CELLTRION LXTR WATER CUSHION NO 23 NATURAL BEIGE- titanium dioxide, octinoxate, octisalate, zinc oxide powder 
Celltrion Skincure Co.,Ltd.

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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47469-500_Deactivation

ACTIVE INGREDIENT

Active ingredients: TITANIUM DIOXIDE 7.68%, ETHYLHEXYL METHOXYCINNAMATE 7.00%, ETHYLHEXYL SALICYLATE 4.00%, ZINC OXIDE 2.94%

INACTIVE INGREDIENT

Inactive ingredients:

water, propanediol, diphenylsiloxy phenyl trimethicone, cyclopentasiloxane, cetyl PEG/PPG-10/1 dimethicone, diethylamino hydroxybenzoyl hexyl benzoate, butylene glycol dicaprylate/dicaprate, bis-ethylhexyloxyphenol methoxyphenyl triazine, sodium chloride, disteardimonium hectorite, diisostearyl malate, cyclohexasiloxane, polymethyl methacrylate, gynostemma pentaphyllum extract, fragrance, dimethicone, glyceryl behenate/eicosadioate, sorbitan sesquioleate, allantoin, PEG-30 dipolyhydroxystearate, triethoxycaprylylsilane, triethyl citrate, aluminum hydroxide, acrylates/ethylhexyl acrylate/dimethicone methacrylate copolymer, dimethicone/vinyl dimethicone crosspolymer, 1,2-hexanediol, disodium EDTA, biosaccharide gum-1, mica, glycerin, butylene glycol, barium sulfate, nacre powder, diamond powder, sapphire powder, amethyst powder, hydrogen dimethicone, vinyl dimethicone, ethylhexylglycerin, limnanthes alba (meadowfoam) seed oil, rosa ambassador/rosa peace phytoplacenta extract, sodium hyaluronate, asparagus officinalis stem extract, gluconolactone, undaria pinnatifida extract, calcium gluconate, hydrolyzed sodium hyaluronate, lecithin, polysorbate 20, alcohol, sh-oligopeptide-1, dipotassium phosphate, sodium ascorbyl phosphate, oligopeptide-2, oligopeptide-4, tromethamine, potassium phosphate, hydrochloric acid, iron oxides(CI 77492), iron oxides(CI 77491), iron oxides(CI 77499)

PURPOSE

Purpose: Sunscreen

WARNINGS

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 use and ask a doctor if rash occurs

Replace the cap after use

Keep out of reach of children. if swallowed, get medical help or contact a Poison Control Center right away.

DESCRIPTION

Uses:

● helps prevent sunburn

● if used as directed with other sun protection measures (see Directions), decreases the risk of skin cancer and early skin aging caused by the sun

Directions:

● apply liberally 15 minutes before sun exposure

● reapply at least every 2 hours

● use a water resistant sunscreen if swimming or sweating

● children under 6 months of age: Ask a doctor

● 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 value of 15 or higher and other sun protection measures including:

 ● limit time in the sun, especially from 10 a.m.-2 p.m.

 ● wear long-sleeved shirts, pants, hats, and sunglasses

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Image of carton

CELLTRION LXTR WATER CUSHION NO 23 NATURAL BEIGE 
titanium dioxide, octinoxate, octisalate, zinc oxide powder
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:47469-500
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
TITANIUM DIOXIDE (UNII: 15FIX9V2JP) (TITANIUM DIOXIDE - UNII:15FIX9V2JP) TITANIUM DIOXIDE0.92 g  in 12 g
OCTINOXATE (UNII: 4Y5P7MUD51) (OCTINOXATE - UNII:4Y5P7MUD51) OCTINOXATE0.84 g  in 12 g
OCTISALATE (UNII: 4X49Y0596W) (OCTISALATE - UNII:4X49Y0596W) OCTISALATE0.48 g  in 12 g
ZINC OXIDE (UNII: SOI2LOH54Z) (ZINC CATION - UNII:13S1S8SF37) ZINC CATION0.35 g  in 12 g
Inactive Ingredients
Ingredient NameStrength
WATER (UNII: 059QF0KO0R)  
PROPANEDIOL (UNII: 5965N8W85T)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:47469-500-022 in 1 CARTON01/02/201801/27/2020
1NDC:47469-500-0112 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 finalpart35201/02/201801/27/2020
Labeler - Celltrion Skincure Co.,Ltd. (690306386)
Registrant - Celltrion Skincure Co.,Ltd. (690306386)
Establishment
NameAddressID/FEIBusiness Operations
Kolmar Korea Co., Ltd.689512611manufacture(47469-500)

Revised: 1/2020
 
Celltrion Skincure Co.,Ltd.