NDC Code(s) : 49404-122-01, 49404-122-02
Packager : Have and Be Co., Ltd.

Category : HUMAN PRESCRIPTION DRUG LABEL

DEA Schedule : none

Marketing Status : New Drug Application

INGREDIENTS AND APPEARANCE

Dr.Jart Ceramidin Day TintOctinoxate, Octisalate CREAM
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:49404-122
Route of Administration TOPICAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
OCTINOXATE(UNII: 4Y5P7MUD51)
(OCTINOXATE - UNII:4Y5P7MUD51) 		OCTINOXATE3 mg in 50 mL
OCTISALATE(UNII: 4X49Y0596W)
(OCTISALATE - UNII:4X49Y0596W) 		OCTISALATE1 mg in 50 mL
Inactive Ingredients
Ingredient Name Strength
WATER(UNII: 059QF0KO0R)
CYCLOMETHICONE 5(UNII: 0THT5PCI0R)
TITANIUM DIOXIDE(UNII: 15FIX9V2JP)
DIPROPYLENE GLYCOL(UNII: E107L85C40)
ISODODECANE(UNII: A8289P68Y2)
GLYCERIN(UNII: PDC6A3C0OX)
ISOPROPYL ISOSTEARATE(UNII: C67IXB9Y7T)
PEG-10 DIMETHICONE (600 CST)(UNII: 8PR7V1SVM0)
HEXYLDECYL MYRISTOYL METHYLAMINOPROPIONATE(UNII: 1959TW0O9A)
ZINC OXIDE(UNII: SOI2LOH54Z)
TALC(UNII: 7SEV7J4R1U)
BIOSACCHARIDE GUM-1(UNII: BB4PU4V09H)
DISTEARDIMONIUM HECTORITE(UNII: X687XDK09L)
MAGNESIUM SULFATE(UNII: DE08037SAB)
FERRIC OXIDE RED(UNII: 1K09F3G675)
DIMETHICONE(UNII: 92RU3N3Y1O)
PURSLANE(UNII: M6S840WXG5)
BETAINE(UNII: 3SCV180C9W)
C12-14 PARETH-3(UNII: 93RY22U87E)
PHENOXYETHANOL(UNII: HIE492ZZ3T)
ALUMINUM HYDROXIDE(UNII: 5QB0T2IUN0)
ALUMINUM STEARATE(UNII: U6XF9NP8HM)
METHICONE (20 CST)(UNII: 6777U11MKT)
CERAMIDE 3(UNII: 4370DF050B)
ETHYLHEXYLGLYCERIN(UNII: 147D247K3P)
.ALPHA.-TOCOPHEROL ACETATE(UNII: 9E8X80D2L0)
BERGAMOT OIL(UNII: 39W1PKE3JI)
PELARGONIUM GRAVEOLENS FLOWER OIL(UNII: 3K0J1S7QGC)
POLYMETHYLSILSESQUIOXANE (4.5 MICRONS)(UNII: 59Z907ZB69)
SAGE OIL(UNII: U27K0H1H2O)
PATCHOULI OIL(UNII: F3IN55X5PO)
AMARANTHUS CAUDATUS SEED(UNII: FJ722PPQ9M)
ARTEMISIA VULGARIS ROOT(UNII: 32MP823R8S)
BEET(UNII: N487KM8COK)
ULMUS DAVIDIANA ROOT(UNII: URQ79U8261)
CNIDIUM OFFICINALE ROOT(UNII: 8S3OZD358J)
GLYCYRRHIZA GLABRA(UNII: 2788Z9758H)
PAEONIA LACTIFLORA ROOT(UNII: 3Z3866YW6P)
PUERARIA MONTANA VAR. LOBATA ROOT(UNII: PET93F4I3C)
ALOE VERA LEAF(UNII: ZY81Z83H0X)
HYDROGENATED SOYBEAN LECITHIN(UNII: H1109Z9J4N)
HYALURONATE SODIUM(UNII: YSE9PPT4TH)
XANTHAN GUM(UNII: TTV12P4NEE)
ACETIC ACID(UNII: Q40Q9N063P)
LACTIC ACID(UNII: 33X04XA5AT)
Packaging
# Item Code Package Description Marketing Start Date Marketing End Date
1NDC:49404-122-021 in 1 CARTON 14/01/2015
1NDC:49404-122-0150 mL in 1 TUBE 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 01/14/2015

PRINCIPAL DISPLAY PANEL

Ceramidin