FDA.reportPublic FDA data

Mineral Sunscreen Lotion + ANTIOXIDANTS SPF50

Manufacturer
Hello Bello
Effective date
2025-05-14
Label type
HUMAN OTC DRUG LABEL
Version
2
Source
full-release
Hydrated at
2026-06-01 01:01:03

Label at a glance#

ProductHello Bello Mineral Sunscreen SPF 50
Active ingredientZINC OXIDE, TITANIUM DIOXIDE
Label structure9 sections

Indications and uses

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

Dosage and administration

Shake well before use Apply liberally and spread evenly by hand 15 minutes before sun exposure Reapply: after 80 minutes of swimming or sweating immediately after towel use at least every 2 hours Sun Protection Measures Spending time in the sun can increase your risk of skin cancer and early skin aging. To decrease this risk, regularly use sunscreen with a Broad Spectrum SPF value of 15 or higher and other sun pro...

Label contents#

Full prescribing information#

Other Information

OTHER SAFETY INFORMATION

Protect this product from excessive heat and direct sun

Avoid long-term exposure storage above 40°C (104°F)

May stain some fabrics

Active Ingredients

OTC - ACTIVE INGREDIENT SECTION

Titanium Dioxide 8%

Zinc Oxide 10%

Purpose

OTC - PURPOSE SECTION

Sunscreen

Uses

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

Directions

INSTRUCTIONS FOR USE SECTION

Shake well before use

Apply liberally and spread evenly by hand 15 minutes before sun exposure

Reapply:

after 80 minutes of swimming or sweating immediately after towel use
at least every 2 hours

Sun Protection Measures

Spending time in the sun can increase your risk of skin cancer and early skin aging. To decrease this risk, regularly use sunscreen with a Broad Spectrum SPF value of 15 or higher and other sun protection measures including:

Limiting time in the sun, especially from 10a.m. - 2p.m.
Wearing long-sleeved shirts, pants, hats and sunglasses

Children under six months: Ask a doctor

Other Information

OTHER SAFETY INFORMATION

Protect this product from excessive heat and direct sun

Avoid long-term exposure storage above 40°C (104°F)

May stain some fabrics

Inactive Ingredients

INACTIVE INGREDIENT SECTION

1,2-Hexanediol, Alumina, Aluminum Stearate, Aphanizomenon Flos-aquae Extract, Butyloctyl Salicylate, C12-15 Alkyl Benzoate, Caprylyl Glycol, Cetyl Dimethicone, Cetyl PEG/PPG-10/1 Dimethicone, Dimethicone, Disodium EDTA, Ethylhexyl Palmitate, Ethylhexyl Stearate, Euphorbia Cerifera (Candelilla) Wax, Glycerin, Hexyl Laurate, Hydroxyacetophenone, Methyl Glucose Dioleate, Octyldodecyl Neopentanoate, PEG-7 Hydrogenated Castor Oil, Polyglyceryl-4 Isostearate, Polyhydroxystearic Acid, Potassium Sorbate, Propanediol, Sodium Benzoate, Tocopherol (Vitamin E), Tocopheryl Acetate, Triethoxycaprylylsilane, Trimethylsiloxysilicate, VP/Hexadecene Copolymer, Water.

Questions?

OTC - QUESTIONS SECTION

Support@HelloBello.com

Sunscreen Label

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

HB Mineral Sunscreen Tube 050925HB Mineral Sunscreen Tube 050925

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
73418-106-05Hello Bello Mineral Sunscreen SPF 50141.75 g in 1 TUBELOTION141.752

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
73418-106HELLO BELLO MINERAL SUNSCREEN SPF 50 (ZINC OXIDE TITANIUM OXIDE) LOTION [HELLO BELLO]21 package rows20250516_34bb8560-8223-e810-e063-6394a90ad45d.zip

Products#

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

DailyMed product names page 1 of 1 · 35 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
73418-10673418-106-05

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 33 matching rows.

Name, UNII, Kind table
NameUNIIKind
PROPANEDIOL5965N8W85TIACT
SODIUM BENZOATEOJ245FE5EUIACT
CETYL PEG/PPG-10/1 DIMETHICONE (HLB 5)035JKJ76MTIACT
DIMETHICONE 100RO266O364UIACT
ALUMINUM STEARATEU6XF9NP8HMIACT
C12-15 ALKYL BENZOATEA9EJ3J61HQIACT
CAPRYLYL GLYCOL00YIU5438UIACT
ETHYLHEXYL PALMITATE2865993309IACT
OCTYLDODECYL NEOPENTANOATEX8725R883TIACT
TRIETHOXYCAPRYLYLSILANELDC331P08EIACT
POTASSIUM SORBATE1VPU26JZZ4IACT
HYDROXYACETOPHENONEG1L3HT4CMHIACT
EDETATE DISODIUM7FLD91C86KIACT
HEXYL LAURATE4CG9F9W01QIACT
POLYGLYCERYL-4 ISOSTEARATE820DPX33S7IACT
POLYHYDROXYSTEARIC ACID (2300 MW)YXH47AOU0FIACT
WATER059QF0KO0RIACT
METHYL GLUCOSE DIOLEATEFA9KFJ4Z6PIACT
GLYCERINPDC6A3C0OXIACT
TOCOPHEROLR0ZB2556P8IACT
ZINC OXIDESOI2LOH54ZACTIB
ETHYLHEXYL STEARATEEG3PA2K3K5IACT
.ALPHA.-TOCOPHEROL ACETATE, D-A7E6112E4NIACT
ALUMINALMI26O6933IACT
VP/HEXADECENE COPOLYMERKFR5QEN0N9IACT
EUPHORBIA CERIFERA (CANDELILLA) WAXWL0328HX19IACT
PEG-7 HYDROGENATED CASTOR OILWE09129TH5IACT
TRIMETHYLSILOXYSILICATE (M/Q 0.8-1.0)25LXE464L2IACT
TITANIUM DIOXIDE15FIX9V2JPACTIB
APHANIZOMENON FLOSAQUAE49VG1X560XIACT
BUTYLOCTYL SALICYLATE2EH13UN8D3IACT
CETYL DIMETHICONE 25U4AS1BW4ZBIACT
1,2-HEXANEDIOLTR046Y3K1GIACT

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
35220878-3212-7974-e063-6294a90a981d34bb8560-8223-e810-e063-6394a90ad45d2025-05-14WarningsExact identifier
spl id: 35220878-3212-7974-e063-6294a90a981d
spl set id: 34bb8560-8223-e810-e063-6394a90ad45d

Reported adverse events (FAERS/openFDA)#

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