NDC Code(s) : 64127-114-01, 64127-114-02
Packager : Laboratoires dermo Cosmetik Inc

Category : HUMAN PRESCRIPTION DRUG LABEL

DEA Schedule : none

Marketing Status : New Drug Application

INGREDIENTS AND APPEARANCE

GM Collin titanium dioxide and zinc oxide CREAM
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:64127-114
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 dioxide8.5 mg in 100 mL
zinc oxide(UNII: SOI2LOH54Z)
(zinc oxide - UNII:SOI2LOH54Z) 		zinc oxide4.2 mg in 100 mL
Inactive Ingredients
Ingredient Name Strength
CYCLOMETHICONE 5(UNII: 0THT5PCI0R)
CYCLOMETHICONE 6(UNII: XHK3U310BA)
ISOHEXADECANE(UNII: 918X1OUF1E)
TRIETHYLHEXANOIN(UNII: 7K3W1BIU6K)
ALUMINUM STEARATE(UNII: U6XF9NP8HM)
ALUMINUM OXIDE(UNII: LMI26O6933)
PEG/PPG-19/19 DIMETHICONE(UNII: EHH90CO7TL)
WATER(UNII: 059QF0KO0R)
TRIETHOXYCAPRYLYLSILANE(UNII: LDC331P08E)
ISONONYL ISONONANOATE(UNII: S4V5BS6GCX)
GLYCERIN(UNII: PDC6A3C0OX)
WATERMELON(UNII: 231473QB6R)
APPLE(UNII: B423VGH5S9)
LENS CULINARIS FRUIT(UNII: ZYZ076G9JH)
SODIUM LACTATE(UNII: TU7HW0W0QT)
SODIUM PYRROLIDONE CARBOXYLATE(UNII: 469OTG57A2)
FERRIC OXIDE RED(UNII: 1K09F3G675)
LAURYL PEG/PPG-18/18 METHICONE(UNII: ZJ5S27D9NX)
DECARBOXY CARNOSINE HYDROCHLORIDE(UNII: 6X7K9I5QR7)
BUTYLENE GLYCOL(UNII: 3XUS85K0RA)
ALBIZIA JULIBRISSIN BARK(UNII: 0J9G6W44DV)
HYALURONATE SODIUM(UNII: YSE9PPT4TH)
CETEARETH-25(UNII: 8FA93U5T67)
CETYL ALCOHOL(UNII: 936JST6JCN)
BEHENIC ACID(UNII: H390488X0A)
CHOLESTEROL(UNII: 97C5T2UQ7J)
N-HEXANOYLSPHINGOSINE(UNII: 038753E78J)
.ALPHA.-TOCOPHEROL(UNII: H4N855PNZ1)
PHENOXYETHANOL(UNII: HIE492ZZ3T)
ETHYLHEXYLGLYCERIN(UNII: 147D247K3P)
Packaging
# Item Code Package Description Marketing Start Date Marketing End Date
1NDC:64127-114-011 in 1 BOX
150 mL in 1 TUBE
2NDC:64127-114-021 in 1 BOX
2120 mL in 1 TUBE
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
OTC MONOGRAPH NOT FINAL part352 02/14/2014

PRINCIPAL DISPLAY PANEL

PARIS
COLLIN®
G.M.

BEIGE
TINTED

MINERAL BB
CREAM

25 SPF

Broad-Spectrum UVA-UVB
SUNSCREEN

NDC 64127-114-01

All Skin Types

50 ml - Net wt. 1.7 oz.

Principal Display Panel - 50 ml Tube Box