NDC | 71261-001-01, 71261-001-02 |
Set ID | cc90067d-d4b0-47f4-b603-718f85e0cda9 |
Category | HUMAN OTC DRUG LABEL |
Packager | Jungsaemmool Beauty Co., Ltd. |
Generic Name | |
Product Class | |
Product Number | |
Application Number | PART352 |
- ACTIVE INGREDIENT
- PURPOSE
- INDICATIONS & USAGE
-
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
-
INACTIVE INGREDIENT
Water, Cyclopentasiloxane, Trimethylsiloxysilicate, Glycerin, PEG-10 Dimethicone, Butylene Glycol, Niacinamide, Cetyl Ethylhexanoate, Pentylene Glycol, Iron Oxides (CI 77492), VP/Hexadecene Copolymer, Caprylyl Methicone, Polypropylsilsesquioxane, Magnesium Sulfate, Phenoxyethanol, Cetyl PEG/PPG-10/1 Dimethicone, Synthetic Fluorphlogopite, Stearic Acid, Disteardimonium Hectorite, Iron Oxides (CI 77491), Alumina, Acrylates/Dimethicone Copolymer, Aluminum Hydroxide, Triethoxycaprylylsilane, Dimethicone, Fragrance(Parfum), Iron Oxides (CI 77499), 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
-
INGREDIENTS AND APPEARANCE
JUNGSAEMMOOL ESSENTIAL SKIN NUDER CUSHION LIGHT
titanium dioxide, octinoxate, octisalate creamProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:71261-001 Route of Administration TOPICAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength OCTINOXATE (UNII: 4Y5P7MUD51) (OCTINOXATE - UNII:4Y5P7MUD51) OCTINOXATE 67 mg in 1 g TITANIUM DIOXIDE (UNII: 15FIX9V2JP) (TITANIUM DIOXIDE - UNII:15FIX9V2JP) TITANIUM DIOXIDE 131.9 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) BUTYLENE GLYCOL (UNII: 3XUS85K0RA) NIACINAMIDE (UNII: 25X51I8RD4) CETYL ETHYLHEXANOATE (UNII: 134647WMX4) PENTYLENE GLYCOL (UNII: 50C1307PZG) FERRIC OXIDE YELLOW (UNII: EX438O2MRT) VINYLPYRROLIDONE/HEXADECENE COPOLYMER (UNII: KFR5QEN0N9) CAPRYLYL TRISILOXANE (UNII: Q95M2P1KJL) MAGNESIUM SULFATE, UNSPECIFIED FORM (UNII: DE08037SAB) PHENOXYETHANOL (UNII: HIE492ZZ3T) CETYL PEG/PPG-10/1 DIMETHICONE (HLB 2) (UNII: V2W71V8T0X) STEARIC ACID (UNII: 4ELV7Z65AP) DISTEARDIMONIUM HECTORITE (UNII: X687XDK09L) FERRIC OXIDE RED (UNII: 1K09F3G675) ALUMINUM OXIDE (UNII: LMI26O6933) ALUMINUM HYDROXIDE (UNII: 5QB0T2IUN0) TRIETHOXYCAPRYLYLSILANE (UNII: LDC331P08E) DIMETHICONE (UNII: 92RU3N3Y1O) FERROSOFERRIC OXIDE (UNII: XM0M87F357) 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:71261-001-02 1 in 1 CARTON 10/16/2020 1 NDC:71261-001-01 14 g in 1 CONTAINER; Type 0: Not a Combination Product 2 NDC:71261-001-04 2 in 1 CARTON 10/16/2020 2 NDC:71261-001-03 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(71261-001)