NDC Code(s) : 31720-710-17
Packager : S+

Category : HUMAN OTC DRUG LABEL

DEA Schedule : none

Marketing Status : New Drug Application

INGREDIENTS AND APPEARANCE

Bright future skin tint SPF 25 44 PralineOCTINOXATE, TITANIUM DIOXIDE CREAM
Product Information
Product Type HUMAN OTC DRUG Item Code (Source) NDC:31720-710
Route of Administration TOPICAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
OCTINOXATE(UNII: 4Y5P7MUD51)
(OCTINOXATE - UNII:4Y5P7MUD51) 		OCTINOXATE74.9 mg in 1 mL
TITANIUM DIOXIDE(UNII: 15FIX9V2JP)
(TITANIUM DIOXIDE - UNII:15FIX9V2JP) 		TITANIUM DIOXIDE22.8 mg in 1 mL
Inactive Ingredients
Ingredient Name Strength
WATER(UNII: 059QF0KO0R)
CYCLOMETHICONE 5(UNII: 0THT5PCI0R)
GLYCERIN(UNII: PDC6A3C0OX)
ISODODECANE(UNII: A8289P68Y2)
PENTYLENE GLYCOL(UNII: 50C1307PZG)
ALCOHOL(UNII: 3K9958V90M)
DIMETHICONE(UNII: 92RU3N3Y1O)
VINYL DIMETHICONE/METHICONE SILSESQUIOXANE CROSSPOLYMER(UNII: 9NH1UDD2RR)
PEG-10 DIMETHICONE (600 CST)(UNII: 8PR7V1SVM0)
XANTHAN GUM(UNII: TTV12P4NEE)
SORBITAN SESQUIOLEATE(UNII: 0W8RRI5W5A)
DISTEARDIMONIUM HECTORITE(UNII: X687XDK09L)
PHENOXYETHANOL(UNII: HIE492ZZ3T)
ALUMINUM HYDROXIDE(UNII: 5QB0T2IUN0)
ISOSTEARIC ACID(UNII: X33R8U0062)
BUTYLENE GLYCOL(UNII: 3XUS85K0RA)
SODIUM MYRISTOYL GLUTAMATE(UNII: AYU7QD893W)
PROPYLENE CARBONATE(UNII: 8D08K3S51E)
STEARIC ACID(UNII: 4ELV7Z65AP)
SODIUM METABISULFITE(UNII: 4VON5FNS3C)
BUTYLATED HYDROXYTOLUENE(UNII: 1P9D0Z171K)
TOCOPHEROL(UNII: R0ZB2556P8)
FERRIC OXIDE YELLOW(UNII: EX438O2MRT)
FERRIC OXIDE RED(UNII: 1K09F3G675)
FERROSOFERRIC OXIDE(UNII: XM0M87F357)
Packaging
# Item Code Package Description Marketing Start Date Marketing End Date
1NDC:31720-710-171 in 1 CARTON 28/08/2017
125 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 Drug M020 08/28/2017

LABELER - S+(572406531)

PRINCIPAL DISPLAY PANEL

Label10

PRINCIPAL DISPLAY PANEL

Praline