FDA.reportPublic FDA data

Belo Sun Expert Tinted Sunscreen

Manufacturer
Intelligent Skin Care Inc. | A.M. Rieta Corporation
Effective date
2022-11-29
Label type
HUMAN OTC DRUG LABEL
Version
5
Source
full-release
Hydrated at
2026-05-31 23:51:56

Label at a glance#

ProductBelo Sun Expert Tinted Sunscreen
Active ingredientTITANIUM DIOXIDE, OCTOCRYLENE, OCTINOXATE
Label structure9 sections

Dosage and administration

apply liberally 15 minutes before sun exposure. reapply at least every 2 hours. use a water-resistant sunscreen if swimming or sweating. children under 6 months of age: Ask a doctor.

Label contents#

Full prescribing information#

Active Ingredients

OTC - ACTIVE INGREDIENT SECTION

Active Ingredients Purpose

Octyl methoxycinnamate 5% Sunscreen

Titanium dioxide 6.13%

Octocrylene .8%

Use

INDICATIONS & USAGE SECTION

Use

helps prevent sunburn

Warnings

WARNINGS SECTION

Skin Cancer/Skin Aging Alert: Spending time in the sun increases your risk of skin cancer and early skin aging. This product has been shown only to help prevent sunburn, not skin cancer or early skin aging.

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 reach of children. If product is swallowed, get Poison Control Center right away.

Directions

DOSAGE & ADMINISTRATION SECTION

  • apply liberally 15 minutes before sun exposure.
  • reapply at least every 2 hours.
  • use a water-resistant sunscreen if swimming or sweating.
  • children under 6 months of age: Ask a doctor.

Other Information

OTHER SAFETY INFORMATION

Other Information

protect the product in this container from excessive heat and direct sun

  • high sun protection product

Inactive Ingredients

INACTIVE INGREDIENT SECTION

Inactive Ingredients

water, aluminum hydroxide, lauroyl lysine, cyclotetrasiloxane, cyclopentasiloxane, cetyl alcohol, glyceryl stearate, ceteareth-20, ceteraeth-12, cetearyl alcohol, cetyl palmitate, butylene glycol, bee venom, dimethicone, cetearyl dimethicone crosspolymer, methylsisesquioxane resin, niacinamide, alumina, simethicone, ethylhexyl methoxycrylene, avobenzone, butyrospermum parkii, hydrogenated dimer dilinoleyl/dimethylcarbonate copolymer, sorbitan palmitate, sorbitan olivate, benzyl alcohol, glyceryl caprylate, glyceryl undecylenate, iron oxides lauroyl lysine (CI 77492), fragrance, iron oxides lauroyl lysine (CI 66491), iron oxides lauroyl lysine (CI 77499) bisabolol, tetrasodium EDTA, citric acid

Questions or Comments?

OTC - QUESTIONS SECTION

Questions or Comments?

+63 2 7500 3825 or inquiries@iskincareinc.com

Purpose

OTC - PURPOSE SECTION

Purpose

Helps prevent sunburn

label

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

LabelLabel

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
82701-001-012024-01-30C16284748780-11030e365-1051-111a-e063-dadaa90a10e2Intelligent Skin Belo private labeled

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
82701-001-01Belo Sun Expert Tinted Sunscreen50 mg in 1 TUBECREAM505

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
82701-001BELO SUN EXPERT TINTED SUNSCREEN (OCTYL METHOXYCINNAMATE, TITANIUM DIOXIDE, OCTOCRYLENE) CREAM [INTELLIGENT SKIN CARE INC.]5Legacy NDC, 1 package rows20221130_e20dd234-8d8f-da10-e053-2995a90acd1b.zip

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
82701-00182701-001-01

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 35 matching rows.

Name, UNII, Kind table
NameUNIIKind
APIS MELLIFERA VENOM76013O881MIACT
BUTYROSPERMUM PARKII (SHEA) BUTTER UNSAPONIFIABLES0C9AC7D6XUIACT
NIACINAMIDE25X51I8RD4IACT
GLYCERYL CAPRYLATETM2TZD4G4AIACT
WATER059QF0KO0RIACT
ALUMINUM OXIDELMI26O6933IACT
BENZYL ALCOHOLLKG8494WBHIACT
CYCLOMETHICONE 50THT5PCI0RIACT
LAUROYL LYSINE113171Q70BIACT
TITANIUM DIOXIDE15FIX9V2JPACTIB
OCTOCRYLENE5A68WGF6WMACTIB
POLYMETHYLSILSESQUIOXANE/TRIMETHYLSILOXYSILICATEX2PZH4Y6HTIACT
FERROSOFERRIC OXIDEXM0M87F357IACT
LEVOMENOL24WE03BX2TIACT
OCTINOXATE4Y5P7MUD51ACTIB
CETOSTEARYL ALCOHOL2DMT128M1SIACT
DIMETHICONE92RU3N3Y1OIACT
BUTYLENE GLYCOL3XUS85K0RAIACT
GLYCERYL 1-UNDECYLENATEB68LJT9544IACT
FERRIC OXIDE YELLOWEX438O2MRTIACT
ALUMINUM HYDROXIDE5QB0T2IUN0IACT
ETHYLHEXYL METHOXYCRYLENES3KFG6Q5X8IACT
CETYL ALCOHOL936JST6JCNIACT
C30-45 ALKYL CETEARYL DIMETHICONE CROSSPOLYMER4ZK9VP326RIACT
SILICON DIOXIDEETJ7Z6XBU4IACT
AVOBENZONEG63QQF2NOXIACT
CITRIC ACID MONOHYDRATE2968PHW8QPIACT
CETEARETH-127V4MR24V5PIACT
CETYL PALMITATE5ZA2S6B08XIACT
GLYCERYL MONOSTEARATE230OU9XXE4IACT
FERRIC OXIDE RED1K09F3G675IACT
EDETATE SODIUMMP1J8420LUIACT
PEG-80 SORBITAN PALMITATE4NR71FN0IAIACT
CYCLOMETHICONE 4CZ227117JEIACT
POLYOXYL 20 CETOSTEARYL ETHERYRC528SWUYIACT

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
eea0e8a4-124d-744b-e053-2a95a90a711ae20dd234-8d8f-da10-e053-2995a90acd1b2022-11-29WarningsExact identifier
spl id: eea0e8a4-124d-744b-e053-2a95a90a711a
spl set id: e20dd234-8d8f-da10-e053-2995a90acd1b

Reported adverse events (FAERS/openFDA)#

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