FDA.reportPublic FDA data

Tender Moments Delicate Baby Diaper Rash Balm

Manufacturer
Distribuidora Comercial Jafra, S.A. de C.V. | Jafra Cosmetics International, Inc.
Effective date
2026-03-13
Label type
HUMAN OTC DRUG LABEL
Version
7
Source
full-release
Hydrated at
2026-06-01 01:50:16

Label at a glance#

ProductTender Moments Delicate Baby Diaper Rash Balm
Active ingredientDIMETHICONE, ZINC OXIDE
Label structure9 sections

Indications and uses

▪ Helps treat and prevent diaper rash ▪ Protects chafed skin due to diaper rash and helps seal out wetness

Dosage and administration

▪ 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, especially at bedtime or anytime when exposure to wet diapers may be prolonged

Label contents#

Full prescribing information#

Active Ingredients

OTC - ACTIVE INGREDIENT SECTION

Dimethicone 2.0%, Zinc Oxide 10.0%

Purpose

OTC - PURPOSE SECTION

Skin Protectant

Uses

INDICATIONS & USAGE SECTION

▪ Helps treat and prevent diaper rash
▪ Protects chafed skin due to diaper rash and helps seal out wetness

Warnings

WARNINGS SECTION

For external use only
When using this product do not get into eyes.
Stop use and ask a doctor if
▪ condition worsens
▪ symptoms last more than 7 days or clear up and occur again in a few days
Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center right away.

Directions

DOSAGE & ADMINISTRATION SECTION

▪ 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, especially at bedtime or anytime when exposure to wet diapers may be prolonged

Other information

SPL UNCLASSIFIED SECTION

  •  protect this product from excessive heat and direct sun

Inactive Ingredients

INACTIVE INGREDIENT SECTION

Water, Petrolatum, Isopropyl Palmitate, Diisostearoyl Polyglyceryl-3 Dimer Dilinoleate, Ethylhexyl Stearate, Cetyl Dimethicone, Phenoxyethanol, Magnesium Sulfate, Panthenol, Beeswax/Cera Alba, Butyrospermum Parkii (Shea) Butter, Butylene Glycol, Ethylhexylglycerin, Glycine Soja (Soybean) Oil, Aloe Barbadensis Leaf Extract, Avena Sativa (Oat) Kernel Extract

SPL UNCLASSIFIED SECTION

Questions?Call 1-800-551-2345 or visit www.jafra .com

Product label

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

image descriptionimage description

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYSPL version
2562886dimethicone 2 % / zinc oxide 10 % Topical CreamPSN7
2562886dimethicone 20 MG/ML / zinc oxide 100 MG/ML Topical CreamSCD7
2562886dimethicone 2 % / zinc oxide 10 % Topical CreamSY7
2562886dimethicone 20 MG/ML / ZNO 100 MG/ML Topical CreamSY7

DailyMed Pharmacologic Classes#

Class, Version, Type table
ClassVersionTypeEffective
DIMETHICONE Pharmacologic Class Indexing3Indexing - Pharmacologic Class20180813
ZINC CATION Pharmacologic Class Indexing2Indexing - Pharmacologic Class20180813

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
baf7f49c-75b6-496b-a00e-8e766a8e4f03Product name120210127
ebc62596-fc97-4d03-9483-7ba095d25db7Product name120151210
0ca1d589-929b-4b33-bc5b-1d84abdafa6aProduct name120150324
fc363c46-397b-4476-ac0f-70e43e8e4592Product name120150324

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
68828-700-01Tender Moments Delicate Baby Diaper Rash Balm50 mL in 1 TUBECREAM507
68828-700-01Tender Moments Delicate Baby Diaper Rash Balm1 in 1 CARTONCREAM17

Products#

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

DailyMed product names page 1 of 1 · 21 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
68828-70068828-700-01

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 18 matching rows.

Name, UNII, Kind table
NameUNIIKind
WATER059QF0KO0RIACT
PETROLATUM4T6H12BN9UIACT
ISOPROPYL PALMITATE8CRQ2TH63MIACT
DIISOSTEAROYL POLYGLYCERYL-3 DIMER DILINOLEATEG3232Z5S2OIACT
ETHYLHEXYL STEARATEEG3PA2K3K5IACT
CETYL DIMETHICONE 25U4AS1BW4ZBIACT
MAGNESIUM SULFATE, UNSPECIFIED FORMDE08037SABIACT
WHITE WAX7G1J5DA97FIACT
SHEA BUTTERK49155WL9YIACT
PANTHENOLWV9CM0O67ZIACT
BUTYLENE GLYCOL3XUS85K0RAIACT
OATZ6J799EAJKIACT
SOYBEAN OIL241ATL177AIACT
PHENOXYETHANOLHIE492ZZ3TIACT
ETHYLHEXYLGLYCERIN147D247K3PIACT
ALOE VERA LEAFZY81Z83H0XIACT
DIMETHICONE92RU3N3Y1OACTIB
ZINC OXIDESOI2LOH54ZACTIM

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
Tender Moments Delicate Baby Diaper Rash BalmDIMETHICONE,ZINC OXIDEDistribuidora Comercial Jafra, S.A. de C.V.f09ba452-e1a6-4f45-901f-bb63d4f8e8842026-03-13WarningsExact identifier
ndc (package): 68828-700-01
ndc (product): 68828-700
ndc11 (package): 68828070001
spl id: 4ced5cfb-b40e-968f-e063-6394a90a80f5
spl set id: f09ba452-e1a6-4f45-901f-bb63d4f8e884

Reported adverse events (FAERS/openFDA)#

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