Zealios Sport Performance Ultralight Spf 50 Sunscreen Cream
FDA Label NDC 83326-003

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 Sport Performance Ultralight Spf 50 Sunscreen (NDC 83326-003). 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
Homosalate15%Sunscreen
Octocrylene10%Sunscreen
Octyl Salicylate5%Sunscreen
Avobenzone3%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 as soon as possible.

Directions

Apply liberally 15 minutes before sun exposure. Reapply after 80 minutes of swimming or sweating, immediately after towel drying, and 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 limiting time in the sun, especially from 10 am – 2 pm and wearing long-sleeved shirts, pants, hats, and sunglasses.

Inactive Ingredients

Water, Butyloctyl Salicylate, Coconut Alkanes, Coco-Caprylate/Caprate, Hydrogenated Methyl Abietate, Organic Aloe Barbadensis Leaf Juice, Glycerin, Hydrolyzed Jojoba Esters, Glyceryl Stearate, Glyceryl Stearate Citrate, Sodium Stearoyl Glutamate, Rosa Canina (Rosehip) Fruit Oil, Daucus Carota Sativa (Carrot) Seed Oil, Rice Starch, Polyglyceryl-4 Isostearate, Lysolecithin, Sclerotium Gum, Xanthan Gum, Pullulan, Phenoxyethanol, Biosaccharide Gum-1, Ethylhexylglycerin, Niacinamide, Tocopherol

Other Info

Protect this product from excessive heat and direct sun.

Principal Display Panel - 946 Ml Bottle Label

zealios ®

SPORT PERFORMANCE
SUNSCREEN
50

ULTRALIGHT

+ Hydration

Broad Spectrum SPF 50
Water Resistant (80 min.)
Fragrance Free

32 fl oz (946 ml)

Principal Display Panel (946 ml Bottle Label)

Principal Display Panel (946 ml Bottle Label)

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