FDA.reportPublic FDA data

Mineral Sunscreen Spray SPF50

Manufacturer
Hello Bello
Effective date
2025-10-02
Label type
HUMAN OTC DRUG LABEL
Version
3
Source
full-release
Hydrated at
2026-06-01 01:15:32

Label at a glance#

ProductKids Mineral Sunscreen SPF50
Active ingredientZINC OXIDE, TITANIUM DIOXIDE
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 Hold 4 to 6 inches away from body when spraying For children under 6 months of age, ask a doctor Do not spray directly on face Spray on hand and apply to face. Use in well-ventilated areas. Do not apply in wind conditions. Reapply: • after 80 minutes of swimming or sweating • immediately after towel use • at least every ...

Label contents#

Full prescribing information#

Active Ingredients

OTC - ACTIVE INGREDIENT SECTION

Titanium Dioxide 3.4%

Zinc Oxide 16%

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

Flammable: Do not use near heat, flame, or while smoking

Do not use on

OTC - DO NOT USE SECTION

broken or damaged skin

When using this product

OTC - WHEN USING SECTION

Keep away from face and avoid breathing it. Keep out of eyes. Rinse with water to remove. Do not puncture or incinerate. Contents under pressure. Do not store at temperatures above 120F.

Stop use and ask a doctor

OTC - STOP USE SECTION

if 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
  • Hold 4 to 6 inches away from body when spraying
  • For children under 6 months of age, ask a doctor
  • Do not spray directly on face
  • Spray on hand and apply to face. Use in well-ventilated areas. Do not apply in wind conditions.
  • 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: • 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 this product from excessive heat and direct sun
  • May stain some fabrics

Inactive Ingredients

INACTIVE INGREDIENT SECTION

Water (Aqua), Butyloctyl Salicylate, Isononyl Isnonanoate, Dicaprylyl Carbonate, Methyl Dihydroabietate, Propanediol, Isocetyl Stearoyl Stearate, Cetearyl Alcohol, Sodium Stearoyl Glutamate, Polyester-8, C18-21 Alkane, Silica, Alumina, Tocopherol, Bisabolol, Polyhydroxystearic Acid, Coco-Glucoside, Glycerin, Caprylyl Glycol, Caprylhydroxamic Acid, Musa Sapientum (Banana) Fruit Extract, Sodium Gluconate, Citric Acid, Aloe Barbadensis Leaf Juice, Bentonite, Microcrystalline Cellulose, Cellulose Gum

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

KMSCS000L5ZCANHB1KMSCS000L5ZCANHB1

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
73418-105-05Kids Mineral Sunscreen SPF50142 g in 1 BOTTLE, SPRAYSPRAY1423

Products#

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

DailyMed product names page 1 of 1 · 30 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
73418-10573418-105-05

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 28 matching rows.

Name, UNII, Kind table
NameUNIIKind
WATER059QF0KO0RIACT
ISONONYL ISONONANOATES4V5BS6GCXIACT
POLYESTER-8 (1400 MW, CYANODIPHENYLPROPENOYL CAPPED)T9296U138PIACT
ISOCETYL STEAROYL STEARATEIJV4LS383RIACT
C18-C21 ALKANE33822S0M40IACT
DICAPRYLYL CARBONATE609A3V1SUAIACT
METHYL DIHYDROABIETATE7666FJ0J9FIACT
SODIUM STEAROYL GLUTAMATE65A9F4P024IACT
SILICON DIOXIDEETJ7Z6XBU4IACT
ALUMINUM OXIDELMI26O6933IACT
CITRIC ACID MONOHYDRATE2968PHW8QPIACT
MICROCRYSTALLINE CELLULOSEOP1R32D61UIACT
CARBOXYMETHYLCELLULOSE SODIUMK679OBS311IACT
LEVOMENOL24WE03BX2TIACT
POLYHYDROXYSTEARIC ACID STEARATE8KQ7I65XZEIACT
SODIUM GLUCONATER6Q3791S76IACT
TOCOPHEROLR0ZB2556P8IACT
ZINC OXIDESOI2LOH54ZACTIB
GLYCERINPDC6A3C0OXIACT
CAPRYLHYDROXAMIC ACIDUPY805K99WIACT
ALOE VERA LEAFZY81Z83H0XIACT
CETOSTEARYL ALCOHOL2DMT128M1SIACT
CAPRYLYL GLYCOL00YIU5438UIACT
TITANIUM DIOXIDE15FIX9V2JPACTIB
BUTYLOCTYL SALICYLATE2EH13UN8D3IACT
PROPANEDIOL5965N8W85TIACT
COCO GLUCOSIDEICS790225BIACT
BANANA4AJZ4765R9IACT

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 Mineral Sunscreen SPF50SUNSCREENHello Bello01cc554b-9241-d891-e063-6394a90a84502025-10-02WarningsExact identifier
ndc (package): 73418-105-05
ndc (product): 73418-105
ndc11 (package): 73418010505
spl id: 4033b5a6-fafb-22c5-e063-6294a90adfd0
spl set id: 01cc554b-9241-d891-e063-6394a90a8450

Reported adverse events (FAERS/openFDA)#

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