JUNGSAEMMOOL MASTERCLASS RADIANT CUSHION Y4 SAND- titanium dioxide, octinoxate, octisalate cream 
Jungsaemmool Beauty 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.

----------

71261-017_JUNGSAEMMOOL Masterclass Radiant Cushion Y4 Sand

Titanium Dioxide 14.63%
Octinoxate 6.70%
Octisalate 4.00%

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, Dimethicone, Methyl Trimethicone, Glycerin, Butylene Glycol Dicaprylate/Dicaprate, Diphenylsiloxy Phenyl Trimethicone, Lauryl PEG-10 Tris (Trimethylsiloxy)silylethyl Dimethicone, Cyclopentasiloxane, Iron Oxides (CI 77492), Butylene Glycol, Diisostearyl Malate, Niacinamide, Pentylene Glycol, Synthetic Fluorphlogopite, Cetyl Dimethicone, Cetyl PEG/PPG-10/1 Dimethicone, Diglycerin, Disteardimonium Hectorite, 1,2-Hexanediol, Acrylates/Stearyl Acrylate/Dimethicone Methacrylate Copolymer, Magnesium Sulfate, Phenoxyethanol, Dimethicone Crosspolymer, Lauroyl Lysine, Iron Oxides (CI 77491), Iron Oxides (CI 77499), Stearic Acid, Triethoxycaprylylsilane, Alumina, Polyhydroxystearic Acid, Aluminum Hydroxide, Isododecane, Octyldodecanol, PEG-9 Polydimethylsiloxyethyl Dimethicone, Polymethylsilsesquioxane, Propanediol, Fragrance(Parfum), Ethylhexylglycerin, Ethylhexyl Palmitate, Isopropyl Myristate, Isostearic Acid, Lecithin, Polypropylsilsesquioxane, Adenosine, Trisodium Ethylenediamine Disuccinate, Polyglyceryl-3 Polyricinoleate, Polyglyceryl-4 Isostearate, Opuntia Ficus-Indica Fruit Extract, Isopropyl Titanium Triisostearate, Benzyl Glycol, Hydrolyzed Glycosaminoglycans, Sodium Hyaluronate, Calcium Sodium Borosilicate, Trimethylsiloxysilicate, Sodium Hyaluronate Crosspolymer, Hydrolyzed Hyaluronic Acid, Cholesteryl Chloride, Cholesteryl Isostearate, Cholesteryl Nonanoate, Tocopherol, Diamond powder, Hydroxypropyltrimonium Hyaluronate, Tin Oxide (CI 77861), Hyaluronic Acid, BHT, Silica, Sodium Acetylated Hyaluronate

Protect the product in the container from excessive heat and direct sun

image description

JUNGSAEMMOOL MASTERCLASS RADIANT CUSHION Y4 SAND 
titanium dioxide, octinoxate, octisalate cream
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:71261-017
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
TITANIUM DIOXIDE (UNII: 15FIX9V2JP) (TITANIUM DIOXIDE - UNII:15FIX9V2JP) TITANIUM DIOXIDE146.3 mg  in 1 g
OCTINOXATE (UNII: 4Y5P7MUD51) (OCTINOXATE - UNII:4Y5P7MUD51) OCTINOXATE67 mg  in 1 g
OCTISALATE (UNII: 4X49Y0596W) (OCTISALATE - UNII:4X49Y0596W) OCTISALATE40 mg  in 1 g
Inactive Ingredients
Ingredient NameStrength
WATER (UNII: 059QF0KO0R)  
DIMETHICONE (UNII: 92RU3N3Y1O)  
METHYL TRIMETHICONE (UNII: S73ZQI0GXM)  
GLYCERIN (UNII: PDC6A3C0OX)  
BUTYLENE GLYCOL DICAPRYLATE/DICAPRATE (UNII: 75D21FL1PI)  
DIPHENYLSILOXY PHENYL TRIMETHICONE (UNII: I445L28B12)  
BUTYLENE GLYCOL (UNII: 3XUS85K0RA)  
DIISOSTEARYL MALATE (UNII: QBS8A3XZGQ)  
NIACINAMIDE (UNII: 25X51I8RD4)  
PENTYLENE GLYCOL (UNII: 50C1307PZG)  
MAGNESIUM POTASSIUM ALUMINOSILICATE FLUORIDE (UNII: YK3DC63Y5M)  
CYCLOMETHICONE 5 (UNII: 0THT5PCI0R)  
FERRIC OXIDE YELLOW (UNII: EX438O2MRT)  
CETYL PEG/PPG-10/1 DIMETHICONE (HLB 2) (UNII: V2W71V8T0X)  
DIGLYCERIN (UNII: 3YC120743U)  
1,2-HEXANEDIOL (UNII: TR046Y3K1G)  
DISTEARDIMONIUM HECTORITE (UNII: X687XDK09L)  
MAGNESIUM SULFATE, UNSPECIFIED FORM (UNII: DE08037SAB)  
PHENOXYETHANOL (UNII: HIE492ZZ3T)  
DIMETHICONE CROSSPOLYMER (450000 MPA.S AT 12% IN CYCLOPENTASILOXANE) (UNII: UF7620L1W6)  
LAUROYL LYSINE (UNII: 113171Q70B)  
STEARIC ACID (UNII: 4ELV7Z65AP)  
FERRIC OXIDE RED (UNII: 1K09F3G675)  
ALUMINUM OXIDE (UNII: LMI26O6933)  
POLYHYDROXYSTEARIC ACID (2300 MW) (UNII: YXH47AOU0F)  
ALUMINUM HYDROXIDE (UNII: 5QB0T2IUN0)  
TRIETHOXYCAPRYLYLSILANE (UNII: LDC331P08E)  
FERROSOFERRIC OXIDE (UNII: XM0M87F357)  
ISODODECANE (UNII: A8289P68Y2)  
OCTYLDODECANOL (UNII: 461N1O614Y)  
POLYMETHYLSILSESQUIOXANE (4.5 MICRONS) (UNII: 59Z907ZB69)  
PROPANEDIOL (UNII: 5965N8W85T)  
PEG-9 POLYDIMETHYLSILOXYETHYL DIMETHICONE (UNII: TYP81E471F)  
ETHYLHEXYLGLYCERIN (UNII: 147D247K3P)  
ETHYLHEXYL PALMITATE (UNII: 2865993309)  
ISOPROPYL MYRISTATE (UNII: 0RE8K4LNJS)  
ISOSTEARIC ACID (UNII: X33R8U0062)  
ADENOSINE (UNII: K72T3FS567)  
TRISODIUM ETHYLENEDIAMINE DISUCCINATE (UNII: YA22H34H9Q)  
POLYGLYCERYL-3 PENTARICINOLEATE (UNII: 7Q0OK5DOT4)  
PRICKLY PEAR FRUIT (UNII: 18V8PAQ629)  
POLYGLYCERYL-4 ISOSTEARATE (UNII: 820DPX33S7)  
ETHYLENE GLYCOL MONOBENZYL ETHER (UNII: 06S8147L47)  
ISOPROPYL TITANIUM TRIISOSTEARATE (UNII: 949E3KBJ1I)  
HYDROLYZED GLYCOSAMINOGLYCANS (BOVINE; 50000 MW) (UNII: 997385V0VV)  
HYALURONATE SODIUM (UNII: YSE9PPT4TH)  
CHOLESTERYL CHLORIDE (UNII: 39EHZ05V39)  
CHOLESTERYL ISOSTEARATE (UNII: JD5KDN9464)  
CHOLESTERYL NONANOATE (UNII: 4313O7P4XW)  
TOCOPHEROL (UNII: R0ZB2556P8)  
DIAMOND (UNII: 6GRV67N0U2)  
STANNIC OXIDE (UNII: KM7N50LOS6)  
HYALURONIC ACID (UNII: S270N0TRQY)  
BUTYLATED HYDROXYTOLUENE (UNII: 1P9D0Z171K)  
SILICON DIOXIDE (UNII: ETJ7Z6XBU4)  
SODIUM ACETYLATED HYALURONATE (UNII: WN66R7GL93)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:71261-017-022 in 1 CARTON11/19/2020
1NDC:71261-017-0115 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 finalpart35211/19/2020
Labeler - Jungsaemmool Beauty Co., Ltd. (694214725)
Registrant - Jungsaemmool Beauty Co., Ltd. (694214725)
Establishment
NameAddressID/FEIBusiness Operations
Cosmax, Inc689049693manufacture(71261-017)

Revised: 11/2020
Document Id: b4804284-a048-be12-e053-2a95a90a9acc
Set id: 6cdd03a9-594a-47c3-bcad-691bc25d245d
Version: 1
Effective Time: 20201119
 
Jungsaemmool Beauty Co., Ltd.