NDC | 71261-006-01, 71261-006-02 |
Set ID | 34dc9b4f-fd4f-49f7-8975-1047c9589eaa |
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, Phenyl Trimethicone, Triethylhexanoin, Cyclopentasiloxane, Dipropylene Glycol, PEG-10 Dimethicone, Cyclohexasiloxane, Niacinamide, Butylene Glycol Dicaprylate/Dicaprate, Pentylene Glycol, Iron Oxides (CI 77492), Methyl Methacrylate Crosspolymer, Polypropylsilsesquioxane, Disteardimonium Hectorite, Trimethylsiloxyphenyl Dimethicone, Magnesium Sulfate, Phenoxyethanol, Silica, Lauroyl Lysine, Vinyl Dimethicone/Methicone Silsesquioxane Crosspolymer, Beeswax, Sorbitan Isostearate, Lauryl PEG-9 Polydimethylsiloxyethyl Dimethicone, HDI/Trimethylol Hexyllactone Crosspolymer, Iron Oxides (CI 77491), Triethoxycaprylylsilane, Iron Oxides (CI 77499), Aluminum Hydroxide, Ceresin, Stearic Acid, Dimethicone, Fragrance(Parfum), Ethylhexylglycerin, Dimethicone Crosspolymer, Adenosine, Disodium EDTA, Silica Dimethyl Silylate, Nelumbo Nucifera Flower Water, Mica (CI 77019), Tocopherol, Tin Oxide (CI 77861)
- OTHER SAFETY INFORMATION
- PRINCIPAL DISPLAY PANEL
-
INGREDIENTS AND APPEARANCE
JUNGSAEMMOOL ESSENTIAL STAR CEALER FOUNDATION MEDIUM
titanium dioxide, octinoxate, zinc oxide creamProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:71261-006 Route of Administration TOPICAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength TITANIUM DIOXIDE (UNII: 15FIX9V2JP) (TITANIUM DIOXIDE - UNII:15FIX9V2JP) TITANIUM DIOXIDE 128 mg in 1 g OCTINOXATE (UNII: 4Y5P7MUD51) (OCTINOXATE - UNII:4Y5P7MUD51) OCTINOXATE 40 mg in 1 g ZINC OXIDE (UNII: SOI2LOH54Z) (ZINC CATION - UNII:13S1S8SF37) ZINC CATION 9.8 mg in 1 g Inactive Ingredients Ingredient Name Strength WATER (UNII: 059QF0KO0R) PHENYL TRIMETHICONE (UNII: DR0K5NOJ4R) TRIETHYLHEXANOIN (UNII: 7K3W1BIU6K) CYCLOMETHICONE 5 (UNII: 0THT5PCI0R) DIPROPYLENE GLYCOL (UNII: E107L85C40) PEG-10 DIMETHICONE (600 CST) (UNII: 8PR7V1SVM0) CYCLOMETHICONE 6 (UNII: XHK3U310BA) NIACINAMIDE (UNII: 25X51I8RD4) BUTYLENE GLYCOL DICAPRYLATE/DICAPRATE (UNII: 75D21FL1PI) PENTYLENE GLYCOL (UNII: 50C1307PZG) FERRIC OXIDE YELLOW (UNII: EX438O2MRT) DISTEARDIMONIUM HECTORITE (UNII: X687XDK09L) MAGNESIUM SULFATE, UNSPECIFIED FORM (UNII: DE08037SAB) PHENOXYETHANOL (UNII: HIE492ZZ3T) SILICON DIOXIDE (UNII: ETJ7Z6XBU4) LAUROYL LYSINE (UNII: 113171Q70B) VINYL DIMETHICONE/METHICONE SILSESQUIOXANE CROSSPOLYMER (UNII: 9NH1UDD2RR) YELLOW WAX (UNII: 2ZA36H0S2V) SORBITAN ISOSTEARATE (UNII: 01S2G2C1E4) LAURYL PEG-9 POLYDIMETHYLSILOXYETHYL DIMETHICONE (UNII: 25G622K2RA) HEXAMETHYLENE DIISOCYANATE/TRIMETHYLOL HEXYLLACTONE CROSSPOLYMER (UNII: WB5K9Y35Y9) FERRIC OXIDE RED (UNII: 1K09F3G675) TRIETHOXYCAPRYLYLSILANE (UNII: LDC331P08E) FERROSOFERRIC OXIDE (UNII: XM0M87F357) ALUMINUM HYDROXIDE (UNII: 5QB0T2IUN0) CERESIN (UNII: Q1LS2UJO3A) STEARIC ACID (UNII: 4ELV7Z65AP) DIMETHICONE (UNII: 92RU3N3Y1O) ETHYLHEXYLGLYCERIN (UNII: 147D247K3P) DIMETHICONE CROSSPOLYMER (450000 MPA.S AT 12% IN CYCLOPENTASILOXANE) (UNII: UF7620L1W6) ADENOSINE (UNII: K72T3FS567) EDETATE DISODIUM (UNII: 7FLD91C86K) SILICA DIMETHYL SILYLATE (UNII: EU2PSP0G0W) NELUMBO NUCIFERA FLOWER OIL (UNII: P658Q19EG2) MICA (UNII: V8A1AW0880) TOCOPHEROL (UNII: R0ZB2556P8) STANNIC OXIDE (UNII: KM7N50LOS6) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:71261-006-02 1 in 1 CARTON 12/06/2017 1 NDC:71261-006-01 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 12/06/2017 Labeler - Jungsaemmool Beauty Co., Ltd. (694214725) Registrant - Jungsaemmool Beauty Co., Ltd. (694214725) Establishment Name Address ID/FEI Business Operations Cosmax, Inc 689049693 manufacture(71261-006)