KLAVUU UV PROTECTION SECRET TONE UP SUNSCREEN- zinc oxide, homosalate, octisalate, titanium dioxide 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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70976-007_KLAVUU UV Protection Secret Tone Up Sunscreen

Zinc Oxide 12.70%

Homosalate 7.50%

Octisalate 4.50%

Titanium Dioxide 2.20%

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, 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

image description

KLAVUU UV PROTECTION SECRET TONE UP SUNSCREEN 
zinc oxide, homosalate, octisalate, titanium dioxide cream
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:70976-007
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
ZINC OXIDE (UNII: SOI2LOH54Z) (ZINC CATION - UNII:13S1S8SF37) ZINC CATION6.35 mg  in 50 mL
HOMOSALATE (UNII: V06SV4M95S) (HOMOSALATE - UNII:V06SV4M95S) HOMOSALATE3.75 mg  in 50 mL
OCTISALATE (UNII: 4X49Y0596W) (OCTISALATE - UNII:4X49Y0596W) OCTISALATE2.25 mg  in 50 mL
TITANIUM DIOXIDE (UNII: 15FIX9V2JP) (TITANIUM DIOXIDE - UNII:15FIX9V2JP) TITANIUM DIOXIDE1.1 mg  in 50 mL
Inactive Ingredients
Ingredient NameStrength
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 CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:70976-007-021 in 1 CARTON03/17/2021
1NDC:70976-007-0150 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 finalpart35203/17/2021
Labeler - Bekeikorea (689846410)
Registrant - Bekeikorea (689846410)
Establishment
NameAddressID/FEIBusiness Operations
Kolmar Korea Co.,LTD. Gwanjeong Factory689512611manufacture(70976-007)

Revised: 4/2021
Document Id: bfca6333-4235-5f12-e053-2995a90a26ae
Set id: 479d3d89-029e-4e78-914a-fee839877e02
Version: 2
Effective Time: 20210412
 
Bekeikorea