FDA.reportPublic FDA data

Avalon Organics Baby Protective Zinc Diaper Balm

Manufacturer
The Hain Celestial Group, Inc
Effective date
2012-04-30
Label type
HUMAN OTC DRUG LABEL
Version
2
Source
full-release
Hydrated at
2026-05-31 22:31:42

Label at a glance#

ProductAvalon Organics Baby Protective Zinc Diaper Balm
Active ingredientZinc Oxide
Label structure9 sections

Label contents#

Full prescribing information#

OTC - ACTIVE INGREDIENT SECTION

Zinc Oxide  21.0%

OTC - PURPOSE SECTION

Natural Skin Protectant

INDICATIONS & USAGE SECTION

  • Helps treat and prevent diaper rash.
  • Protects chafed skin associated with diaper rash.
  • Helps protect against wetness

WARNINGS SECTION

When using this product keep out of eyes. Rinse with water to remove. Stop use and ask doctor if rash or irritation develops and lasts.

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

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

DOSAGE & ADMINISTRATION SECTION

  • Apply liberally to clean,dry skin. Use as needed with diaper changes, especially at bedtime when exposure to wetness may be prolonged.

INACTIVE INGREDIENT SECTION

Helianthus Annuus (Sunflower) Seed Oil *, Glyceryl  Dibehenate, Tribehenin, Beeswax*, Carthamus Tinctorius (Safflower) Oil* , Olea Europea (Olive) Fruit Oil *, Simmondsia Chinensis (Jojoba) Seed Oil*, Aloe Barbadensis Leaf Juice* , Calendula Officinalis Flower Extract* , Chamomilla Recutita (Matricaria) Flower Extract *, Glycerin *, Glyceryl Behenate, Retinyl Palmitate, Tocopheryl Acetate.

* Certified Organic Ingredients

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL


       
image of front bottle label
image of front bottle label
               
image of back bottle label
image of back bottle label
       

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYSPL version
416750zinc oxide 21 % Topical CreamPSN2
416750zinc oxide 210 MG/ML Topical CreamSCD2
416750zinc oxide 21 % Topical CreamSY2
416750ZNO 210 MG/ML Topical CreamSY2

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
61995-1110-32019-11-13C16284748780-197449f38-ccb9-f6ea-e053-dbdaa90aa703Drug Facts

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
61995-1110-3Avalon Organics Baby Protective Zinc Diaper Balm85 g in 1 BOTTLECREAM852

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
61995-1110AVALON ORGANICS BABY PROTECTIVE ZINC DIAPER BALM (ZINC OXIDE) CREAM [THE HAIN CELESTIAL GROUP, INC]2Legacy NDC, 1 package rows20120508_482114d3-793f-46b4-ae93-b278e0613d65.zip

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIISPL versionUploaded
Zinc OxideACTIVE INGREDIENTSOI2LOH54Z2
Zinc OxideACTIVE MOIETYSOI2LOH54Z2
SUNFLOWER OILINACTIVE INGREDIENT3W1JG795YI2
TRIBEHENININACTIVE INGREDIENT8OC9U7TQZ02
WHITE WAXINACTIVE INGREDIENT7G1J5DA97F2

Products#

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

DailyMed product names page 1 of 1 · 5 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
61995-111061995-1110-3

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 4 matching rows.

Name, UNII, Kind table
NameUNIIKind
Zinc OxideSOI2LOH54ZACTIB
SUNFLOWER OIL3W1JG795YIIACT
TRIBEHENIN8OC9U7TQZ0IACT
WHITE WAX7G1J5DA97FIACT

Source Document#

Source XML

Inactive ingredient matches#

Inactive Ingredient Database values describe FDA-listed use contexts. The match method and ambiguity count are shown because ingredient names, routes, and dosage forms are not always unique. Browse recovered IID releases and source provenance.

Inactive ingredient links page 1 of 1 · 15 matching rows.

DailyMed ingredient, IID ingredient, UNII table
DailyMed ingredientIID ingredientUNIIDosage form / routePotencyMaximum daily exposureMatch
WHITE WAXWHITE WAX7G1J5DA97FTABLET, DELAYED RELEASE / ORAL0.08 mgExact identifier — unii candidate
15 equally ranked IID candidates
WHITE WAXWHITE WAX7G1J5DA97FLOTION / TOPICAL1 %w/wExact identifier — unii candidate
15 equally ranked IID candidates
WHITE WAXWHITE WAX7G1J5DA97FCAPSULE, EXTENDED RELEASE / ORAL71 mgExact identifier — unii candidate
15 equally ranked IID candidates
WHITE WAXWHITE WAX7G1J5DA97FCAPSULE / ORAL79 mgExact identifier — unii candidate
15 equally ranked IID candidates
WHITE WAXWHITE WAX7G1J5DA97FCREAM / TOPICAL500 mgExact identifier — unii candidate
15 equally ranked IID candidates
WHITE WAXWHITE WAX7G1J5DA97FTABLET / ORAL5 mgExact identifier — unii candidate
15 equally ranked IID candidates
WHITE WAXWHITE WAX7G1J5DA97FSUPPOSITORY / RECTAL265 mgExact identifier — unii candidate
15 equally ranked IID candidates
WHITE WAXWHITE WAX7G1J5DA97FTABLET, EXTENDED RELEASE / ORAL14 mgExact identifier — unii candidate
15 equally ranked IID candidates
WHITE WAXWHITE WAX7G1J5DA97FCREAM / VAGINAL40 mgExact identifier — unii candidate
15 equally ranked IID candidates
WHITE WAXWHITE WAX7G1J5DA97FCREAM, AUGMENTED / TOPICAL10 %w/wExact identifier — unii candidate
15 equally ranked IID candidates
WHITE WAXWHITE WAX7G1J5DA97FTABLET, FILM COATED / ORAL0.2 mgExact identifier — unii candidate
15 equally ranked IID candidates
WHITE WAXWHITE WAX7G1J5DA97FAEROSOL, FOAM / TOPICAL2 %w/wExact identifier — unii candidate
15 equally ranked IID candidates
WHITE WAXWHITE WAX7G1J5DA97FOINTMENT / TOPICAL2100 mgExact identifier — unii candidate
15 equally ranked IID candidates
WHITE WAXWHITE WAX7G1J5DA97FTABLET, COATED / ORAL3 mgExact identifier — unii candidate
15 equally ranked IID candidates
WHITE WAXWHITE WAX7G1J5DA97FOINTMENT, AUGMENTED / TOPICAL429 mgExact identifier — unii candidate
15 equally ranked IID candidates

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
78ffc894-e69c-4445-a32c-d271d7ceb8ed482114d3-793f-46b4-ae93-b278e0613d652012-04-30WarningsExact identifier
spl id: 78ffc894-e69c-4445-a32c-d271d7ceb8ed
spl set id: 482114d3-793f-46b4-ae93-b278e0613d65

Reported adverse events (FAERS/openFDA)#

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