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  5. Label Information: Sei Bella Skin Refining Tinted Moisturizer Natural

FDA Label for Sei Bella Skin Refining Tinted Moisturizer Natural

View Indications, Usage & Precautions

Table of Contents

    1. ACTIVE INGREDIENTS
    2. PURPOSE
    3. USES
    4. WARNINGS
    5. OTC - DO NOT USE
    6. OTC - WHEN USING
    7. OTC - STOP USE
    8. OTC - KEEP OUT OF REACH OF CHILDREN
    9. DIRECTIONS
    10. OTHER INFORMATION
    11. CLINICAL STUDIES
    12. STORAGE AND HANDLING
    13. INACTIVE INGREDIENTS
    14. PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Sei Bella Skin Refining Tinted Moisturizer Natural 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.

Active Ingredients



Titanium Dioxide 6.5%


Purpose



Sunscreen


Uses



  • helps prevent sunburn
  • is 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


Otc - Do Not Use



Do not use on damaged or broken skin


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 occurs


Otc - Keep Out Of Reach Of Children



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


Directions



  • apply smoothly on cleased skin
  • 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 of age: 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 10a.m.-2p.m.
  • wear long-sleeve shirts, pants, hats, and sunglasses

Other Information



for normal-to-oily skin


Clinical Studies



dermatologist and allergy tested


Storage And Handling



  • may stain some fabrics
  • protect this product from excessive heat and direct sun
  • do not store at temperatures below 32oF (0oC) or above 120oF (49oC)

Inactive Ingredients



1,2-hexandiol, aloe barbadensis leaf juice, alumina, aminomethyl propanol, aqua (water/eau), beta-glucan, butylene glycol, butyrospermum parkii (shea butter), caprylic/capric tryglyceride, caprylyl glycol, carnosine, cetearyl alcohol, ceteth-10 phosphate, cetyl palmitate, cucumis sativus (cucumber) fruit extract, cyclopentasilloxane, dicetyl phosphate, disodium EDTA, ethylhexylglycerin, glycerin, glycine soja (soybean) oil, hydrogenated cottonseed oil, hydrogenated palm glycerides, iron oxides (CI77491, CI77492, CI77499), isostearic acid, lecithin, octyldodecyl neopentanoate, PEG/PPG-20/15 dimethicone, pentylene glycol, phenyl methicone, polyethylene, polyglyceryl-3, polyricinoleate, polyhydroxystearic acid, polymethylsilsesquioxane, polysorbate 60, polysorbate 80, potassium cetyl phosphate, propylheptyl caprylate, simethicone, stearic acid, tetrahexyldecyl ascorbate, tetrapeptide-21, titanium dioxide (CI77891), tocopheryl acetate, tremella fuciformis sporocarp extract, vitis vinifera (grape) leaf extract, xanthan gum


Package Label.Principal Display Panel



Tint Moist Box - tintmoistbox

Tint Moist Box - tintmoistbox


* Please review the disclaimer below.