![WIKLAR UV COVER SHIELD (OCTINOXATE, ZINC OXIDE, OCTISALATE, TITANIUM DIOXIDE) CREAM [FANIPINKOREA CO., LTD.]](https://medic.hrt.org//dailymed/images/f1a9532e-589d-4070-83e9-fe44279bab3a/Wiklar UV Cover Shield.jpg)
| NDC | 71460-001-01, 71460-001-02 |
| Set ID | f1a9532e-589d-4070-83e9-fe44279bab3a |
| Category | HUMAN OTC DRUG LABEL |
| Packager | Fanipinkorea Co., Ltd. |
| Generic Name | |
| Product Class | |
| Product Number | |
| Application Number | PART352 |
- 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, 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 - PRINCIPAL DISPLAY PANEL
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INGREDIENTS AND APPEARANCE
WIKLAR UV COVER SHIELD
octinoxate, zinc oxide, octisalate, titanium dioxide creamProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:71460-001 Route of Administration TOPICAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength OCTINOXATE (UNII: 4Y5P7MUD51) (OCTINOXATE - UNII:4Y5P7MUD51) OCTINOXATE 3.5 g in 50 g ZINC OXIDE (UNII: SOI2LOH54Z) (ZINC CATION - UNII:13S1S8SF37) ZINC CATION 2.3 g in 50 g OCTISALATE (UNII: 4X49Y0596W) (OCTISALATE - UNII:4X49Y0596W) OCTISALATE 2.25 g in 50 g TITANIUM DIOXIDE (UNII: 15FIX9V2JP) (TITANIUM DIOXIDE - UNII:15FIX9V2JP) TITANIUM DIOXIDE 0.5 g in 50 g Inactive Ingredients Ingredient Name Strength WATER (UNII: 059QF0KO0R) CYCLOMETHICONE 5 (UNII: 0THT5PCI0R) ALKYL (C12-15) BENZOATE (UNII: A9EJ3J61HQ) GLYCERIN (UNII: PDC6A3C0OX) DICAPRYLYL CARBONATE (UNII: 609A3V1SUA) BEMOTRIZINOL (UNII: PWZ1720CBH) CETYL PEG/PPG-10/1 DIMETHICONE (HLB 3) (UNII: G300307ZXP) AMILOXATE (UNII: 376KTP06K8) NIACINAMIDE (UNII: 25X51I8RD4) GLYCERYL BEHENATE/EICOSADIOATE (UNII: 73CJJ317SR) DISTEARDIMONIUM HECTORITE (UNII: X687XDK09L) NYLON-12 (UNII: 446U8J075B) CYCLOMETHICONE 6 (UNII: XHK3U310BA) CERESIN (UNII: Q1LS2UJO3A) SODIUM CHLORIDE (UNII: 451W47IQ8X) POLYHYDROXYSTEARIC ACID (2300 MW) (UNII: YXH47AOU0F) SORBITAN ISOSTEARATE (UNII: 01S2G2C1E4) HYDROGEN DIMETHICONE (20 CST) (UNII: 12Z59IF64N) TRIETHYL CITRATE (UNII: 8Z96QXD6UM) PHENOXYETHANOL (UNII: HIE492ZZ3T) DIMETHICONE CROSSPOLYMER (450000 MPA.S AT 12% IN CYCLOPENTASILOXANE) (UNII: UF7620L1W6) ALUMINUM STEARATE (UNII: U6XF9NP8HM) TRIMETHYLSILOXYSILICATE (M/Q 0.6-0.8) (UNII: 5041RX63GN) BUTYLENE GLYCOL (UNII: 3XUS85K0RA) ALUMINUM OXIDE (UNII: LMI26O6933) ETHYLHEXYLGLYCERIN (UNII: 147D247K3P) .ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0) HYALURONATE SODIUM (UNII: YSE9PPT4TH) BOMBYX MORI FIBER (UNII: 6LK42KUV6W) PROPOLIS WAX (UNII: 6Y8XYV2NOF) ADENOSINE (UNII: K72T3FS567) EDETATE DISODIUM (UNII: 7FLD91C86K) ETHOHEXADIOL (UNII: M9JGK7U88V) 1,2-HEXANEDIOL (UNII: TR046Y3K1G) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:71460-001-02 1 in 1 CARTON 06/14/2018 1 NDC:71460-001-01 50 g 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 06/14/2018 Labeler - Fanipinkorea Co., Ltd. (688227653) Registrant - Fanipinkorea Co., Ltd. (688227653) Establishment Name Address ID/FEI Business Operations Fanipinkorea Co., Ltd. 688227653 manufacture(71460-001)
