Sei Bella

Manufacturer
Melaleuca, Inc.
Effective date
2020-03-19
Label type
HUMAN OTC DRUG LABEL
Version
2
Source
full-release
Hydrated at
2026-05-31 23:04:03

Label at a glance#

ProductSei Bella Advanced Revital R3 Age Defying Creme
Active ingredientAVOBENZONE, HOMOSALATE, OCTOCRYLENE
Label structure13 sections

Storage and handling

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%, Octocrylane 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 6 months of age: ask a doctor

CLINICAL STUDIES SECTION

Other information

  • dermatologist and allergy tested

GENERAL PRECAUTIONS SECTION

  • 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

  • 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, trisloxane, 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

Age Defying Triple Benefit CremeAge Defying Triple Benefit Creme

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
59361619-24d9-b610-eca6-5a7f25ed5e03Product name520240909
5e18e798-5614-cf5c-0185-38b1cb77a093Product name220160822

FDA-Initiated Inactive NDC Indexing#

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
54473-276-01Sei BellaAdvanced Revital R3 Age Defying Creme1 in 1 BOXCREAM12
54473-276-50Sei BellaAdvanced Revital R3 Age Defying Creme50 mL in 1 JARCREAM502

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
54473-276SEI BELLA ADVANCED REVITAL R3 AGE DEFYING CREME (AVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENE, OXYBENZONE) CREAM [MELALEUCA, INC.]2Legacy NDC, 2 package rows20200320_66251385-58bd-0bee-e053-2991aa0aa83b.zip

Products#

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

DailyMed product names page 1 of 2 · 47 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
54473-27654473-276-50, 54473-276-01

Ingredients#

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

DailyMed ingredient rows page 1 of 2 · 45 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
a13cf156-59a3-0cbc-e053-2a95a90a169066251385-58bd-0bee-e053-2991aa0aa83b2020-03-19WarningsExact identifier
spl id: a13cf156-59a3-0cbc-e053-2a95a90a1690
spl set id: 66251385-58bd-0bee-e053-2991aa0aa83b

Reported adverse events (FAERS/openFDA)#

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