KLAVUU BLUEPEARLSATION HIGH COVERAGE MARINE COLLAGEN AQUA CUSHION 23- titanium dioxide, octinoxate, zinc oxide, octisalate cream 
Bekeikorea

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

Titanium Dioxide 8.83%
Octinoxate 7.00%
Zinc Oxide 4.90%
Octisalate 4.50%

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.

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

image description

KLAVUU BLUEPEARLSATION HIGH COVERAGE MARINE COLLAGEN AQUA CUSHION 23 
titanium dioxide, octinoxate, zinc oxide, octisalate cream
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:70976-004
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
TITANIUM DIOXIDE (UNII: 15FIX9V2JP) (TITANIUM DIOXIDE - UNII:15FIX9V2JP) TITANIUM DIOXIDE1.06 g  in 12 g
OCTINOXATE (UNII: 4Y5P7MUD51) (OCTINOXATE - UNII:4Y5P7MUD51) OCTINOXATE0.84 g  in 12 g
ZINC OXIDE (UNII: SOI2LOH54Z) (ZINC CATION - UNII:13S1S8SF37) ZINC CATION0.59 g  in 12 g
OCTISALATE (UNII: 4X49Y0596W) (OCTISALATE - UNII:4X49Y0596W) OCTISALATE0.54 g  in 12 g
Inactive Ingredients
Ingredient NameStrength
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 CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:70976-004-021 in 1 CARTON12/12/201612/17/2021
1NDC:70976-004-0112 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 finalpart35212/12/201612/17/2021
Labeler - Bekeikorea (689846410)
Registrant - Bekeikorea (689846410)
Establishment
NameAddressID/FEIBusiness Operations
Cosmax, Inc.689049693manufacture(70976-004)

Revised: 12/2021
 
Bekeikorea