FDA.reportPublic FDA data

Zinc Oxide

Manufacturer
Hello Bello | Unconditional Love
Effective date
2021-01-13
Label type
HUMAN OTC DRUG LABEL
Version
1
Source
full-release
Hydrated at
2026-05-31 23:37:26

Label at a glance#

ProductZinc Oxide
Active ingredientZinc Oxide
Label structure10 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 15 minutes before sun exposure Reapply: After 80 minutes of swimming or sweating + immediately after towel drying At least every 2 hours For children under 6 months of age: ask a doctor

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

WARNING:

WARNINGS SECTION

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

DIRECTIONS:

DOSAGE & ADMINISTRATION SECTION

Apply liberally 15 minutes before sun exposure

  • Reapply: After 80 minutes of swimming or sweating + immediately after towel drying
  • At least every 2 hours
  • For children under 6 months of age: ask a doctor

SUN PROTECTION MEASURES:

SPL UNCLASSIFIED SECTION

Spending time in the sun increases your risk of skin cancer and early skin aging. To decrease this risk, regularly use a sunscreen with a Broad Spectrum SPF value of 15 or higher and other sun protection measures including: limited time in the sun, especially from 10 am. - 2 p.m. Wear long-sleeved shirts, pants, hats, and sunglasses.

INACTIVE INGREDIENTS:

INACTIVE INGREDIENT SECTION

Helianthus Annuus (Sunflower) Seed Oil, Cocos Nucifera (Coconut) Oil*, Euphorbia Cerifera (Candelilla) Wax, Ricinus Communis (Castor) Seed Oil, Rubus Idaeus (Red Raspberry) Seed Oil, Butyrospermum Parkii (Shea) Butter*, Prunus Armeniaca (Apricot) Kernel Oil, Argania Spinosa (Argan) Kernel Oil*, Copernicia Cerifera (Carnauba) Wax*, Rosa Canina (Rosehip) Fruit Oil, Tocopherol - *Certified Organic

Principal Display Panel - 29 g Box Label

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

hello
bello

Mineral
Sunscreen
Stick

30
SPF

1.0 fl oz (29 g) e

Principal Display Panel - 29 g Box Label
Principal Display Panel - 29 g Box Label

Principal Display Panel - 29 g Stick Label

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

hello
bello

Mineral
Sunscreen
Stick

30
SPF

1.0 fl oz (29 g) e

Reef
Friendly

Vegan

Principal Display Panel - 29 g Stick Label
Principal Display Panel - 29 g Stick Label

Principal Display Panel - 88.7 mL Carton Label

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

50+
SPF

Broad Spectrum UVA + UVB Protection

Non- Nano Zinc Oxide

hello
bello™

• Dermatologist Tested

• Clinically Tested • Non-Greasy

• Hypoallergenic

Safe & Effective for
Adults & Kids

Mineral
Sunscreen

3.0 fl. oz. (88.7 ml) e

Reef
Friendly

Water Resistant
(80 Minutes)

Principal Display Panel - 88.7 mL Carton Label
Principal Display Panel - 88.7 mL Carton Label

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
73418-020-012023-07-28C16284748780-1e4f33bdf-a1f2-d8a0-e053-dadaa90a6e4eDrug Facts
73418-021-012023-07-28C16284748780-1e4f33bdf-a1f2-d8a0-e053-dadaa90a6e4eDrug Facts
73418-020-012022-09-09C16284748780-1e4f33bdf-a1f2-d8a0-e053-dadaa90a6e4eDrug Facts
73418-021-012022-09-09C16284748780-1e4f33bdf-a1f2-d8a0-e053-dadaa90a6e4eDrug Facts
73418-020-012022-07-29C16284748780-1e4f33bdf-a1f2-d8a0-e053-dadaa90a6e4eDrug Facts
73418-021-012022-07-29C16284748780-1e4f33bdf-a1f2-d8a0-e053-dadaa90a6e4eDrug Facts

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
73418-020-01Zinc Oxide1 in 1 BOXSTICK11
73418-020-01Zinc Oxide29 mL in 1 APPLICATORSTICK291
73418-021-01Zinc Oxide88.7 mL in 1 TUBELOTION88.71

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
73418-020ZINC OXIDE STICK ZINC OXIDE LOTION [HELLO BELLO]1Legacy NDC, 2 package rows20210128_787419e7-30ce-40c1-b2b9-98e3ac17df59.zip
73418-021ZINC OXIDE STICK ZINC OXIDE LOTION [HELLO BELLO]1Legacy NDC, 1 package rows20210128_787419e7-30ce-40c1-b2b9-98e3ac17df59.zip

Products#

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

DailyMed product names page 1 of 1 · 12 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
73418-02073418-020-01
73418-02173418-021-01

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 22 matching rows.

Name, UNII, Kind table
NameUNIIKind
Zinc OxideSOI2LOH54ZACTIB
Sunflower Oil3W1JG795YIIACT
Coconut OilQ9L0O73W7LIACT
Candelilla WaxWL0328HX19IACT
Castor OilD5340Y2I9GIACT
Raspberry Seed Oil9S8867952AIACT
Apricot Kernel Oil54JB35T06AIACT
Argan Oil4V59G5UW9XIACT
Carnauba WaxR12CBM0EIZIACT
Aloe Vera LeafZY81Z83H0XIACT
TocopherolR0ZB2556P8IACT
Zinc OxideSOI2LOH54ZACTIB
Sunflower Oil3W1JG795YIIACT
Coconut OilQ9L0O73W7LIACT
Candelilla WaxWL0328HX19IACT
Castor OilD5340Y2I9GIACT
Raspberry Seed Oil9S8867952AIACT
Apricot Kernel Oil54JB35T06AIACT
Argan Oil4V59G5UW9XIACT
Carnauba WaxR12CBM0EIZIACT
Rosa Canina Fruit OilCR7307M3QZIACT
TocopherolR0ZB2556P8IACT

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
c634b272-b6a9-4364-85ae-410c8baaa961787419e7-30ce-40c1-b2b9-98e3ac17df592021-01-13WarningsExact identifier
spl id: c634b272-b6a9-4364-85ae-410c8baaa961
spl set id: 787419e7-30ce-40c1-b2b9-98e3ac17df59

Reported adverse events (FAERS/openFDA)#

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