Sei Bella
FDA Label NDC 54473-276

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 (NDC 54473-276). 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 otc - active ingredient, otc - purpose, indications & usage, warnings, otc - when using, otc - stop use, otc - keep out of reach of children, dosage & administration, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.

Label Section Quick Index

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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