NDC Code(s) : 70803-300-00
Packager : SIBORG

Category : HUMAN PRESCRIPTION DRUG LABEL

DEA Schedule : none

Marketing Status : New Drug Application

INGREDIENTS AND APPEARANCE

SIROT 24-Hour Hand Care Transformative Glass Technology Age-Fighting Protection Day and NightOCTINOXATE, OCTOCRYLENE, TITANIUM DIOXIDE, ZINC OXIDE CREAM
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:70803-300
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
MACADAMIA OIL(UNII: 515610SU8C)
SHEA BUTTER(UNII: K49155WL9Y)
ALOE VERA LEAF(UNII: ZY81Z83H0X)
SODIUM ASCORBYL PHOSPHATE(UNII: 836SJG51DR)
TEA LEAF(UNII: GH42T47V24)
CANANGA OIL(UNII: 8YOY78GNNX)
TRIBEHENIN(UNII: 8OC9U7TQZ0)
CERAMIDE NG(UNII: C04977SRJ5)
NIACINAMIDE(UNII: 25X51I8RD4)
OLEYL ALCOHOL(UNII: 172F2WN8DV)
XANTHAN GUM(UNII: TTV12P4NEE)
POLYSORBATE 60(UNII: CAL22UVI4M)
CAPRYLYL GLYCOL(UNII: 00YIU5438U)
MICA(UNII: V8A1AW0880)
CITRIC ACID MONOHYDRATE(UNII: 2968PHW8QP)
CARBOMER INTERPOLYMER TYPE A (ALLYL SUCROSE CROSSLINKED)(UNII: 59TL3WG5CO)
HEXYLENE GLYCOL(UNII: KEH0A3F75J)
TRIETHOXYCAPRYLYLSILANE(UNII: LDC331P08E)
.ALPHA.-TOCOPHEROL ACETATE(UNII: 9E8X80D2L0)
HYDROGENATED OLIVE OIL UNSAPONIFIABLES(UNII: B8MIX97W95)
ALKYL (C12-15) BENZOATE(UNII: A9EJ3J61HQ)
PENTYLENE GLYCOL(UNII: 50C1307PZG)
HYDROGENATED SOYBEAN LECITHIN(UNII: H1109Z9J4N)
ETHYLHEXYLGLYCERIN(UNII: 147D247K3P)
PALMITOYL HEXAPEPTIDE-12(UNII: HO4ZT5S86C)
VITAMIN A PALMITATE(UNII: 1D1K0N0VVC)
SODIUM METHYL STEAROYL TAURATE(UNII: JFM219LJ55)
PHENOXYETHANOL(UNII: HIE492ZZ3T)
WATER(UNII: 059QF0KO0R)
GLYCERIN(UNII: PDC6A3C0OX)
CETOSTEARYL ALCOHOL(UNII: 2DMT128M1S)
OCTYLDODECANOL(UNII: 461N1O614Y)
ISONONYL ISONONANOATE(UNII: S4V5BS6GCX)
BUTYLENE GLYCOL(UNII: 3XUS85K0RA)
DIMETHICONE(UNII: 92RU3N3Y1O)
ALUMINUM STARCH OCTENYLSUCCINATE(UNII: I9PJ0O6294)
CETEARYL OLIVATE(UNII: 58B69Q84JO)
CETYL ALCOHOL(UNII: 936JST6JCN)
SORBITAN OLIVATE(UNII: MDL271E3GR)
PANTHENOL(UNII: WV9CM0O67Z)
SODIUM SILICATE(UNII: IJF18F77L3)
Packaging
# Item Code Package Description Marketing Start Date Marketing End Date
1NDC:70803-300-001 in 1 BOX 05/07/2016
1100 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 07/05/2016

PRINCIPAL DISPLAY PANEL

24 hours

24 hours