Label: JUNGSAEMMOOL ESSENTIAL SKIN NUDER CUSHION MEDIUM DEEP- titanium dioxide, octinoxate, octisalate cream
- NDC Code(s): 71261-034-01, 71261-034-02
- Packager: Jungsaemmool Beauty Co., Ltd.
- Category: HUMAN OTC DRUG LABEL
- DEA Schedule: None
Drug Label Information
Updated August 4, 2024
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- ACTIVE INGREDIENT
- PURPOSE
- INDICATIONS & USAGE
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DOSAGE & ADMINISTRATION
For sunscreen use:
Apply liberally 15 minutes before sun exposureReapply at least every two hours
Use a water-resistant sunscreen if swimming or sweating
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 sunglassesAsk a doctor to use for children under 6 months
- WARNINGS
- KEEP OUT OF REACH OF CHILDREN
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INACTIVE INGREDIENT
Water, Cyclopentasiloxane, Titanium Dioxide (CI 77891), Glycerin, Propanediol, Trimethylsiloxysilicate, Iron Oxides (CI 77492), PEG-10 Dimethicone, Cetyl Ethylhexanoate, Trisiloxane, 1,2-Hexanediol, Caprylyl Methicone, Dimethicone, Hydrogenated Coconut Oil, Polypropylsilsesquioxane, VP/Hexadecene Copolymer, Disteardimonium Hectorite, Magnesium Sulfate, Acrylates/Dimethicone Copolymer, Iron Oxides (CI 77491), Cetyl PEG/PPG-10/1 Dimethicone, Synthetic Fluorphlogopite, Iron Oxides (CI 77499), Triethoxycaprylylsilane, Stearic Acid, Alumina, Aluminum Hydroxide, Glyceryl Caprylate, Fragrance(Parfum), Dimethicone Crosspolymer, Trisodium Ethylenediamine Disuccinate, BHT, Mica (CI 77019), Pentaerythrityl Tetra-di-t-butyl Hydroxyhydrocinnamate, Tin Oxide (CI 77861)
- OTHER SAFETY INFORMATION
- PRINCIPAL DISPLAY PANEL
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INGREDIENTS AND APPEARANCE
JUNGSAEMMOOL ESSENTIAL SKIN NUDER CUSHION MEDIUM DEEP
titanium dioxide, octinoxate, octisalate creamProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:71261-034 Route of Administration TOPICAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength TITANIUM DIOXIDE (UNII: 15FIX9V2JP) (TITANIUM DIOXIDE - UNII:15FIX9V2JP) TITANIUM DIOXIDE 65.1 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) CYCLOMETHICONE 5 (UNII: 0THT5PCI0R) GLYCERIN (UNII: PDC6A3C0OX) PROPANEDIOL (UNII: 5965N8W85T) TRIMETHYLSILOXYSILICATE (M/Q 0.6-0.8) (UNII: 5041RX63GN) FERRIC OXIDE YELLOW (UNII: EX438O2MRT) PEG-10 DIMETHICONE (200 CST) (UNII: 287GF3Y3WC) CETYL ETHYLHEXANOATE (UNII: 134647WMX4) TRISILOXANE (UNII: 9G1ZW13R0G) 1,2-HEXANEDIOL (UNII: TR046Y3K1G) CAPRYLYL TRISILOXANE (UNII: Q95M2P1KJL) DIMETHICONE (UNII: 92RU3N3Y1O) HYDROGENATED COCONUT OIL (UNII: JY81OXM1OM) VINYLPYRROLIDONE/HEXADECENE COPOLYMER (UNII: KFR5QEN0N9) DISTEARDIMONIUM HECTORITE (UNII: X687XDK09L) MAGNESIUM SULFATE, UNSPECIFIED FORM (UNII: DE08037SAB) 2-ETHYLHEXYL ACRYLATE, METHACRYLATE, METHYL METHACRYLATE, OR BUTYL METHACRYLATE/HYDROXYPROPYL DIMETHICONE COPOLYMER (30000-300000 MW) (UNII: S7ZA3CCJ4M) FERRIC OXIDE RED (UNII: 1K09F3G675) CETYL PEG/PPG-10/1 DIMETHICONE (HLB 4) (UNII: 8INO2K35FA) FERROSOFERRIC OXIDE (UNII: XM0M87F357) TRIETHOXYCAPRYLYLSILANE (UNII: LDC331P08E) STEARIC ACID (UNII: 4ELV7Z65AP) ALUMINUM OXIDE (UNII: LMI26O6933) ALUMINUM HYDROXIDE (UNII: 5QB0T2IUN0) GLYCERYL MONOCAPRYLATE (UNII: TM2TZD4G4A) DIMETHICONE CROSSPOLYMER (UNII: UF7620L1W6) TRISODIUM ETHYLENEDIAMINE DISUCCINATE (UNII: YA22H34H9Q) BUTYLATED HYDROXYTOLUENE (UNII: 1P9D0Z171K) MICA (UNII: V8A1AW0880) PENTAERYTHRITOL TETRAKIS(3-(3,5-DI-TERT-BUTYL-4-HYDROXYPHENYL)PROPIONATE) (UNII: 255PIF62MS) STANNIC OXIDE (UNII: KM7N50LOS6) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:71261-034-02 2 in 1 CARTON 07/29/2024 1 NDC:71261-034-01 14 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 Drug M020 07/29/2024 Labeler - Jungsaemmool Beauty Co., Ltd. (694214725) Registrant - Jungsaemmool Beauty Co., Ltd. (694214725) Establishment Name Address ID/FEI Business Operations Cosmax, Inc. 689049693 manufacture(71261-034)
