HANSKIN NONTOURING GRADATION PACT L21 FAIR SERUM COVER BALM- 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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47469-410 Deactivation

ACTIVE INGREDIENT

Active Ingredient: Titanium Dioxide 8.43%, Ethylhexyl Methoxycinnamate 6.00%, Ethylhexyl Salicylate 2.00%, Zinc Oxide 1.92%

INACTIVE INGREDIENT

Inactive ingredients: Water, Glycerin, Euphorbia Cerifera (Candelilla) Wax, Phenyl Trimethicone, Isoeicosane, Hexyldecyl Myristoyl Methylaminopropionate, Tridecyl Trimellitate, Butylene Glycol Dicaprylate/Dicaprate, Bis-Hydroxyethoxypropyl Dimethicone, Niacinamide, Dipropylene Glycol, Talc, Dimethicone, Lauryl PEG-8 Dimethicone, Sorbitan Sesquioleate, Disteardimonium Hectorite, Myristyl Myristate, Ceresin, Octyldodecanol, Phenoxyethanol, Propanediol, Dimethicone/PEG-10/15 Crosspolymer, C30-45 Alkyl Methicone, C30-45 Olefin, Isododecane, Fragrance, Aluminum Hydroxide, Aluminum Stearate, Methicone, Triethoxycaprylylsilane, Ethylhexylglycerin, Bis-Hydroxyethoxypropyl Dimethicone/IPDI Copolymer Ethylcarbamate, Echium Plantagineum Seed Oil, Adenosine, Xanthan Gum, Trimethylsiloxysilicate, Dimethiconol, Viscum Album (Mistletoe) Leaf Extract, Centella Asiatica Extract, Portulaca Oleracea Extract, Cardiospermum Halicacabum Flower/Leaf/Vine Extract, Helianthus Annuus (Sunflower) Seed Oil Unsaponifiables, Sodium Citrate, Tocopherol, Sodium Hyaluronate, Hydrogenated Polyisobutene, Sodium Starch Octenylsuccinate, Calcium Pantothenate, Maltodextrin, Ceramide NP, Ascorbic Acid Polypeptide, Sodium Ascorbyl Phosphate, Butylene Glycol, Pyridoxine HCL, Tocopheryl Acetate, Caprylyl Glycol, Pentylene Glycol, Silica, Soluble Collagen, Acetyl Hexapeptide-8, Anemarrhena Asphodeloides Root Extract, Triethanolamine, Iron Oxides(CI 77492), Iron Oxide(CI 77491), Iron Oxides(CI 77499)

PURPOSE

Purpose: Sunscreen

WARNINGS

Warnings: For external use only Avoid contact with eyes. Discontinue use if signs of irritation or rashes appear. If any adverse reaction occurs, stop using the product and consult with the dermatologist if symptoms persist. Do not use on deep puncture wounds, animal bites or serious burns. Replace the cap after use. Keep Out of Reach of Children

DESCRIPTION

Indications & Usage: - Helps protect skin from UV rays with SPF30 PA++. - The facial contour pact defines the natural face line conveniently anytime, anywhere by simply tapping the edge cover balm with natural non-touring effect and the moisture radiance serum. - Naturally contours the face for more balanced look of face line.

Dosage & Administration: - Take an appropriate amount with the puff and pat evenly on the entire face. - For more hygienic use of the applicator, use the brighter side of the puff to take the foundation balm while using the darker side of the puff for contouring balm. - Use the enclosed brush at your preference for more naturally smudging application of the two products. - You may mix the two products and customize your own color.

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Image of carton

HANSKIN NONTOURING GRADATION PACT L21 FAIR SERUM COVER BALM 
titanium dioxide, octinoxate, octisalate, zinc oxide powder
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:47469-410
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
TITANIUM DIOXIDE (UNII: 15FIX9V2JP) (TITANIUM DIOXIDE - UNII:15FIX9V2JP) TITANIUM DIOXIDE0.8 g  in 9.5 g
OCTINOXATE (UNII: 4Y5P7MUD51) (OCTINOXATE - UNII:4Y5P7MUD51) OCTINOXATE0.57 g  in 9.5 g
OCTISALATE (UNII: 4X49Y0596W) (OCTISALATE - UNII:4X49Y0596W) OCTISALATE0.19 g  in 9.5 g
ZINC OXIDE (UNII: SOI2LOH54Z) (ZINC CATION - UNII:13S1S8SF37) ZINC CATION0.18 g  in 9.5 g
Inactive Ingredients
Ingredient NameStrength
WATER (UNII: 059QF0KO0R)  
GLYCERIN (UNII: PDC6A3C0OX)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:47469-410-021 in 1 CARTON08/01/201712/17/2018
1NDC:47469-410-019.5 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 finalpart35208/01/201712/17/2018
Labeler - Celltrion Skincure Co.,Ltd. (690306386)
Registrant - Celltrion Skincure Co.,Ltd. (690306386)
Establishment
NameAddressID/FEIBusiness Operations
Kolmar Korea Co., Ltd.689512611manufacture(47469-410)

Revised: 12/2018
 
Celltrion Skincure Co.,Ltd.