WIKLAR UV COVER SHIELD- octinoxate, zinc oxide, octisalate, 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.

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Drug Facts

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

image description

WIKLAR UV COVER SHIELD 
octinoxate, zinc oxide, octisalate, titanium dioxide cream
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:71460-001
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
OCTINOXATE (UNII: 4Y5P7MUD51) (OCTINOXATE - UNII:4Y5P7MUD51) OCTINOXATE3.5 g  in 50 g
ZINC OXIDE (UNII: SOI2LOH54Z) (ZINC CATION - UNII:13S1S8SF37) ZINC CATION2.3 g  in 50 g
OCTISALATE (UNII: 4X49Y0596W) (OCTISALATE - UNII:4X49Y0596W) OCTISALATE2.25 g  in 50 g
TITANIUM DIOXIDE (UNII: 15FIX9V2JP) (TITANIUM DIOXIDE - UNII:15FIX9V2JP) TITANIUM DIOXIDE0.5 g  in 50 g
Inactive Ingredients
Ingredient NameStrength
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 CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:71460-001-021 in 1 CARTON06/14/2018
1NDC:71460-001-0150 g in 1 CONTAINER; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph not finalpart35206/14/2018
Labeler - Fanipinkorea Co., Ltd. (688227653)
Registrant - Fanipinkorea Co., Ltd. (688227653)
Establishment
NameAddressID/FEIBusiness Operations
Fanipinkorea Co., Ltd.688227653manufacture(71460-001)

Revised: 6/2018
Document Id: 6ea1ceaa-0d2a-5e6e-e053-2991aa0ac2f3
Set id: f1a9532e-589d-4070-83e9-fe44279bab3a
Version: 2
Effective Time: 20180614
 
Fanipinkorea Co., Ltd.