JUNGSAEMMOOL MASTERCLASS RADIANT CUSHION N2 VANILA- titanium dioxide, octinoxate, octisalate cream

JUNGSAEMMOOL Masterclass Radiant Cushion N2 Vanila by

Drug Labeling and Warnings

JUNGSAEMMOOL Masterclass Radiant Cushion N2 Vanila by is a Otc medication manufactured, distributed, or labeled by Jungsaemmool Beauty Co., Ltd., Cosmax, Inc. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

ACTIVE INGREDIENT

Titanium Dioxide 14.63%
Octinoxate 6.70%
Octisalate 4.00%

PURPOSE

Sunscreen

INDICATIONS & USAGE

Helps prevent sunburn

DOSAGE & ADMINISTRATION

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

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 using and ask a doctor if rash occurs.

KEEP OUT OF REACH OF CHILDREN

Keep out of reach of the children. If product is swallowed, get medical help or contact a poison control center right away.

INACTIVE INGREDIENT

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

OTHER SAFETY INFORMATION

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

PRINCIPAL DISPLAY PANEL

INGREDIENTS AND APPEARANCE

JUNGSAEMMOOL MASTERCLASS RADIANT CUSHION N2 VANILA 
titanium dioxide, octinoxate, octisalate cream

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 71261-016
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
TITANIUM DIOXIDE (UNII: 15FIX9V2JP) (TITANIUM DIOXIDE - UNII:15FIX9V2JP)	TITANIUM DIOXIDE	146.3 mg  in 1 g
OCTINOXATE (UNII: 4Y5P7MUD51) (OCTINOXATE - UNII:4Y5P7MUD51)	OCTINOXATE	67 mg  in 1 g
OCTISALATE (UNII: 4X49Y0596W) (OCTISALATE - UNII:4X49Y0596W)	OCTISALATE	40 mg  in 1 g

Inactive Ingredients
Ingredient Name	Strength
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 Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 71261-016-02	2 in 1 CARTON	11/19/2020
1	NDC: 71261-016-01	15 g in 1 CONTAINER; Type 0: Not a Combination Product

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph not final	part352	11/19/2020

Labeler - Jungsaemmool Beauty Co., Ltd. (694214725)

Registrant - Jungsaemmool Beauty Co., Ltd. (694214725)

Establishment
Name	Address	ID/FEI	Business Operations
Cosmax, Inc		689049693	manufacture(71261-016)