FDA.reportPublic FDA data

Tender Moments Delicate Baby Bottom Balm

Manufacturer
Jafra Cosmetics International | Distribuidora Comercial Jafra, S.A. de C.V.
Effective date
2022-05-13
Label type
HUMAN OTC DRUG LABEL
Version
3
Source
legacy-cache
Hydrated at
2026-08-01 22:01:18

Label at a glance#

ProductTender Moments Delicate Baby Bottom Balm
Active ingredientDIMETHICONE, ZINC OXIDE
Label structure8 sections

Label contents#

Full prescribing information#

OTC - ACTIVE INGREDIENT SECTION

Active Ingredients Purpose

Dimethicone 2% Skin Protectant

Zinc Oxide 10% Skin Protectant

OTC - PURPOSE SECTION

Uses

  • Helps treat and prevent diaper rash
  • Helps Minor skin irritation due to diaper rash and helps protect from wetness

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

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

INDICATIONS & USAGE SECTION

Stop use and ask a doctor if condition worsens or does not improve within 7 days

WARNINGS SECTION

Warnings

For external use only

When using this product, avoid contact with eyes

DOSAGE & ADMINISTRATION SECTION

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, especially at bedtime or anytime when exposure to wet diapers may be prolongued.

INACTIVE INGREDIENT SECTION

Inactive ingredients

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

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Jafra Tender Moments

Delicate Baby Bottom Balm

50 ml 1.7 FL OZ

Baby Bottom Unit CartonBaby Bottom Unit Carton

Baby Bottom Balm TubeBaby Bottom Balm Tube

Products#

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

DailyMed product names page 1 of 1 · 18 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
68828-29868828-298-01

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 16 matching rows.

Name, UNII, Kind table
NameUNIIKind
PETROLATUM4T6H12BN9UIACT
ISOPROPYL PALMITATE8CRQ2TH63MIACT
DIISOSTEAROYL POLYGLYCERYL-3 DIMER DILINOLEATEG3232Z5S2OIACT
OATZ6J799EAJKIACT
ETHYLHEXYL STEARATEEG3PA2K3K5IACT
CETYL DIMETHICONE 25U4AS1BW4ZBIACT
MAGNESIUM SULFATE, UNSPECIFIED FORMDE08037SABIACT
DMDM HYDANTOINBYR0546TOWIACT
WATER059QF0KO0RIACT
SHEA BUTTERK49155WL9YIACT
PANTHENOLWV9CM0O67ZIACT
WHITE WAX7G1J5DA97FIACT
BUTYLENE GLYCOL3XUS85K0RAIACT
SOYBEAN OIL241ATL177AIACT
DIMETHICONE92RU3N3Y1OACTIB
ZINC OXIDESOI2LOH54ZACTIB

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
e8cce259-13f1-7a8e-e053-2995a90aa3b2c6174455-4f37-e2e3-e053-2a95a90ae9c02022-09-16WarningsExact identifier
spl set id: c6174455-4f37-e2e3-e053-2a95a90ae9c0

Reported adverse events (FAERS/openFDA)#

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