NDC Code(s) : 70734-001-01, 70734-001-02
Packager : WISHCOMPANY INC.

Category : HUMAN PRESCRIPTION DRUG LABEL

DEA Schedule : none

Marketing Status : New Drug Application

INGREDIENTS AND APPEARANCE

DEAR KLAIRS Illuminating Supple Blemish CreamOctinoxate, Titanium Dioxide, Zinc Oxide CREAM
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:70734-001
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 40 mL
Titanium Dioxide(UNII: 15FIX9V2JP)
(TITANIUM DIOXIDE - UNII:15FIX9V2JP) 		Titanium Dioxide1.6 mg in 40 mL
Zinc Oxide(UNII: SOI2LOH54Z)
(ZINC CATION - UNII:13S1S8SF37) 		ZINC CATION0.32 mg in 40 mL
Inactive Ingredients
Ingredient Name Strength
WATER(UNII: 059QF0KO0R)
CYCLOMETHICONE 5(UNII: 0THT5PCI0R)
BETAINE(UNII: 3SCV180C9W)
CETYL ETHYLHEXANOATE(UNII: 134647WMX4)
MEDIUM-CHAIN TRIGLYCERIDES(UNII: C9H2L21V7U)
NIACINAMIDE(UNII: 25X51I8RD4)
POLYSORBATE 60(UNII: CAL22UVI4M)
DIMETHICONE(UNII: 92RU3N3Y1O)
CETYL PEG/PPG-10/1 DIMETHICONE (HLB 2)(UNII: V2W71V8T0X)
FERRIC OXIDE YELLOW(UNII: EX438O2MRT)
AMILOXATE(UNII: 376KTP06K8)
DIETHYLAMINO HYDROXYBENZOYL HEXYL BENZOATE(UNII: ANQ870JD20)
BENTONITE(UNII: A3N5ZCN45C)
SODIUM CHLORIDE(UNII: 451W47IQ8X)
SILICON DIOXIDE(UNII: ETJ7Z6XBU4)
FERRIC OXIDE RED(UNII: 1K09F3G675)
BEMOTRIZINOL(UNII: PWZ1720CBH)
STEARIC ACID(UNII: 4ELV7Z65AP)
DIMETHICONE/VINYL DIMETHICONE CROSSPOLYMER (HARD PARTICLE)(UNII: H895X08VNQ)
CHLORPHENESIN(UNII: I670DAL4SZ)
TALC(UNII: 7SEV7J4R1U)
FERROSOFERRIC OXIDE(UNII: XM0M87F357)
.ALPHA.-TOCOPHEROL ACETATE(UNII: 9E8X80D2L0)
CENTELLA ASIATICA(UNII: 7M867G6T1U)
HYALURONATE SODIUM(UNII: YSE9PPT4TH)
GLYCYRRHIZA GLABRA(UNII: 2788Z9758H)
PURSLANE(UNII: M6S840WXG5)
STAR ANISE FRUIT(UNII: CK15HA8438)
GRAPEFRUIT(UNII: O82C39RR8C)
NELUMBO NUCIFERA FLOWER(UNII: 61W322NLDV)
PAEONIA SUFFRUTICOSA ROOT(UNII: 7M7E9A2C8J)
SCUTELLARIA BAICALENSIS ROOT(UNII: 7J95K7ID2S)
1,2-HEXANEDIOL(UNII: TR046Y3K1G)
CAPRYLYL GLYCOL(UNII: 00YIU5438U)
BUTYLENE GLYCOL(UNII: 3XUS85K0RA)
ADENOSINE(UNII: K72T3FS567)
SODIUM ASCORBYL PHOSPHATE(UNII: 836SJG51DR)
FLAX SEED(UNII: 4110YT348C)
OKRA(UNII: 51ME2L7STL)
ALOE VERA LEAF(UNII: ZY81Z83H0X)
ARCTIUM LAPPA ROOT(UNII: 597E9BI3Z3)
HIBISCUS MUTABILIS FLOWER(UNII: 2O22799NBH)
CORCHORUS OLITORIUS LEAF(UNII: 1FG47O9LG5)
Packaging
# Item Code Package Description Marketing Start Date Marketing End Date
1NDC:70734-001-021 in 1 CARTON 18/12/2017
1NDC:70734-001-0140 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 12/18/2017

PRINCIPAL DISPLAY PANEL

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