Sei Bella Tinted BB Moisturizing Creme Broadspectrum SPF 20

Manufacturer
Melaleuca Inc | Northwest Cosmetic Labs
Effective date
2016-05-06
Label type
HUMAN OTC DRUG LABEL
Version
2
Source
full-release
Hydrated at
2026-05-31 22:46:59

Label at a glance#

ProductSei Bella Tinted BB Moisturizing Creme Broadspectrum SPF 20 Blush 140 C
Active ingredientAVOBENZONE, OCTINOXATE
Label structure8 sections

Indications and uses

helps prevent sunburn is used as directed with other sun protection measures (see  Directions ), decreases the risk of skin cancer and early skin aging caused by the sun

Dosage and administration

Directions apply smoothly on cleased 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...

Storage and handling

may stain some fabrics protect this product from excessive heat and direct sun do not store at temperatures below 32oF (0oC) or above 120oF (49oC) dermatologist and allergy tested

Label contents#

Full prescribing information#

Active Ingredients

OTC - ACTIVE INGREDIENT SECTION

Avobenzone 3.0%

Octinoxate 7.5%

Purpose

OTC - PURPOSE SECTION

Sunscreen

Uses

INDICATIONS & USAGE SECTION

  • helps prevent sunburn
  • is 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

WARNINGS AND PRECAUTIONS SECTION

For External Use Only

Keep Out of the Reach of Children

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

Keep out of the reach of children. If swallowed, get medical help or contact a Poison Control Center right away.

When using

OTC - WHEN USING SECTION

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

Do not use

OTC - DO NOT USE SECTION

Do not use on damaged or broken skin.

Directions

INSTRUCTIONS FOR USE SECTION

Directions

  • apply smoothly on cleased 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 10a.m.-2p.m
  • wear long-sleeve shirts, pants, hats, and sunglasses

Other Information

STORAGE AND HANDLING SECTION

  • may stain some fabrics
  • protect this product from excessive heat and direct sun
  • do not store at temperatures below 32oF (0oC) or above 120oF (49oC)

Other Information

CLINICAL STUDIES SECTION

dermatologist and allergy tested

Inactive ingredients

INACTIVE INGREDIENT SECTION

aqua (water/eau), isododecane, glycerin, acrylates crosspolymer, isoamyl laurate, octyldodecyl oleate, polyglyceryl-4 diisostearate/polyhydroxustearate/sebacate, titanium dioxide (CI 77891), polypropylene, cyclopentasiloxane, ethylhexyl palmitate, dimethicone, magnesium sulfate, glyceryl caprylate, microcrystalline wax, phenyl trimethicone, quaternium-90 bentonite, sodium chloride, hydrogenated castor oil, hydrolyzed jojoba esters, gluconolactone, mica (CI 77019), citrullur lanatus (watermelon), polysilicone-11, isoamyl cocoate, iron oxides (CI 77491, CI 77492, CI 77499), sodium benzoate, lens esculenta (lentil) fruit extract, propylene carbonate, glyceryl undecylenate, pyrus malus (apple) fruit extract, tetrahexyldecyl ascorbate, tocopheryl acetate, laminaria digitata extract, sodium lactate, hydroxypropyl cyclodextrin, sodium PCA, calcium gluconate, phenoxyethanol, potassium sorbate, tin oxide, palmitoyl tripeptide-38

Principal Display Panel

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Tinted BB Moistrizing Creme BoxTinted BB Moistrizing Creme Box

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
bee4fa8d-8d82-423a-a0b5-40a89dd13a99Product name120250618
444b3e50-f226-46ef-bfca-2e7035d140cdProduct name120190611
597b1cfd-7b31-5048-62be-ca5cd740da2fProduct name120140508
ec2149b3-5c6d-5344-f757-c86411073075Product name120140508

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
54473-261-012020-01-31C16284748780-19d75b9d0-ce65-f424-e053-dadaa90a57ceTinted BB Moisturizing Creme Broad-Spectrum SPF 20 Sunscreen

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
54473-261-01Sei Bella Tinted BB Moisturizing Creme Broadspectrum SPF 20Blush 140 C1 in 1 BOXLOTION12
54473-261-01Sei Bella Tinted BB Moisturizing Creme Broadspectrum SPF 20Blush 140 C44.4 mL in 1 TUBELOTION44.42

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
54473-261SEI BELLA TINTED BB MOISTURIZING CREME BROADSPECTRUM SPF 20 BLUSH 140 C (AVOBENZONE AND OCTINOXATE) LOTION [MELALEUCA INC]2Legacy NDC, 2 package rows20160901_2fff86aa-630f-464b-e054-00144ff8d46c.zip

Products#

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

DailyMed product names page 1 of 1 · 39 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
54473-26154473-261-01

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 37 matching rows.

Source Document#

Source XML · Source PDF

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
32329d9d-5b72-5cdf-e054-00144ff8d46c2fff86aa-630f-464b-e054-00144ff8d46c2016-05-06WarningsExact identifier
spl id: 32329d9d-5b72-5cdf-e054-00144ff8d46c
spl set id: 2fff86aa-630f-464b-e054-00144ff8d46c

Reported adverse events (FAERS/openFDA)#

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