drug facts

drug facts
SPL v1
SPL
SPL Set ID cdd4166e-058a-4819-bc79-b877e4e4f2f7
Route
topical
Published
Effective Date 2021-01-08
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
zinc oxide (480 g)
Inactive Ingredients
sunflower oil castor oil hydrogenated palm oil cocoa butter cetyl palmitate shea butter coconut oil tamanu oil .alpha.-tocopherol acetate starch, corn

Identifiers & Packaging

Marketing Status
otc monograph final active Since 2019-02-01
Purpose

Skin Protectant

Description

Zinc Oxide-40%

Medication Information

Warnings

For external use only

Uses
  • Helps treat and prevent diaper rash
  • Protects chafed skin due to diaper rash and helps seal out wetness
Purpose

Skin Protectant

Directions

Change wet and soiled diapers promptly

  • Cleanse the diaper area and allow to dry
  • Apply cream liberally as often as necessary, with each diaper change, and especially at bedtime or anytime when exposure to wet diapers may be prolonged
Description

Zinc Oxide-40%

Section 50565-1
  • Keep out of reach of children
  • If swallowed, get medical help or contact a Poison Control Center right away
Section 50566-9
  • Stop use and ask a doctor if condition worsens or symptoms last more than 7 days or clear up and occur again within a few days
Section 50567-7
  • When using this product, do not get into eyes
Section 50570-1

Do not use if quality seal is broken

  • Do not store above 104°F/40°C
Section 51727-6

Helianthus Annuus (Sunflower) Seed Oil, Ricinus Communis (Castor) Seed Oil*, Hydrogenated Palm Oil**, Theobroma Cacao (Cocoa) Seed Butter**, Cetyl Palmitate**, Butyrospermum Parkii (Shea) Butter, Cocos Nucifera (Coconut) Oil, Calophyllum Inophyllum Seed Oil, Tocopherol, Zea Mays (Corn) Starch*

*Organic **RSPO Certified

Active Ingredient

Zinc Oxide-40%

Principal Display Panel – 118 Ml Carton Label

Skin Protectant

hello

bello™

Made with sunflower seed,

coconut, and tamanu oils

Soothing Relief

Zinc Oxide Treatment

Diaper Rash

Cream

NET WT 4.0 fl. oz. (118ml) e

  • Hypoallergenic
  • Non-Nano Zinc Oxide
  • Pediatrician Tested

Structured Label Content

Warnings

For external use only

Uses
  • Helps treat and prevent diaper rash
  • Protects chafed skin due to diaper rash and helps seal out wetness
Purpose

Skin Protectant

Directions

Change wet and soiled diapers promptly

  • Cleanse the diaper area and allow to dry
  • Apply cream liberally as often as necessary, with each diaper change, and especially at bedtime or anytime when exposure to wet diapers may be prolonged
Section 50565-1 (50565-1)
  • Keep out of reach of children
  • If swallowed, get medical help or contact a Poison Control Center right away
Section 50566-9 (50566-9)
  • Stop use and ask a doctor if condition worsens or symptoms last more than 7 days or clear up and occur again within a few days
Section 50567-7 (50567-7)
  • When using this product, do not get into eyes
Section 50570-1 (50570-1)

Do not use if quality seal is broken

  • Do not store above 104°F/40°C
Section 51727-6 (51727-6)

Helianthus Annuus (Sunflower) Seed Oil, Ricinus Communis (Castor) Seed Oil*, Hydrogenated Palm Oil**, Theobroma Cacao (Cocoa) Seed Butter**, Cetyl Palmitate**, Butyrospermum Parkii (Shea) Butter, Cocos Nucifera (Coconut) Oil, Calophyllum Inophyllum Seed Oil, Tocopherol, Zea Mays (Corn) Starch*

*Organic **RSPO Certified

Active Ingredient (Active ingredient)

Zinc Oxide-40%

Principal Display Panel – 118 Ml Carton Label (Principal Display Panel – 118 mL Carton Label)

Skin Protectant

hello

bello™

Made with sunflower seed,

coconut, and tamanu oils

Soothing Relief

Zinc Oxide Treatment

Diaper Rash

Cream

NET WT 4.0 fl. oz. (118ml) e

  • Hypoallergenic
  • Non-Nano Zinc Oxide
  • Pediatrician Tested

Advanced Ingredient Data

Raw Label Data

All Sections (JSON)

Additional Information

Back to search View SPL set listing Open on DailyMed ↗

Source: dailymed · Ingested: 2026-02-15T11:59:16.758847 · Updated: 2026-03-14T22:59:11.576282