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  5. Label Information: Macroantioxidant Sun Protection

FDA Label for Macroantioxidant Sun Protection

View Indications, Usage & Precautions

Table of Contents

    1. OTC - ACTIVE INGREDIENT
    2. OTC - PURPOSE
    3. OTC - KEEP OUT OF REACH OF CHILDREN
    4. INDICATIONS & USAGE
    5. DOSAGE & ADMINISTRATION
    6. WARNINGS
    7. INACTIVE INGREDIENT
    8. PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Macroantioxidant Sun Protection Product Label

The following document was submitted to the FDA by the labeler of this product Natura Bisse International Sa. 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.

Otc - Active Ingredient



Active Ingredients                                                 Purpose

Avobenzone 3% .................................................... Sunscreen

Homosalate 10% ................................................... Sunscreen

Octinoxate 7.5% .................................................... Sunscreen

Octocrylene 10% ................................................... Sunscreen

Oxybenzone 3% .................................................... Sunscreen


Otc - Purpose



Uses

helps prevent sunburn


Otc - Keep Out Of Reach Of Children



Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center right away.


Indications & Usage



Natura Bissé Barcelona

C+C Oil-Free MacroAntioxidant Sun Protection

Broad Spectrum SPF 30

Net Wet 1 oz 30 ml


Dosage & Administration



Directions

  • apply liberally 15 minutes before sun exposure
  • use a water resistant sunscreen if swimming or sweating
  • reapply 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 a.m. - 2p.m.
  • wear long-sleeved shirts, pants, hats, and sun-glasses.

Warnings



Warnings

  • For external use only
  • Do not use on damaged or broken skin
  • When using this product keep out of eyes. Rinse with water to remove.
  • Stop use and ask a doctor if rash occurs.


Inactive Ingredient



Inactive Ingredients

water, alcohol denat., propanediol, glycerin, propylheptyl caprylate, glyceryl stearate, oryza sativa (rice) starch, PEG-100 stearate, benzotriazolyl dodecyl p-cresol, citrus sinensis (orange) peel extract, tocopheryl acetate, glyceryl linoleate, hydrolyzed collagen, bisabolol, citrus nobilis (mandarin orange) oil, citrus aurantium dulcis (orange) oil, glyceryl linolenate, 7-dehydrocholesterol, polyacrylate crosspolymer-11, disodium EDTA, glyceryl polyacrylate, ethylhexylglycerin, tricalcium phosphate, citric acid, phenoxyethanol, fragrance, limonene, linalool, amyl cinnamal, geraniol, yellow 5 (CI 19140), red 4 (CI 14700).


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