Active Ingredients
| Active Ingredients | Purpose |
| Avobenzone 3.0%............. | Sunscreen |
| Homosalate 6.8% ............. | Sunscreen |
| Octisalate 5.0%................ | Sunscreen |
| Octocrylene 10.0% ........... | Sunscreen |
Zo Skin Health Daily Sheer Broad-spectrum Sunscreen Spf 50 Water Resistant (40 Minutes) Cream
FDA Label NDC 42851-095
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 Daily Sheer Broad-spectrum Sunscreen Spf 50 Water Resistant (40 Minutes) (NDC 42851-095). 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 active ingredients, uses, warnings, do not use, when using this product, stop use and ask a doctor if, keep out of reach of children., directions, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.
Label Section Quick Index
Uses
■ helps prevent sunburn
■ higher SPF gives more sunburn protection
■ provides high protection against sunburn
■ retains SPF after 40 minutes of perspiring
■ 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.
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
■ Reapply: ■ at least every 2 hours ■ after 40 minutes of swimming or sweating
■ 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.
Inactive Ingredients
Water, Butyloctyl Salicylate, Silica, Dimethicone, Cetearyl Alcohol, Diethylhexyl 2,6-Naphthalate, Triacontanyl PVP, Argania Spinosa Kernel Oil, Tocopheryl Acetate, Glyceryl Stearate, PEG-100 Stearate, Isododecane, Glycerin, Bisabolol, Propanediol, Steareth-21, Helianthus Annuus (Sunflower) Seed Oil, Rosmarinus Officinalis (Rosemary) Leaf Extract, Tocopherol, Ascorbic Acid, Retinyl Palmitate, Dipotassium Glycyrrhizate, Squalane, Beta-Glucan, Melanin, Cetearyl Glucoside, Steareth-2, Polysorbate 60, Hydroxyethyl Acrylate/Sodium Acryloyldimethyl Taurate Copolymer, Acrylates Copolymer, Polymethyl Methacrylate, Disodium EDTA, Ethyl Ferulate, Sodium C14-16 Olefin Sulfonate, Sodium Hydroxide, Phenoxyethanol, Ethylhexylglycerin, Pentylene Glycol, 1,2-Hexanediol, Fragrance, Iron Oxides.
Principal Display Panel
ZO® Skin Health
by Zein Obagi MD
NDC 42851-095-45
Daily Sheer Broad-Spectrum Sunscreen SPF 50
Water Resistant
(40 Minutes)
ZOX12®
45 mL / 1.5 Fl. Oz.
* Please review the disclaimer below.
