CELLTRION UV PERFECTION ALWAYS SUN- octinoxate, octisalate, homosalate, octocrylene, titanium dioxide cream 
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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47469-480_Deactivation

ACTIVE INGREDIENT

Active ingredients: ETHYLHEXYL METHOXYCINNAMATE 6.80%, ETHYLHEXYL SALICYLATE 4.50%, HOMOSALATE 3.00%, OCTOCRYLENE 2.50%, TITANIUM DIOXIDE 2.10%

INACTIVE INGREDIENT

Inactive ingredients:

water, alcohol, C12-15 alkyl benzoate, diethylamino hydroxybenzoyl hexyl benzoate, dipropylene glycol, cyclomethicone, cetyl ethylhexanoate, C20-22 alkyl phosphate, C20-22 alcohols, 1,2-hexanediol, echium plantagineum seed oil, portulaca oleracea extract, centella asiatica extract, houttuynia cordata extract, cardiospermum halicacabum flower/leaf/vine extract, poria cocos sclerotium extract, hippophae rhamnoides fruit extract, helichrysum italicum flower water, glyceryl stearate, behenyl alcohol, aluminum stearate, tromethamine, polyhydroxystearic acid, sodium acrylate/sodium acryloyldimethyl taurate copolymer, propanediol, octyldodecanol, isohexadecane, microcrystalline cellulose, alumina, glyceryl caprylate, niacinamide, polyacrylate crosspolymer-6, xanthan gum, ethylhexylglycerin, hydroxyethyl acrylate/sodium acryloyldimethyl taurate copolymer, polysorbate 80, cellulose gum, sodium hyaluronate, butylene glycol, t-butyl alcohol, helianthus annuus (sunflower) seed oil unsaponifiables, glycerin, tocopherol, fragrance

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 UV PERFECTION ALWAYS SUN 
octinoxate, octisalate, homosalate, octocrylene, titanium dioxide cream
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:47469-480
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
OCTINOXATE (UNII: 4Y5P7MUD51) (OCTINOXATE - UNII:4Y5P7MUD51) OCTINOXATE3.4 g  in 50 mL
OCTISALATE (UNII: 4X49Y0596W) (OCTISALATE - UNII:4X49Y0596W) OCTISALATE2.25 g  in 50 mL
HOMOSALATE (UNII: V06SV4M95S) (HOMOSALATE - UNII:V06SV4M95S) HOMOSALATE1.5 g  in 50 mL
OCTOCRYLENE (UNII: 5A68WGF6WM) (OCTOCRYLENE - UNII:5A68WGF6WM) OCTOCRYLENE1.25 g  in 50 mL
TITANIUM DIOXIDE (UNII: 15FIX9V2JP) (TITANIUM DIOXIDE - UNII:15FIX9V2JP) TITANIUM DIOXIDE1.05 g  in 50 mL
Inactive Ingredients
Ingredient NameStrength
WATER (UNII: 059QF0KO0R)  
ALCOHOL (UNII: 3K9958V90M)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:47469-480-021 in 1 CARTON01/02/201801/27/2020
1NDC:47469-480-0150 mL in 1 TUBE; 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(47469-480)

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