Zo Skin Health Smart Tone Broad-spectrum Sunscreen Spf 50 Lotion
FDA Label NDC 42851-055

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

Structured Product Label

The following Structured Product Label (SPL) was submitted to the FDA by Zo Skin Health, Inc. for the product Zo Skin Health Smart Tone Broad-spectrum Sunscreen Spf 50 (NDC 42851-055). 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, otc - purpose, uses, warnings, do not use, when using this product, stop use and ask a doctor if, otc - keep out of reach of children, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.

Label Section Quick Index

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.