Label: JUNGSAEMMOOL ESSENTIAL SKIN NUDER CUSHION MEDIUM DEEP- titanium dioxide, octinoxate, octisalate cream
- NDC Code(s): 71261-003-01, 71261-003-02
- 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 October 16, 2020
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- Download DRUG LABEL INFO: PDF XML
- 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
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INACTIVE INGREDIENT
Water, Cyclopentasiloxane, Trimethylsiloxysilicate, Glycerin, PEG-10 Dimethicone, Iron Oxides (CI 77492), Butylene Glycol, Niacinamide, Cetyl Ethylhexanoate, Pentylene Glycol, VP/Hexadecene Copolymer, Caprylyl Methicone, Polypropylsilsesquioxane, Magnesium Sulfate, Phenoxyethanol, Iron Oxides (CI 77491), Cetyl PEG/PPG-10/1 Dimethicone, Iron Oxides (CI 77499), Stearic Acid, Disteardimonium Hectorite, Alumina, Triethoxycaprylylsilane, Acrylates/Dimethicone Copolymer, Aluminum Hydroxide, Dimethicone, Synthetic Fluorphlogopite, Fragrance(Parfum), Ethylhexylglycerin, Dimethicone Crosspolymer, Adenosine, Disodium EDTA, Dimethicone/Vinyl Dimethicone Crosspolymer, Mica (CI 77019), Tin Oxide (CI 77861), Polyglutamic Acid
- 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:71261-003 Route of Administration TOPICAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength TITANIUM DIOXIDE (UNII: 15FIX9V2JP) (TITANIUM DIOXIDE - UNII:15FIX9V2JP) TITANIUM DIOXIDE 131.9 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) TRIMETHYLSILOXYSILICATE (M/Q 0.6-0.8) (UNII: 5041RX63GN) GLYCERIN (UNII: PDC6A3C0OX) PEG-10 DIMETHICONE (600 CST) (UNII: 8PR7V1SVM0) FERRIC OXIDE YELLOW (UNII: EX438O2MRT) BUTYLENE GLYCOL (UNII: 3XUS85K0RA) NIACINAMIDE (UNII: 25X51I8RD4) CETYL ETHYLHEXANOATE (UNII: 134647WMX4) PENTYLENE GLYCOL (UNII: 50C1307PZG) VINYLPYRROLIDONE/HEXADECENE COPOLYMER (UNII: KFR5QEN0N9) CAPRYLYL TRISILOXANE (UNII: Q95M2P1KJL) MAGNESIUM SULFATE, UNSPECIFIED FORM (UNII: DE08037SAB) PHENOXYETHANOL (UNII: HIE492ZZ3T) FERRIC OXIDE RED (UNII: 1K09F3G675) CETYL PEG/PPG-10/1 DIMETHICONE (HLB 2) (UNII: V2W71V8T0X) FERROSOFERRIC OXIDE (UNII: XM0M87F357) STEARIC ACID (UNII: 4ELV7Z65AP) DISTEARDIMONIUM HECTORITE (UNII: X687XDK09L) ALUMINUM OXIDE (UNII: LMI26O6933) TRIETHOXYCAPRYLYLSILANE (UNII: LDC331P08E) ALUMINUM HYDROXIDE (UNII: 5QB0T2IUN0) DIMETHICONE (UNII: 92RU3N3Y1O) ETHYLHEXYLGLYCERIN (UNII: 147D247K3P) DIMETHICONE CROSSPOLYMER (450000 MPA.S AT 12% IN CYCLOPENTASILOXANE) (UNII: UF7620L1W6) ADENOSINE (UNII: K72T3FS567) EDETATE DISODIUM (UNII: 7FLD91C86K) DIMETHICONE/VINYL DIMETHICONE CROSSPOLYMER (HARD PARTICLE) (UNII: H895X08VNQ) MICA (UNII: V8A1AW0880) STANNIC OXIDE (UNII: KM7N50LOS6) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:71261-003-02 1 in 1 CARTON 10/16/2020 1 NDC:71261-003-01 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 not final part352 10/16/2020 Labeler - Jungsaemmool Beauty Co., Ltd. (694214725) Registrant - Jungsaemmool Beauty Co., Ltd. (694214725) Establishment Name Address ID/FEI Business Operations Cosmax, Inc 689049693 manufacture(71261-003)
