FDA.reportPublic FDA data

Sofskin Baby

Manufacturer
Nova Petroleum & Chemicals Corporation | Kim Chemicals LTD
Effective date
2010-03-08
Label type
HUMAN OTC DRUG LABEL
Version
1
Source
legacy-cache
Hydrated at
2026-08-02 01:53:26

Label at a glance#

ProductSofskin Baby
Active ingredientMINERAL OIL
Label structure8 sections

Indications and uses

Use after Shower or bath on wet skin as a skin moisturizer. Also use as Eye makeup remover. Helps soften dry skin.

Dosage and administration

Apply product liberally, as often as necessary             Made in India Imported by:       Nova Petroleum & Chemicals Corp.       3 Roethal Drive Suite 1 D       Hopewell Junction, NY 12533       www.novawax.com Distributed by:       Vini Health and Beauty Products Inc.       3 Roethal Drive Suite 1 D       Hopewell Junction, NY 12533

Label contents#

Full prescribing information#

SPL UNCLASSIFIED SECTION

Label for 
NOVA PETROLEUM & CHEMICALS CORP. 
Baby Oil

Drug Facts:

Active Ingredients: 

DESCRIPTION SECTION

Mineral Oil 100%  

Fragrance Q.S

Purpose:       

DESCRIPTION SECTION

Skin protectant, Keeps skin moist and prevents from drying skin.

USES: 

INDICATIONS & USAGE SECTION

Use after Shower or bath on wet skin as a skin moisturizer. Also use as Eye makeup remover. Helps soften dry skin.

Warnings: For external use only.  

WARNINGS SECTION

When using this product,avoid contact with eyes.

Keep out of the reach of

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

children if swallowed get medical help or contact a Poison Control Center right away.

Directions: 

DOSAGE & ADMINISTRATION SECTION

Apply product liberally, as often as necessary

            Made in India


Imported by:

      Nova Petroleum & Chemicals Corp.

      3 Roethal Drive Suite 1 D

      Hopewell Junction, NY 12533

      www.novawax.com

Distributed by:

      Vini Health and Beauty Products Inc.

      3 Roethal Drive Suite 1 D

      Hopewell Junction, NY 12533

Principal Display Panel

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Sofskin
Baby
Oil
Aceite de Bebe
Mild & Safe
For all your moisturizing needs
7fl. Oz. (200ml)
7 ONZAS

Principal Display Panel Sofskin Baby Oil 7 fl. oz. (200ml)Principal Display Panel Sofskin Baby Oil 7 fl. oz. (200ml)

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
52069-102-072025-01-16C16284748780-1956f9ecf-dd46-621f-e053-dbdaa90a74adBaby Oil
52069-102-072019-10-21C16284748780-1956f9ecf-dd46-621f-e053-dbdaa90a74adBaby Oil

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIISPL versionUploaded
MINERAL OILACTIVE INGREDIENTT5L8T28FGP1
MINERAL OILACTIVE MOIETYT5L8T28FGP1

Products#

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

DailyMed product names page 1 of 1 · 2 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
52069-10252069-102-07

Ingredients#

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

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

Name, UNII, Kind table
NameUNIIKind
MINERAL OILT5L8T28FGPACTIB

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
28ee5296-5911-5d84-e063-6394a90ab3c94698d646-4901-409d-b0c8-9e22e0abd77d2024-12-10WarningsExact identifier
spl set id: 4698d646-4901-409d-b0c8-9e22e0abd77d

Reported adverse events (FAERS/openFDA)#

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