Label: KLAVUU WHITE PEARLSATION IDEAL ACTRESS BACKSTAGE CREAM SPF30- octinoxate, titanium dioxide, octisalate cream
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Contains inactivated NDC Code(s)
NDC Code(s): 70976-002-01, 70976-002-02 - Packager: Bekeikorea
- Category: HUMAN OTC DRUG LABEL
- DEA Schedule: None
- Marketing Status: OTC monograph not final
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.
Drug Label Information
Updated October 30, 2018
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- Official Label (Printer Friendly)
- 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
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
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INGREDIENTS AND APPEARANCE
KLAVUU WHITE PEARLSATION IDEAL ACTRESS BACKSTAGE CREAM SPF30
octinoxate, titanium dioxide, octisalate creamProduct 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)
