FDA.reportPublic FDA data

Sei Bella Tinted BB Moisturizing Creme

Manufacturer
Melaleuca Inc. | Mana
Effective date
2025-12-31
Label type
HUMAN OTC DRUG LABEL
Version
3
Source
full-release
Hydrated at
2026-06-01 01:30:19

Label at a glance#

ProductSei Bella Tinted BB Moisturizing Creme Light to Medium 200 N
Active ingredientTITANIUM DIOXIDE, ZINC OXIDE
Label structure10 sections

Dosage and administration

apply smoothly on cleansed 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: ask a doctor Sun Protection Measures . Spending time in the sun increases you 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...

Label contents#

Full prescribing information#

Active Ingredient

OTC - ACTIVE INGREDIENT SECTION

Titanium Dioxide 5%

Zinc Oxide 5%

Purpose

OTC - PURPOSE SECTION

Sunscreen

Use

INDICATIONS & USAGE SECTION

  • helps prevent sunburn
  • If 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 SECTION

For external use only

OTC - DO NOT USE SECTION

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

Keep out of reach of children.

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

If product is swallowed, get medical help or contact a Poison Control Center right away.

Directions

DOSAGE & ADMINISTRATION SECTION

  • apply smoothly on cleansed 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: ask a doctor
  • Sun Protection Measures. Spending time in the sun increases you 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 10 a.m.-2 p.m.
  • wear long-sleeve shirts, pants, hats, and sunglasses

Other information

CLINICAL STUDIES SECTION

  • for normal to oily skin
  • dermatologist tested
  • may stain some fabrics
STORAGE AND HANDLING SECTION
  • protect this product from excesssive heat and direct sun
  • do not store at temperatures below 32°F (0°C) or above 120°F (49°C)

Inactive ingredients

INACTIVE INGREDIENT SECTION

Water (Aqua), Cyclopentasiloxane, Butylene Glycol, Octyldodecyl Neopentanoate, PEG/PPG-18/18 Dimethicone, Dimethicone, Magnesium Chloride, Potassium Chloride, Sodium Chloride, Zinc Chloride, Lysine, Tocopherol, Tetrahexyldecyl Ascorbate, Magnesium Ascorbyl Phosphate, Retinyl Palmitate, Camellia Oleifera Leaf Extract, Chamomilla Recutita (Matricaria) Flower Extract, Ginkgo Biloba Leaf Extract, Panax Ginseng Root Extract, Octyldodecanol, Sodium Hyaluronate, Phytantriol, Glycerin, Triethoxycaprylylsilane, Boron Nitride, Dextrin Palmitate, Palmitic Acid, Methicone, Stearic Acid, Aluminum Hydroxide, Hexylene Glycol, Disodium EDTA, Potassium Sorbate, Sodium Dehydroacetate, Caprylyl Glycol, Phenoxyethanol

May Contain (+/-): Mica, Titanium Dioxide (CI 77891), Iron Oxides (CI 77491, CI 77492, CI 77499)

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Sei Bella Tinted BB Moisturizing Cream tube.jpgSei Bella Tinted BB Moisturizing Cream tube.jpg

Tinted BB Cream box.jpgTinted BB Cream box.jpg

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
9e37788c-b1bf-42ae-aac9-b60601606144Product name820260122
030ce964-9b2d-45aa-b5d3-f78ce03ef61cProduct name220250515
1527ac37-808d-43be-a63e-74e1258dbe46Product name920250219
bed0530e-f939-4541-956b-6928a2f6404fProduct name120241008
cefa60e2-a5b5-493e-9c54-24735b7dc509Product name620240814
362d7abb-94e6-4c60-9a58-266894157713Product name120231023
9fcb7a91-de07-4f00-aabf-e4d6fda403d5Product name820230322
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9badc7be-250a-44ab-aa36-926af3f02679Product name120210527
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419aab54-5d5a-4146-9453-026d4a9991beProduct name220170525
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290f523a-f9db-9774-b5a9-e1f908ac1782Product name120150828
0ca1d589-929b-4b33-bc5b-1d84abdafa6aProduct name120150324
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8dbefedf-0a0d-a224-5a3c-66dc9e11c2ddProduct 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
54473-284-01Sei Bella Tinted BB Moisturizing CremeLight to Medium 200 N1 in 1 BOXLOTION13
54473-284-30Sei Bella Tinted BB Moisturizing CremeLight to Medium 200 N30 mL in 1 BOTTLE, DISPENSINGLOTION303

Products#

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

DailyMed product names page 1 of 1 · 37 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
54473-28454473-284-30, 54473-284-01

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 34 matching rows.

Name, UNII, Kind table
NameUNIIKind
POTASSIUM SORBATE1VPU26JZZ4IACT
PEG/PPG-18/18 DIMETHICONE9H0AO7T794IACT
WATER059QF0KO0RIACT
MAGNESIUM CHLORIDE02F3473H9OIACT
TITANIUM DIOXIDE15FIX9V2JPACTIB
ZINC OXIDESOI2LOH54ZACTIB
CAMELLIA OLEIFERA LEAF5077EL0C60IACT
TETRAHEXYLDECYL ASCORBATE9LBV3F07AZIACT
OCTYLDODECANOL461N1O614YIACT
BORON NITRIDE2U4T60A6YDIACT
DEXTRIN PALMITATE (CORN; 20000 MW)89B2BSF9I3IACT
STEARIC ACID4ELV7Z65APIACT
PANAX GINSENG ROOT OILP9T4K47OM0IACT
MATRICARIA CHAMOMILLA FLOWERING TOP OILSA8AR2W4ERIACT
TRIETHOXYCAPRYLYLSILANELDC331P08EIACT
ALUMINUM HYDROXIDE5QB0T2IUN0IACT
GLYCERINPDC6A3C0OXIACT
HEXYLENE GLYCOLKEH0A3F75JIACT
BUTYLENE GLYCOL3XUS85K0RAIACT
OCTYLDODECYL NEOPENTANOATEX8725R883TIACT
POTASSIUM CHLORIDE660YQ98I10IACT
SODIUM CHLORIDE451W47IQ8XIACT
ZINC CHLORIDE86Q357L16BIACT
LYSINEK3Z4F929H6IACT
TOCOPHEROLR0ZB2556P8IACT
MAGNESIUM ASCORBYL PHOSPHATE0R822556M5IACT
DIMETHICONE92RU3N3Y1OIACT
GINKGO BILOBA LEAF OILY5967KO1JHIACT
PHYTANTRIOL8LVI07A72WIACT
PALMITIC ACID2V16EO95H1IACT
METHICONE (20 CST)6777U11MKTIACT
SODIUM DEHYDROACETATE8W46YN971GIACT
CAPRYLYL GLYCOL00YIU5438UIACT
PHENOXYETHANOLHIE492ZZ3TIACT

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
Sei Bella Tinted BB Moisturizing Creme Light to Medium 200 NTITANIUM DIOXIDE 5% AND ZINC OXIDE 5%Melaleuca Inc.68e2dfaa-d173-e6a9-e053-2a91aa0a46632025-12-31WarningsExact identifier
ndc (package): 54473-284-01
ndc (package): 54473-284-30
ndc (product): 54473-284
ndc11 (package): 54473028401
ndc11 (package): 54473028430
spl id: 4747899e-6ce0-93f0-e063-6394a90a91d7
spl set id: 68e2dfaa-d173-e6a9-e053-2a91aa0a4663

Reported adverse events (FAERS/openFDA)#

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