Label: JUNGSAEMMOOL MASTERCLASS RADIANT CUSHION Y4 SAND- titanium dioxide, octinoxate, octisalate cream
- NDC Code(s): 71261-017-01, 71261-017-02
- Packager: Jungsaemmool Beauty Co., Ltd.
- Category: HUMAN OTC DRUG LABEL
- DEA Schedule: None
- Marketing Status: OTC monograph not final
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.
Drug Label Information
Updated November 19, 2020
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- Official Label (Printer Friendly)
- ACTIVE INGREDIENT
- PURPOSE
- INDICATIONS & USAGE
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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
- KEEP OUT OF REACH OF CHILDREN
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INACTIVE INGREDIENT
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
- OTHER SAFETY INFORMATION
- PRINCIPAL DISPLAY PANEL
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INGREDIENTS AND APPEARANCE
JUNGSAEMMOOL MASTERCLASS RADIANT CUSHION Y4 SAND
titanium dioxide, octinoxate, octisalate creamProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:71261-017 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:71261-017-02 2 in 1 CARTON 11/19/2020 1 NDC:71261-017-01 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(71261-017)
