Zealios Sun Barrier Spf 45
FDA Label NDC 83326-001

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

Structured Product Label

The following Structured Product Label (SPL) was submitted to the FDA by Personal Best Products Inc. Dba Zealios for the product Zealios Sun Barrier Spf 45 (NDC 83326-001). 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 other, otc - purpose, uses, warnings, otc - keep out of reach of children, directions, inactive ingredients, other info, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.

Label Section Quick Index

Other

Drug Facts

Otc - Purpose

Active Ingredients:Purpose
Zinc Oxide 8.00%Sunscreen
Octinoxate 7.50%Sunscreen
Octisalate 3.00%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.

Otc - Keep Out Of Reach Of Children

  • -Keep out of reach of children. If swallowed, get medical help or contact 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

Ascorbyl Palmitate, Butylene Glycol, Cyclopentasiloxane, Dimethicone, Dimethicone/PEG-10/15 Crosspolymer, Dimethicone/Vinyl Dimethicone Crosspolymer, Ethyl Hexyl Isononanoate, Iodopropynyl Butylcarbarnate, Lauryl PEG-9 Polymethylsiloxyethyl Dimethicone, Phenoxyethanol, Purified Water, Retinyl Palmitate, Sodium Chloride, Triethoxycaprylysilane

Other Info

Protect this product from excessive heat and direct sun.

Principal Display Panel - 88 Ml Tube Label

SPORT PERFORMANCE
SUN BARRIER

SPF 45
BROAD SPECTRUM
8% Micronized Zinc Oxide

DRIES
CLEAR

Water Restant (80 min.)
Oil & Fragrance Free
Non-Greasy Sunscreen

3 fl oz (88 ml)

Principal Display Panel (88 ml Tube Label)

Principal Display Panel (88 ml Tube Label)

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