KLAVUU BLUEPEARLSATION HIGH COVERAGE MARINE COLLAGEN AQUA CUSHION 21- titanium dioxide, octinoxate, zinc oxide, octisalate cream

KLAVUU BLUEPEARLSATION High Coverage Marine Collagen Aqua Cushion 21 by

Drug Labeling and Warnings

KLAVUU BLUEPEARLSATION High Coverage Marine Collagen Aqua Cushion 21 by is a Otc medication manufactured, distributed, or labeled by Bekeikorea, Cosmax, Inc.. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

ACTIVE INGREDIENT

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

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

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, Cetyl PEG/PPG-10/1 Dimethicone, Aluminum Hydroxide, Synthetic Fluorphlogopite, Stearic Acid, Dimethicone/Vinyl Dimethicone Crosspolymer, Fragrance(Parfum), Iron Oxides (CI 77491), 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

INGREDIENTS AND APPEARANCE

KLAVUU BLUEPEARLSATION HIGH COVERAGE MARINE COLLAGEN AQUA CUSHION 21 
titanium dioxide, octinoxate, zinc oxide, octisalate cream

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 70976-003
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
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)
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)
DIMETHICONE/VINYL DIMETHICONE CROSSPOLYMER (HARD PARTICLE) (UNII: H895X08VNQ)
FERRIC OXIDE RED (UNII: 1K09F3G675)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 70976-003-02	1 in 1 CARTON	12/12/2016
1	NDC: 70976-003-01	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(70976-003)