KLAVUU UV PROTECTION SECRET TONE UP SUNSCREEN- zinc oxide, homosalate, octisalate, titanium dioxide cream

KLAVUU UV Protection Secret Tone Up Sunscreen by

Drug Labeling and Warnings

KLAVUU UV Protection Secret Tone Up Sunscreen by is a Otc medication manufactured, distributed, or labeled by Bekeikorea, Kolmar Korea Co.,LTD. Gwanjeong Factory. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

ACTIVE INGREDIENT

Zinc Oxide 12.70%

Homosalate 7.50%

Octisalate 4.50%

Titanium Dioxide 2.20%

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, 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

INGREDIENTS AND APPEARANCE

KLAVUU UV PROTECTION SECRET TONE UP SUNSCREEN 
zinc oxide, homosalate, octisalate, titanium dioxide cream

Product 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)