KLAVUU WHITE PEARLSATION IDEAL ACTRESS BACKSTAGE CREAM SPF30- octinoxate, titanium dioxide, 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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70976-002_KLAVUU WHITE PEARLSATION Ideal Actress Backstage Cream SPF30

Octinoxate 6.70%
Titanium Dioxide 3.53%
Octisalate 2.50%

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.

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)

image description

KLAVUU WHITE PEARLSATION IDEAL ACTRESS BACKSTAGE CREAM SPF30 
octinoxate, titanium dioxide, octisalate cream
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:70976-002
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
OCTINOXATE (UNII: 4Y5P7MUD51) (OCTINOXATE - UNII:4Y5P7MUD51) OCTINOXATE2.01 mg  in 30 mL
TITANIUM DIOXIDE (UNII: 15FIX9V2JP) (TITANIUM DIOXIDE - UNII:15FIX9V2JP) TITANIUM DIOXIDE1.06 mg  in 30 mL
OCTISALATE (UNII: 4X49Y0596W) (OCTISALATE - UNII:4X49Y0596W) OCTISALATE0.075 mg  in 30 mL
Inactive Ingredients
Ingredient NameStrength
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 CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:70976-002-021 in 1 CARTON09/17/2016
1NDC:70976-002-0130 mL in 1 CONTAINER; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph not finalpart35209/17/2016
Labeler - Bekeikorea (689846410)
Registrant - Bekeikorea (689846410)
Establishment
NameAddressID/FEIBusiness Operations
Cosmax, Inc.689049693manufacture(70976-002)

Revised: 10/2018
Document Id: 797993e7-c4b7-60d8-e053-2a91aa0a08f2
Set id: 8cf1a052-a61b-453c-8e55-090256f0f97d
Version: 2
Effective Time: 20181030
 
Bekeikorea