FDA.reportPublic FDA data

Skin Relief Oatmeal Daily Moisturizing

Manufacturer
Greenbrier International | China Ningbo Shangge Cosmetic Technology Corp
Effective date
2019-02-11
Label type
HUMAN OTC DRUG LABEL
Version
2
Source
full-release
Hydrated at
2026-05-31 22:58:31

Label at a glance#

ProductSkin Relief Oatmeal Daily Moisturizing
Active ingredientDIMETHICONE
Label structure9 sections

Label contents#

Full prescribing information#

OTC - ACTIVE INGREDIENT SECTION

Active Ingredient                  Purpose

Dimethicone 1/3% ...... Skin Protectant

OTC - PURPOSE SECTION

XtraCare Skin Relief Oatmeal Daily Moisturizing Lotion

dimethicone skin protectant

with soothing oat essence

To Protect & Relieve Dry Skin

12 fl oz (354 mL)

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

Use help prevent and temporarily protets chafed, chapped, or cracked skin.

WARNINGS SECTION

Warnings For external use only.

When using this product avoid contact with eyes. In case of eye contact, flush with water.

Stop use and ask a doctor if condition worsens. Symptoms last more than 7 days or clear up and occur again within a few days.

DOSAGE & ADMINISTRATION SECTION

Directions  apply liberally as often as needed.

OTHER SAFETY INFORMATION

Other information Store at room temperature.

DISTRIBUTED BY: 

GREENBRIER INTERNATIONAL, INC.

500 VOLVO PARKWAY, CHESAPEAKE, VA 23320

MADE IN CHINA

INACTIVE INGREDIENT SECTION

Inactive Ingredients water, paraffinum liquidum, isopropyl myristate, glycerin, glyceryl stearate, propylene glycol, PEG-100 stearate, polyacrylamide, cetyl alcohol, avena sativa kernel extract, fragrance, DMDM hydantoin, stearyl alcohol, c13-14 isoparaffin, laureth-7, disodium EDTA, methylparaben, propylparaben.

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

labellabel

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYSPL version
891710dimethicone 1.3 % Topical LotionPSN2
891710dimethicone 13 MG/ML Topical LotionSCD2
891710dimethicone 1.3 % Topical LotionSY2

DailyMed Pharmacologic Classes#

Class, Version, Type table
ClassVersionTypeEffective
DIMETHICONE Pharmacologic Class Indexing3Indexing - Pharmacologic Class20180813

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
33992-0057-12024-01-30C16284748780-11030e365-51a0-111a-e063-dadaa90a10e2Skin Relief Oatmeal Daily Moisturizing

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
33992-0057-1Skin Relief Oatmeal Daily Moisturizing340 mg in 1 BOTTLELOTION3402

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
33992-0057SKIN RELIEF OATMEAL DAILY MOISTURIZING (DIMETHICONE) LOTION [GREENBRIER INTERNATIONAL]2Legacy NDC, 1 package rows20190212_5f100b27-d483-514d-e053-2991aa0a0dd2.zip

Products#

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

DailyMed product names page 1 of 1 · 19 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
33992-005733992-0057-1

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
MINERAL OILT5L8T28FGPIACT
ISOPROPYL MYRISTATE0RE8K4LNJSIACT
GLYCERINPDC6A3C0OXIACT
GLYCERYL MONOSTEARATE230OU9XXE4IACT
PROPYLENE GLYCOL6DC9Q167V3IACT
PEG-100 STEARATEYD01N1999RIACT
POLYACRYLAMIDE (1500 MW)5D6TC4BRWVIACT
CETYL ALCOHOL936JST6JCNIACT
OATZ6J799EAJKIACT
DMDM HYDANTOINBYR0546TOWIACT
STEARYL ALCOHOL2KR89I4H1YIACT
C13-14 ISOPARAFFINE4F12ROE70IACT
LAURETH-7Z95S6G8201IACT
EDETATE DISODIUM7FLD91C86KIACT
METHYLPARABENA2I8C7HI9TIACT
PROPYLPARABENZ8IX2SC1OHIACT
DIMETHICONE92RU3N3Y1OACTIB

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
81a43c29-4bcd-0a69-e053-2a91aa0a4a8a5f100b27-d483-514d-e053-2991aa0a0dd22019-02-11WarningsExact identifier
spl id: 81a43c29-4bcd-0a69-e053-2a91aa0a4a8a
spl set id: 5f100b27-d483-514d-e053-2991aa0a0dd2

Reported adverse events (FAERS/openFDA)#

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