ALGENIST- octinoxate, titanium dioxide, zinc oxide cream 
Solazyme, Inc.

Disclaimer: Most OTC drugs are not reviewed and approved by FDA, however they may be marketed if they comply with applicable regulations and policies. FDA has not evaluated whether this product complies.

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Drug Facts

Active Ingredients

Octinoxate 7.5%

Titanium Dioxide 2.0%

Zinc Oxide 17.1%

Purpose

Sunscreen

Sunscreen

Sunscreen

Uses

Helps prevent sunburn

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

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 – 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

Principal Display Panel – Carton Label
ALGENIST 
octinoxate, titanium dioxide, zinc oxide cream
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:53407-138
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
Octinoxate (UNII: 4Y5P7MUD51) (Octinoxate - UNII:4Y5P7MUD51) Octinoxate75 mg  in 1 mL
Titanium Dioxide (UNII: 15FIX9V2JP) (Titanium Dioxide - UNII:15FIX9V2JP) Titanium Dioxide20 mg  in 1 mL
Zinc Oxide (UNII: SOI2LOH54Z) (Zinc Oxide - UNII:SOI2LOH54Z) Zinc Oxide171 mg  in 1 mL
Inactive Ingredients
Ingredient NameStrength
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 CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:53407-138-301 in 1 BOX
11 in 1 CARTON
130 mL in 1 JAR
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph not finalpart35208/01/2012
Labeler - Solazyme, Inc. (145862012)
Registrant - PhytogenX,Inc (010297942)
Establishment
NameAddressID/FEIBusiness Operations
PhytogenX,Inc010297942MANUFACTURE(53407-138)

Revised: 8/2012
Document Id: a060dff3-d195-41fc-8b67-8bd9a162fbc7
Set id: 4ece1847-1c94-4bf7-b936-109556a460a7
Version: 2
Effective Time: 20120808
 
Solazyme, Inc.