FDA.reportPublic FDA data

Baby Mineral Sunscreen SPF55

Manufacturer
Hello Bello
Effective date
2025-01-08
Label type
HUMAN OTC DRUG LABEL
Version
2
Source
full-release
Hydrated at
2026-06-01 00:51:16

Label at a glance#

ProductBaby Mineral Sunscreen SPF55
Active ingredientZINC OXIDE
Label structure8 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 For children under 6 months of age, ask a doctor 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 Sp...

Label contents#

Full prescribing information#

Active Ingredients

OTC - ACTIVE INGREDIENT SECTION

Zinc Oxide 20.0%

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

Warnings

WARNINGS SECTION

For external use only

Do not use on

OTC - DO NOT USE SECTION

broken or damaged skin

When using this product

OTC - WHEN USING SECTION

Keep out of eyes. Rinse with water to remove

Stop use and ask a doctor if

OTC - STOP USE SECTION

rash occurs

Keep out of reach of children

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

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

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
  • For children under 6 months of age, ask a doctor
  • 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

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

Arachidyl Alcohol, Arachidyl Glucoside, Behenyl Alcohol, Bisabolol*, Butyloctyl Salicylate, Butyrospermum Parkii (Shea) Butter*, Calendula Officinalis Flower Extract*, Camellia Sinensis Leaf Extract*, Caprylhydroxamic Acid, Capryloyl Glycerin/Sebacic Acid Copolymer, Caprylyl Glycol, Cellulose Gum, Cetearyl Alcohol, Cetyl Alcohol, Chamomilla Recutita (Matricaria) Flower Extract*, Citric Acid, Citrus Aurantium Dulcis (Orange) Peel Oil, Coco Glucoside, Cocos Nucifera (Coconut) Oil*, Cucumis Sativus (Cucumber) Fruit Extract*, Diheptyl Succinate, Glycerin, Methyl Dihydroabietate, Microcrystalline Cellulose, Persea Gratissima (Avocado) Fruit Extract*, Polyhydroxystearic Acid, Prunus Armeniaca (Apricot) Kernel Oil*, Sodium Gluconate, Sodium Hyaluronate, Sodium Stearoyl Glutamate, Theobroma Cacao (Cocoa) Seed Butter, Tocopherol, Triethyl Citrate, Vanilla Planifolia Fruit Extract, Water (Aqua) *Organic

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

HelloBello_sunscreen_dieline_109C_March2022_AOHelloBello_sunscreen_dieline_109C_March2022_AO

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
6bd95106-a412-1dad-b9cc-4cb74bfb27ceProduct name220230315
3c386306-c48a-413e-bb69-70cb268496f3Product name120210727
290f523a-f9db-9774-b5a9-e1f908ac1782Product name120150828
c6b65c52-69c7-df49-550a-a50c137f6218Product name120140508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
73418-100-03Baby Mineral Sunscreen SPF5585.05 g in 1 TUBELOTION85.052

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
73418-100BABY MINERAL SUNSCREEN SPF55 (ZINC OXIDE) LOTION [HELLO BELLO]2Current NDC, 1 package rows20250110_0190eeaf-c5a0-3253-e063-6294a90a43c4.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
73418-10073418-100-03

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 36 matching rows.

Name, UNII, Kind table
NameUNIIKind
LEVOMENOL24WE03BX2TIACT
BUTYLOCTYL SALICYLATE2EH13UN8D3IACT
CAPRYLHYDROXAMIC ACIDUPY805K99WIACT
CETOSTEARYL ALCOHOL2DMT128M1SIACT
CETYL ALCOHOL936JST6JCNIACT
CHAMOMILEFGL3685T2XIACT
ORANGE OILAKN3KSD11BIACT
DIHEPTYL SUCCINATE057N7SS26YIACT
POLYHYDROXYSTEARIC ACID STEARATE8KQ7I65XZEIACT
APRICOT KERNEL OIL54JB35T06AIACT
SODIUM GLUCONATER6Q3791S76IACT
HYALURONATE SODIUMYSE9PPT4THIACT
SODIUM STEAROYL GLUTAMATE65A9F4P024IACT
TOCOPHEROLR0ZB2556P8IACT
VANILLA BEANQ74T35078HIACT
WATER059QF0KO0RIACT
MICROCRYSTALLINE CELLULOSEOP1R32D61UIACT
GREEN TEA LEAFW2ZU1RY8B0IACT
ARACHIDYL ALCOHOL1QR1QRA9BUIACT
DOCOSANOL9G1OE216XYIACT
COCOA BUTTER512OYT1CRRIACT
ARACHIDYL GLUCOSIDE6JVW35JOOJIACT
CALENDULA OFFICINALIS FLOWERP0M7O4Y7YDIACT
CAPRYLOYL GLYCERIN/SEBACIC ACID COPOLYMER (2000 MPA.S)N7YC58165TIACT
CAPRYLYL GLYCOL00YIU5438UIACT
CARBOXYMETHYLCELLULOSE SODIUMK679OBS311IACT
CITRIC ACID MONOHYDRATE2968PHW8QPIACT
COCO GLUCOSIDEICS790225BIACT
COCONUT OILQ9L0O73W7LIACT
CUCUMBERYY7C30VXJTIACT
GLYCERINPDC6A3C0OXIACT
METHYL DIHYDROABIETATE7666FJ0J9FIACT
AVOCADOSDS87L369FIACT
TRIETHYL CITRATE8Z96QXD6UMIACT
SHEA BUTTERK49155WL9YIACT
ZINC OXIDESOI2LOH54ZACTIB

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
Baby Mineral Sunscreen SPF55ZINC OXIDEHello Bello0190eeaf-c5a0-3253-e063-6294a90a43c42025-01-08WarningsExact identifier
ndc (package): 73418-100-03
ndc (product): 73418-100
ndc11 (package): 73418010003
spl id: 2b362a56-3e1e-37c6-e063-6294a90aaa74
spl set id: 0190eeaf-c5a0-3253-e063-6294a90a43c4

Reported adverse events (FAERS/openFDA)#

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