Active Ingredient
Octinoxate 7.5%
Sei Bella Flawless Liquid Foundation
FDA Label NDC 54473-331
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 Flawless Liquid Foundation (NDC 54473-331). 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 ingredient, purpose, use, warnings, otc - do not use, otc - when using, otc - stop use, 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
Purpose
Sunscreen
Use
■ helps prevent sunburn
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
Keep Out Of Reach Of Children.
If swallowed, get medical help or contact a Poison Control Center right away.
Directions
■ apply after cleanser, toner, and foundation primer. Blend outward with Sei Bella foundation brush or fingers.
■ 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: ask a doctor
■ Sun Protection Measures. Spending time in the sun increases you 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 10 a.m.-2 p.m.
■ wear long-sleeve shirts, pants, hats, and sunglasses
Other Information
■ dermatologist and allergy tested
Storage And Handling
■ protect this product from excesssive heat and direct sun
Inactive Ingredients
isododecane, water, titanium oxide, dodecane, ethylhexyl palmitate, propanediol, polymethylsilsesquioxane, trimethylsiloxysilicate, peg-10 dimethicone, polysilicone-11, peg/ppg-18/18 dimethicone, dimethicone, barium sulfate, lecithin, glycerin, disteardimonium hectorite, magnesium aluminum silicate, phenoxyethanol, polysorbate 20, c18-36 acid triglyceride, caprylyl glycol, propylene carbonate, triethoxycaprylylsilane, calcium silicate, xanthum gum, cellulose gum, ouptnia ficus-indica stem extract, quartz, palmitoyl hexapeptide-19, may contain: iron oxide CI 77492, iron oxide 77491, iron oxide 77499
Package Label.Principal Display Panel
Box (Sb Liquidfoundation Box 01201)
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