Zinc Oxide
FDA Label NDC 73418-021

Full FDA labeling including Indications, Dosage, Usage, and Precautions

Structured Product Label

The following Structured Product Label (SPL) was submitted to the FDA by Hello Bello for the product Zinc Oxide (NDC 73418-021). This document serves as the official prescribing information, containing essential scientific data and clinical materials required for healthcare providers and patients.

This specific version of the label includes detailed information regarding active ingredients, purpose, uses:, warning:, otc - do not use, otc - when using, otc - stop use, otc - keep out of reach of children, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.

Label Section Quick Index

Active Ingredients

Zinc Oxide - 20.0%

Purpose

Sunscreen

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

Warning:

For external use only

Otc - Do Not Use

  • Do not use on damaged or broken skin

Otc - When Using

  • When using this product keep out of eyes. Rinse with water to remove.

Otc - Stop Use

  • Stop use and ask a doctor if rash occurs

Otc - Keep Out Of Reach Of Children

  • Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center right away.

Directions:

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:

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:

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

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

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

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)

* Please review the disclaimer below.