDETATE DISODIUM ETHOHEXADIOL 1,2-HEXANEDIOL

Packaging # Item Code Package Description Multilevel Packaging 1 NDC:71460-001-02 1 CONTAINER in 1 CARTON contains a CONTAINER (71460-001-01) 1 NDC:71460-001-01 50 g in 1 CONTAINER This package is contained within the CARTON (71460-001-02)

Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC monograph not final part352 06/14/2018

Labeler — Fanipinkorea Co., Ltd. (688227653)

Registrant — Fanipinkorea Co., Ltd. (688227653)

Establishment
Name	Address	ID/FEI	Operations
Fanipinkorea Co., Ltd.		688227653	manufacture (71460-001)

Revised: 06/2018 Fanipinkorea Co., Ltd.