Label: JUNGSAEMMOOL ESSENTIAL SKIN NUDER LONGWEAR CUSHION LIGHT- titanium dioxide, octinoxate, zinc oxide, octisalate cream
- NDC Code(s): 71261-012-01, 71261-012-02
- 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 July 19, 2023
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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, Cyclopentasiloxane, Methyl Methacrylate Crosspolymer, Butylene Glycol, Methyl Trimethicone, Dimethicone, Glycerin, Niacinamide, Pentylene Glycol, Cetyl PEG/PPG-10/1 Dimethicone, Silica, Caprylyl Methicone, Butylene Glycol Dicaprylate/Dicaprate, PEG/PPG-17/6 Copolymer, Lauryl PEG-10 Tris(Trimethylsiloxy)silylethyl Dimethicone, Iron Oxides (CI 77492), Magnesium Sulfate, Phenoxyethanol, Sorbitan Isostearate, Aluminum Hydroxide, Dimethicone/Vinyl Dimethicone Crosspolymer, Disteardimonium Hectorite, Stearic Acid, Iron Oxides (CI 77491), Triethoxycaprylylsilane, Fragrance(Parfum), Ethylhexylglycerin, Iron Oxides (CI 77499), Adenosine, Trisodium Ethylenediamine Disuccinate, Camellia Sinensis Seed Oil, Carthamus Tinctorius (Safflower) Seed Oil, Ceramide NP, Helianthus Annuus (Sunflower) Seed Oil, Panthenol, Jasminum Officinale (Jasmine) Flower/Leaf Extract, Nelumbo Nucifera Flower Extract, Pentaerythrityl Tetra-di-t-butyl Hydroxyhydrocinnamate, Tocopherol, Freesia Refracta Extract, Iris Ensata Extract, Iris Versicolor Extract, Leontopodium Alpinum Flower/Leaf Extract, Lilium Candidum Bulb Extract, Narcissus Pseudonarcissus (Daffodil) Flower Extract, Rose Extract
- OTHER SAFETY INFORMATION
- PRINCIPAL DISPLAY PANEL
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INGREDIENTS AND APPEARANCE
JUNGSAEMMOOL ESSENTIAL SKIN NUDER LONGWEAR CUSHION LIGHT
titanium dioxide, octinoxate, zinc oxide, octisalate creamProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:71261-012 Route of Administration TOPICAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength TITANIUM DIOXIDE (UNII: 15FIX9V2JP) (TITANIUM DIOXIDE - UNII:15FIX9V2JP) TITANIUM DIOXIDE 96 mg in 1 g OCTINOXATE (UNII: 4Y5P7MUD51) (OCTINOXATE - UNII:4Y5P7MUD51) OCTINOXATE 70 mg in 1 g ZINC OXIDE (UNII: SOI2LOH54Z) (ZINC CATION - UNII:13S1S8SF37) ZINC CATION 49 mg in 1 g OCTISALATE (UNII: 4X49Y0596W) (OCTISALATE - UNII:4X49Y0596W) OCTISALATE 45 mg in 1 g Inactive Ingredients Ingredient Name Strength WATER (UNII: 059QF0KO0R) CYCLOMETHICONE 5 (UNII: 0THT5PCI0R) METHYL METHACRYLATE/GLYCOL DIMETHACRYLATE CROSSPOLYMER (UNII: EG97988M5Q) BUTYLENE GLYCOL (UNII: 3XUS85K0RA) METHYL TRIMETHICONE (UNII: S73ZQI0GXM) DIMETHICONE (UNII: 92RU3N3Y1O) CETYL PEG/PPG-10/1 DIMETHICONE (HLB 2) (UNII: V2W71V8T0X) GLYCERIN (UNII: PDC6A3C0OX) NIACINAMIDE (UNII: 25X51I8RD4) PENTYLENE GLYCOL (UNII: 50C1307PZG) SILICON DIOXIDE (UNII: ETJ7Z6XBU4) CAPRYLYL TRISILOXANE (UNII: Q95M2P1KJL) BUTYLENE GLYCOL DICAPRYLATE/DICAPRATE (UNII: 75D21FL1PI) PEG/PPG-17/6 COPOLYMER (UNII: P5QZM4T259) FERRIC OXIDE YELLOW (UNII: EX438O2MRT) MAGNESIUM SULFATE, UNSPECIFIED FORM (UNII: DE08037SAB) PHENOXYETHANOL (UNII: HIE492ZZ3T) DIMETHICONE/VINYL DIMETHICONE CROSSPOLYMER (HARD PARTICLE) (UNII: H895X08VNQ) SORBITAN ISOSTEARATE (UNII: 01S2G2C1E4) ALUMINUM HYDROXIDE (UNII: 5QB0T2IUN0) DISTEARDIMONIUM HECTORITE (UNII: X687XDK09L) STEARIC ACID (UNII: 4ELV7Z65AP) FERRIC OXIDE RED (UNII: 1K09F3G675) TRIETHOXYCAPRYLYLSILANE (UNII: LDC331P08E) FERROSOFERRIC OXIDE (UNII: XM0M87F357) ETHYLHEXYLGLYCERIN (UNII: 147D247K3P) ADENOSINE (UNII: K72T3FS567) EDETATE DISODIUM (UNII: 7FLD91C86K) CAMELLIA SINENSIS SEED OIL (UNII: O5R6DK2M9K) SAFFLOWER OIL (UNII: 65UEH262IS) CERAMIDE NP (UNII: 4370DF050B) SUNFLOWER OIL (UNII: 3W1JG795YI) PANTHENOL (UNII: WV9CM0O67Z) JASMINUM OFFICINALE FLOWER (UNII: 0Q8K841432) NELUMBO NUCIFERA FLOWER (UNII: 61W322NLDV) IRIS VERSICOLOR ROOT (UNII: X43D4L3DQC) LEONTOPODIUM NIVALE SUBSP. ALPINUM FLOWERING TOP (UNII: QQC1AK06RK) LILIUM CANDIDUM BULB (UNII: AHG15J8AM0) NARCISSUS PSEUDONARCISSUS FLOWER (UNII: L879RBF1WN) TOCOPHEROL (UNII: R0ZB2556P8) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:71261-012-02 2 in 1 CARTON 07/16/2020 1 NDC:71261-012-01 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 07/16/2020 Labeler - Jungsaemmool Beauty Co., Ltd. (694214725) Registrant - Jungsaemmool Beauty Co., Ltd. (694214725) Establishment Name Address ID/FEI Business Operations Cosmax, Inc 689049693 manufacture(71261-012)
