Sei Bella Skin Refining Tinted Moisturizer

Manufacturer
Melaleuca Inc.
Effective date
2014-04-30
Label type
HUMAN OTC DRUG LABEL
Version
2
Source
full-release
Hydrated at
2026-05-31 22:39:08

Label at a glance#

ProductSei Bella Skin Refining Tinted Moisturizer Procelain
Active ingredientTITANIUM DIOXIDE
Label structure12 sections

Indications and uses

helps prevent sunburn is used as directed with other sun protection measures (see  Directions ), decreases the risk of skin cancer and early skin aging caused by the sun

Dosage and administration

apply smoothly on cleased 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 of age: ask a doctor 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...

Label contents#

Full prescribing information#

Active Ingredients

OTC - ACTIVE INGREDIENT SECTION

Titanium Dioxide 6.5%

Purpose

OTC - PURPOSE SECTION

Sunscreen

Uses

INDICATIONS & USAGE SECTION

  • helps prevent sunburn
  • is 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 AND PRECAUTIONS 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

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

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

Directions

DOSAGE & ADMINISTRATION SECTION

  • apply smoothly on cleased 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 of age: ask a doctor
  • 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:
  • limit time in the sun, especially from 10a.m.-2p.m.
  • wear long-sleeve shirts, pants, hats, and sunglasses

Other Information

GENERAL PRECAUTIONS SECTION

for normal-to-oily skin

CLINICAL STUDIES SECTION

dermatologist and allergy tested

STORAGE AND HANDLING SECTION
  • may stain some fabrics
  • protect this product from excessive heat and direct sun
  • do not store at temperatures below 32oF (0oC) or above 120oF (49oC)

Inactive Ingredients

INACTIVE INGREDIENT SECTION

1,2-hexandiol, aloe barbadensis leaf juice, alumina, aminomethyl propanol, aqua (water/eau), beta-glucan, butylene glycol, butyrospermum parkii (shea butter), caprylic/capric tryglyceride, caprylyl glycol, carnosine, cetearyl alcohol, ceteth-10 phosphate, cetyl palmitate, cucumis sativus (cucumber) fruit extract, cyclopentasilloxane, dicetyl phosphate, disodium EDTA, ethylhexylglycerin, glycerin, glycine soja (soybean) oil, hydrogenated cottonseed oil, hydrogenated palm glycerides, iron oxides (CI77491, CI77492, CI77499), isostearic acid, lecithin, octyldodecyl neopentanoate, PEG/PPG-20/15 dimethicone, pentylene glycol, phenyl methicone, polyethylene, polyglyceryl-3, polyricinoleate, polyhydroxystearic acid, polymethylsilsesquioxane, polysorbate 60, polysorbate 80, potassium cetyl phosphate, propylheptyl caprylate, simethicone, stearic acid, tetrahexyldecyl ascorbate, tetrapeptide-21, titanium dioxide (CI77891), tocopheryl acetate, tremella fuciformis sporocarp extract, vitis vinifera (grape) leaf extract, xanthan gum

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Tint Moist BoxTint Moist Box

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
baf7f49c-75b6-496b-a00e-8e766a8e4f03Product name120210127
ebc62596-fc97-4d03-9483-7ba095d25db7Product name120151210
0ca1d589-929b-4b33-bc5b-1d84abdafa6aProduct name120150324
fc363c46-397b-4476-ac0f-70e43e8e4592Product name120150324

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
54473-247-012019-11-27C16284748780-19855e2a2-4563-60a7-e053-dbdaa90a05bdSei Bella Skin-Refining Tinted Moisturizer - Broadspectrum SPF 20 - Procelain

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
54473-247-01Sei Bella Skin Refining Tinted MoisturizerProcelain1 in 1 BOXLOTION12
54473-247-01Sei Bella Skin Refining Tinted MoisturizerProcelain44.4 mL in 1 TUBELOTION44.42

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
54473-247SEI BELLA SKIN REFINING TINTED MOISTURIZER PROCELAIN (TITANIUM DIOXIDE) LOTION [MELALEUCA INC.]2Legacy NDC, 2 package rows20140430_e369a765-4ea0-476f-80dd-822ce3547192.zip

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIISPL versionUploaded
TITANIUM DIOXIDEACTIVE INGREDIENT15FIX9V2JP2
TITANIUM DIOXIDEACTIVE MOIETY15FIX9V2JP2
1,2-HEXANEDIOLINACTIVE INGREDIENTTR046Y3K1G2
ALOE VERA LEAFINACTIVE INGREDIENTZY81Z83H0X2
ALPHA-TOCOPHEROL ACETATEINACTIVE INGREDIENT9E8X80D2L02
ALUMINUM OXIDEINACTIVE INGREDIENTLMI26O69332
AMINOMETHYLPROPANOLINACTIVE INGREDIENTLU49E6626Q2
BUTYLENE GLYCOLINACTIVE INGREDIENT3XUS85K0RA2
CAPRYLYL GLYCOLINACTIVE INGREDIENT00YIU5438U2
CARNOSINEINACTIVE INGREDIENT8HO6PVN24W2
CETETH-10 PHOSPHATEINACTIVE INGREDIENT4E05O5N49G2
CETOSTEARYL ALCOHOLINACTIVE INGREDIENT2DMT128M1S2
CETYL PALMITATEINACTIVE INGREDIENT5ZA2S6B08X2
CUCUMBERINACTIVE INGREDIENTYY7C30VXJT2
CYCLOMETHICONE 5INACTIVE INGREDIENT0THT5PCI0R2
DIHEXADECYL PHOSPHATEINACTIVE INGREDIENT2V6E5WN99N2
EDETATE DISODIUMINACTIVE INGREDIENT7FLD91C86K2
ETHYLHEXYLGLYCERININACTIVE INGREDIENT147D247K3P2
FERRIC OXIDE REDINACTIVE INGREDIENT1K09F3G6752
FERRIC OXIDE YELLOWINACTIVE INGREDIENTEX438O2MRT2
FERROSOFERRIC OXIDEINACTIVE INGREDIENTXM0M87F3572
glycerinINACTIVE INGREDIENTPDC6A3C0OX2
HIGH DENSITY POLYETHYLENEINACTIVE INGREDIENTUG00KM4WR72
HYDROGENATED COTTONSEED OILINACTIVE INGREDIENTZ82Y2C65EA2
HYDROGENATED PALM GLYCERIDESINACTIVE INGREDIENTYCZ8EM144Q2
ISOSTEARIC ACIDINACTIVE INGREDIENTX33R8U00622
LECITHIN, SOYBEANINACTIVE INGREDIENT1DI56QDM622
MEDIUM-CHAIN TRIGLYCERIDESINACTIVE INGREDIENTC9H2L21V7U2
OCTYLDODECYL NEOPENTANOATEINACTIVE INGREDIENTX8725R883T2
PEG/PPG-20/15 DIMETHICONEINACTIVE INGREDIENT06R6X77P9C2
PENTYLENE GLYCOLINACTIVE INGREDIENT50C1307PZG2
POLYGLYCERYL-3 RICINOLEATEINACTIVE INGREDIENTMZQ63P0N0W2
POLYHYDROXYSTEARIC ACID (2300 MW)INACTIVE INGREDIENTYXH47AOU0F2
POLYMETHYLSILSESQUIOXANE (4.5 MICRONS)INACTIVE INGREDIENT59Z907ZB692
POLYSORBATE 60INACTIVE INGREDIENTCAL22UVI4M2
POLYSORBATE 80INACTIVE INGREDIENT6OZP39ZG8H2
POTASSIUM CETYL PHOSPHATEINACTIVE INGREDIENT03KCY6P7UT2
PROPYLHEPTYL CAPRYLATEINACTIVE INGREDIENT991Z19V2OD2
SHEA BUTTERINACTIVE INGREDIENTK49155WL9Y2
SOYBEAN OILINACTIVE INGREDIENT241ATL177A2
STEARIC ACIDINACTIVE INGREDIENT4ELV7Z65AP2
TETRAHEXYLDECYL ASCORBATEINACTIVE INGREDIENT9LBV3F07AZ2
TETRAPEPTIDE-21INACTIVE INGREDIENT179JUC43HU2
TREMELLA FUCIFORMIS FRUITING BODYINACTIVE INGREDIENTGG8N28393G2
VITIS VINIFERA LEAFINACTIVE INGREDIENTR1H893D80E2
XANTHAN GUMINACTIVE INGREDIENTTTV12P4NEE2

Products#

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

DailyMed product names page 1 of 2 · 46 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
54473-24754473-247-01

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

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 8 · 435 matching rows.

DailyMed ingredient, IID ingredient, UNII table
DailyMed ingredientIID ingredientUNIIDosage form / routePotencyMaximum daily exposureMatch
HIGH DENSITY POLYETHYLENEHIGH DENSITY POLYETHYLENEUG00KM4WR7OINTMENT / TOPICAL94 %w/wExact identifier — unii candidate
18 equally ranked IID candidates
CETOSTEARYL ALCOHOLCETOSTEARYL ALCOHOL2DMT128M1SOINTMENT / TOPICAL1.2 %w/wExact identifier — unii candidate
9 equally ranked IID candidates
glycerinGLYCERINPDC6A3C0OXOINTMENT / TOPICALNAExact identifier — unii candidate
75 equally ranked IID candidates
glycerinGLYCERINPDC6A3C0OXJELLY / TOPICALNAExact identifier — unii candidate
75 equally ranked IID candidates
FERRIC OXIDE REDFERRIC OXIDE RED1K09F3G675CAPSULE, DELAYED RELEASE / ORAL14 mgExact identifier — unii candidate
21 equally ranked IID candidates
STEARIC ACIDSTEARIC ACID4ELV7Z65APEMULSION / TOPICALNAExact identifier — unii candidate
26 equally ranked IID candidates
EDETATE DISODIUMEDETATE DISODIUM7FLD91C86KINJECTION / INFILTRATION6 mgExact identifier — unii candidate
77 equally ranked IID candidates
glycerinGLYCERINPDC6A3C0OXCAPSULE, LIQUID FILLED / ORAL185 mgExact identifier — unii candidate
75 equally ranked IID candidates
MEDIUM-CHAIN TRIGLYCERIDESMEDIUM-CHAIN TRIGLYCERIDESC9H2L21V7UFILM, EXTENDED RELEASE / TRANSDERMALNAExact identifier — unii candidate
18 equally ranked IID candidates
HIGH DENSITY POLYETHYLENEHIGH DENSITY POLYETHYLENEUG00KM4WR7FILM, EXTENDED RELEASE / TRANSDERMAL85 mgExact identifier — unii candidate
18 equally ranked IID candidates
glycerinGLYCERINPDC6A3C0OXSUSPENSION, EXTENDED RELEASE / ORAL2000 mgExact identifier — unii candidate
75 equally ranked IID candidates
FERRIC OXIDE YELLOWFERRIC OXIDE YELLOWEX438O2MRTTABLET, EXTENDED RELEASE / ORAL15 mgExact identifier — unii candidate
20 equally ranked IID candidates
STEARIC ACIDSTEARIC ACID4ELV7Z65APCAPSULE, EXTENDED RELEASE / ORAL64 mgExact identifier — unii candidate
26 equally ranked IID candidates
FERRIC OXIDE REDFERRIC OXIDE RED1K09F3G675CAPSULE, COATED PELLETS / ORAL2 mgExact identifier — unii candidate
21 equally ranked IID candidates
EDETATE DISODIUMEDETATE DISODIUM7FLD91C86KSUSPENSION / ORAL30 mgExact identifier — unii candidate
77 equally ranked IID candidates
POLYSORBATE 80POLYSORBATE 806OZP39ZG8HCAPSULE, COATED / ORAL0.04 mgExact identifier — unii candidate
78 equally ranked IID candidates
HYDROGENATED COTTONSEED OILHYDROGENATED COTTONSEED OILZ82Y2C65EATABLET / ORAL72 mgExact identifier — unii candidate
7 equally ranked IID candidates
POLYSORBATE 80POLYSORBATE 806OZP39ZG8HCAPSULE, EXTENDED RELEASE / ORAL10 mgExact identifier — unii candidate
78 equally ranked IID candidates
XANTHAN GUMXANTHAN GUMTTV12P4NEETABLET, EXTENDED RELEASE / ORAL528 mgExact identifier — unii candidate
29 equally ranked IID candidates
POLYSORBATE 80POLYSORBATE 806OZP39ZG8HINJECTION, SUSPENSION / INTRASYNOVIAL4 mgExact identifier — unii candidate
78 equally ranked IID candidates
POLYSORBATE 80POLYSORBATE 806OZP39ZG8HCAPSULE, LIQUID FILLED / ORAL24 mgExact identifier — unii candidate
78 equally ranked IID candidates
HIGH DENSITY POLYETHYLENEHIGH DENSITY POLYETHYLENEUG00KM4WR7TABLET / ORAL50 mgExact identifier — unii candidate
18 equally ranked IID candidates
POLYSORBATE 80POLYSORBATE 806OZP39ZG8HINJECTION, SOLUTION / INTRAMUSCULAR5 %w/vExact identifier — unii candidate
78 equally ranked IID candidates
glycerinGLYCERINPDC6A3C0OXTABLET, CHEWABLE / ORAL12 mgExact identifier — unii candidate
75 equally ranked IID candidates
FERRIC OXIDE YELLOWFERRIC OXIDE YELLOWEX438O2MRTTABLET, FILM COATED / ORAL6 mgExact identifier — unii candidate
20 equally ranked IID candidates
glycerinGLYCERINPDC6A3C0OXSOLUTION/ DROPS / OPHTHALMIC12 mgExact identifier — unii candidate
75 equally ranked IID candidates
glycerinGLYCERINPDC6A3C0OXELIXIR / ORAL5621 mgExact identifier — unii candidate
75 equally ranked IID candidates
MEDIUM-CHAIN TRIGLYCERIDESMEDIUM-CHAIN TRIGLYCERIDESC9H2L21V7UTABLET / ORAL2 mgExact identifier — unii candidate
18 equally ranked IID candidates
EDETATE DISODIUMEDETATE DISODIUM7FLD91C86KTABLET, EXTENDED RELEASE / ORAL10 mgExact identifier — unii candidate
77 equally ranked IID candidates
EDETATE DISODIUMEDETATE DISODIUM7FLD91C86KSUSPENSION/ DROPS / AURICULAR (OTIC)0.01 %w/vExact identifier — unii candidate
77 equally ranked IID candidates
EDETATE DISODIUMEDETATE DISODIUM7FLD91C86KTABLET / ORAL100 mgExact identifier — unii candidate
77 equally ranked IID candidates
SOYBEAN OILSOYBEAN OIL241ATL177AAEROSOL, FOAM / TOPICAL50 %w/wExact identifier — unii candidate
7 equally ranked IID candidates
POLYSORBATE 80POLYSORBATE 806OZP39ZG8HINJECTION / INTRA-ARTICULAR4 mgExact identifier — unii candidate
78 equally ranked IID candidates
FERRIC OXIDE YELLOWFERRIC OXIDE YELLOWEX438O2MRTTABLET, ORALLY DISINTEGRATING, DELAYED RELEASE / ORAL2 mgExact identifier — unii candidate
20 equally ranked IID candidates
glycerinGLYCERINPDC6A3C0OXSOLUTION / AURICULAR (OTIC)63.64 %w/vExact identifier — unii candidate
75 equally ranked IID candidates
STEARIC ACIDSTEARIC ACID4ELV7Z65APOINTMENT / TOPICAL15 %w/wExact identifier — unii candidate
26 equally ranked IID candidates
FERRIC OXIDE YELLOWFERRIC OXIDE YELLOWEX438O2MRTFILM / BUCCAL0.27 mgExact identifier — unii candidate
20 equally ranked IID candidates
POLYSORBATE 80POLYSORBATE 806OZP39ZG8HTABLET, CHEWABLE / ORAL84 mgExact identifier — unii candidate
78 equally ranked IID candidates
XANTHAN GUMXANTHAN GUMTTV12P4NEEPOWDER / ORAL275 mgExact identifier — unii candidate
29 equally ranked IID candidates
glycerinGLYCERINPDC6A3C0OXLIQUID / ORAL2400 mgExact identifier — unii candidate
75 equally ranked IID candidates
POLYSORBATE 80POLYSORBATE 806OZP39ZG8HTABLET, FILM COATED, EXTENDED RELEASE / ORAL8 mgExact identifier — unii candidate
78 equally ranked IID candidates
FERRIC OXIDE REDFERRIC OXIDE RED1K09F3G675CREAM / TOPICALNAExact identifier — unii candidate
21 equally ranked IID candidates
CETYL PALMITATECETYL PALMITATE5ZA2S6B08XCREAM / TOPICAL0.32 %w/wExact identifier — unii candidate
4 equally ranked IID candidates
glycerinGLYCERINPDC6A3C0OXFILM, EXTENDED RELEASE / TRANSDERMAL306.2 mgExact identifier — unii candidate
75 equally ranked IID candidates
MEDIUM-CHAIN TRIGLYCERIDESMEDIUM-CHAIN TRIGLYCERIDESC9H2L21V7USOLUTION / ORAL5566 mgExact identifier — unii candidate
18 equally ranked IID candidates
MEDIUM-CHAIN TRIGLYCERIDESMEDIUM-CHAIN TRIGLYCERIDESC9H2L21V7UGEL / TOPICAL12 mgExact identifier — unii candidate
18 equally ranked IID candidates
POLYSORBATE 80POLYSORBATE 806OZP39ZG8HINJECTION, POWDER, FOR SUSPENSION / INTRAMUSCULAR4 mgExact identifier — unii candidate
78 equally ranked IID candidates
POLYSORBATE 80POLYSORBATE 806OZP39ZG8HELIXIR / ORAL2.5 mg/15mlExact identifier — unii candidate
78 equally ranked IID candidates
POLYSORBATE 80POLYSORBATE 806OZP39ZG8HSYSTEM / TOPICAL28 mgExact identifier — unii candidate
78 equally ranked IID candidates
glycerinGLYCERINPDC6A3C0OXJELLY / VAGINALNAExact 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
EDETATE DISODIUMEDETATE DISODIUM7FLD91C86KINJECTION, SOLUTION / INTRAMUSCULAR4 mgExact identifier — unii candidate
77 equally ranked IID candidates
FERROSOFERRIC OXIDEFERROSOFERRIC OXIDEXM0M87F357TABLET / ORAL2 mgExact identifier — unii candidate
10 equally ranked IID candidates
FERRIC OXIDE YELLOWFERRIC OXIDE YELLOWEX438O2MRTTABLET, COATED / ORAL1 mgExact identifier — unii candidate
20 equally ranked IID candidates
EDETATE DISODIUMEDETATE DISODIUM7FLD91C86KGEL / TRANSDERMAL1 mgExact identifier — unii candidate
77 equally ranked IID candidates
CYCLOMETHICONE 5CYCLOMETHICONE 50THT5PCI0RAEROSOL / TOPICAL2.5 %w/wExact identifier — unii candidate
3 equally ranked IID candidates
XANTHAN GUMXANTHAN GUMTTV12P4NEELOTION / TOPICAL0.3 %w/vExact identifier — unii candidate
29 equally ranked IID candidates
XANTHAN GUMXANTHAN GUMTTV12P4NEEAEROSOL, FOAM / TOPICAL0.27 %w/wExact identifier — unii candidate
29 equally ranked IID candidates
EDETATE DISODIUMEDETATE DISODIUM7FLD91C86KAEROSOL, FOAM / TOPICAL0.05 %w/wExact identifier — unii candidate
77 equally ranked IID candidates
glycerinGLYCERINPDC6A3C0OXTABLET, FILM COATED / ORAL1.55 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
7384e471-b97e-4b83-892b-42b12d69ef51e369a765-4ea0-476f-80dd-822ce35471922014-04-30WarningsExact identifier
spl id: 7384e471-b97e-4b83-892b-42b12d69ef51
spl set id: e369a765-4ea0-476f-80dd-822ce3547192

Reported adverse events (FAERS/openFDA)#

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