Algenist Cream
FDA Label NDC 53407-138

Full FDA labeling including Indications, Dosage, Usage, and Precautions

Structured Product Label

The following Structured Product Label (SPL) was submitted to the FDA by Solazyme, Inc. for the product Algenist (NDC 53407-138). This document serves as the official prescribing information, containing essential scientific data and clinical materials required for healthcare providers and patients.

This specific version of the label includes detailed information regarding other, active ingredients, purpose, uses, warnings, otc - do not use, otc - when using, otc - stop use, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.

Label Section Quick Index

Other

Drug Facts

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.

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

Otc - Do Not Use

  • Do not use on damaged or broken skin

Otc - When Using

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

Otc - Stop Use

  • Stop use and ask a doctor if rash occurs

Otc - Keep Out Of Reach Of Children

  • 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.

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

Package Label.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

Principal Display Panel – Carton Label (Alg00 0002 01)

Principal Display Panel – Carton Label (Alg00 0002 01)

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