NDC Code(s) : 53407-138-30
Packager : Solazyme, Inc.

Category : HUMAN OTC DRUG LABEL

DEA Schedule : none

Marketing Status : New Drug Application

INGREDIENTS AND APPEARANCE

Algenist Octinoxate, Titanium Dioxide, Zinc Oxide CREAM
Product Information
Product Type HUMAN OTC DRUG Item Code (Source) NDC:53407-138
Route of Administration TOPICAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
Octinoxate (UNII: 4Y5P7MUD51)
(Octinoxate - UNII:4Y5P7MUD51) 		Octinoxate 75 mg in 1 mL
Titanium Dioxide (UNII: 15FIX9V2JP)
(Titanium Dioxide - UNII:15FIX9V2JP) 		Titanium Dioxide 20 mg in 1 mL
Zinc Oxide (UNII: SOI2LOH54Z)
(Zinc Oxide - UNII:SOI2LOH54Z) 		Zinc Oxide 171 mg in 1 mL
Inactive Ingredients
Ingredient Name Strength
CYCLOMETHICONE 5(UNII: 0THT5PCI0R)
water(UNII: 059QF0KO0R)
alcohol(UNII: 3K9958V90M)
glycerin(UNII: PDC6A3C0OX)
METHYL METHACRYLATE(UNII: 196OC77688)
peg/ppg-18/18 dimethicone(UNII: 9H0AO7T794)
echinacea purpurea(UNII: QI7G114Y98)
.ALPHA.-TOCOPHEROL ACETATE(UNII: 9E8X80D2L0)
camellia oleifera seed(UNII: 59ED29FM2J)
ARCTOSTAPHYLOS UVA-URSI LEAF(UNII: 3M5V3D1X36)
GLYCYRRHIZA GLABRA(UNII: 2788Z9758H)
stearic acid(UNII: 4ELV7Z65AP)
ethylhexylglycerin(UNII: 147D247K3P)
caprylyl glycol(UNII: 00YIU5438U)
aluminum hydroxide(UNII: 5QB0T2IUN0)
phenoxyethanol(UNII: HIE492ZZ3T)
hexylene glycol(UNII: KEH0A3F75J)
Packaging
# Item Code Package Description Marketing Start Date Marketing End Date
1NDC:53407-138-301 in 1 BOX 08/01/2012
11 in 1 CARTON
130 mL in 1 JAR 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 08/01/2012

LABELER - Solazyme, Inc.(145862012)

REGISTRANT - Phytogenx, Inc.(624386772)

Establishment
Name Address ID/FEI Business Operations
Phytogenx, Inc. 624386772 MANUFACTURE(53407-138)

PRINCIPAL DISPLAY PANEL

URBAN PROTECTION

SUBLIME DEFENSE

Ultra Lightweight
UV Defense Fluid

Sunscreen Broad Spectrum
SPF 50

ALGENIST
with Alguronic Acid

1 US fl. oz. / 30 ml

Principal Display Panel – 30 mL Carton Label

PRINCIPAL DISPLAY PANEL

SUBLIME
DEFENSE

Ultra Lightweight
UV Defense Fluid

Fluide UV Défense
Ultra Léger

Sunscreen Broad Spectrum
SPF 50

Écran Solaire Large Spectre
FPS 50

ALGENIST

Biotechnology from
San Francisco

Principal Display Panel – 30 mL Jar Label