NDC Code(s) : 51630-003-01
Packager : Schmid and Son Packaging

Category : HUMAN PRESCRIPTION DRUG LABEL

DEA Schedule : none

Marketing Status : New Drug Application

INGREDIENTS AND APPEARANCE

No7 Protect and Perfect Day Sunscreen Broad Spectrum SPF 15Avobenzone, Octinoxate, Octisalate CREAM
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:51630-003
Route of Administration TOPICAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
Avobenzone(UNII: G63QQF2NOX)
(Avobenzone - UNII:G63QQF2NOX) 		Avobenzone1.5 g in 50 g
Octinoxate(UNII: 4Y5P7MUD51)
(Octinoxate - UNII:4Y5P7MUD51) 		Octinoxate3 g in 50 g
Octisalate(UNII: 4X49Y0596W)
(Octisalate - UNII:4X49Y0596W) 		Octisalate1.25 g in 50 g
Inactive Ingredients
Ingredient Name Strength
Water(UNII: 059QF0KO0R)
Glycerin(UNII: PDC6A3C0OX)
ALKYL (C12-15) BENZOATE(UNII: A9EJ3J61HQ)
SHEA BUTTER(UNII: K49155WL9Y)
Dimethicone(UNII: 92RU3N3Y1O)
ISONONYL ISONONANOATE(UNII: S4V5BS6GCX)
CETOSTEARYL ALCOHOL(UNII: 2DMT128M1S)
PHENOXYETHANOL(UNII: HIE492ZZ3T)
SORBITAN MONOSTEARATE(UNII: NVZ4I0H58X)
mica(UNII: V8A1AW0880)
POLYSORBATE 20(UNII: 7T1F30V5YH)
ALCOHOL(UNII: 3K9958V90M)
C13-14 ISOPARAFFIN(UNII: E4F12ROE70)
BUTYLENE GLYCOL(UNII: 3XUS85K0RA)
METHYLPARABEN(UNII: A2I8C7HI9T)
POTASSIUM CETYL PHOSPHATE(UNII: 03KCY6P7UT)
ETHYLPARABEN(UNII: 14255EXE39)
LAURETH-7(UNII: Z95S6G8201)
VITAMIN A PALMITATE(UNII: 1D1K0N0VVC)
SUCROSE COCOATE(UNII: 3H18P0UK73)
DIPROPYLENE GLYCOL(UNII: E107L85C40)
XANTHAN GUM(UNII: TTV12P4NEE)
ASCORBYL GLUCOSIDE(UNII: 2V52R0NHXW)
EDETATE SODIUM(UNII: MP1J8420LU)
CITRIC ACID MONOHYDRATE(UNII: 2968PHW8QP)
LUPINUS ALBUS SEED(UNII: 24GB753W3B)
PHYLLANTHUS EMBLICA FRUIT(UNII: YLX4CW2576)
POTASSIUM HYDROXIDE(UNII: WZH3C48M4T)
GINKGO(UNII: 19FUJ2C58T)
BUTYLATED HYDROXYTOLUENE(UNII: 1P9D0Z171K)
TOCOPHEROL(UNII: R0ZB2556P8)
BUTYLPARABEN(UNII: 3QPI1U3FV8)
PALMITOYL OLIGOPEPTIDE(UNII: HO4ZT5S86C)
PROPYLPARABEN(UNII: Z8IX2SC1OH)
ISOBUTYLPARABEN(UNII: 0QQJ25X58G)
PALMITOYL TETRAPEPTIDE-7(UNII: Q41S464P1R)
TITANIUM DIOXIDE(UNII: 15FIX9V2JP)
Packaging
# Item Code Package Description Marketing Start Date Marketing End Date
1NDC:51630-003-011 in 1 CARTON
150 g in 1 JAR
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
OTC monograph not final part352 01/18/2013

PRINCIPAL DISPLAY PANEL

No7 Protect and Perfect

Day Cream

Protects young skin to delay the appearance of fine lines

Sunscreen broad spectrum SPF 15

50ml 1.6US Fl.Oz

P and P Day Cream carton.jpgP and P Day Cream jar

PRINCIPAL DISPLAY PANEL

JAR TEXT

No7 Protect and Perfect Day Cream

Hypo-allergenic

Sunscreen Broad Spectrum SPF 15

50ml 1.6 US Fl.Oz

P and P Day Cream jar.jpg