70976-005 KLAVUU CITY DEFENSE TONE CHANGE SUN CUSHION

Drug Labeling and Warnings

Drug Details [pdf]

KLAVUU CITY DEFENSE TONE CHANGE SUN CUSHION- zinc oxide, 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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70976-005 KLAVUU CITY DEFENSE TONE CHANGE SUN CUSHION

Zinc Oxide 9.70%

Titanium Dioxide 5.95%

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, Acrylates Copolymer, Cyclohexasiloxane, Butyloctyl Salicylate, Dimethicone, Dipropylene Glycol, Alcohol Denat., Lauryl PEG-10 Tris(Trimethylsiloxy)silylethyl Dimethicone, Silica, Caprylyl Methicone, Niacinamide, Propanediol, Cetyl PEG/PPG-10/1 Dimethicone, Sodium Chloride, Dimethicone/Vinyl Dimethicone Crosspolymer, Disteardimonium Hectorite, Methyl Methacrylate Crosspolymer, Triethoxycaprylylsilane, Glyceryl Caprylate, Caprylyl Glycol, Lavandula Angustifolia (Lavender) Oil, Iron Oxides (CI 77492), Iron Oxides (CI 77491), Talc, Adenosine, Disodium EDTA, Hydrolyzed Pearl, Glycerin, Gossypium Herbaceum (Cotton) Extract, Butylene Glycol, Phenoxyethanol, Gluconolactone, Sodium Benzoate, Hydrogenated Lecithin, Calcium Gluconate, PEG-40 Hydrogenated Castor Oil, Sodium Hyaluronate

image description

KLAVUU CITY DEFENSE TONE CHANGE SUN CUSHION 
zinc oxide, titanium dioxide cream
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC: 70976-005
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
ZINC OXIDE (UNII: SOI2LOH54Z) (ZINC CATION - UNII:13S1S8SF37) ZINC CATION1.164 g  in 12 g
TITANIUM DIOXIDE (UNII: 15FIX9V2JP) (TITANIUM DIOXIDE - UNII:15FIX9V2JP) TITANIUM DIOXIDE0.714 g  in 12 g
Inactive Ingredients
Ingredient NameStrength
CYCLOMETHICONE 5 (UNII: 0THT5PCI0R)  
WATER (UNII: 059QF0KO0R)  
CYCLOMETHICONE 6 (UNII: XHK3U310BA)  
BUTYLOCTYL SALICYLATE (UNII: 2EH13UN8D3)  
DIMETHICONE (UNII: 92RU3N3Y1O)  
DIPROPYLENE GLYCOL (UNII: E107L85C40)  
ALCOHOL (UNII: 3K9958V90M)  
SILICON DIOXIDE (UNII: ETJ7Z6XBU4)  
CAPRYLYL TRISILOXANE (UNII: Q95M2P1KJL)  
NIACINAMIDE (UNII: 25X51I8RD4)  
PROPANEDIOL (UNII: 5965N8W85T)  
CETYL PEG/PPG-10/1 DIMETHICONE (HLB 2) (UNII: V2W71V8T0X)  
SODIUM CHLORIDE (UNII: 451W47IQ8X)  
DIMETHICONE/VINYL DIMETHICONE CROSSPOLYMER (HARD PARTICLE) (UNII: H895X08VNQ)  
TRIETHOXYCAPRYLYLSILANE (UNII: LDC331P08E)  
GLYCERYL MONOCAPRYLATE (UNII: TM2TZD4G4A)  
CAPRYLYL GLYCOL (UNII: 00YIU5438U)  
LAVENDER OIL (UNII: ZBP1YXW0H8)  
FERRIC OXIDE YELLOW (UNII: EX438O2MRT)  
FERRIC OXIDE RED (UNII: 1K09F3G675)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC: 70976-005-021 in 1 CARTON08/24/201711/04/2019
1NDC: 70976-005-0112 g in 1 CONTAINER; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph not finalpart35208/24/201711/04/2019
Labeler - Bekeikorea (689846410)
Registrant - Bekeikorea (689846410)
Establishment
NameAddressID/FEIBusiness Operations
Cosmax, Inc.689049693manufacture(70976-005)

Revised: 11/2019
 
Bekeikorea