Active Ingredients (W/W)
Zinc Oxide 9.9%
Octocrylene 8%
Octinoxate 7.5%
Octisalate 5%
Vivier Sheer Spf 45 Lotion
FDA Label NDC 67226-2852
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 45 (NDC 67226-2852). 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 • Sun Protection Factor 45 • 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
avoid 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 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.
Other Information
Store at room temperature (15-30°C / 59-86°F).
Inactive Ingredients
Behenyl Alcohol, Butylparaben, Butyrospermum Parkii (Shea) Butter, C12-15 Alkyl Benzoate, Ceteareth-20, Cetearyl Alcohol, Cyclohexasiloxane, Cyclopentasiloxane, Ethylparaben, Methylparaben, Phenoxyethanol, Phenyl Trimethicone, Propylparaben, Silica, Tetrasodium EDTA, Tocopherol, Triethoxycaprylylsilane, Water.
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