Otc - Active Ingredient
Titanium Dioxide 5%
Zinc Oxide 5%
Sei Bella Tinted Bb Moisturizing Cream Lotion
FDA Label NDC 59735-890
Full FDA labeling including Indications, Dosage, Usage, and Precautions
Structured Product Label
The following Structured Product Label (SPL) was submitted to the FDA by Pml Nyc, Llc for the product Sei Bella Tinted Bb Moisturizing Cream (NDC 59735-890). 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 - 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
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 and early skin aging caused by the sun
Warnings
For external use only
Otc - Do Not Use
Do not useon damaged or broken skin
Otc - When Using
When using this productkeep out of eyes. Rinse with water to remove.
Otc - Stop Use
Stop use and ask a doctor ifrash occurs
Otc - Keep Out Of Reach Of Children
Keep out of reach of children.
If product is swallowed, get medical help or contact a Poison Control Center right away.
Dosage & Administration
■ apply smoothly on cleansed 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 10 a.m. – 2 p.m.
■ wear long-sleeve shirts, pants, hats, and sunglasses
Clinical Studies
■ for normal to oily skin
■ dermatologist tested
■ may stain some fabrics
Storage And Handling
■ protect this product from excessive heat and direct sun
■ do not store at temperatures below 32°F (0°C) or above 120°F (49°C)
Inactive Ingredient
water (aqua), cyclopentasiloxane, butylene glycol, octyldodecyl neopentanoate, PEG/PPG-18/18 dimethicone, dimethicone, magnesium chloride, potassium chloride, sodium chloride, zinc chloride, lysine, tocopherol, tetrahexyldecyl ascorbate, magnesium ascorbyl phosphate, retinyl palmitate, panax ginseng root extract, ginkgo biloba leaf extract, camellia sinensis leaf extract, chamomilla recutita (matricaria) flower extract, octyldodecanol, sodium hyaluronate, phytantriol, glycerin, triethoxycaprylylsilane, boron nitride, dextrin palmitate, palmitic acid, methicone, stearic acid, aluminum hydroxide, hexylene glycol, disodium EDTA, potassium sorbate, sodium dehydroacetate, caprylyl glycol, phenoxyethanol, (+/-): iron oxides (CI 77491, CI 77492, CI 77499), titanium dioxide (CI 77891), mica
Package Label.Principal Display Panel
* Please review the disclaimer below.
