Sei Bella Flawless Liquid Foundation

Manufacturer
Melaleuca Inc. | Process Technologies & Packaging LLC.
Effective date
2023-01-11
Label type
HUMAN OTC DRUG LABEL
Version
2
Source
full-release
Hydrated at
2026-05-31 23:53:10

Label at a glance#

ProductSei Bella Flawless Liquid Foundation 460 N
Active ingredientOCTISALATE, OCTINOXATE, TITANIUM DIOXIDE
Label structure10 sections

Dosage and administration

■ 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...

Label contents#

Full prescribing information#

Active Ingredient

OTC - ACTIVE INGREDIENT SECTION

Octinoxate 7.5%

Purpose

OTC - PURPOSE SECTION

Sunscreen

Use

INDICATIONS & USAGE SECTION

■ helps prevent sunburn

Warnings

WARNINGS SECTION

For external use only

OTC - DO NOT USE SECTION

Do not use on damaged or broken skin

OTC - WHEN USING SECTION

When using this product keep out of eyes. Rinse with water to remove.

OTC - STOP USE SECTION

Stop use and ask a doctor if rash occurs

Keep out of reach of children.

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

If swallowed, get medical help or contact a Poison Control Center right away.

Directions

DOSAGE & ADMINISTRATION SECTION

■ 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

CLINICAL STUDIES SECTION

■ dermatologist and allergy tested

STORAGE AND HANDLING SECTION

■ protect this product from excesssive heat and direct sun

Inactive ingredients

INACTIVE INGREDIENT SECTION

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

BoxBox

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
5dbf91a8-ec29-4ffc-807c-e3bae7fb67b1Product name120201123
85bed648-23ca-4804-98e6-e36aee999cadProduct name120190717
80de93b4-8a94-428d-beb7-d644353ee70bProduct name120180424
eb4f7d5b-1286-40dc-b8bf-ad87ff51c688Product name120170522
db8eb201-78c7-4590-8a71-fac0a539bd8cProduct name120170404
141092be-5eb5-452e-9f69-2d350aa70a87Product name120161208

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
54473-323-012025-01-30C16284748780-12cef2736-880a-d83d-e063-dadaa90ab31fSei Bella Flawless Liquid Foundation - 460 N

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
54473-323-01Sei Bella Flawless Liquid Foundation460 N1 in 1 BOXLOTION12
54473-323-01Sei Bella Flawless Liquid Foundation460 N30 mL in 1 BOTTLE, DISPENSINGLOTION302

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
54473-323SEI BELLA FLAWLESS LIQUID FOUNDATION 460 N (OCTINOXATE 6% OCTISALATE 5% TITANIUM DIOXIDE 2%) LOTION [MELALEUCA INC.]2Legacy NDC, 2 package rows20230112_a7da520f-a1ca-6f7e-e053-2a95a90aa41e.zip

Products#

Every source-derived product name is available through these pages.

DailyMed product names page 1 of 1 · 36 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
54473-32354473-323-01

Ingredients#

Every source-derived ingredient row is available through these pages.

DailyMed ingredient rows page 1 of 1 · 34 matching rows.

Source Document#

Source XML

openFDA label cross-check#

OpenFDA label data provides additional search and identifier links. DailyMed’s Structured Product Label is the canonical label on FDA.report. Matching records are deduplicated before they are shown below.

Matched openFDA labels page 1 of 1 · 1 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
f20602ca-ed08-6fdd-e053-2995a90a494ca7da520f-a1ca-6f7e-e053-2a95a90aa41e2023-01-11WarningsExact identifier
spl id: f20602ca-ed08-6fdd-e053-2995a90a494c
spl set id: a7da520f-a1ca-6f7e-e053-2a95a90aa41e

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.