FDA.reportPublic FDA data

Kids Face and Body Sunscreen SPF 50

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#

ProductKids Face and Body Sunscreen SPF 50
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

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...

Label contents#

Full prescribing information#

Active Ingredients

OTC - ACTIVE INGREDIENT SECTION

Zinc Oxide 21.0%

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

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: • Limit time in the sun, especially from 10a.m. - 2p.m. • Wear long-sleeved shirts, pants, hats and sunglasses

Other Information

OTHER SAFETY INFORMATION

  • Protect the product in this container 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

Bisabolol, Butyloctyl Salicylate, Butyrospermum Parkii (Shea) Butter*, Cocos Nucifera (Coconut) Oil*, Copernicia Cerifera (Carnauba) Wax, Euphorbia Cerifera (Candelila) Wax, Helianthus Annuus (Sunflower) Seed Oil, Olea Europaea (Olive) Fruit Oil, Oryzanol, Theobroma Cacao (Cocoa) Seed Butter, Tocopherol.
*Organic

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

HelloBello-sunscreen-family-stick_BIORIUS_Aug2023_AOHelloBello-sunscreen-family-stick_BIORIUS_Aug2023_AOHelloBello-sunscreen-family-stick-box_BIORIUS_Aug2023_AOHelloBello-sunscreen-family-stick-box_BIORIUS_Aug2023_AO

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
ebc62596-fc97-4d03-9483-7ba095d25db7Product name120151210

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
73418-103-01Kids Face and Body Sunscreen SPF 5028 g in 1 CYLINDERSTICK282
73418-103-08Kids Face and Body Sunscreen SPF 501 in 1 CARTONSTICK12

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
73418-103KIDS FACE AND BODY SUNSCREEN SPF 50 (ZINC OXIDE) STICK [HELLO BELLO]2Current NDC, 2 package rows20250110_01cc4ea0-e3de-32f1-e063-6394a90a1375.zip

Products#

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

DailyMed product names page 1 of 1 · 13 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
73418-10373418-103-01, 73418-103-08

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 12 matching rows.

Name, UNII, Kind table
NameUNIIKind
OLIVE OIL6UYK2W1W1EIACT
COCOA BUTTER512OYT1CRRIACT
SHEA BUTTERK49155WL9YIACT
CANDELILLA WAXWL0328HX19IACT
BUTYLOCTYL SALICYLATE2EH13UN8D3IACT
ZINC OXIDESOI2LOH54ZACTIB
LEVOMENOL24WE03BX2TIACT
TOCOPHEROLR0ZB2556P8IACT
COCONUT OILQ9L0O73W7LIACT
ORYZANOLSST9XCL51MIACT
CARNAUBA WAXR12CBM0EIZIACT
SUNFLOWER OIL3W1JG795YIIACT

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
Kids Face and Body Sunscreen SPF 50ZINC OXIDEHello Bello01cc4ea0-e3de-32f1-e063-6394a90a13752025-01-08WarningsExact identifier
ndc (package): 73418-103-08
ndc (package): 73418-103-01
ndc (product): 73418-103
ndc11 (package): 73418010301
ndc11 (package): 73418010308
spl id: 2b3620f5-171a-7afc-e063-6394a90a7aab
spl set id: 01cc4ea0-e3de-32f1-e063-6394a90a1375

Reported adverse events (FAERS/openFDA)#

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