NDC Code(s) : 75936-132-01, 75936-132-02
Packager : Taylor James Ltd

Category : HUMAN PRESCRIPTION DRUG LABEL

DEA Schedule : none

Marketing Status : New Drug Application

INGREDIENTS AND APPEARANCE

Soft Focus City Suncreen Serum Broad Spectrum SPF 30 Avobenzone, Homosalate, Octisalate, Octocrylene LIQUID
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:75936-132
Route of Administration TOPICAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
AVOBENZONE(UNII: G63QQF2NOX)
(AVOBENZONE - UNII:G63QQF2NOX) 		AVOBENZONE3 g in 100 mL
HOMOSALATE(UNII: V06SV4M95S)
(HOMOSALATE - UNII:V06SV4M95S) 		HOMOSALATE8 g in 100 mL
OCTISALATE(UNII: 4X49Y0596W)
(OCTISALATE - UNII:4X49Y0596W) 		OCTISALATE4 g in 100 mL
OCTOCRYLENE(UNII: 5A68WGF6WM)
(OCTOCRYLENE - UNII:5A68WGF6WM) 		OCTOCRYLENE2 g in 100 mL
Inactive Ingredients
Ingredient Name Strength
WATER(UNII: 059QF0KO0R)
CYCLOMETHICONE 5(UNII: 0THT5PCI0R)
ISOSTEARYL NEOPENTANOATE(UNII: 411THY156Q)
GLYCERIN(UNII: PDC6A3C0OX)
CYCLOMETHICONE 6(UNII: XHK3U310BA)
POLYOXYL 20 CETOSTEARYL ETHER(UNII: YRC528SWUY)
CETOSTEARYL ALCOHOL(UNII: 2DMT128M1S)
CAPRYLYL GLYCOL(UNII: 00YIU5438U)
XANTHAN GUM(UNII: TTV12P4NEE)
PEG-40 STEARATE(UNII: ECU18C66Q7)
TRICONTANYL POVIDONE(UNII: N0SS3Q238D)
SILICON DIOXIDE(UNII: ETJ7Z6XBU4)
AMMONIUM ACRYLOYLDIMETHYLTAURATE/VP COPOLYMER(UNII: W59H9296ZG)
PANTHENOL TRIACETATE, (+)-(UNII: 1206E8961B)
CETYL DIMETHICONE 25(UNII: U4AS1BW4ZB)
ETHYL LINOLEATE(UNII: MJ2YTT4J8M)
CAPRYLHYDROXAMIC ACID(UNII: UPY805K99W)
OLEYL ALCOHOL(UNII: 172F2WN8DV)
TOCOPHEROL(UNII: R0ZB2556P8)
EDETATE DISODIUM(UNII: 7FLD91C86K)
PANTHENOL(UNII: WV9CM0O67Z)
TROLAMINE(UNII: 9O3K93S3TK)
PENTYLENE GLYCOL(UNII: 50C1307PZG)
SODIUM LACTATE(UNII: TU7HW0W0QT)
LACTIC ACID(UNII: 33X04XA5AT)
SERINE(UNII: 452VLY9402)
UREA(UNII: 8W8T17847W)
SORBITOL(UNII: 506T60A25R)
SODIUM CHLORIDE(UNII: 451W47IQ8X)
ALLANTOIN(UNII: 344S277G0Z)
FERRIC OXIDE RED(UNII: 1K09F3G675)
FERRIC OXIDE YELLOW(UNII: EX438O2MRT)
FERROSOFERRIC OXIDE(UNII: XM0M87F357)
Packaging
# Item Code Package Description Marketing Start Date Marketing End Date
1NDC:75936-132-021 in 1 CARTON 30/12/2014
1NDC:75936-132-0160 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 final part352 12/30/2014

PRINCIPAL DISPLAY PANEL

Supergoop!

City Sunscreen Serum With vitamins E & B5

Broad Spectrum SPF 30

Soft Focus Finish

Lightweight, Anti-aging Serum moisturizes and repairs while protecting from premature photoaging

1.7 fl. oz. / 60 ml

Secondary

Secondary

Secondary