NDC Code(s) : 51621-204-01, 51621-204-02
Packager : GOWOONSESANG COSMETICS CO., LTD.

Category : HUMAN PRESCRIPTION DRUG LABEL

DEA Schedule : none

Marketing Status : New Drug Application

INGREDIENTS AND APPEARANCE

Derma Dr.lab Daily Mild SunOCTINOXATE, OCTISALATE, ZINC OXIDE, TITANIUM DIOXIDE CREAM
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:51621-204
Route of Administration TOPICAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
OCTINOXATE(UNII: 4Y5P7MUD51)
(OCTINOXATE - UNII:4Y5P7MUD51) 		OCTINOXATE75 mg in 1 mL
OCTISALATE(UNII: 4X49Y0596W)
(OCTISALATE - UNII:4X49Y0596W) 		OCTISALATE50 mg in 1 mL
ZINC OXIDE(UNII: SOI2LOH54Z)
(ZINC CATION - UNII:13S1S8SF37) 		ZINC CATION48 mg in 1 mL
TITANIUM DIOXIDE(UNII: 15FIX9V2JP)
(TITANIUM DIOXIDE - UNII:15FIX9V2JP) 		TITANIUM DIOXIDE24.9 mg in 1 mL
Inactive Ingredients
Ingredient Name Strength
WATER(UNII: 059QF0KO0R)
CYCLOMETHICONE 5(UNII: 0THT5PCI0R)
DIPROPYLENE GLYCOL(UNII: E107L85C40)
GLYCERIN(UNII: PDC6A3C0OX)
PEG-10 DIMETHICONE (600 CST)(UNII: 8PR7V1SVM0)
DICAPRYLYL CARBONATE(UNII: 609A3V1SUA)
MICA(UNII: V8A1AW0880)
DISTEARDIMONIUM HECTORITE(UNII: X687XDK09L)
DIMETHICONE(UNII: 92RU3N3Y1O)
SILICON DIOXIDE(UNII: ETJ7Z6XBU4)
PHENOXYETHANOL(UNII: HIE492ZZ3T)
VINYL DIMETHICONE/METHICONE SILSESQUIOXANE CROSSPOLYMER(UNII: 9NH1UDD2RR)
ALUMINUM HYDROXIDE(UNII: 5QB0T2IUN0)
ALUMINUM STEARATE(UNII: U6XF9NP8HM)
DIMETHICONE/VINYL DIMETHICONE CROSSPOLYMER (HARD PARTICLE)(UNII: H895X08VNQ)
METHICONE (20 CST)(UNII: 6777U11MKT)
GLYCERYL MONOCAPRYLATE(UNII: TM2TZD4G4A)
CAPRYLYL GLYCOL(UNII: 00YIU5438U)
FERRIC OXIDE YELLOW(UNII: EX438O2MRT)
TRIETHOXYCAPRYLYLSILANE(UNII: LDC331P08E)
FERRIC OXIDE RED(UNII: 1K09F3G675)
FERROSOFERRIC OXIDE(UNII: XM0M87F357)
BUTYLENE GLYCOL(UNII: 3XUS85K0RA)
CAMELLIA JAPONICA SEED OIL(UNII: U37N0S910T)
MORINGA OLEIFERA SEED OIL(UNII: REM6A5QMC0)
SUNFLOWER OIL(UNII: 3W1JG795YI)
PROPYLENE GLYCOL(UNII: 6DC9Q167V3)
GLYCYRRHIZA GLABRA(UNII: 2788Z9758H)
OPUNTIA FICUS-INDICA(UNII: 23Z87HTQ6P)
NELUMBO NUCIFERA FLOWER(UNII: 61W322NLDV)
BELLIS PERENNIS FLOWER(UNII: 26I94X9A1K)
SORBITOL(UNII: 506T60A25R)
SODIUM HYDROXIDE(UNII: 55X04QC32I)
CITRIC ACID MONOHYDRATE(UNII: 2968PHW8QP)
TANGERINE PEEL(UNII: JU3D414057)
MELISSA OFFICINALIS(UNII: YF70189L0N)
PRUNUS PERSICA LEAF(UNII: VN3501T41P)
ETHYLHEXYLGLYCERIN(UNII: 147D247K3P)
TOCOPHEROL(UNII: R0ZB2556P8)
POTASSIUM SORBATE(UNII: 1VPU26JZZ4)
Packaging
# Item Code Package Description Marketing Start Date Marketing End Date
1NDC:51621-204-021 in 1 CARTON 17/08/2017
1NDC:51621-204-0145 mL 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 08/17/2017

PRINCIPAL DISPLAY PANEL

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