BELLAGIO ® SUNSCREEN LOTION SPF 45

Manufacturer
Lifetech Resources, LLC
Effective date
2010-09-13
Label type
HUMAN OTC DRUG LABEL
Version
1
Source
legacy-cache
Hydrated at
2026-08-02 01:52:24

Label at a glance#

ProductBellagio Sunscreen SPF 45
Active ingredientHomosalate, Octinoxate, Octisalate, Oxybenzone, Zinc Oxide
Label structure8 sections

Dosage and administration

Apply evenly and liberally to all exposed areas before sun exposure. Ensure complete coverage. Reapply as needed or after swimming, towel drying, perspiring, or vigorous activity. Ask a doctor before use on children under 6 months of age.

Label contents#

Full prescribing information#

SPL UNCLASSIFIED SECTION

DRUG FACTS

ACTIVE INGREDIENTS

OTC - ACTIVE INGREDIENT SECTION

Homosalate 14.00%, Octinoxate 6.50%, Octisalate 5.00%, Oxybenzone 5.00%, Zinc Oxide 2.74%

PURPOSE

OTC - PURPOSE SECTION

Sunscreen

USE

INDICATIONS & USAGE SECTION

Helps prevent sunburn. Higher SPF gives more sunburn protection.

DIRECTIONS FOR USE

DOSAGE & ADMINISTRATION SECTION

Apply evenly and liberally to all exposed areas before sun exposure. Ensure complete coverage. Reapply as needed or after swimming, towel drying, perspiring, or vigorous activity. Ask a doctor before use on children under 6 months of age.

WARNING

WARNINGS SECTION

OTC - DO NOT USE SECTION

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.

INACTIVE INGREDIENTS

INACTIVE INGREDIENT SECTION

Water, Acrylates Copolymer, Caprylic/Capric Triglyceride, Cyclopentasiloxane, Polysorbate 60, Polysorbate 20, Glycerin, Cetearyl Alcohol, Ceteareth-20, Sorbitan Stearate, Potassium Cetyl Phosphate, Dimethicone, Butyrospermum Parkii (Shea Butter), Squalane, Sodium PCA, Panthenol, Tocopheryl Acetate, Xanthan Gum, Triethoxycaprylylsilane, Disodium EDTA, Sodium Benzoate, Potassium Sorbate, Imidazolidinyl Urea.

PRINCIPAL DISPLAY PANEL - 237 ML Tube Label

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

BELLAGIO®
SUNSCREEN
LOTION
SPF 45

8 FL OZ / 237 ML

Principal Display Panel - 237 ML Tube Label
Principal Display Panel - 237 ML Tube Label

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
65643-335-182019-10-21C16284748780-1956f9ecf-d842-621f-e053-dbdaa90a74adBELLAGIO ® SUNSCREEN LOTION SPF 45

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIISPL versionUploaded
HomosalateACTIVE INGREDIENTV06SV4M95S1
OctinoxateACTIVE INGREDIENT4Y5P7MUD511
OctisalateACTIVE INGREDIENT4X49Y0596W1
OxybenzoneACTIVE INGREDIENT95OOS7VE0Y1
Zinc OxideACTIVE INGREDIENTSOI2LOH54Z1
HomosalateACTIVE MOIETYV06SV4M95S1
OctinoxateACTIVE MOIETY4Y5P7MUD511
OctisalateACTIVE MOIETY4X49Y0596W1
OxybenzoneACTIVE MOIETY95OOS7VE0Y1
Zinc OxideACTIVE MOIETYSOI2LOH54Z1
.ALPHA.-TOCOPHEROL ACETATE, D-INACTIVE INGREDIENTA7E6112E4N1
Cetostearyl AlcoholINACTIVE INGREDIENT2DMT128M1S1
Cyclomethicone 5INACTIVE INGREDIENT0THT5PCI0R1
DimethiconeINACTIVE INGREDIENT92RU3N3Y1O1
Edetate DisodiumINACTIVE INGREDIENT7FLD91C86K1
ImidureaINACTIVE INGREDIENTM629807ATL1
Medium-Chain TriglyceridesINACTIVE INGREDIENTC9H2L21V7U1
OCTYLTRIETHOXYSILANEINACTIVE INGREDIENTLDC331P08E1
PanthenolINACTIVE INGREDIENTWV9CM0O67Z1
POLYOXYL 20 CETOSTEARYL ETHERINACTIVE INGREDIENTYRC528SWUY1
Polysorbate 20INACTIVE INGREDIENT7T1F30V5YH1
Polysorbate 60INACTIVE INGREDIENTCAL22UVI4M1
Potassium Cetyl PhosphateINACTIVE INGREDIENT03KCY6P7UT1
Potassium SorbateINACTIVE INGREDIENT1VPU26JZZ41
Shea ButterINACTIVE INGREDIENTK49155WL9Y1
Sodium BenzoateINACTIVE INGREDIENTOJ245FE5EU1
Sodium Pyrrolidone CarboxylateINACTIVE INGREDIENT469OTG57A21
Sorbitan MonostearateINACTIVE INGREDIENTNVZ4I0H58X1
SqualaneINACTIVE INGREDIENTGW89575KF91
WaterINACTIVE INGREDIENT059QF0KO0R1
Xanthan GumINACTIVE INGREDIENTTTV12P4NEE1

Products#

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

DailyMed product names page 1 of 1 · 28 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
65643-33565643-335-18

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 26 matching rows.

Source Document#

Source XML · Source PDF

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 5 · 259 matching rows.

DailyMed ingredient, IID ingredient, UNII table
DailyMed ingredientIID ingredientUNIIDosage form / routePotencyMaximum daily exposureMatch
Edetate DisodiumEDETATE DISODIUM7FLD91C86KSPRAY / NASAL1 mgExact identifier — unii candidate
77 equally ranked IID candidates
Sodium BenzoateSODIUM BENZOATEOJ245FE5EUSOLUTION / TOPICAL0.1 %w/vExact identifier — unii candidate
35 equally ranked IID candidates
Xanthan GumXANTHAN GUMTTV12P4NEETABLET / ORAL56 mgExact identifier — unii candidate
29 equally ranked IID candidates
Polysorbate 60POLYSORBATE 60CAL22UVI4MSHAMPOO / TOPICAL14.55 %w/wExact identifier — unii candidate
13 equally ranked IID candidates
Cetostearyl AlcoholCETOSTEARYL ALCOHOL2DMT128M1SSUPPOSITORY / VAGINALNAExact identifier — unii candidate
9 equally ranked IID candidates
Xanthan GumXANTHAN GUMTTV12P4NEEPOWDER, FOR SUSPENSION / ORAL600 mgExact identifier — unii candidate
29 equally ranked IID candidates
Polysorbate 60POLYSORBATE 60CAL22UVI4MSUSPENSION / ORAL125 mgExact identifier — unii candidate
13 equally ranked IID candidates
POLYOXYL 20 CETOSTEARYL ETHERPOLYOXYL 20 CETOSTEARYL ETHERYRC528SWUYSPRAY / TOPICAL2.42 %w/wExact identifier — unii candidate
7 equally ranked IID candidates
Medium-Chain TriglyceridesMEDIUM-CHAIN TRIGLYCERIDESC9H2L21V7USPRAY, METERED / SUBLINGUAL110 mgExact identifier — unii candidate
18 equally ranked IID candidates
Polysorbate 60POLYSORBATE 60CAL22UVI4MSUPPOSITORY / RECTAL0.05 mg/mgExact identifier — unii candidate
13 equally ranked IID candidates
Sodium BenzoateSODIUM BENZOATEOJ245FE5EUTABLET, FILM COATED / ORAL1 mgExact identifier — unii candidate
35 equally ranked IID candidates
Polysorbate 20POLYSORBATE 207T1F30V5YHAEROSOL, FOAM / TOPICAL3.7 %w/wExact identifier — unii candidate
28 equally ranked IID candidates
Xanthan GumXANTHAN GUMTTV12P4NEESOLUTION / OPHTHALMIC0.6 %w/vExact identifier — unii candidate
29 equally ranked IID candidates
Sodium BenzoateSODIUM BENZOATEOJ245FE5EUFILM / BUCCAL1 mgExact identifier — unii candidate
35 equally ranked IID candidates
Edetate DisodiumEDETATE DISODIUM7FLD91C86KSPRAY / RESPIRATORY (INHALATION)0.05 %w/wExact identifier — unii candidate
77 equally ranked IID candidates
Edetate DisodiumEDETATE DISODIUM7FLD91C86KINJECTION, SOLUTION / INTRAMUSCULAR4 mgExact identifier — unii candidate
77 equally ranked IID candidates
Xanthan GumXANTHAN GUMTTV12P4NEESUSPENSION / ORAL360 mgExact identifier — unii candidate
29 equally ranked IID candidates
Potassium SorbatePOTASSIUM SORBATE1VPU26JZZ4SPRAY, METERED / NASAL0.06 mgExact identifier — unii candidate
19 equally ranked IID candidates
Edetate DisodiumEDETATE DISODIUM7FLD91C86KSUSPENSION / OPHTHALMIC0.06 %w/vExact identifier — unii candidate
77 equally ranked IID candidates
Edetate DisodiumEDETATE DISODIUM7FLD91C86KINJECTION / SUBCUTANEOUS6 mgExact identifier — unii candidate
77 equally ranked IID candidates
Edetate DisodiumEDETATE DISODIUM7FLD91C86KAEROSOL, FOAM / RECTAL2 mgExact identifier — unii candidate
77 equally ranked IID candidates
Edetate DisodiumEDETATE DISODIUM7FLD91C86KINJECTION / INFILTRATION6 mgExact identifier — unii candidate
77 equally ranked IID candidates
Potassium SorbatePOTASSIUM SORBATE1VPU26JZZ4SOLUTION/ DROPS / OPHTHALMIC0.47 %w/vExact identifier — unii candidate
19 equally ranked IID candidates
Xanthan GumXANTHAN GUMTTV12P4NEESUSPENSION/ DROPS / ORAL22 mgExact identifier — unii candidate
29 equally ranked IID candidates
Sodium BenzoateSODIUM BENZOATEOJ245FE5EUPASTE / DENTAL0.08 %w/wExact identifier — unii candidate
35 equally ranked IID candidates
Edetate DisodiumEDETATE DISODIUM7FLD91C86KSUSPENSION/ DROPS / OPHTHALMIC1 mgExact identifier — unii candidate
77 equally ranked IID candidates
Polysorbate 20POLYSORBATE 207T1F30V5YHSUSPENSION / ORAL80 mgExact identifier — unii candidate
28 equally ranked IID candidates
Polysorbate 20POLYSORBATE 207T1F30V5YHLOTION / TOPICAL2000 mgExact identifier — unii candidate
28 equally ranked IID candidates
Sorbitan MonostearateSORBITAN MONOSTEARATENVZ4I0H58XTABLET / ORAL4 mgExact identifier — unii candidate
11 equally ranked IID candidates
Edetate DisodiumEDETATE DISODIUM7FLD91C86KCAPSULE / ORAL5 mgExact identifier — unii candidate
77 equally ranked IID candidates
Cyclomethicone 5CYCLOMETHICONE 50THT5PCI0RCREAM, AUGMENTED / TOPICAL260 mgExact identifier — unii candidate
3 equally ranked IID candidates
Medium-Chain TriglyceridesMEDIUM-CHAIN TRIGLYCERIDESC9H2L21V7UCREAM / TOPICAL3300 mgExact identifier — unii candidate
18 equally ranked IID candidates
SqualaneSQUALANEGW89575KF9SOLUTION / TOPICAL1 %w/wExact identifier — unii candidate
5 equally ranked IID candidates
Cetostearyl AlcoholCETOSTEARYL ALCOHOL2DMT128M1SOINTMENT / TOPICAL1.2 %w/wExact identifier — unii candidate
9 equally ranked IID candidates
Potassium SorbatePOTASSIUM SORBATE1VPU26JZZ4CONCENTRATE / ORAL1 mgExact identifier — unii candidate
19 equally ranked IID candidates
Xanthan GumXANTHAN GUMTTV12P4NEEFILM, SOLUBLE / ORAL1 mgExact identifier — unii candidate
29 equally ranked IID candidates
Edetate DisodiumEDETATE DISODIUM7FLD91C86KINJECTION, SUSPENSION / SOFT TISSUE1 mgExact identifier — unii candidate
77 equally ranked IID candidates
Medium-Chain TriglyceridesMEDIUM-CHAIN TRIGLYCERIDESC9H2L21V7UTABLET, ORALLY DISINTEGRATING / ORAL1 mgExact identifier — unii candidate
18 equally ranked IID candidates
POLYOXYL 20 CETOSTEARYL ETHERPOLYOXYL 20 CETOSTEARYL ETHERYRC528SWUYCREAM / TOPICAL180 mgExact identifier — unii candidate
7 equally ranked IID candidates
Edetate DisodiumEDETATE DISODIUM7FLD91C86KSOLUTION / RECTAL97 mgExact identifier — unii candidate
77 equally ranked IID candidates
Edetate DisodiumEDETATE DISODIUM7FLD91C86KSYSTEM / IONTOPHORESIS0.1 mgExact identifier — unii candidate
77 equally ranked IID candidates
Edetate DisodiumEDETATE DISODIUM7FLD91C86KINJECTION / INTRACARDIAC2 mgExact identifier — unii candidate
77 equally ranked IID candidates
Edetate DisodiumEDETATE DISODIUM7FLD91C86KCREAM, AUGMENTED / TOPICAL2 mgExact identifier — unii candidate
77 equally ranked IID candidates
POLYOXYL 20 CETOSTEARYL ETHERPOLYOXYL 20 CETOSTEARYL ETHERYRC528SWUYLOTION / TOPICAL71 mgExact identifier — unii candidate
7 equally ranked IID candidates
Edetate DisodiumEDETATE DISODIUM7FLD91C86KINJECTION, POWDER, FOR SUSPENSION / INTRAVENOUS0.4 mgExact identifier — unii candidate
77 equally ranked IID candidates
Cyclomethicone 5CYCLOMETHICONE 50THT5PCI0RAEROSOL / TOPICAL2.5 %w/wExact identifier — unii candidate
3 equally ranked IID candidates
Potassium SorbatePOTASSIUM SORBATE1VPU26JZZ4SUSPENSION / ORAL400 mgExact identifier — unii candidate
19 equally ranked IID candidates
Xanthan GumXANTHAN GUMTTV12P4NEEPASTE / ORAL1050 mgExact identifier — unii candidate
29 equally ranked IID candidates
Sodium BenzoateSODIUM BENZOATEOJ245FE5EUPASTE / ORAL28 mgExact identifier — unii candidate
35 equally ranked IID candidates
Sodium BenzoateSODIUM BENZOATEOJ245FE5EUSPONGE / TOPICALNAExact identifier — unii candidate
35 equally ranked IID candidates
Edetate DisodiumEDETATE DISODIUM7FLD91C86KSHAMPOO, SUSPENSION / TOPICAL1 %w/wExact identifier — unii candidate
77 equally ranked IID candidates
Cetostearyl AlcoholCETOSTEARYL ALCOHOL2DMT128M1SCREAM / TOPICAL1428 mgExact identifier — unii candidate
9 equally ranked IID candidates
Polysorbate 20POLYSORBATE 207T1F30V5YHSHAMPOO / TOPICAL8 %w/wExact identifier — unii candidate
28 equally ranked IID candidates
Potassium SorbatePOTASSIUM SORBATE1VPU26JZZ4CAPSULE / ORALNAExact identifier — unii candidate
19 equally ranked IID candidates
Sodium BenzoateSODIUM BENZOATEOJ245FE5EUSUSPENSION, EXTENDED RELEASE / ORAL24 mgExact identifier — unii candidate
35 equally ranked IID candidates
Polysorbate 60POLYSORBATE 60CAL22UVI4MOINTMENT / TOPICAL2 %w/wExact identifier — unii candidate
13 equally ranked IID candidates
Sorbitan MonostearateSORBITAN MONOSTEARATENVZ4I0H58XSUSPENSION / ORAL62.5 mg/5mlExact identifier — unii candidate
11 equally ranked IID candidates
Sodium BenzoateSODIUM BENZOATEOJ245FE5EUTABLET, COATED / ORAL0.2 mgExact identifier — unii candidate
35 equally ranked IID candidates
Edetate DisodiumEDETATE DISODIUM7FLD91C86KSUSPENSION/ DROPS / AURICULAR (OTIC)0.01 %w/vExact identifier — unii candidate
77 equally ranked IID candidates
Polysorbate 20POLYSORBATE 207T1F30V5YHINJECTION, SUSPENSION, EXTENDED RELEASE / INTRAMUSCULAR60 mgExact identifier — unii candidate
28 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
6ff19afa-8f16-4d33-99b6-04d8530c48a1f60ff88f-4bdf-4737-ae76-3ada73d133ee2010-09-13WarningsExact identifier
spl id: 6ff19afa-8f16-4d33-99b6-04d8530c48a1
spl set id: f60ff88f-4bdf-4737-ae76-3ada73d133ee

Reported adverse events (FAERS/openFDA)#

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