Otc - Active Ingredient
Drug Facts
Active Ingredients
Titanium Dioxide 5.4%
Zinc Oxide 13.2%
Zo Skin Health Daily Mineral Sunshade Broad-spectrum Sunscreen Spf 45 (light Medium) Lotion
FDA Label NDC 42851-203
15 label sections · Submitted to the FDA by Zo Skin Health Inc. · 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 Mineral Sunshade Broad-spectrum Sunscreen Spf 45 (light Medium) (NDC 42851-203). 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 otc - active ingredient, otc - purpose, indications & usage, warnings and precautions, warnings, otc - do not use, otc - when using, otc - stop use, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.
Label Section Quick Index
Otc - Purpose
Propose
Sunscreen
Indications & Usage
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 the sun
Warnings And Precautions
Warnings
For external use only.
Warnings
For external use only.
Otc - Do Not Use
on damaged or broken skin.
Otc - When Using
keep out of eyes. Rinse with water to remove.
Otc - Stop Use
Stop use and ask a doctor if
■ rash occurs
Otc - Ask Doctor
Stop use and ask a doctor if
■ rash occurs
Otc - Keep Out Of Reach Of Children
If swallowed, get medical help or contact a Poison Control Center right away.
Dosage & Administration
Directions
■ Apply liberally 15 minutes before sun exposure and as needed.
■ 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 Safety Information
Protect this product from excessive heat and direct sun
Inactive Ingredient
Dimethicone, Water, Squalane, PEG-10 Dimethicone, Propanediol, Glycerin, Tribehenin, Dimethicone Crosspolymer, Cetyl PEG/PPG-10/1 Dimethicone, Silica, Hexyl Laurate, Polyglyceryl-4 Isostearate, Titanium Dioxide, Bisabolol, Lactobacillus Ferment, Scutellaria Baicalensis Root Extract, Cordyceps Militaris Mycelium Extract, Glycyrrhiza Uralensis (Licorice) Root Extract, Tocopheryl Acetate, Medicago Sativa (Alfalfa) Extract, Phormidium Persicinum Extract, Lecithin, Phenoxyethanol, Plankton Extract, Beta-Glucan, Stearic Acid, Microcrystalline Cellulose, Alumina, Butylene Glycol, Sea Water, Sodium Chloride, Sodium Citrate, Mica, Triethoxycaprylylsilane, Melanin, Pentylene Glycol, Ascorbic Acid, 1,2-Hexanediol, Ethylhexylglycerin, Tin Oxide, Retinyl Palmitate, Titanium Dioxide (CI 77891), Iron Oxides (CI 77492, CI 77491, CI77499).
Other
Dist. by ZO Skin Health, Inc. Irvine, CA 92618 | Made in USA with US & imported materials zoskinhealth.com | 931900
Package Label.Principal Display Panel
ZO® SKIN HEALTH
BY ZEIN OBAGI MD
NDC 42851-203-45
DAILY MINERAL SUNSHADE BROAD-SPECTRUM SUNSCREEN SPF 45
ZOX12
Light Medium
Sun Protection
45mL/ 1.5Fl.Oz.
* Please review the disclaimer below.
