FDA Label for Zealios Sun Barrier Spf 45

View Indications, Usage & Precautions

Zealios Sun Barrier Spf 45 Product Label

The following document was submitted to the FDA by the labeler of this product Personal Best Products Inc. Dba Zealios. The document includes published materials associated whith this product with the essential scientific information about this product as well as other prescribing information. Product labels may durg indications and usage, generic names, contraindications, active ingredients, strength dosage, routes of administration, appearance, warnings, inactive ingredients, etc.

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)


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