NDC | 71261-005-01, 71261-005-02 |
Set ID | a6d906cf-4736-4ae2-a529-51eb5815cdfc |
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
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INACTIVE INGREDIENT
Water, Phenyl Trimethicone, Triethylhexanoin, Cyclopentasiloxane, Iron Oxides (CI 77492), Dipropylene Glycol, PEG-10 Dimethicone, Cyclohexasiloxane, Butylene Glycol Dicaprylate/Dicaprate, Niacinamide, Pentylene Glycol, Polypropylsilsesquioxane, Disteardimonium Hectorite, Trimethylsiloxyphenyl Dimethicone, Magnesium Sulfate, Iron Oxides (CI 77491), Phenoxyethanol, Methyl Methacrylate Crosspolymer, Silica, Beeswax, Lauroyl Lysine, Sorbitan Isostearate, Vinyl Dimethicone/Methicone Silsesquioxane Crosspolymer, Lauryl PEG-9 Polydimethylsiloxyethyl Dimethicone, HDI/Trimethylol Hexyllactone Crosspolymer, Iron Oxides (CI 77499), Triethoxycaprylylsilane, Aluminum Hydroxide, Ceresin, Stearic Acid, Dimethicone, Fragrance(Parfum), Ethylhexylglycerin, Dimethicone Crosspolymer, Adenosine, Disodium EDTA
- OTHER SAFETY INFORMATION
- PRINCIPAL DISPLAY PANEL
-
INGREDIENTS AND APPEARANCE
JUNGSAEMMOOL ESSENTIAL STAR CEALER FOUNDATION MEDIUM DEEP
titanium dioxide, octinoxate, zinc oxide creamProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:71261-005 Route of Administration TOPICAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength TITANIUM DIOXIDE (UNII: 15FIX9V2JP) (TITANIUM DIOXIDE - UNII:15FIX9V2JP) TITANIUM DIOXIDE 126.3 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 9.3 mg in 1 g Inactive Ingredients Ingredient Name Strength WATER (UNII: 059QF0KO0R) PHENYL TRIMETHICONE (UNII: DR0K5NOJ4R) TRIETHYLHEXANOIN (UNII: 7K3W1BIU6K) CYCLOMETHICONE 5 (UNII: 0THT5PCI0R) FERRIC OXIDE YELLOW (UNII: EX438O2MRT) DIPROPYLENE GLYCOL (UNII: E107L85C40) DISTEARDIMONIUM HECTORITE (UNII: X687XDK09L) PEG-10 DIMETHICONE (600 CST) (UNII: 8PR7V1SVM0) CYCLOMETHICONE 6 (UNII: XHK3U310BA) BUTYLENE GLYCOL DICAPRYLATE/DICAPRATE (UNII: 75D21FL1PI) NIACINAMIDE (UNII: 25X51I8RD4) PENTYLENE GLYCOL (UNII: 50C1307PZG) MAGNESIUM SULFATE, UNSPECIFIED FORM (UNII: DE08037SAB) FERRIC OXIDE RED (UNII: 1K09F3G675) PHENOXYETHANOL (UNII: HIE492ZZ3T) SILICON DIOXIDE (UNII: ETJ7Z6XBU4) YELLOW WAX (UNII: 2ZA36H0S2V) LAUROYL LYSINE (UNII: 113171Q70B) SORBITAN ISOSTEARATE (UNII: 01S2G2C1E4) VINYL DIMETHICONE/METHICONE SILSESQUIOXANE CROSSPOLYMER (UNII: 9NH1UDD2RR) LAURYL PEG-9 POLYDIMETHYLSILOXYETHYL DIMETHICONE (UNII: 25G622K2RA) HEXAMETHYLENE DIISOCYANATE/TRIMETHYLOL HEXYLLACTONE CROSSPOLYMER (UNII: WB5K9Y35Y9) FERROSOFERRIC OXIDE (UNII: XM0M87F357) TRIETHOXYCAPRYLYLSILANE (UNII: LDC331P08E) 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) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:71261-005-02 1 in 1 CARTON 12/06/2017 1 NDC:71261-005-01 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(71261-005)