Otc - Active Ingredient
Active ingredients
Avobenzone 1.8%, Homosalate 6%, Octisalate 3%, Octocrylene 1.86%, Oxybenzone 1.8%
Sei Bella
FDA Label NDC 54473-187
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 54473-187). 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 - Purpose
Purpose
Sunscreen
Indications & Usage
Use
- provides moderate protection against sunburn
Warnings
Warnings
Foe 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 six months or age: ask a doctor
General Precautions
Other information
- 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
Clinical Studies
Other information
- dermatologist and allergy tested
Storage And Handling
Other information
- do not store at temperatures below 32°F (0°C) or above 120°C (49°C)
Inactive Ingredient
Inactive ingredients
aqua (water/eau), polyacrylate-15, polyacrylate-17, C20-22 phosphate, C20-22 alcohols, trisiloxane, dimethicone, cyclopentasiloxane, dimethicone crosspolymer, cetyl palmitate, glycerin, butyrospermum parkii (shea butter), C12-15 alkyl benzoate, dicaprylyl carbonate, C14-22 alcohols, C12-20 alkyl glucoside, propylheptyl caprylate, acetyl tetrapeptide-9, phenoxyethanol, cetyl alcohol, caprylyl glycol, 1,2 hexanediol, triethanolamine, xanthan gum, trisodium ethylenediamine disuccinate, parfum, bisabolol, panax ginseng root extract, lycium barbarum fruit extract, aloe barbadensis leaf juice, camellia oleifera leaf extract, butylene glycol, allantoin, tocopheryl acetate, limonene, butylphenyl methylpropional
Package Label.Principal Display Panel
Image Of Box (Daylotionbox)
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