NDC | 70976-004-01, 70976-004-02 |
Set ID | 6dc7146e-e9f7-4f1d-9314-5d1d9fd6d6b7 |
Category | HUMAN OTC DRUG LABEL |
Packager | Bekeikorea |
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
Cyclopentasiloxane, Chondrus Crispus Extract, Plankton Extract, Sea Whip Extract, Jania Rubens Extract, Phenyl Trimethicone, Glycerin, Lauryl PEG-10 Tris(Trimethylsiloxy)silylethyl Dimethicone, Trimethylsiloxysilicate, Butylene Glycol, Butylene Glycol Dicaprylate/Dicaprate, Methyl Trimethicone, Niacinamide, Pentylene Glycol, Iron Oxides (CI 77492), Acrylates/Stearyl Acrylate/Dimethicone Methacrylate Copolymer, Magnesium Sulfate, Phenoxyethanol, Disteardimonium Hectorite, Dimethicone, Caprylyl Methicone, Synthetic Fluorphlogopite, Cetyl PEG/PPG-10/1 Dimethicone, Aluminum Hydroxide, Stearic Acid, Iron Oxides (CI 77491), Dimethicone/Vinyl Dimethicone Crosspolymer, Fragrance(Parfum), Triethoxycaprylylsilane, Iron Oxides (CI 77499), Ethylhexylglycerin, Adenosine, Disodium EDTA, Water, Hydrolyzed Collagen, Hydrolyzed Pearl, Dimethicone Crosspolymer, Sodium Hyaluronate, Hydrogenated Castor Oil Isostearate, 1,2-Hexanediol, Polyglutamic Acid
- PRINCIPAL DISPLAY PANEL
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INGREDIENTS AND APPEARANCE
KLAVUU BLUEPEARLSATION HIGH COVERAGE MARINE COLLAGEN AQUA CUSHION 23
titanium dioxide, octinoxate, zinc oxide, octisalate creamProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:70976-004 Route of Administration TOPICAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength TITANIUM DIOXIDE (UNII: 15FIX9V2JP) (TITANIUM DIOXIDE - UNII:15FIX9V2JP) TITANIUM DIOXIDE 1.06 g in 12 g OCTINOXATE (UNII: 4Y5P7MUD51) (OCTINOXATE - UNII:4Y5P7MUD51) OCTINOXATE 0.84 g in 12 g ZINC OXIDE (UNII: SOI2LOH54Z) (ZINC CATION - UNII:13S1S8SF37) ZINC CATION 0.59 g in 12 g OCTISALATE (UNII: 4X49Y0596W) (OCTISALATE - UNII:4X49Y0596W) OCTISALATE 0.54 g in 12 g Inactive Ingredients Ingredient Name Strength CYCLOMETHICONE 5 (UNII: 0THT5PCI0R) CHONDRUS CRISPUS CARRAGEENAN (UNII: UE856F2T78) PSEUDOPTEROGORGIA ELISABETHAE (UNII: UDY3H1OUX5) PHENYL TRIMETHICONE (UNII: DR0K5NOJ4R) GLYCERIN (UNII: PDC6A3C0OX) TRIMETHYLSILOXYSILICATE (M/Q 0.6-0.8) (UNII: 5041RX63GN) BUTYLENE GLYCOL (UNII: 3XUS85K0RA) BUTYLENE GLYCOL DICAPRYLATE/DICAPRATE (UNII: 75D21FL1PI) METHYL TRIMETHICONE (UNII: S73ZQI0GXM) NIACINAMIDE (UNII: 25X51I8RD4) PENTYLENE GLYCOL (UNII: 50C1307PZG) FERRIC OXIDE YELLOW (UNII: EX438O2MRT) MAGNESIUM SULFATE, UNSPECIFIED FORM (UNII: DE08037SAB) PHENOXYETHANOL (UNII: HIE492ZZ3T) DISTEARDIMONIUM HECTORITE (UNII: X687XDK09L) DIMETHICONE (UNII: 92RU3N3Y1O) CAPRYLYL TRISILOXANE (UNII: Q95M2P1KJL) CETYL PEG/PPG-10/1 DIMETHICONE (HLB 2) (UNII: V2W71V8T0X) ALUMINUM HYDROXIDE (UNII: 5QB0T2IUN0) STEARIC ACID (UNII: 4ELV7Z65AP) FERRIC OXIDE RED (UNII: 1K09F3G675) DIMETHICONE/VINYL DIMETHICONE CROSSPOLYMER (HARD PARTICLE) (UNII: H895X08VNQ) TRIETHOXYCAPRYLYLSILANE (UNII: LDC331P08E) FERROSOFERRIC OXIDE (UNII: XM0M87F357) ETHYLHEXYLGLYCERIN (UNII: 147D247K3P) ADENOSINE (UNII: K72T3FS567) EDETATE DISODIUM (UNII: 7FLD91C86K) WATER (UNII: 059QF0KO0R) CALCIUM CARBONATE (UNII: H0G9379FGK) DIMETHICONE CROSSPOLYMER (450000 MPA.S AT 12% IN CYCLOPENTASILOXANE) (UNII: UF7620L1W6) HYALURONATE SODIUM (UNII: YSE9PPT4TH) 1,2-HEXANEDIOL (UNII: TR046Y3K1G) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:70976-004-02 1 in 1 CARTON 12/12/2016 1 NDC:70976-004-01 12 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 12/12/2016 Labeler - Bekeikorea (689846410) Registrant - Bekeikorea (689846410) Establishment Name Address ID/FEI Business Operations Cosmax, Inc. 689049693 manufacture(70976-004)