Tizo Ultra Non Tinted Mineral Sunscreen Lotion
FDA Label NDC 58892-072
Full FDA labeling including Indications, Dosage, Usage, and Precautions
Structured Product Label
The following Structured Product Label (SPL) was submitted to the FDA by Fallien Cosmeceuticals, Ltd for the product Tizo Ultra Non Tinted Mineral Sunscreen (NDC 58892-072). 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 zinc oxide 20% ........................................................ sunscreen, uses, warnings:, keep out of reach of children., directions, other information, inactive ingredients, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.
Label Section Quick Index
Uses
■ helps prevent 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
Do not useon damaged or broken skin.
When using this product■ keep out of eyes. Rinse eyes with water
to remove.
Stop use and ask a doctor ifrash occurs.
Keep Out Of Reach Of Children.
If swallowed, get medical help or contact a Polson Control Center right away.
Directions
■ apply liberally 15 minutes before sun exposure.
Reapply: ■ after 40 minutes of swimming or sweating ■ Immediately
after towel drying ■ at least every 2 hours.
Sun protection
measures:Spending time In the sun Increases your risk of skin
cancer and early skin aging. To decrease risk, regularly use a
sunscreen with broad spectrum SPF of 15 or higher and other sun
protection measures lncludlng: ■ limit time In the sun, especlally
from 10am to 2pm ■ wear long-sleeved shirts, pants, hats, and
sunglasses ■ children under 6 months: ask a doctor ■ do not spray
directly Into face. Spray on hands then apply to face ■ use In
well-ventilated area.
Other Information
protect this product from excessive
heat and direct sun ■ may stain fabrics.
Inactive Ingredients
Cyclopentasiloxane
Dimethicone Crosspolymer
Cyclopentasiloxane
Cyclohexasiloxane
Cyclopentasiloxane
Dimethiconol
Stearyl Dimethicone
Octadecene
Dimethicone
Polyglyceryl-4 Isostearate
Cetyl PEG/PPG-10/1 Dimethicone
PEG-30 Dipolyhydroxystearate
Tetrahexyldecyl Ascorbate
Tocopheryl Acetate
C12-15 Alkyl Benzoate
Microcrystalline Wax
Caprylhydroxamic Acid
Caprylyl Glycol
Glycerin
Disodium EDTA
Sodium Chloride
Polysorbate 20
Triethanolamine
Water
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