Sei Bella Skin Refining Tinted Moisturizer
FDA Label NDC 54473-251

Full FDA labeling including Indications, Dosage, Usage, and Precautions

Structured Product Label

The following Structured Product Label (SPL) was submitted to the FDA by Melaleuca Inc. for the product Sei Bella Skin Refining Tinted Moisturizer (NDC 54473-251). 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 active ingredients, purpose, uses, warnings, otc - do not use, otc - when using, otc - stop use, otc - keep out of reach of children, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.

Label Section Quick Index

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)

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