Otc - Active Ingredient
Zinc Oxide 16.0%
Zo Skin Health Sheer Fluid Tint Broad-spectrum Sunscreen Spf 45 Fair-light Liquid
FDA Label NDC 42851-207
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 Sheer Fluid Tint Broad-spectrum Sunscreen Spf 45 Fair-light (NDC 42851-207). 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, otc - do not use, otc - when using, otc - stop use, otc - ask doctor, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.
Label Section Quick Index
Otc - Purpose
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
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.
Other Safety Information
Other Information
■ Protect this product from
excessive heat and direct sun.
Dosage & Administration
Directions
■ Apply liberally 15 minutes before sun exposure
■ 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.
Inactive Ingredient
Water, Dimethicone, C12-15 Alkyl Benzoate, Dicaprylyl Carbonate, Silica, Cetyl PEG/PPG-10/1 Dimethicone, Butylene Glycol, Glycerin, Dimethicone Crosspolymer, Argania Spinosa Kernel Oil, Tocopheryl Acetate, Polysorbate 20, Bisabolol, Phenoxyethanol, Ethyl Ferulate, Triethoxycaprylylsilane, Microcrystalline Cellulose, Cellulose Acetate, Sodium Chloride, Acrylates/Ammonium Methacrylate Copolymer, Caprylyl Glycol, Chlorphenesin, Propylene Glycol Stearate, Sea Water, Sodium Citrate, Helianthus Annuus (Sunflower) Seed Oil, Magnesium Stearate, Medicago Sativa (Alfalfa) Extract, Ascorbic Acid, Melanin, Pentylene Glycol, Phormidium Persicinum Extract, 1,2-Hexanediol, Lecithin, Plankton Extract, Beta-Glucan, Rosmarinus Officinalis (Rosemary) Leaf Extract, Tocopherol, Ethylhexylglycerin, Farnesol, Benzyl Benzoate, Retinyl Palmitate, Titanium Dioxide (CI 77891), Iron Oxides (CI 77491, CI 77492, CI 77499).
Other
Dist. by ZO Skin Health, Inc. Irvine,
CA 92618 | Made in USA with US
& imported materials
zoskinhealth.com | 927100
Package Label.Principal Display Panel
ZO SKIN HEALTH
BY ZEIN OBAGI MD
NDC 42851-207-50
SHEER FLUID TINT BROAD-SPECTRUM SUNSCREEN SPF 45
ZOX 12
50 mL/ 1.7 Fl. Oz.
Fair-Light
SUN PROTECTION
* Please review the disclaimer below.
