Sei Bella

Manufacturer
Melaleuca, Inc.
Effective date
2011-01-26
Label type
HUMAN OTC DRUG LABEL
Version
1
Source
full-release
Hydrated at
2026-05-31 22:27:07

Label at a glance#

ProductSei Bella Daytime Delivery
Active ingredientAVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENE, Oxybenzone
Label structure13 sections

Storage and handling

Other information do not store at temperatures below 32°F (0°C) or above 120°F (49°C)

Label contents#

Full prescribing information#

OTC - ACTIVE INGREDIENT SECTION

Active ingredients
Avobenzone 1.8%, Homosalate 6%, Octisalate, 3%, Octocrylene 1.86%, Oxybenzone 1.8%

OTC - PURPOSE SECTION

Purpose
Sunscreen

INDICATIONS & USAGE SECTION

Use

  • provides moderate protection against sunburn

WARNINGS SECTION

Warnings
For external use only

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 or irritation develops and lasts

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

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

DOSAGE & ADMINISTRATION SECTION

Directions

  • apply smoothly on cleansed skin before sun exposure and as needed
  • children under six months of age: ask a doctor

CLINICAL STUDIES SECTION

Other information
  • dermatologist and allergy tested

GENERAL PRECAUTIONS SECTION

Other information

  • Sun alert: Limiting sun exposure, wearing protective clothing, and using sunscreens may reduce the risks of skin aging, skin cancer, and other harmful effects of the sun
  • may stain some fabrics

STORAGE AND HANDLING SECTION

Other information

  • do not store at temperatures below 32°F (0°C) or above 120°F (49°C)

INACTIVE INGREDIENT SECTION

Inactive ingredients
aqua (water/eau), polyacrylate-15, polyacrylate-17, glycerin, cetyl palmitate, C20-22 alkyl phosphate, C20-22 alcohols, butyrospermum parkii (shea butter), C12-15 alkyl benzoate, trisiloxane, dimethicone, cyclopentasiloxane, dimethicone crosspolymer, C14-22 alcohols, C12-20 alkyl glucoside, propylheptyl caprylate, caprylic/capric triglycerides, acetyl tetrapeptide-9, phenoxyethanol, cetyl alcohol, xanthan gum, triethanolamine, sodium polyacrylate, potassium sorbate, trisodium ethylenediamine disuccinate, parfum, bisabolol, panax ginseng root extract, camellia oleifera leaf extract, lycium barbarum fruit extract, aloe barbadensis leaf juice, ginkgo biloba leaf extract, butylene glycol, allantoin, tocopheryl acetate, linalool, hexyl cinnamal, benzyl salicylate, alpha isomethyl ionone

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

image of boximage of box

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
54473-186-022019-10-29C16284748780-1960f7f55-cc6e-8e05-e053-dbdaa90a074aSei Bella Daytime Delivery Creme Content of Label

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
54473-186-02Sei BellaDaytime Delivery1 in 1 BOXCREAM11
54473-186-02Sei BellaDaytime Delivery50 mL in 1 JARCREAM501

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
54473-186SEI BELLA DAYTIME DELIVERY (AVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENE, OXYBENZONE) CREAM [MELALEUCA, INC.]1Legacy NDC, 2 package rows20110203_af2086a9-eae0-484e-aa9f-9697e2b05fb5.zip

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIISPL versionUploaded
AVOBENZONEACTIVE INGREDIENTG63QQF2NOX1
HOMOSALATEACTIVE INGREDIENTV06SV4M95S1
OCTISALATEACTIVE INGREDIENT4X49Y0596W1
OCTOCRYLENEACTIVE INGREDIENT5A68WGF6WM1
OxybenzoneACTIVE INGREDIENT95OOS7VE0Y1
AVOBENZONEACTIVE MOIETYG63QQF2NOX1
HOMOSALATEACTIVE MOIETYV06SV4M95S1
OCTISALATEACTIVE MOIETY4X49Y0596W1
OCTOCRYLENEACTIVE MOIETY5A68WGF6WM1
OxybenzoneACTIVE MOIETY95OOS7VE0Y1
ALLANTOININACTIVE INGREDIENT344S277G0Z1
ALOE VERA LEAFINACTIVE INGREDIENTZY81Z83H0X1
ALPHA-TOCOPHEROL ACETATEINACTIVE INGREDIENT9E8X80D2L01
ASIAN GINSENGINACTIVE INGREDIENTCUQ3A77YXI1
BUTYLENE GLYCOLINACTIVE INGREDIENT3XUS85K0RA1
C12-15 ALKYL BENZOATEINACTIVE INGREDIENTA9EJ3J61HQ1
C14-22 ALCOHOLSINACTIVE INGREDIENTB1K89384RJ1
CAMELLIA OLEIFERA LEAFINACTIVE INGREDIENT5077EL0C601
Cetyl AlcoholINACTIVE INGREDIENT936JST6JCN1
CETYL PALMITATEINACTIVE INGREDIENT5ZA2S6B08X1
Cyclomethicone 5INACTIVE INGREDIENT0THT5PCI0R1
DIMETHICONEINACTIVE INGREDIENT92RU3N3Y1O1
GINKGOINACTIVE INGREDIENT19FUJ2C58T1
GlycerinINACTIVE INGREDIENTPDC6A3C0OX1
LEVOMENOLINACTIVE INGREDIENT24WE03BX2T1
MEDIUM-CHAIN TRIGLYCERIDESINACTIVE INGREDIENTC9H2L21V7U1
PHENOXYETHANOLINACTIVE INGREDIENTHIE492ZZ3T1
POTASSIUM SORBATEINACTIVE INGREDIENT1VPU26JZZ41
SHEA BUTTERINACTIVE INGREDIENTK49155WL9Y1
TRISILOXANEINACTIVE INGREDIENT9G1ZW13R0G1
TrolamineINACTIVE INGREDIENT9O3K93S3TK1
WaterINACTIVE INGREDIENT059QF0KO0R1
XANTHAN GUMINACTIVE INGREDIENTTTV12P4NEE1

Products#

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

DailyMed product names page 1 of 1 · 30 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
54473-18654473-186-02

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 28 matching rows.

Source Document#

Source XML

Inactive ingredient matches#

Inactive Ingredient Database values describe FDA-listed use contexts. The match method and ambiguity count are shown because ingredient names, routes, and dosage forms are not always unique. Browse recovered IID releases and source provenance.

Inactive ingredient links page 1 of 4 · 203 matching rows.

DailyMed ingredient, IID ingredient, UNII table
DailyMed ingredientIID ingredientUNIIDosage form / routePotencyMaximum daily exposureMatch
POTASSIUM SORBATEPOTASSIUM SORBATE1VPU26JZZ4EMULSION / OPHTHALMIC0.47 %w/vExact identifier — unii candidate
19 equally ranked IID candidates
Cetyl AlcoholCETYL ALCOHOL936JST6JCNSUSPENSION / OPHTHALMIC0.5 %w/vExact identifier — unii candidate
20 equally ranked IID candidates
GlycerinGLYCERINPDC6A3C0OXSOAP / TOPICAL0.76 %w/wExact identifier — unii candidate
75 equally ranked IID candidates
MEDIUM-CHAIN TRIGLYCERIDESMEDIUM-CHAIN TRIGLYCERIDESC9H2L21V7UTABLET, EXTENDED RELEASE / ORAL0.37 mgExact identifier — unii candidate
18 equally ranked IID candidates
Cetyl AlcoholCETYL ALCOHOL936JST6JCNSUSPENSION / AURICULAR (OTIC)1 %w/vExact identifier — unii candidate
20 equally ranked IID candidates
GlycerinGLYCERINPDC6A3C0OXSOLUTION/ DROPS / AURICULAR (OTIC)25 mgExact identifier — unii candidate
75 equally ranked IID candidates
GlycerinGLYCERINPDC6A3C0OXFILM, EXTENDED RELEASE / BUCCAL34 mgExact identifier — unii candidate
75 equally ranked IID candidates
GlycerinGLYCERINPDC6A3C0OXAEROSOL / TOPICAL3 %w/wExact identifier — unii candidate
75 equally ranked IID candidates
GlycerinGLYCERINPDC6A3C0OXPASTE / ORAL3822 mgExact identifier — unii candidate
75 equally ranked IID candidates
XANTHAN GUMXANTHAN GUMTTV12P4NEETABLET / ORAL56 mgExact identifier — unii candidate
29 equally ranked IID candidates
GlycerinGLYCERINPDC6A3C0OXSYSTEM / IONTOPHORESIS168.1 mgExact identifier — unii candidate
75 equally ranked IID candidates
XANTHAN GUMXANTHAN GUMTTV12P4NEETABLET, FILM COATED / ORAL0.08 mgExact identifier — unii candidate
29 equally ranked IID candidates
GlycerinGLYCERINPDC6A3C0OXGEL / OPHTHALMIC0.88 %w/wExact identifier — unii candidate
75 equally ranked IID candidates
GlycerinGLYCERINPDC6A3C0OXEMULSION / INTRAVENOUS2.2 %w/vExact identifier — unii candidate
75 equally ranked IID candidates
XANTHAN GUMXANTHAN GUMTTV12P4NEETABLET, EXTENDED RELEASE / ORAL528 mgExact identifier — unii candidate
29 equally ranked IID candidates
TrolamineTROLAMINE9O3K93S3TKLOTION / TOPICAL360 mgExact identifier — unii candidate
22 equally ranked IID candidates
GlycerinGLYCERINPDC6A3C0OXINJECTION, SOLUTION / INTRAVENOUS15 %w/vExact identifier — unii candidate
75 equally ranked IID candidates
MEDIUM-CHAIN TRIGLYCERIDESMEDIUM-CHAIN TRIGLYCERIDESC9H2L21V7UINJECTION, SUSPENSION, EXTENDED RELEASE / SUBCUTANEOUS990.3 mgExact identifier — unii candidate
18 equally ranked IID candidates
GlycerinGLYCERINPDC6A3C0OXCAPSULE, EXTENDED RELEASE / ORAL265 mgExact identifier — unii candidate
75 equally ranked IID candidates
XANTHAN GUMXANTHAN GUMTTV12P4NEELOTION / TOPICAL0.3 %w/vExact identifier — unii candidate
29 equally ranked IID candidates
XANTHAN GUMXANTHAN GUMTTV12P4NEEPOWDER / ORAL275 mgExact identifier — unii candidate
29 equally ranked IID candidates
TrolamineTROLAMINE9O3K93S3TKAEROSOL, METERED / RECTALADJ PHExact identifier — unii candidate
22 equally ranked IID candidates
Cetyl AlcoholCETYL ALCOHOL936JST6JCNEMULSION / TOPICALNAExact identifier — unii candidate
20 equally ranked IID candidates
XANTHAN GUMXANTHAN GUMTTV12P4NEETABLET, CHEWABLE, EXTENDED RELEASE / ORAL6 mgExact identifier — unii candidate
29 equally ranked IID candidates
Cetyl AlcoholCETYL ALCOHOL936JST6JCNTABLET, EXTENDED RELEASE / ORAL132 mgExact identifier — unii candidate
20 equally ranked IID candidates
Cetyl AlcoholCETYL ALCOHOL936JST6JCNAEROSOL, FOAM / RECTAL17 mgExact identifier — unii candidate
20 equally ranked IID candidates
GlycerinGLYCERINPDC6A3C0OXSOLUTION / OPHTHALMIC6 %w/vExact identifier — unii candidate
75 equally ranked IID candidates
XANTHAN GUMXANTHAN GUMTTV12P4NEESOLUTION / ORAL84 mgExact identifier — unii candidate
29 equally ranked IID candidates
POTASSIUM SORBATEPOTASSIUM SORBATE1VPU26JZZ4SOLUTION/ DROPS / OPHTHALMIC0.47 %w/vExact identifier — unii candidate
19 equally ranked IID candidates
POTASSIUM SORBATEPOTASSIUM SORBATE1VPU26JZZ4TABLET, EXTENDED RELEASE / ORAL0.2 mgExact identifier — unii candidate
19 equally ranked IID candidates
MEDIUM-CHAIN TRIGLYCERIDESMEDIUM-CHAIN TRIGLYCERIDESC9H2L21V7UTABLET / ORAL2 mgExact identifier — unii candidate
18 equally ranked IID candidates
TrolamineTROLAMINE9O3K93S3TKAEROSOL, FOAM / TOPICAL2.6 %w/wExact identifier — unii candidate
22 equally ranked IID candidates
GlycerinGLYCERINPDC6A3C0OXSPRAY / NASAL22.3 mg/1mlExact identifier — unii candidate
75 equally ranked IID candidates
GlycerinGLYCERINPDC6A3C0OXSYRUP / ORAL16734 mgExact identifier — unii candidate
75 equally ranked IID candidates
TrolamineTROLAMINE9O3K93S3TKSOAP / TOPICAL0.08 %w/wExact identifier — unii candidate
22 equally ranked IID candidates
XANTHAN GUMXANTHAN GUMTTV12P4NEETABLET, ORALLY DISINTEGRATING, DELAYED RELEASE / ORAL36 mgExact identifier — unii candidate
29 equally ranked IID candidates
GlycerinGLYCERINPDC6A3C0OXSUSPENSION / OPHTHALMIC58 mgExact identifier — unii candidate
75 equally ranked IID candidates
XANTHAN GUMXANTHAN GUMTTV12P4NEESOLUTION, GEL FORMING, EXTENDED RELEASE / OPHTHALMIC0.6 %w/wExact identifier — unii candidate
29 equally ranked IID candidates
POTASSIUM SORBATEPOTASSIUM SORBATE1VPU26JZZ4TABLET / ORAL6 mgExact identifier — unii candidate
19 equally ranked IID candidates
GlycerinGLYCERINPDC6A3C0OXINJECTION / SUBCUTANEOUS450 mgExact identifier — unii candidate
75 equally ranked IID candidates
TrolamineTROLAMINE9O3K93S3TKINJECTION, POWDER, FOR SUSPENSION / INTRAVENOUS0.02 %w/vExact identifier — unii candidate
22 equally ranked IID candidates
TrolamineTROLAMINE9O3K93S3TKSOLUTION / TOPICALNAExact identifier — unii candidate
22 equally ranked IID candidates
POTASSIUM SORBATEPOTASSIUM SORBATE1VPU26JZZ4SOLUTION / ORAL1000 mg/15mlExact identifier — unii candidate
19 equally ranked IID candidates
GlycerinGLYCERINPDC6A3C0OXSOLUTION / NASAL25 mg/1mlExact identifier — unii candidate
75 equally ranked IID candidates
TrolamineTROLAMINE9O3K93S3TKCREAM / VAGINAL56 mgExact identifier — unii candidate
22 equally ranked IID candidates
MEDIUM-CHAIN TRIGLYCERIDESMEDIUM-CHAIN TRIGLYCERIDESC9H2L21V7USOLUTION / ORAL5566 mgExact identifier — unii candidate
18 equally ranked IID candidates
GlycerinGLYCERINPDC6A3C0OXPASTE / DENTAL20 %w/wExact identifier — unii candidate
75 equally ranked IID candidates
CETYL PALMITATECETYL PALMITATE5ZA2S6B08XOINTMENT / TOPICALNAExact identifier — unii candidate
4 equally ranked IID candidates
TrolamineTROLAMINE9O3K93S3TKGEL, METERED / TOPICAL20 mgExact identifier — unii candidate
22 equally ranked IID candidates
GlycerinGLYCERINPDC6A3C0OXINJECTION, EMULSION / INTRAVENOUS24100 mgExact identifier — unii candidate
75 equally ranked IID candidates
GlycerinGLYCERINPDC6A3C0OXJELLY / VAGINALNAExact identifier — unii candidate
75 equally ranked IID candidates
GlycerinGLYCERINPDC6A3C0OXSUSPENSION, EXTENDED RELEASE / ORAL2000 mgExact identifier — unii candidate
75 equally ranked IID candidates
GlycerinGLYCERINPDC6A3C0OXGUM, CHEWING / BUCCAL230 mgExact identifier — unii candidate
75 equally ranked IID candidates
POTASSIUM SORBATEPOTASSIUM SORBATE1VPU26JZZ4PASTE / ORAL48 mgExact identifier — unii candidate
19 equally ranked IID candidates
MEDIUM-CHAIN TRIGLYCERIDESMEDIUM-CHAIN TRIGLYCERIDESC9H2L21V7UOINTMENT / TOPICAL20 %w/wExact identifier — unii candidate
18 equally ranked IID candidates
MEDIUM-CHAIN TRIGLYCERIDESMEDIUM-CHAIN TRIGLYCERIDESC9H2L21V7UINJECTION, EMULSION / INTRAVENOUS1.1 %w/vExact identifier — unii candidate
18 equally ranked IID candidates
SHEA BUTTERSHEA BUTTERK49155WL9YLOTION / TOPICAL2340 mgExact identifier — unii candidate
XANTHAN GUMXANTHAN GUMTTV12P4NEEGEL / TOPICAL58 mgExact identifier — unii candidate
29 equally ranked IID candidates
XANTHAN GUMXANTHAN GUMTTV12P4NEEPOWDER, FOR SOLUTION / ORAL10 mg/5mlExact identifier — unii candidate
29 equally ranked IID candidates
GlycerinGLYCERINPDC6A3C0OXCLOTH / TOPICAL0.05 mg/mgExact identifier — unii candidate
75 equally ranked IID candidates

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
58c8da02-a1d6-492e-9bc1-c5c26fac5ec5af2086a9-eae0-484e-aa9f-9697e2b05fb52011-01-26WarningsExact identifier
spl id: 58c8da02-a1d6-492e-9bc1-c5c26fac5ec5
spl set id: af2086a9-eae0-484e-aa9f-9697e2b05fb5

Reported adverse events (FAERS/openFDA)#

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