NDC Code(s) : 70803-450-01
Packager : SIBORG

Category : HUMAN PRESCRIPTION DRUG LABEL

DEA Schedule : none

Marketing Status : New Drug Application

INGREDIENTS AND APPEARANCE

Sirot Hand and Body Trio Transformative glass Technology Complete Age Resistance Day and NightOctinoxate, Octocrylene, Titanium dioxide, Zinc Oxide CREAM
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:70803-450
Route of Administration TOPICAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
OCTINOXATE(UNII: 4Y5P7MUD51)
(OCTINOXATE - UNII:4Y5P7MUD51) 		OCTINOXATE60 mg in 1 mL
OCTOCRYLENE(UNII: 5A68WGF6WM)
(OCTOCRYLENE - UNII:5A68WGF6WM) 		OCTOCRYLENE25 mg in 1 mL
TITANIUM DIOXIDE(UNII: 15FIX9V2JP)
(TITANIUM DIOXIDE - UNII:15FIX9V2JP) 		TITANIUM DIOXIDE2.2 mg in 1 mL
ZINC OXIDE(UNII: SOI2LOH54Z)
(ZINC CATION - UNII:13S1S8SF37) 		ZINC CATION29 mg in 1 mL
Inactive Ingredients
Ingredient Name Strength
WATER(UNII: 059QF0KO0R)
GLYCERIN(UNII: PDC6A3C0OX)
OCTYLDODECANOL(UNII: 461N1O614Y)
ISONONYL ISONONANOATE(UNII: S4V5BS6GCX)
BUTYLENE GLYCOL(UNII: 3XUS85K0RA)
DIMETHICONE(UNII: 92RU3N3Y1O)
ALUMINUM STARCH OCTENYLSUCCINATE(UNII: I9PJ0O6294)
CETYL ALCOHOL(UNII: 936JST6JCN)
SORBITAN OLIVATE(UNII: MDL271E3GR)
PANTHENOL(UNII: WV9CM0O67Z)
SODIUM SILICATE(UNII: IJF18F77L3)
MACADAMIA OIL(UNII: 515610SU8C)
SODIUM ASCORBYL PHOSPHATE(UNII: 836SJG51DR)
TRIBEHENIN(UNII: 8OC9U7TQZ0)
CERAMIDE NG(UNII: C04977SRJ5)
NIACINAMIDE(UNII: 25X51I8RD4)
OLEYL ALCOHOL(UNII: 172F2WN8DV)
PEG-9 DIGLYCIDYL ETHER/SODIUM HYALURONATE CROSSPOLYMER(UNII: 788QAG3W8A)
XANTHAN GUM(UNII: TTV12P4NEE)
POLYSORBATE 60(UNII: CAL22UVI4M)
CAPRYLYL GLYCOL(UNII: 00YIU5438U)
MICA(UNII: V8A1AW0880)
CITRIC ACID MONOHYDRATE(UNII: 2968PHW8QP)
HEXYLENE GLYCOL(UNII: KEH0A3F75J)
TRIETHOXYCAPRYLYLSILANE(UNII: LDC331P08E)
DISODIUM EDTA-COPPER(UNII: 6V475AX06U)
HYDROGENATED OLIVE OIL UNSAPONIFIABLES(UNII: B8MIX97W95)
PENTYLENE GLYCOL(UNII: 50C1307PZG)
HYDROGENATED SOYBEAN LECITHIN(UNII: H1109Z9J4N)
PALMITOYL HEXAPEPTIDE-12(UNII: HO4ZT5S86C)
SODIUM METHYL STEAROYL TAURATE(UNII: JFM219LJ55)
PHENOXYETHANOL(UNII: HIE492ZZ3T)
Packaging
# Item Code Package Description Marketing Start Date Marketing End Date
1NDC:70803-450-01100 mL in 1 BOX Type 0: Not a Combination Product14/10/2016
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
OTC monograph not final part352 10/14/2016

PRINCIPAL DISPLAY PANEL

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