Sara Elizabeth Sheer Tinted Sunscreen Spf40
FDA Label NDC 83651-203

Full FDA labeling including Indications, Dosage, Usage, and Precautions

Structured Product Label

The following Structured Product Label (SPL) was submitted to the FDA by Sara Elizabeth Skincare for the product Sara Elizabeth Sheer Tinted Sunscreen Spf40 (NDC 83651-203). 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:, purpose:, uses:, warnings:, directions:, inactive ingredients:, other information:, principal display panel – 53 g bottle label, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.

Label Section Quick Index

Active Ingredients:

Titanium Dioxide 8%

Zinc Oxide 3.8%

Purpose:

Sunscreen

Sunscreen

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 use on damaged or broken skin. Stop use and ask a doctor if rash occurs. When using this product, keep out of eyes. Rinse with water to remove. Keep out of the reach of children. If swallowed, get medical help or contact a Poison Control Center right away.

Directions:

  • Apply liberally 15 minutes before sun exposure.
  • Reapply:
    • After 80 minutes of swimming or sweating
    • Immediately after towel drying
    • At least every 2 hours
    • Children under 6 months: 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 am-2 pm
      • Wear long-sleeved shirts, pants, hats, and sunglasses

Inactive Ingredients:

Alumina, Cyclohexasiloxane, Cyclopentasiloxane, Dimethicone, Dimethicone Crosspolymer, Dimethicone/Vinyl Dimethicone Crosspolymer, Dimethiconol, Iron Oxide (CI77491), Lauryl PEG/PPG-18/18-Hydrogen Dimethicone, Hydrogen Dimethicone, PEG-10 Dimethicone, Tetrahexyldecyl Ascorbate, Tocopheryl Acetate

Other Information:

Protect this product from excessive heat and direct sun

May stain some fabrics

PA+++

Principal Display Panel – 53 G Bottle Label

SARA ELIZABETH

sheer tinted sunscreen

spf40

soft mineral primer

broad spectrum (uva/uvb)

water resistant (80 Minutes)

Net Wt. 1.8 oz/53 g

Principal Display Panel – 53 G Bottle Label (Sar08 0000 01)

Principal Display Panel – 53 G Bottle Label (Sar08 0000 01)

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