70976-001_Deactivation

Drug Labeling and Warnings

Drug Details [pdf]

KLAVUU RED PEARLSATION UV PROTECTION CITY DEFENCER SPF50- octinoxate, homosalate, 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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70976-001_Deactivation

Octinoxate 7.00%
Homosalate 6.00%
Octisalate 4.50%

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, Propanediol, Diethylamino Hydroxybenzoyl Hexyl Benzoate, Undecane, Niacinamide, Cyclopentasiloxane, Tridecane, Salvia Hispanica Seed Extract, Centella Asiatica Extract, Houttuynia Cordata Extract, Pentylene Glycol, Polymethyl Methacrylate, Polymethylsilsesquioxane, Phenoxyethanol, Acrylates/C10-30 Alkyl Acrylate Crosspolymer, Triethanolamine, Fragrance, Fructooligosaccharides, Saccharide Hydrolysate, Pullulan, Caprylic/Capric Triglyceride, Sodium Acrylates Copolymer, 1,2-Hexanediol, Ethylhexylglycerin, Octyldodecanol, Adenosine, Butylene Glycol, Disodium EDTA, Echium Plantagineum Seed Oil, Tocopherol, Helianthus Annuus (Sunflower) Seed Oil, Pearl Extract, Cardiospermum Halicacabum Flower/Leaf/Vine Extract, Gelidium Cartilagineum Extract, Undaria Pinnatifida Extract, Enteromorpha Compressa Extract, Laminaria Japonica Extract, Spirulina Platensis Extract, Glyceryl Stearate, Carbomer, Polysorbate 60, Ecklonia Cava Extract, Titanium Dioxide(CI77891), C12-15 Alkyl Benzoate, PEG-100 Stearate, Aluminum Stearate, Oleth-10, Polyhydroxystearic Acid, Alumina, Isodeceth-6, Simethicone, Sargassum Fulvellum Extract, Hizikia Fusiforme Extract

KLAVUU RED PEARLSATION UV PROTECTION CITY DEFENCER SPF50 
octinoxate, homosalate, octisalate cream

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 70976-001
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
OCTINOXATE (UNII: 4Y5P7MUD51) (OCTINOXATE - UNII:4Y5P7MUD51)	OCTINOXATE	3.5 mg  in 50 mL
HOMOSALATE (UNII: V06SV4M95S) (HOMOSALATE - UNII:V06SV4M95S)	HOMOSALATE	3 mg  in 50 mL
OCTISALATE (UNII: 4X49Y0596W) (OCTISALATE - UNII:4X49Y0596W)	OCTISALATE	2.25 mg  in 50 mL

Inactive Ingredients
Ingredient Name	Strength
INVERT SUGAR (UNII: ED959S6ACY)
PULLULAN (UNII: 8ZQ0AYU1TT)
MEDIUM-CHAIN TRIGLYCERIDES (UNII: C9H2L21V7U)
1,2-HEXANEDIOL (UNII: TR046Y3K1G)
ETHYLHEXYLGLYCERIN (UNII: 147D247K3P)
OCTYLDODECANOL (UNII: 461N1O614Y)
ADENOSINE (UNII: K72T3FS567)
BUTYLENE GLYCOL (UNII: 3XUS85K0RA)
EDETATE DISODIUM (UNII: 7FLD91C86K)
ECHIUM PLANTAGINEUM SEED OIL (UNII: PIB7XBU8XW)
TOCOPHEROL (UNII: R0ZB2556P8)
SUNFLOWER OIL (UNII: 3W1JG795YI)
PEARL (HYRIOPSIS CUMINGII) (UNII: A75L5FZ40U)
CARDIOSPERMUM HALICACABUM FLOWERING TOP (UNII: MZP2508BRR)
GELIDIUM CARTILAGINEUM (UNII: 37LBZ0E1UE)
UNDARIA PINNATIFIDA (UNII: ICV1OK7M1S)
ULVA COMPRESSA (UNII: SXZ209FM33)
LAMINARIA JAPONICA (UNII: WE98HW412B)
SPIRULINA PLATENSIS (UNII: 9L3TIH1UUE)
GLYCERYL MONOSTEARATE (UNII: 230OU9XXE4)
CARBOXYPOLYMETHYLENE (UNII: 0A5MM307FC)
POLYSORBATE 60 (UNII: CAL22UVI4M)
ECKLONIA CAVA (UNII: UXX2N5V39P)
TITANIUM DIOXIDE (UNII: 15FIX9V2JP)
ALKYL (C12-15) BENZOATE (UNII: A9EJ3J61HQ)
PEG-100 STEARATE (UNII: YD01N1999R)
ALUMINUM STEARATE (UNII: U6XF9NP8HM)
OLETH-10 (UNII: JD797EF70J)
POLYHYDROXYSTEARIC ACID (2300 MW) (UNII: YXH47AOU0F)
ALUMINUM OXIDE (UNII: LMI26O6933)
ISODECETH-6 (UNII: 278Z9G87XH)
SARGASSUM FULVELLUM (UNII: 245PL7LPSU)
SARGASSUM FUSIFORME (UNII: X436TJ4A11)
WATER (UNII: 059QF0KO0R)
PROPANEDIOL (UNII: 5965N8W85T)
DIETHYLAMINO HYDROXYBENZOYL HEXYL BENZOATE (UNII: ANQ870JD20)
UNDECANE (UNII: JV0QT00NUE)
NIACINAMIDE (UNII: 25X51I8RD4)
CYCLOMETHICONE 5 (UNII: 0THT5PCI0R)
TRIDECANE (UNII: A3LZF0L939)
CHIA SEED (UNII: NU0OLX06F8)
CENTELLA ASIATICA (UNII: 7M867G6T1U)
HOUTTUYNIA CORDATA FLOWERING TOP (UNII: RH041UUZ22)
PENTYLENE GLYCOL (UNII: 50C1307PZG)
POLY(METHYL METHACRYLATE; 450000 MW) (UNII: Z47NNT4J11)
POLYMETHYLSILSESQUIOXANE (4.5 MICRONS) (UNII: 59Z907ZB69)
PHENOXYETHANOL (UNII: HIE492ZZ3T)
CARBOMER INTERPOLYMER TYPE A (ALLYL SUCROSE CROSSLINKED) (UNII: 59TL3WG5CO)
TROLAMINE (UNII: 9O3K93S3TK)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 70976-001-02	1 in 1 CARTON	09/17/2016	11/04/2019
1	NDC: 70976-001-01	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	09/17/2016	11/04/2019

Labeler - Bekeikorea (689846410)

Registrant - Bekeikorea (689846410)

Establishment
Name	Address	ID/FEI	Business Operations
COSON Co., Ltd._Osan Plant		689847210	manufacture(70976-001)

Revised: 11/2019

Document Id: 968f7dc6-97fc-ded3-e053-2995a90a7797

34390-5

Set id: 589efbb6-9672-4e5b-9aa2-325dfb99d531

Version: 2

Effective Time: 20191104

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