Sei Bella Daytime Delivery Lotion Content of Label

Manufacturer
Melaleuca, Inc.
Effective date
2011-02-03
Label type
HUMAN OTC DRUG LABEL
Version
2
Source
full-release
Hydrated at
2026-05-31 22:27:08

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°C (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
Foe 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 or age: ask a doctor

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

CLINICAL STUDIES SECTION

Other information

  • dermatologist and allergy tested

STORAGE AND HANDLING SECTION

Other information

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

INACTIVE INGREDIENT SECTION

Inactive ingredients
aqua (water/eau), polyacrylate-15, polyacrylate-17, C20-22 phosphate, C20-22 alcohols, trisiloxane, dimethicone, cyclopentasiloxane, dimethicone crosspolymer, cetyl palmitate, glycerin, butyrospermum parkii (shea butter), C12-15 alkyl benzoate, dicaprylyl carbonate, C14-22 alcohols, C12-20 alkyl glucoside, propylheptyl caprylate, acetyl tetrapeptide-9, phenoxyethanol, cetyl alcohol, caprylyl glycol, 1,2 hexanediol, triethanolamine, xanthan gum, trisodium ethylenediamine disuccinate, parfum, bisabolol, panax ginseng root extract, lycium barbarum fruit extract, aloe barbadensis leaf juice, camellia oleifera leaf extract, butylene glycol, allantoin, tocopheryl acetate, limonene, butylphenyl methylpropional

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

image of boximage of box

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
54473-187-022019-10-29C16284748780-1960f7f55-d1b7-8e05-e053-dbdaa90a074aSei Bella Daytime Delivery Lotion Content of Label

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
54473-187-02Sei BellaDaytime Delivery1 in 1 BOXLOTION12
54473-187-02Sei BellaDaytime Delivery50 mL in 1 BOTTLELOTION502

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
54473-187SEI BELLA DAYTIME DELIVERY (AVOBENZONE, HOMOSALATE, OCTISALATE, OCRYLENE AND OXYBENZONE) LOTION [MELALEUCA, INC.]2Legacy NDC, 2 package rows20110204_35596166-0aa0-4329-8964-a48217a217b3.zip

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIISPL versionUploaded
AVOBENZONEACTIVE INGREDIENTG63QQF2NOX2
HOMOSALATEACTIVE INGREDIENTV06SV4M95S2
OCTISALATEACTIVE INGREDIENT4X49Y0596W2
OCTOCRYLENEACTIVE INGREDIENT5A68WGF6WM2
OxybenzoneACTIVE INGREDIENT95OOS7VE0Y2
AVOBENZONEACTIVE MOIETYG63QQF2NOX2
HOMOSALATEACTIVE MOIETYV06SV4M95S2
OCTISALATEACTIVE MOIETY4X49Y0596W2
OCTOCRYLENEACTIVE MOIETY5A68WGF6WM2
OxybenzoneACTIVE MOIETY95OOS7VE0Y2
ALLANTOININACTIVE INGREDIENT344S277G0Z2
ALOE VERA LEAFINACTIVE INGREDIENTZY81Z83H0X2
ALPHA-TOCOPHEROL ACETATEINACTIVE INGREDIENT9E8X80D2L02
ASIAN GINSENGINACTIVE INGREDIENTCUQ3A77YXI2
BUTYLENE GLYCOLINACTIVE INGREDIENT3XUS85K0RA2
C12-15 ALKYL BENZOATEINACTIVE INGREDIENTA9EJ3J61HQ2
C14-22 ALCOHOLSINACTIVE INGREDIENTB1K89384RJ2
CAMELLIA OLEIFERA LEAFINACTIVE INGREDIENT5077EL0C602
CAPRYLYL GLYCOLINACTIVE INGREDIENT00YIU5438U2
Cetyl AlcoholINACTIVE INGREDIENT936JST6JCN2
CETYL PALMITATEINACTIVE INGREDIENT5ZA2S6B08X2
Cyclomethicone 5INACTIVE INGREDIENT0THT5PCI0R2
DICAPRYLYL CARBONATEINACTIVE INGREDIENT609A3V1SUA2
DIMETHICONEINACTIVE INGREDIENT92RU3N3Y1O2
GlycerinINACTIVE INGREDIENTPDC6A3C0OX2
LEVOMENOLINACTIVE INGREDIENT24WE03BX2T2
PHENOXYETHANOLINACTIVE INGREDIENTHIE492ZZ3T2
SHEA BUTTERINACTIVE INGREDIENTK49155WL9Y2
TRISILOXANEINACTIVE INGREDIENT9G1ZW13R0G2
TrolamineINACTIVE INGREDIENT9O3K93S3TK2
WaterINACTIVE INGREDIENT059QF0KO0R2
XANTHAN GUMINACTIVE INGREDIENTTTV12P4NEE2

Products#

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

DailyMed product names page 1 of 1 · 29 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
54473-18754473-187-02

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 27 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 3 · 166 matching rows.

DailyMed ingredient, IID ingredient, UNII table
DailyMed ingredientIID ingredientUNIIDosage form / routePotencyMaximum daily exposureMatch
GlycerinGLYCERINPDC6A3C0OXCAPSULE / ORAL3487 mgExact identifier — unii candidate
75 equally ranked IID candidates
Cetyl AlcoholCETYL ALCOHOL936JST6JCNAEROSOL, FOAM / TOPICAL82 mgExact identifier — unii candidate
20 equally ranked IID candidates
TrolamineTROLAMINE9O3K93S3TKGEL / TOPICAL6 mgExact identifier — unii candidate
22 equally ranked IID candidates
TrolamineTROLAMINE9O3K93S3TKLIQUID / TOPICALNAExact identifier — unii candidate
22 equally ranked IID candidates
Cyclomethicone 5CYCLOMETHICONE 50THT5PCI0RAEROSOL / TOPICAL2.5 %w/wExact identifier — unii candidate
3 equally ranked IID candidates
Cetyl AlcoholCETYL ALCOHOL936JST6JCNSUSPENSION / AURICULAR (OTIC)1 %w/vExact identifier — unii candidate
20 equally ranked IID candidates
GlycerinGLYCERINPDC6A3C0OXSOLUTION / OPHTHALMIC6 %w/vExact identifier — unii candidate
75 equally ranked IID candidates
TrolamineTROLAMINE9O3K93S3TKEMULSION / TOPICAL0.5 %w/wExact identifier — unii candidate
22 equally ranked IID candidates
Cetyl AlcoholCETYL ALCOHOL936JST6JCNTABLET, FILM COATED, EXTENDED RELEASE / ORAL59 mgExact identifier — unii candidate
20 equally ranked IID candidates
GlycerinGLYCERINPDC6A3C0OXSOLUTION / NASAL25 mg/1mlExact identifier — unii candidate
75 equally ranked IID candidates
XANTHAN GUMXANTHAN GUMTTV12P4NEESUSPENSION/ DROPS / ORAL22 mgExact identifier — unii candidate
29 equally ranked IID candidates
PHENOXYETHANOLPHENOXYETHANOLHIE492ZZ3TAEROSOL, FOAM / TOPICAL72 mgExact identifier — unii candidate
6 equally ranked IID candidates
GlycerinGLYCERINPDC6A3C0OXSUSPENSION / AURICULAR (OTIC)0.05 %w/wExact identifier — unii candidate
75 equally ranked IID candidates
GlycerinGLYCERINPDC6A3C0OXDOUCHE / VAGINAL1 %w/wExact identifier — unii candidate
75 equally ranked IID candidates
GlycerinGLYCERINPDC6A3C0OXOINTMENT / TOPICALNAExact identifier — unii candidate
75 equally ranked IID candidates
SHEA BUTTERSHEA BUTTERK49155WL9YLOTION / TOPICAL2340 mgExact identifier — unii candidate
ALPHA-TOCOPHEROL ACETATE.ALPHA.-TOCOPHEROL ACETATE9E8X80D2L0FILM / BUCCAL0.09 mgExact identifier — unii candidate
3 equally ranked IID candidates
XANTHAN GUMXANTHAN GUMTTV12P4NEEGEL / TOPICAL58 mgExact identifier — unii candidate
29 equally ranked IID candidates
GlycerinGLYCERINPDC6A3C0OXSUSPENSION / OPHTHALMIC58 mgExact identifier — unii candidate
75 equally ranked IID candidates
XANTHAN GUMXANTHAN GUMTTV12P4NEEENEMA / RECTAL150 mgExact identifier — unii candidate
29 equally ranked IID candidates
XANTHAN GUMXANTHAN GUMTTV12P4NEETABLET, ORALLY DISINTEGRATING / ORAL0.15 mgExact identifier — unii candidate
29 equally ranked IID candidates
GlycerinGLYCERINPDC6A3C0OXTABLET, EXTENDED RELEASE / ORAL7 mgExact identifier — unii candidate
75 equally ranked IID candidates
GlycerinGLYCERINPDC6A3C0OXAEROSOL / TOPICAL3 %w/wExact identifier — unii candidate
75 equally ranked IID candidates
TrolamineTROLAMINE9O3K93S3TKSPRAY / NASALNAExact identifier — unii candidate
22 equally ranked IID candidates
TrolamineTROLAMINE9O3K93S3TKDROPS / NASALNAExact identifier — unii candidate
22 equally ranked IID candidates
TrolamineTROLAMINE9O3K93S3TKCREAM / VAGINAL56 mgExact identifier — unii candidate
22 equally ranked IID candidates
PHENOXYETHANOLPHENOXYETHANOLHIE492ZZ3TCREAM, AUGMENTED / TOPICAL10 mgExact identifier — unii candidate
6 equally ranked IID candidates
Cetyl AlcoholCETYL ALCOHOL936JST6JCNOINTMENT / TOPICAL7 %w/wExact identifier — unii candidate
20 equally ranked IID candidates
Cetyl AlcoholCETYL ALCOHOL936JST6JCNCREAM / VAGINAL200 mgExact identifier — unii candidate
20 equally ranked IID candidates
XANTHAN GUMXANTHAN GUMTTV12P4NEESOLUTION, GEL FORMING, EXTENDED RELEASE / OPHTHALMIC0.6 %w/wExact identifier — unii candidate
29 equally ranked IID candidates
GlycerinGLYCERINPDC6A3C0OXSHAMPOO / TOPICAL5 %w/wExact identifier — unii candidate
75 equally ranked IID candidates
ALPHA-TOCOPHEROL ACETATE.ALPHA.-TOCOPHEROL ACETATE9E8X80D2L0CAPSULE / ORAL2 mgExact identifier — unii candidate
3 equally ranked IID candidates
GlycerinGLYCERINPDC6A3C0OXINJECTION, SOLUTION / INTRAVENOUS15 %w/vExact identifier — unii candidate
75 equally ranked IID candidates
GlycerinGLYCERINPDC6A3C0OXINJECTION, SOLUTION / INTRAMUSCULAR15 %w/vExact identifier — unii candidate
75 equally ranked IID candidates
GlycerinGLYCERINPDC6A3C0OXPASTE, DENTIFRICE / DENTAL18 %w/wExact identifier — unii candidate
75 equally ranked IID candidates
GlycerinGLYCERINPDC6A3C0OXINJECTION / INTRAVENOUS33750 mgExact identifier — unii candidate
75 equally ranked IID candidates
XANTHAN GUMXANTHAN GUMTTV12P4NEEAEROSOL, FOAM / TOPICAL0.27 %w/wExact identifier — unii candidate
29 equally ranked IID candidates
GlycerinGLYCERINPDC6A3C0OXEMULSION / INTRAVENOUS2.2 %w/vExact identifier — unii candidate
75 equally ranked IID candidates
TrolamineTROLAMINE9O3K93S3TKSOLUTION / TOPICALNAExact identifier — unii candidate
22 equally ranked IID candidates
TrolamineTROLAMINE9O3K93S3TKSOLUTION / NASALNAExact identifier — unii candidate
22 equally ranked IID candidates
PHENOXYETHANOLPHENOXYETHANOLHIE492ZZ3TAEROSOL / TOPICAL1.05 %w/wExact identifier — unii candidate
6 equally ranked IID candidates
Cetyl AlcoholCETYL ALCOHOL936JST6JCNAEROSOL / TOPICAL1.16 %w/wExact identifier — unii candidate
20 equally ranked IID candidates
TrolamineTROLAMINE9O3K93S3TKPOWDER / TOPICAL0.02 mg/mgExact identifier — unii candidate
22 equally ranked IID candidates
GlycerinGLYCERINPDC6A3C0OXSOLUTION / AURICULAR (OTIC)63.64 %w/vExact identifier — unii candidate
75 equally ranked IID candidates
GlycerinGLYCERINPDC6A3C0OXTABLET, CHEWABLE / ORAL12 mgExact identifier — unii candidate
75 equally ranked IID candidates
Cetyl AlcoholCETYL ALCOHOL936JST6JCNSUSPENSION / TOPICAL2.01 %w/wExact identifier — unii candidate
20 equally ranked IID candidates
XANTHAN GUMXANTHAN GUMTTV12P4NEELOTION / TOPICAL0.3 %w/vExact identifier — unii candidate
29 equally ranked IID candidates
XANTHAN GUMXANTHAN GUMTTV12P4NEETROCHE / ORAL948 mgExact identifier — unii candidate
29 equally ranked IID candidates
GlycerinGLYCERINPDC6A3C0OXSPONGE / TOPICAL2 %w/wExact identifier — unii candidate
75 equally ranked IID candidates
GlycerinGLYCERINPDC6A3C0OXLIQUID / TOPICAL2.5 %w/wExact identifier — unii candidate
75 equally ranked IID candidates
GlycerinGLYCERINPDC6A3C0OXGEL / OPHTHALMIC0.88 %w/wExact identifier — unii candidate
75 equally ranked IID candidates
CETYL PALMITATECETYL PALMITATE5ZA2S6B08XOINTMENT / TOPICALNAExact identifier — unii candidate
4 equally ranked IID candidates
XANTHAN GUMXANTHAN GUMTTV12P4NEESOLUTION / ORAL84 mgExact identifier — unii candidate
29 equally ranked IID candidates
XANTHAN GUMXANTHAN GUMTTV12P4NEESOLUTION / OPHTHALMIC0.6 %w/vExact identifier — unii candidate
29 equally ranked IID candidates
GlycerinGLYCERINPDC6A3C0OXINJECTION, SOLUTION / SUBCUTANEOUS15 %w/vExact identifier — unii candidate
75 equally ranked IID candidates
GlycerinGLYCERINPDC6A3C0OXDROPS / NASAL10 mg/1mlExact identifier — unii candidate
75 equally ranked IID candidates
GlycerinGLYCERINPDC6A3C0OXGEL / TOPICAL500 mgExact identifier — unii candidate
75 equally ranked IID candidates
GlycerinGLYCERINPDC6A3C0OXSOLUTION, CONCENTRATE / ORAL200 mg/1mlExact identifier — unii candidate
75 equally ranked IID candidates
XANTHAN GUMXANTHAN GUMTTV12P4NEETABLET, ORALLY DISINTEGRATING, DELAYED RELEASE / ORAL36 mgExact identifier — unii candidate
29 equally ranked IID candidates
GlycerinGLYCERINPDC6A3C0OXSYSTEM / TOPICAL18144 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
deeaf705-bf52-46a4-81a8-4d36cbbdb04635596166-0aa0-4329-8964-a48217a217b32011-02-03WarningsExact identifier
spl id: deeaf705-bf52-46a4-81a8-4d36cbbdb046
spl set id: 35596166-0aa0-4329-8964-a48217a217b3

Reported adverse events (FAERS/openFDA)#

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