tender moments delicate baby diaper rash balm

Generic: dimethicone,zinc oxide

Labeler: distribuidora comercial jafra, s.a. de c.v.
NDC Directory HUMAN OTC DRUG OTC MONOGRAPH DRUG Inactive Finished

Drug Facts

Product Profile

Brand Name tender moments delicate baby diaper rash balm
Generic Name dimethicone,zinc oxide
Labeler distribuidora comercial jafra, s.a. de c.v.
Dosage Form CREAM
Routes
TOPICAL
Active Ingredients

dimethicone 2 g/100mL, zinc oxide 10 g/100mL

Manufacturer
Distribuidora Comercial Jafra, S.A. de C.V.

Identifiers & Regulatory

Product NDC 68828-700
Product ID 68828-700_2abe5cd1-1a99-fab2-e063-6294a90a8abe
Product Type HUMAN OTC DRUG
Marketing Category OTC MONOGRAPH DRUG
Application Number M016
Listing Expiration 2026-12-31
Marketing Start 2021-12-29

Pharmacologic Class

Physiologic Effect
skin barrier activity [pe]

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 68828700
Hyphenated Format 68828-700

Supplemental Identifiers

RxCUI
2562886
UNII
92RU3N3Y1O SOI2LOH54Z
NUI
N0000010282

Packaging Origin

Original Packager
true

Resolved Product View

Precedence rule: structured NDC data is preferred, falling back to linked label metadata when unavailable. Source tags show the origin of each value.

Resolved Identity

Brand Name tender moments delicate baby diaper rash balm (source: ndc)
Generic Name dimethicone,zinc oxide (source: ndc)
Application Number M016 (source: ndc)
Routes
TOPICAL
source: ndc

Resolved Composition

Strengths
  • 2 g/100mL
  • 10 g/100mL
source: ndc
Packaging
  • 1 TUBE in 1 CARTON (68828-700-01) / 50 mL in 1 TUBE
source: ndc

Packages (1)

Ingredients (2)

dimethicone (2 g/100mL) zinc oxide (10 g/100mL)

Linked Drug Pages (1)

Raw FDA Data

View complete raw FDA NDC JSON payload
{"route": ["TOPICAL"], "spl_id": "2abe5cd1-1a99-fab2-e063-6294a90a8abe", "openfda": {"nui": ["N0000010282"], "unii": ["92RU3N3Y1O", "SOI2LOH54Z"], "rxcui": ["2562886"], "spl_set_id": ["f09ba452-e1a6-4f45-901f-bb63d4f8e884"], "pharm_class_pe": ["Skin Barrier Activity [PE]"], "manufacturer_name": ["Distribuidora Comercial Jafra, S.A. de C.V."], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "1 TUBE in 1 CARTON (68828-700-01)  / 50 mL in 1 TUBE", "package_ndc": "68828-700-01", "marketing_start_date": "20211229"}], "brand_name": "Tender Moments Delicate Baby Diaper Rash Balm", "product_id": "68828-700_2abe5cd1-1a99-fab2-e063-6294a90a8abe", "dosage_form": "CREAM", "pharm_class": ["Copper Absorption Inhibitor [EPC]", "Decreased Copper Ion Absorption [PE]", "Skin Barrier Activity [PE]"], "product_ndc": "68828-700", "generic_name": "DIMETHICONE,ZINC OXIDE", "labeler_name": "Distribuidora Comercial Jafra, S.A. de C.V.", "product_type": "HUMAN OTC DRUG", "brand_name_base": "Tender Moments Delicate Baby Diaper Rash Balm", "active_ingredients": [{"name": "DIMETHICONE", "strength": "2 g/100mL"}, {"name": "ZINC OXIDE", "strength": "10 g/100mL"}], "application_number": "M016", "marketing_category": "OTC MONOGRAPH DRUG", "marketing_start_date": "20211229", "listing_expiration_date": "20261231"}