Sei Bella Daily UV Defense

Manufacturer
Melaleuca Inc.
Effective date
2025-12-31
Label type
HUMAN OTC DRUG LABEL
Version
2
Source
full-release
Hydrated at
2026-06-01 01:29:51

Label at a glance#

ProductSei Bella Daily UV Defense Broad-Spectrum SPF 25 Sunscreen
Active ingredientOCTOCRYLENE, ZINC OXIDE, HOMOSALATE, OCTISALATE, TITANIUM DIOXIDE
Label structure11 sections

Storage and handling

store at room temperature 68-77 F. Protect from freezing.

Label contents#

Full prescribing information#

Active Ingredients

OTC - ACTIVE INGREDIENT SECTION

Homosalate 7.5%
Octocrylene 9%
Octisalate 3.75%
Titanium Dioxide 2%
Zinc Oxide 9.45%

OTC - PURPOSE SECTION

sunscreen

INDICATIONS & USAGE SECTION

helps prevent sunburn

if used as directed with other sun protection measures (see Directions), decreases the risk of skin cancer caused by the sun

Warnings

WARNINGS SECTION

For external use only. 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

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 For sunscreen use:

  • apply liberally 15 minutes before sun exposure
  • reapply at least every 2 hours
  • use a water-resistant sunscreen if swimming or sweating
  • 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:

limiting time in the sun, especially from 10 a.m. - 2 p.m.

wearing long-sleeve shirts, pants, hats, and sunglasses

  • children under 6 months of age: Ask a doctor

STORAGE AND HANDLING SECTION

store at room temperature 68-77 F. Protect from freezing.

INACTIVE INGREDIENT SECTION

water, caprylyl methicone, cyclopentasiloxane, glycerin, caprylic/capric triglyceride, coco-caprylate/caprate, propanediol, pyrus malus (apple) fruit extract, dimethicone, polymethylsilsesquioxane, lauryl peg-9 polydimethylsiloxyethyl dimethicone, PEG-12 dimethicone/PPG-20 crosspolymer, acrylates/dimethicone copolymer, C12-15 alkyl benzoate, polyhydroxystearic acid, dimethicone/peg-10/15 crosspolymer, gossypium hirsutum (cotton) extract, sodium chloride, phenoxyethanol, triethoxycaprylylsilane, ethylhexylglycerin,disteardimonium hectorite, silica, allantoin, sodium citrate, 2,3-butanediol, tocopherol

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Sei Bella Daily UV Defense Box.jpgSei Bella Daily UV Defense Box.jpg

Sei Bella Daily UV Defense Tube.jpgSei Bella Daily UV Defense Tube.jpg

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
362d7abb-94e6-4c60-9a58-266894157713Product name120231023
6bd95106-a412-1dad-b9cc-4cb74bfb27ceProduct name220230315
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6e9d4a47-c464-b93e-aebc-ad7bffc9c4cdProduct name220190619
444b3e50-f226-46ef-bfca-2e7035d140cdProduct name120190611
816b97af-edc5-4060-aff1-b814bdbcad50Product name120190415
7cda52fc-125f-421c-8fea-bc1974370c49Product name220180703
419aab54-5d5a-4146-9453-026d4a9991beProduct name220170525
d5e51f11-ad28-caa4-4b49-4143974782adProduct name120150831
290f523a-f9db-9774-b5a9-e1f908ac1782Product name120150828
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87711080-88eb-65c5-b2dd-bf99e700a372Product name120140508
8dbefedf-0a0d-a224-5a3c-66dc9e11c2ddProduct name120140508
b060cc1a-fe47-856b-0b77-4448b5963de8Product name120140508
c6b65c52-69c7-df49-550a-a50c137f6218Product name120140508
ec2149b3-5c6d-5344-f757-c86411073075Product name120140508
ed912195-5da0-0f2f-6f4b-3ef17710cbe3Product name120140508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
54473-403-01Sei Bella Daily UV DefenseBroad-Spectrum SPF 25 Sunscreen74 mL in 1 TUBECREAM742

Products#

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

DailyMed product names page 1 of 1 · 34 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
54473-40354473-403-01

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 32 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
Sei Bella Daily UV Defense Broad-Spectrum SPF 25 SunscreenSUNSCREENMelaleuca Inc.1f1d1575-cf37-5d66-e063-6394a90ab2a32025-12-31WarningsExact identifier
ndc (package): 54473-403-01
ndc (product): 54473-403
ndc11 (package): 54473040301
spl id: 4747675b-b778-60c4-e063-6294a90a09c8
spl set id: 1f1d1575-cf37-5d66-e063-6394a90ab2a3

Reported adverse events (FAERS/openFDA)#

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