FDA Label for Zo Skin Health Renew

View Indications, Usage & Precautions

Zo Skin Health Renew 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 Ingredients



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 occurs

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
  • children under 6 months of age: ask a doctor
  • reapply at least every two hours
  • 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



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


Principal Display Panel - Kit Carton



ZO® SKIN HEALTH
BY ZEIN OBAGI MD

RENEW

OFFECTS® HYDRATING CLEANSER
40 mL / 1.5 Fl. Oz.

OFFECTS® EXFOLIATING POLISH
Net Wt. 16.2 g / 0.57 Oz.

OCLIPSE® SUNSCREEN + PRIMER
BROAD-SPECTRUM SPF 30

15 mL / 0.5 Fl. Oz.

NDC 42851-163-01


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