Sheer Broad Spectrum Spf45 Lotion
FDA Label NDC 67226-2845

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 Sheer Broad Spectrum Spf45 (NDC 67226-2845). 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 drug facts, active ingredients, purpose, uses, for external use only, 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

Drug Facts

Active Ingredients

9.9% Zinc Oxide
8.0% Octocrylene
7.5% Ethylhexyl Methoxycinnamate
5.0% Ethylhexyl Salicylate

Purpose

Sunscreen

Uses

• Helps prevent sunburn and provides a sun protection factor of 45.
• Ideal for daily use; can be applied under makeup.

For External Use Only

• The sun may cause sunburn, premature aging of the skin and skin cancer. Avoiding the sun, wearing protective clothing and regular use of sunscreens over the years may reduce the chance of these harmful effects.

When Using This Product

• Avoid contact with eyes. If contact occurs, rinse thoroughly with water.
• Do not use on damaged or broken skin.

Stop Use And Ask A Doctor If

• Rash or irritation develops and lasts.

Keep Out Of Reach Of Children.

If swallowed, get medical help or contact a Poison Control Center right away.

Directions

• Apply daily to face, neck and chest.
• Apply liberally and evenly 15 minutes before sun exposure.
• Reapply at least every 2 hours or as needed after towel drying, perspiring heavily or washing.
• For use on children less than 6 months of age, consult a healthcare practitioner.
• Use a water resistant sunscreen if swimming or sweating.

Inactive Ingredients

BEHENYL ALCOHOL, BUTYLPARABEN, BUTYROSPERMUM PARKII, C12-15 ALKYL BENZOATE, CETEARETH-20, CETEARYL ALCOHOL, CYCLOPENTASILOXANE, CYCLOTETRASILOXANE, ETHYLPARABEN, METHYLPARABEN, PHENOXYETHANOL, PHENYL TRIMETHICONE, PROPYLPARABEN, SILICA, TETRASODIUM EDTA, TOCOPHERYL ACETATE, TRIETHOXYCAPRYLYLSILANE, WATER/EAU.

Questions?

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