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  5. Label Information: Sei Bella Advanced Revital R3 Age Defying Creme

FDA Label for Sei Bella Advanced Revital R3 Age Defying Creme

View Indications, Usage & Precautions

Table of Contents

    1. OTC - ACTIVE INGREDIENT
    2. OTC - PURPOSE
    3. INDICATIONS & USAGE
    4. WARNINGS
    5. OTC - WHEN USING
    6. OTC - STOP USE
    7. OTC - KEEP OUT OF REACH OF CHILDREN
    8. DOSAGE & ADMINISTRATION
    9. CLINICAL STUDIES
    10. GENERAL PRECAUTIONS
    11. STORAGE AND HANDLING
    12. INACTIVE INGREDIENT
    13. PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Sei Bella Advanced Revital R3 Age Defying Creme Product Label

The following document was submitted to the FDA by the labeler of this product Melaleuca, Inc.. 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
Avobenzone 1.8%, Homosalate 6%, Octisalate 3%, Octocrylane 1.86%, Oxybenzone 1.8%


Otc - Purpose



Purpose
Sunscreen


Indications & Usage



Use

  • provides moderate protection against sunburn

Warnings



Warnings
For external use only


Otc - When Using



When using this product

  • keep out of eyes. Rinse with water to remove.

Otc - Stop Use



Stop use and ask a doctor if

  • rash or irritation develops and lasts

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.


Dosage & Administration



Directions

  • apply smoothly on cleansed skin before sun exposure and as needed
  • children under 6 months of age: ask a doctor

Clinical Studies



Other information

  • dermatologist and allergy tested

General Precautions



  • Sun alert: Limiting sun exposure, wearing protective clothing, and using sunscreens may reduce the risks of skin aging, skin cancer, and other harmful effects of the sun
  • may stain some fabrics

Storage And Handling



  • do not store at temperatures below 32°F (0°C) or above 120°F (49°C)

Inactive Ingredient



Inactive ingredients
aqua (water/eau), polyacrylate-15, polyacrylate-17, glycerin, cetyl palmitate, C20-22 alkyl phosphate, C20-22 alcohols, butyrospermum parkii (shea butter), C12-15 alkyl benzoate, trisloxane, dimethicone, cyclopentasiloxane, dimethicone crosspolymer, C14-22 alcohols, C12-20 alkyl glucoside, propylheptyl caprylate, caprylic/capric triglycerides, acetyl tetrapeptide-9, phenoxyethanol, cetyl alcohol, xanthan gum, triethanolamine, sodium polyacrylate, potassium sorbate, trisodium ethylenediamine disuccinate, parfum, bisabolol, panax ginseng root extract, camellia oleifera leaf extract, lycium barbarum fruit extract, aloe barbadensis leaf juice, ginkgo biloba leaf extract, butylene glycol, allantoin, tocopheryl acetate, linalool, hexyl cinnamal, benzyl salicylate, alpha isomethyl ionone


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