FDA.reportPublic FDA data

Zinc Oxide

Manufacturer
Kindred Bravely | Royal Labs Natural Cosmetics
Effective date
2022-05-31
Label type
HUMAN OTC DRUG LABEL
Version
2
Source
full-release
Hydrated at
2026-05-31 23:49:49

Label at a glance#

ProductZinc Oxide
Active ingredientZINC OXIDE
Label structure8 sections

Indications and uses

Helps treat and prevent diaper rash Protects minor skin irritation associated with diaper rash Helps seal out wetness

Dosage and administration

Shake well before use Change wet and soiled diapers promptly, cleanse the diaper area, and allow to dry Spray 4-6 inches away from skin. Spray product liberally as often as necessary, with each diaper change, especially at bedtime or anytime when exposure to wet diapers may be prolonged No need to rub in.

Label contents#

Full prescribing information#

Active Ingredient

OTC - ACTIVE INGREDIENT SECTION

Zinc Oxicd 25%

Purpose

OTC - PURPOSE SECTION

Skin Protectant

Uses

INDICATIONS & USAGE SECTION

Helps treat and prevent diaper rash
Protects minor skin irritation associated with diaper rash
Helps seal out wetness

WARNINGS SECTION

Warnings

WARNINGS SECTION

For external use only

When using this product

OTC - WHEN USING SECTION

avoid contact with eyes

Stop use and ask a doctor

OTC - STOP USE SECTION

if symptoms last more than 7 days or clears up and occurs again within a few days.

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

DOSAGE & ADMINISTRATION SECTION

Shake well before use
Change wet and soiled diapers promptly, cleanse the diaper area, and allow to dry
Spray 4-6 inches away from skin.
Spray product liberally as often as necessary, with each diaper change, especially at bedtime or anytime when exposure to wet diapers may be prolonged
No need to rub in.

Inactive Ingredients

INACTIVE INGREDIENT SECTION

Aqua (Water), Helianthus annuus (Sunflower) Oil, Simmondsia chinensis (Jojoba) Seed Oil, Ricinus communis (Castor) Seed Oil, Butyrospermum parkii (Shea) Butter, Cetearyl Alcohol, Cetearyl Glucoside, Organic Aloe barbadensis (Aloe vera) Leaf Juice, Glyceryl Caprylate, Caprylhydroxamic Acid, Xanthan Gum.

OTC - QUESTIONS SECTION

Distributed by Sensible

3913 Oceanic Drive, Suite 502

Oceanside, CA 92056

888-850-3756

www.kindredbravely.com

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Sensible Diaper Cream PDPSensible Diaper Cream PDP

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYSPL version
865073zinc oxide 25 % Topical SprayPSN2
865073zinc oxide 250 MG/ML Topical SpraySCD2
865073zinc oxide 25 % Topical SpraySY2
865073ZNO 250 MG/ML Topical SpraySY2

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
82751-103-012024-01-30C16284748780-11030e365-3467-111a-e063-dadaa90a10e2dfc719fb-d6d0-9cb4-e053-2a95a90a42ae

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
82751-103-01Zinc Oxide89 mL in 1 BOTTLE, SPRAYSPRAY, SUSPENSION892

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
82751-103ZINC OXIDE SPRAY, SUSPENSION [KINDRED BRAVELY]2Legacy NDC, 1 package rows20220614_dfc719fb-d6d0-9cb4-e053-2a95a90a42ae.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
82751-10382751-103-01

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 12 matching rows.

Name, UNII, Kind table
NameUNIIKind
CASTOR OILD5340Y2I9GIACT
SHEA BUTTERK49155WL9YIACT
CETEARYL GLUCOSIDE09FUA47KNAIACT
GLYCERYL CAPRYLATETM2TZD4G4AIACT
WATER O-187QV8F8BYNJIACT
SUNFLOWER OIL3W1JG795YIIACT
CAPRYLHYDROXAMIC ACIDUPY805K99WIACT
XANTHAN GUMTTV12P4NEEIACT
JOJOBA OIL724GKU717MIACT
CETOSTEARYL ALCOHOL2DMT128M1SIACT
ZINC OXIDESOI2LOH54ZACTIB
ALOE VERA LEAFZY81Z83H0XIACT

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
e057ec98-bc28-4b64-e053-2a95a90a28d3dfc719fb-d6d0-9cb4-e053-2a95a90a42ae2022-05-31WarningsExact identifier
spl id: e057ec98-bc28-4b64-e053-2a95a90a28d3
spl set id: dfc719fb-d6d0-9cb4-e053-2a95a90a42ae

Reported adverse events (FAERS/openFDA)#

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