FDA Label for Zo Skin Health Smart Tone Broad-spectrum Sunscreen Spf 50

View Indications, Usage & Precautions

Zo Skin Health Smart Tone Broad-spectrum Sunscreen Spf 50 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.

Other



Drug Facts

DIST BY
ZO Skin Health, Inc. Irvine, CA 92618


Otc - Purpose



Active ingredients    Purpose
Avobenzone 3%Sunscreen
Homosalate 10%Sunscreen
Octisalate 5%Sunscreen
Octocrylene 10%Sunscreen

Uses



  • helps prevent sunburn
  • higher SPF gives more sunburn protection
  • provides high protection against sunburn
  • If used as directed with other sun protection measures (see Directions), decreases the risk of skin cancer and early skin aging caused by 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 and as needed
  • reapply at least every two hours
  • use a water resistant sunscreen if swimming or sweating
  • children under 6 months of age: Ask a doctor

Other Information



  • protect the product in this container from excessive heat and direct sun
  • you may report a serious adverse reaction to: 5 Technology Dr. Irvine, CA 92618

Inactive Ingredients



Water, Dimethicone, Styrene/Acrylates Copolymer, Butyloctyl Salicylate, Dimethicone/Divinyldimethicone/Silsesquioxane Crosspolymer, Glyceryl Stearate, Mica, Butylene Glycol, PEG-100 Stearate, Steareth-21, Polyamide-5, Acrylates Crosspolymer-4, Titanium Dioxide, Argania Acrylates Crosspolymer-4, Titanium Dioxide, Argania Spinosa Kernel Oil, Dimethicone/Vinyl Dimethicone Crosspolymer, Coco-Glucoside, Cetearyl Alcohol, Helianthus Annuus (Sunflower) Seed Oil, Caprylyl Glycol, Ethylene Brassylate, Steareth-2, Phenoxyethanol, Acrylates/Ammonium Methacrylate Copolymer, Boron Nitride, Polymethyl Methacrylate, Panthenyl Triacetate, Isostearic Acid, Ethyl Linoleate, Fragrance, Hexylene Glycol, Glycerin, Disodium EDTA, Oleyl Alcohol, Melanin, Aluminum Hydroxide, Sodium Hydroxide, Tocopheryl Acetate, Tocopherol, Polyglyceryl-5 Trioleate, Ethyl Ferulate, C12-15 Alkyl Benzoate, Tetrahexyldecyl Ascorbate, Retinyl Palmitate, Ascorbic Acid, Silica Dimethyl Silylate, Petasites Japonicus Root Extract, Disodium Uridine Phosphate, Rosmarinus Officinalis (Rosemary) Leaf Extract, PEG-6 Stearate, Beta-Glucan, Potassium Sorbate, PEG-32, PEG-100, Cyclotetrasiloxane, Pentylene Glycol, Ethylhexylglycerin, Sorbic Acid, Iron Oxides.


Principal Display Panel - 20 Ml Tube Carton



ZO® SKIN HEALTH
BY ZEIN OBAGI MD

NDC 42851-055-17

OCLIPSE®
SMART TONE
BROAD-SPECTRUM
SUNSCREEN SPF 50

UVA / UVB / HEV / IR-A
PROTECTION

ZOX12

20 mL / 0.67 Fl. Oz.


* Please review the disclaimer below.