NDC Code(s) : 61543-1082-2
Packager : CCA Industries Inc

Category : HUMAN PRESCRIPTION DRUG LABEL

DEA Schedule : none

Marketing Status : New Drug Application

INGREDIENTS AND APPEARANCE

Sudden Change Intensive Restoration Daily Moisturizer SPF 15 ZINC OXIDE, OCTINOXATE CREAM
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:61543-1082
Route of Administration TOPICAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
ZINC OXIDE(UNII: SOI2LOH54Z)
(ZINC OXIDE - UNII:SOI2LOH54Z) 		ZINC OXIDE2 mL in 100 mL
OCTINOXATE(UNII: 4Y5P7MUD51)
(OCTINOXATE - UNII:4Y5P7MUD51) 		OCTINOXATE6 mL in 100 mL
Inactive Ingredients
Ingredient Name Strength
ALLANTOIN(UNII: 344S277G0Z)
ALOE VERA LEAF(UNII: ZY81Z83H0X)
LEVOMENOL(UNII: 24WE03BX2T)
BUTYLENE GLYCOL(UNII: 3XUS85K0RA)
ALKYL (C12-15) BENZOATE(UNII: A9EJ3J61HQ)
GREEN TEA LEAF(UNII: W2ZU1RY8B0)
MEDIUM-CHAIN TRIGLYCERIDES(UNII: C9H2L21V7U)
CAPRYLYL GLYCOL(UNII: 00YIU5438U)
CETEARYL OLIVATE(UNII: 58B69Q84JO)
CETYL ALCOHOL(UNII: 936JST6JCN)
CITRUS AURANTIUM FLOWER(UNII: O730ZX2Z83)
DIMETHICONE(UNII: 92RU3N3Y1O)
EDETATE DISODIUM(UNII: 7FLD91C86K)
GLYCERIN(UNII: PDC6A3C0OX)
HEXYLENE GLYCOL(UNII: KEH0A3F75J)
OLIVE OIL(UNII: 6UYK2W1W1E)
PALMITOYL OLIGOPEPTIDE(UNII: HO4ZT5S86C)
PEG-10 RAPESEED STEROL(UNII: 258O76T85M)
PENTYLENE GLYCOL(UNII: 50C1307PZG)
PHENOXYETHANOL(UNII: HIE492ZZ3T)
POTASSIUM SORBATE(UNII: 1VPU26JZZ4)
JOJOBA OIL(UNII: 724GKU717M)
HYALURONATE SODIUM(UNII: YSE9PPT4TH)
SORBITAN OLIVATE(UNII: MDL271E3GR)
TETRAHEXYLDECYL ASCORBATE(UNII: 9LBV3F07AZ)
TRIBEHENIN(UNII: 8OC9U7TQZ0)
TRIETHOXYCAPRYLYLSILANE(UNII: LDC331P08E)
WATER(UNII: 059QF0KO0R)
XANTHAN GUM(UNII: TTV12P4NEE)
Packaging
# Item Code Package Description Marketing Start Date Marketing End Date
1NDC:61543-1082-250 mL in 1 BOTTLE
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
OTC monograph final part352 09/18/2011

PRINCIPAL DISPLAY PANEL

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