NDC Code(s) : 59078-113-01
Packager : Tonymoly Co., Ltd.

Category : HUMAN PRESCRIPTION DRUG LABEL

DEA Schedule : none

Marketing Status : New Drug Application

INGREDIENTS AND APPEARANCE

TONYMOLY Regencia Homme Multi BB Cream SPF43Titanium Dioxide CREAM
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:59078-113
Route of Administration TOPICAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
TITANIUM DIOXIDE(UNII: 15FIX9V2JP)
(TITANIUM DIOXIDE - UNII:15FIX9V2JP) 		TITANIUM DIOXIDE18612 mg in 50 mL
ZINC OXIDE(UNII: SOI2LOH54Z)
(ZINC OXIDE - UNII:SOI2LOH54Z) 		ZINC OXIDE10995.6 mg in 50 mL
Inactive Ingredients
Ingredient Name Strength
OCTISALATE(UNII: 4X49Y0596W)
SALIX NIGRA BARK(UNII: QU52J3A5B3)
GLYCYRRHIZA GLABRA(UNII: 2788Z9758H)
MEDIUM-CHAIN TRIGLYCERIDES(UNII: C9H2L21V7U)
ALOE VERA LEAF(UNII: ZY81Z83H0X)
CNIDIUM OFFICINALE ROOT(UNII: 8S3OZD358J)
PUERARIA MONTANA VAR. LOBATA ROOT(UNII: PET93F4I3C)
PORTULACA OLERACEA WHOLE(UNII: D5J3623SV2)
ACACIA SENEGAL FLOWER(UNII: 72P931MTC2)
BETAINE(UNII: 3SCV180C9W)
ETHYLHEXYLGLYCERIN(UNII: 147D247K3P)
XANTHAN GUM(UNII: TTV12P4NEE)
CERAMIDE 3(UNII: 4370DF050B)
DIPROPYLENE GLYCOL(UNII: E107L85C40)
WATER(UNII: 059QF0KO0R)
BUTYLENE GLYCOL(UNII: 3XUS85K0RA)
DICAPRYLYL CARBONATE(UNII: 609A3V1SUA)
NIACINAMIDE(UNII: 25X51I8RD4)
C12-14 PARETH-3(UNII: 93RY22U87E)
ALUMINUM HYDROXIDE(UNII: 5QB0T2IUN0)
PHENOXYETHANOL(UNII: HIE492ZZ3T)
TRIHYDROXYSTEARIN(UNII: 06YD7896S3)
STEARIC ACID(UNII: 4ELV7Z65AP)
PECTIN(UNII: 89NA02M4RX)
ADENOSINE(UNII: K72T3FS567)
DIETHYLAMINO HYDROXYBENZOYL HEXYL BENZOATE(UNII: ANQ870JD20)
DISTEARDIMONIUM HECTORITE(UNII: X687XDK09L)
TALC(UNII: 7SEV7J4R1U)
CREATINE(UNII: MU72812GK0)
CHOLESTEROL(UNII: 97C5T2UQ7J)
GLYCERIN(UNII: PDC6A3C0OX)
MAGNESIUM SULFATE(UNII: DE08037SAB)
DIMETHICONE(UNII: 92RU3N3Y1O)
.ALPHA.-TOCOPHEROL ACETATE(UNII: 9E8X80D2L0)
HYALURONATE SODIUM(UNII: YSE9PPT4TH)
PAEONIA LACTIFLORA ROOT(UNII: 3Z3866YW6P)
Packaging
# Item Code Package Description Marketing Start Date Marketing End Date
1NDC:59078-113-011 in 1 CARTON 19/01/2016
150 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 01/14/2016

PRINCIPAL DISPLAY PANEL

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