KLAVUU WHITE PEARLSATION IDEAL ACTRESS BACKSTAGE CREAM SPF30- octinoxate, titanium dioxide, octisalate cream

KLAVUU WHITE PEARLSATION Ideal Actress Backstage Cream SPF30 by

Drug Labeling and Warnings

KLAVUU WHITE PEARLSATION Ideal Actress Backstage Cream SPF30 by is a Otc medication manufactured, distributed, or labeled by Bekeikorea, Cosmax, Inc.. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

ACTIVE INGREDIENT

Octinoxate 6.70%
Titanium Dioxide 3.53%
Octisalate 2.50%

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

Water, Butylene Glycol, Glycerin, Cyclopentasiloxane, Cyclohexasiloxane, Cetyl Ethylhexanoate, Dicaprylyl Carbonate, Niacinamide, Octyldodecanol, Pentylene Glycol, Pearl Extract, Chlorella Vulgaris Extract, Codium Tomentosum Extract, Ecklonia Cava Extract, Enteromorpha Compressa Extract, Macrocystis Pyrifera (Kelp) Extract, Gelidium Cartilagineum Extract, Laminaria Japonica Extract, Sea Whip Extract, Spirulina Platensis Extract, Diethylamino Hydroxybenzoyl Hexyl Benzoate, Diphenylsiloxy Phenyl Trimethicone, Triceteareth-4 Phosphate, Glycol Stearate, Glyceryl Stearate, PEG-100 Stearate, PEG-2 Stearate, Potassium Cetyl Phosphate, Silica, Lauryl PEG-9 Polydimethylsiloxyethyl Dimethicone, Triethanolamine, Aluminum Hydroxide, Stearic Acid, Hydroxyethyl Acrylate/Sodium Acryloyldimethyl Taurate Copolymer, Squalane, Ethylhexylglycerin, Adenosine, Triethoxycaprylylsilane, Polysorbate 60, Sorbitan Isostearate, Tocopherol, 1,2-Hexanediol, Caprylyl Glycol, Carbomer, Disodium EDTA, Phenoxyethanol, Methylparaben, Fragrance(Parfum), Mica (CI 77019), Iron Oxides (CI 77492), Iron Oxides (CI 77491)

PRINCIPAL DISPLAY PANEL

INGREDIENTS AND APPEARANCE

KLAVUU WHITE PEARLSATION IDEAL ACTRESS BACKSTAGE CREAM SPF30 
octinoxate, titanium dioxide, octisalate cream

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 70976-002
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
OCTINOXATE (UNII: 4Y5P7MUD51) (OCTINOXATE - UNII:4Y5P7MUD51)	OCTINOXATE	2.01 mg  in 30 mL
TITANIUM DIOXIDE (UNII: 15FIX9V2JP) (TITANIUM DIOXIDE - UNII:15FIX9V2JP)	TITANIUM DIOXIDE	1.06 mg  in 30 mL
OCTISALATE (UNII: 4X49Y0596W) (OCTISALATE - UNII:4X49Y0596W)	OCTISALATE	0.075 mg  in 30 mL

Inactive Ingredients
Ingredient Name	Strength
WATER (UNII: 059QF0KO0R)
BUTYLENE GLYCOL (UNII: 3XUS85K0RA)
GLYCERIN (UNII: PDC6A3C0OX)
CYCLOMETHICONE 5 (UNII: 0THT5PCI0R)
CYCLOMETHICONE 6 (UNII: XHK3U310BA)
CETYL ETHYLHEXANOATE (UNII: 134647WMX4)
DICAPRYLYL CARBONATE (UNII: 609A3V1SUA)
NIACINAMIDE (UNII: 25X51I8RD4)
OCTYLDODECANOL (UNII: 461N1O614Y)
PENTYLENE GLYCOL (UNII: 50C1307PZG)
DIETHYLAMINO HYDROXYBENZOYL HEXYL BENZOATE (UNII: ANQ870JD20)
DIPHENYLSILOXY PHENYL TRIMETHICONE (UNII: I445L28B12)
TRICETEARETH-4 PHOSPHATE (UNII: 69534Y66NO)
GLYCOL STEARATE (UNII: 0324G66D0E)
PHENOXYETHANOL (UNII: HIE492ZZ3T)
GLYCERYL MONOSTEARATE (UNII: 230OU9XXE4)
PEG-100 STEARATE (UNII: YD01N1999R)
PEG-2 STEARATE (UNII: 94YQ11Y95F)
POTASSIUM CETYL PHOSPHATE (UNII: 03KCY6P7UT)
SILICON DIOXIDE (UNII: ETJ7Z6XBU4)
MICA (UNII: V8A1AW0880)
CARBOXYPOLYMETHYLENE (UNII: 0A5MM307FC)
LAURYL PEG-9 POLYDIMETHYLSILOXYETHYL DIMETHICONE (UNII: 25G622K2RA)
TROLAMINE (UNII: 9O3K93S3TK)
ALUMINUM HYDROXIDE (UNII: 5QB0T2IUN0)
STEARIC ACID (UNII: 4ELV7Z65AP)
HYDROXYETHYL ACRYLATE/SODIUM ACRYLOYLDIMETHYL TAURATE COPOLYMER (100000 MPA.S AT 1.5%) (UNII: 86FQE96TZ4)
SQUALANE (UNII: GW89575KF9)
ETHYLHEXYLGLYCERIN (UNII: 147D247K3P)
ADENOSINE (UNII: K72T3FS567)
TRIETHOXYCAPRYLYLSILANE (UNII: LDC331P08E)
FERRIC OXIDE YELLOW (UNII: EX438O2MRT)
FERRIC OXIDE RED (UNII: 1K09F3G675)
EDETATE DISODIUM (UNII: 7FLD91C86K)
POLYSORBATE 60 (UNII: CAL22UVI4M)
SORBITAN ISOSTEARATE (UNII: 01S2G2C1E4)
PEARL (HYRIOPSIS CUMINGII) (UNII: A75L5FZ40U)
CODIUM TOMENTOSUM (UNII: B8B45BRU87)
ECKLONIA CAVA (UNII: UXX2N5V39P)
ULVA COMPRESSA (UNII: SXZ209FM33)
MACROCYSTIS PYRIFERA (UNII: K31S3OG5C4)
GELIDIUM CARTILAGINEUM (UNII: 37LBZ0E1UE)
LAMINARIA JAPONICA (UNII: WE98HW412B)
TOCOPHEROL (UNII: R0ZB2556P8)
PSEUDOPTEROGORGIA ELISABETHAE (UNII: UDY3H1OUX5)
CHLORELLA VULGARIS (UNII: RYQ4R60M02)
SPIRULINA PLATENSIS (UNII: 9L3TIH1UUE)
1,2-HEXANEDIOL (UNII: TR046Y3K1G)
CAPRYLYL GLYCOL (UNII: 00YIU5438U)
METHYLPARABEN (UNII: A2I8C7HI9T)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 70976-002-02	1 in 1 CARTON	09/17/2016
1	NDC: 70976-002-01	30 mL 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	09/17/2016

Labeler - Bekeikorea (689846410)

Registrant - Bekeikorea (689846410)

Establishment
Name	Address	ID/FEI	Business Operations
Cosmax, Inc.		689049693	manufacture(70976-002)