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

WIKLAR UV COVER SHIELD by

Drug Labeling and Warnings

WIKLAR UV COVER SHIELD by is a Otc medication manufactured, distributed, or labeled by Fanipinkorea Co., Ltd.. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

ACTIVE INGREDIENT

Octinoxate 7.00%

Zinc Oxide 4.6%
Octisalate 4.50%
Titanium Dioxide 1.00%

PURPOSE

Sunscreen

INDICATIONS & USAGE

Helps prevent sunburn

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

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 CHILDREN

Keep out of reach of the children. If product is swallowed, get medical help or contact a poison control center right away.

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

INGREDIENTS AND APPEARANCE

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

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)