Active Ingredients (W/W)
Titanium Dioxide 10%
Zinc Oxide 8%
Vivier Sheer Spf 30 Mineral Tinted Lotion
FDA Label NDC 67226-2851
Full FDA labeling including Indications, Dosage, Usage, and Precautions
Structured Product Label
The following Structured Product Label (SPL) was submitted to the FDA by Vivier Pharma, Inc. for the product Vivier Sheer Spf 30 Mineral Tinted (NDC 67226-2851). 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 (w/w), purpose, uses, warnings, do not use, when using this product, stop use and ask a doctor if, 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
Purpose
Sun Protectant
Uses
• Helps prevent sunburn and provides a sun protection factor of 30. • 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 broken skin.
When Using This Product
void contact with eyes. If contact occurs, rinse thoroughly with water.
Stop Use And Ask A Doctor If
rash occurs.
Keep Out Of Reach Of Children.
If swallowed, call a poison control centre or get medical help right away.
Directions
Adults and children over 6 months of age: • Apply daily to face, neck and chest. • Apply liberally and evenly 15 minutes before sun exposure. • Reapply at least every 2 hours. • Use a water resistant sunscreen if swimming or sweating. • 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. ; and • wear long-sleeved shirts, pants, hats, and sunglasses. • Ideal for daily use.
Other Information
Store at room temperature (15-30°C / 59-86°F).
Non-Medicinal Ingredients
Alumina, Ammonium Acryloyldimethyltaurate/VP Copolymer, Bis-PEG/PPG-16/16 PEG/PPG-16/16 Dimethicone, Butylparaben, C12-15 Alkyl Benzoate, Caprylic/Capric Triglyceride, Ceteareth-20, Cetearyl Alcohol, Cetyl Dimethicone, Citrus Aurantium Dulcis (Orange) Peel Extract, Citrus Limon (Lemon) Peel Extract, Cyclohexasiloxane, Cyclopentasiloxane, Dimethicone, Dipropylene Glycol Dibenzoate, DL-alpha Tocopheryl Acetate, Ethylparaben, Glycerin, Glyceryl Stearate, Green Tea Extract, Iron Oxides CI 77491, Iron Oxides CI 77492, Iron Oxides CI 77499, Isopropyl Titanium Triisostearate, Methylparaben, Phenoxyethanol, Phytic Acid, Polyhydroxystearic Acid, Polysorbate 20, PPG-15 Stearyl Ether Benzoate, Propylene Glycol, Propylparaben, Pyrus Malus (Apple) Fruit Extract, Saccharum Officinarum (Sugarcane) Extract, Sodium Ascorbyl Phosphate, Sodium Hydroxide, t-Butyl Alcohol, Triethoxycaprylylsilane, VP/Eicosene Copolymer, Water/Eau, Xanthan Gum.
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