FDA Label for Zo Skin Health Aggressive Anti-aging Program

View Indications, Usage & Precautions

Zo Skin Health Aggressive Anti-aging Program Product Label

The following document was submitted to the FDA by the labeler of this product Zo Skin Health, Inc.. The document includes published materials associated whith this product with the essential scientific information about this product as well as other prescribing information. Product labels may durg indications and usage, generic names, contraindications, active ingredients, strength dosage, routes of administration, appearance, warnings, inactive ingredients, etc.

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Drug Facts

Dist. by ZO Skin Health, Inc. Irvine, CA 92618


Active Ingredient



Titanium Dioxide 8.2%


Purpose



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 or irritation develops and lasts.

Otc - Keep Out Of Reach Of Children



Keep out of reach of children.

  • If swallowed, get medical help or contact a Poison Control Center right away.

Directions



  • apply liberally 15 minutes before sun exposure
  • use a water resistant sunscreen if swimming or sweating
  • reapply at least every 2 hours
  • children under 6 months of age: Ask a doctor
  • 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 value 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-sleeved shirts, pants, hats and sunglasses.

Other Information



  • Protect this product from excessive heat and direct sun.
  • You may report a serious adverse reaction to: 5 Technology Dr. Irvine, CA 92618

Inactive Ingredients



Aluminum Hydroxide, Aqua/Water/Eau, Ascorbic Acid, Behenyl Behenate, Caprylic/Capric Triglyceride, Caprylyl Glycol, Cetyl PEG/PPG-10/1 Dimethicone, Chlorphenesin, Cyclopentasiloxane, Dimethicone Crosspolymer, Dimethicone/Vinyl Dimethicone Crosspolymer, Dimethiconol, Disodium Uridine Phosphate, Ethyl Ferulate, Ethylhexylglycerin, Glycerin, Glycine Soja Extract, Helianthus Annuus Seed Oil, Hexyl Laurate, Iron Oxides, Melanin, Myristoyl Pentapeptide-8, Pentaerythrityl Tetra-di-t-butyl Hydroxyhydrocinnamate, Pentylene Glycol, Phenoxyethanol, Phenyl Trimethicone, Polyglyceryl-3 Polydimethylsiloxyethyl Dimethicone, Polyglyceryl-4 Isostearate, Polyglyceryl-5 Trioleate, Polymethyl Methacrylate, Retinyl Palmitate, Rosmarinus Officinalis Leaf Extract, Squalane, Stearic Acid, Tocopherol, Tocopheryl Acetate, Tribehenin, Triethoxycaprylylsilane.


Principal Display Panel - Kit Carton



ZO® SKIN HEALTH
BY ZEIN OBAGI MD

AGGRESSIVE ANTI-AGING PROGRAM
NDC 42851-168-15

HYDRATING CLEANSER 60 mL / 2 Fl. Oz. EXFOLIATING POLISH Net Wt. 16.2 g / 0.57 Oz.
COMPLEXION RENEWAL PADS 30 Pads DAILY POWER DEFENSE 30 mL / 1 Fl. Oz.
ADVANCED RADICAL NIGHT REPAIR 30 mL / 1 Fl. Oz. RENEWAL CRÈME 50 mL / 1.7 Fl. Oz.
SUNSCREEN + PRIMER SPF 30 15 mL / 0.5 Fl. Oz.


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