Label: KLAVUU UV PROTECTION SECRET TONE UP SUNSCREEN- zinc oxide, homosalate, octisalate, titanium dioxide cream
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Contains inactivated NDC Code(s)
NDC Code(s): 70976-007-01, 70976-007-02 - 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 April 12, 2021
If you are a consumer or patient please visit this version.
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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, CYCLOPENTASILOXANE, DIPROPYLENE GLYCOL, DISILOXANE, LAURYL PEG-10 TRIS(TRIMETHYLSILOXY)SILYLETHYLDIMETHICONE, GLYCERIN, NIACINAMIDE, CAPRYLYL METHICONE, PROPYLHEPTYL CAPRYLATE, SILICA, DIMETHICONE, DISTEARDIMONIUM HECTORITE, MAGNESIUM SULFATE, 1,2-HEXANEDIOL, VINYL DIMETHICONE/METHICONE SILSESQUIOXANECROSSPOLYMER, TRIETHOXYCAPRYLYLSILANE, STEARIC ACID, ALUMINUM HYDROXIDE, SORBITAN CAPRYLATE, DIMETHICONE/PEG-10/15 CROSSPOLYMER, FRAGRANCE, DIMETHICONE/VINYL DIMETHICONE CROSSPOLYMER, GLYCERYL CAPRYLATE, ETHYLHEXYLGLYCERIN, ADENOSINE, SODIUM CITRATE, TOCOPHEROL, CAPRYLIC/CAPRIC TRIGLYCERIDE, BUTYLENE GLYCOL, PEARL EXTRACT, UNDARIA PINNATIFIDA EXTRACT, CENTELLA ASIATICA EXTRACT, ECKLONIA CAVA EXTRACT, SOLUBLE COLLAGEN, HYDROLYZED COLLAGEN
- PRINCIPAL DISPLAY PANEL
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INGREDIENTS AND APPEARANCE
KLAVUU UV PROTECTION SECRET TONE UP SUNSCREEN
zinc oxide, homosalate, octisalate, titanium dioxide creamProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:70976-007 Route of Administration TOPICAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength ZINC OXIDE (UNII: SOI2LOH54Z) (ZINC CATION - UNII:13S1S8SF37) ZINC CATION 6.35 mg in 50 mL HOMOSALATE (UNII: V06SV4M95S) (HOMOSALATE - UNII:V06SV4M95S) HOMOSALATE 3.75 mg in 50 mL OCTISALATE (UNII: 4X49Y0596W) (OCTISALATE - UNII:4X49Y0596W) OCTISALATE 2.25 mg in 50 mL TITANIUM DIOXIDE (UNII: 15FIX9V2JP) (TITANIUM DIOXIDE - UNII:15FIX9V2JP) TITANIUM DIOXIDE 1.1 mg in 50 mL Inactive Ingredients Ingredient Name Strength WATER (UNII: 059QF0KO0R) CYCLOMETHICONE 5 (UNII: 0THT5PCI0R) DIPROPYLENE GLYCOL (UNII: E107L85C40) HEXAMETHYLDISILOXANE (UNII: D7M4659BPU) GLYCERIN (UNII: PDC6A3C0OX) NIACINAMIDE (UNII: 25X51I8RD4) CAPRYLYL TRISILOXANE (UNII: Q95M2P1KJL) PROPYLHEPTYL CAPRYLATE (UNII: 991Z19V2OD) SILICON DIOXIDE (UNII: ETJ7Z6XBU4) DIMETHICONE (UNII: 92RU3N3Y1O) DISTEARDIMONIUM HECTORITE (UNII: X687XDK09L) MAGNESIUM SULFATE, UNSPECIFIED FORM (UNII: DE08037SAB) 1,2-HEXANEDIOL (UNII: TR046Y3K1G) TRIETHOXYCAPRYLYLSILANE (UNII: LDC331P08E) STEARIC ACID (UNII: 4ELV7Z65AP) ALUMINUM HYDROXIDE (UNII: 5QB0T2IUN0) SORBITAN MONOCAPRYLATE (UNII: 1VTA8DCP5Q) DIMETHICONE/PEG-10/15 CROSSPOLYMER (UNII: 21AS8B1BSS) DIMETHICONE/VINYL DIMETHICONE CROSSPOLYMER (HARD PARTICLE) (UNII: H895X08VNQ) GLYCERYL MONOCAPRYLATE (UNII: TM2TZD4G4A) ETHYLHEXYLGLYCERIN (UNII: 147D247K3P) ADENOSINE (UNII: K72T3FS567) SODIUM CITRATE, UNSPECIFIED FORM (UNII: 1Q73Q2JULR) TOCOPHEROL (UNII: R0ZB2556P8) MEDIUM-CHAIN TRIGLYCERIDES (UNII: C9H2L21V7U) BUTYLENE GLYCOL (UNII: 3XUS85K0RA) UNDARIA PINNATIFIDA (UNII: ICV1OK7M1S) CENTELLA ASIATICA WHOLE (UNII: 7M867G6T1U) ECKLONIA CAVA (UNII: UXX2N5V39P) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:70976-007-02 1 in 1 CARTON 03/17/2021 1 NDC:70976-007-01 50 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 03/17/2021 Labeler - Bekeikorea (689846410) Registrant - Bekeikorea (689846410) Establishment Name Address ID/FEI Business Operations Kolmar Korea Co.,LTD. Gwanjeong Factory 689512611 manufacture(70976-007)
