ALGENIST- octinoxate, titanium dioxide, zinc oxide cream

Algenist by

Drug Labeling and Warnings

Algenist by is a Otc medication manufactured, distributed, or labeled by Solazyme, Inc., PhytogenX,Inc. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

SPL UNCLASSIFIED SECTION

Drug Facts

Active Ingredients

Octinoxate 7.5%

Titanium Dioxide 2.0%

Zinc Oxide 17.1%

Purpose

Sunscreen

Sunscreen

Sunscreen

Uses

Helps prevent sunburn

• If used as directed with other sun protection measures (see Directions), decreases the risk of skin cancer and early skin aging caused by the sun.

Warnings

For external use only

• Do not use on damaged or broken skin

• When using this product keep out of eyes. Rinse with water to remove

• Stop use and ask a doctor if rash occurs

• Keep out of reach of children. If product is swallowed, get medical help or contact a Poison Control Center right away.

Directions

Shake bottle well

• Apply liberally to the entire face in the morning or 15 minutes prior to sun exposure
• Reapply at least every 2 hours
• Use a water resistant sunscreen if swimming or sweating
• Children under 6 months: Ask a doctor
• This lightweight fluid can be used alone, over skincare products and under makeup.

Sun Protection Measures. Spending time in the sun increases your risk of skin cancer and early skin aging. To decrease this risk, regularly use a sunscreen with a broad spectrum SPF of 15 or higher and other sun protection measures including:

• Limit time in the sun, especially from 10 a.m. - 2 p.m.
• Wear long-sleeve shirts, pants, hats, and sunglasses.

Inactive Ingredients

Cyclopentasiloxane, Water/Aqua/Eau, Alcohol Denat., Glycerin, Polyglyceryl-3 Polydimethylsiloxyethyl Dimethicone, Methyl Methacrylate Crosspolymer, PEG/PPG-18/18 Dimethicone, Algae Exopolysaccharides, Echinacea Purpurea Extract, Tocopheryl Acetate, Camellia Oleifera Leaf Extract, Arctostaphylos Uva Ursi Leaf Extract, Glycyrrhiza Glabra (Licorice) Root Extract, PEG-9 Polydimethylsiloxyethyl Dimethicone, Stearic Acid, Triethoxysilylethyl Polydimethylsiloxyethyl Hexyl Dimethicone, Ethylhexylglycerin, Caprylyl Glycol, Aluminum Hydroxide, Phenoxyethanol, Hexylene Glycol, Fragrance (Parfum).

Other Information

Protect this product from excessive heat and direct sun.

Questions

Call toll free 1-877-650-1837

PRINCIPAL DISPLAY PANEL

Principal Display Panel – Carton Label

Ultra Lightweight
UV Defense Fluid SPF 50
Fluide UV Défense
Ultra Léger FPS 50

Broad Spectrum
Ecran Solaire Large Spectre

ALGENIST
formulate with Alguronic Acid

Biotechnology from
San Francisco

1 US fl. oz / 30 mL

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

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
1	NDC: 53407-138-30	1 in 1 BOX
1		1 in 1 CARTON
1		30 mL in 1 JAR

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph not final	part352	08/01/2012

Labeler - Solazyme, Inc. (145862012)

Registrant - PhytogenX,Inc (010297942)

Establishment
Name	Address	ID/FEI	Business Operations
PhytogenX,Inc		010297942	MANUFACTURE(53407-138)