Active Ingredients
Homosalate 7.5%
Octocrylene 9%
Octisalate 3.75%
Titanium Dioxide 2%
Zinc Oxide 9.45%
Sei Bella Daily Uv Defense Cream
FDA Label NDC 54473-403
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 Daily Uv Defense (NDC 54473-403). 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, 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
sunscreen
Indications & Usage
helps prevent sunburn
if used as directed with other sun protection measures (see Directions), decreases the risk of skin cancer caused by the sun
Warnings
For external use only. 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 reach of children. If swallowed, get medical help or contact a Poison Control Center right away.
Dosage & Administration
Directions For sunscreen use:
- apply liberally 15 minutes before sun exposure
- reapply at least every 2 hours
- use a water-resistant sunscreen if swimming or sweating
- 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:
- children under 6 months of age: Ask a doctor
limiting time in the sun, especially from 10 a.m. - 2 p.m.
wearing long-sleeve shirts, pants, hats, and sunglasses
Storage And Handling
store at room temperature 68-77 F. Protect from freezing.
Inactive Ingredient
water, caprylyl methicone, cyclopentasiloxane, glycerin, caprylic/capric triglyceride, coco-caprylate/caprate, propanediol, pyrus malus (apple) fruit extract, dimethicone, polymethylsilsesquioxane, lauryl peg-9 polydimethylsiloxyethyl dimethicone, PEG-12 dimethicone/PPG-20 crosspolymer, acrylates/dimethicone copolymer, C12-15 alkyl benzoate, polyhydroxystearic acid, dimethicone/peg-10/15 crosspolymer, gossypium hirsutum (cotton) extract, sodium chloride, phenoxyethanol, triethoxycaprylylsilane, ethylhexylglycerin,disteardimonium hectorite, silica, allantoin, sodium citrate, 2,3-butanediol, tocopherol
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