FDA.reportPublic FDA data

Oatmeal daily moisturizing lotion (8 oz.)

Manufacturer
Rejoice International Inc. | China Ningbo Shangge Cosmetic Technology Corp.
Effective date
2019-03-07
Label type
HUMAN OTC DRUG LABEL
Version
1
Source
full-release
Hydrated at
2026-05-31 22:58:44

Label at a glance#

ProductOatmeal Skin Relief Calming . 8oz
Active ingredientDIMETHICONE
Label structure9 sections

Label contents#

Full prescribing information#

OTC - ACTIVE INGREDIENT SECTION

Active Ingredient

Dimethicone 1.3%

OTC - PURPOSE SECTION

Purpose

Skin protectant

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 immediately.

INDICATIONS & USAGE SECTION

Use

Help prevent and temporarily protects 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.

Do not use on

Deep or puncture wounds
Animal bites
Serious burns

Stop use and ask a doctor if conditions 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.

INACTIVE INGREDIENT SECTION

Inactive Ingredients

Water, Petrolatum, Cetyl Alcohol, Glyceryl Stearate, Propylene Glycol, Glycerin, Stearyl Alcohol, PEG-100 Stearate, Polyacrylamide, DMDM Hydrantoin, Isopropyl Myristate, Fragrance, C13-14 Isoparaffin, Laureth-7, Avena Sativa (Oat) Kernel Extract, 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 LotionPSN1
891710dimethicone 13 MG/ML Topical LotionSCD1
891710dimethicone 1.3 % Topical LotionSY1

DailyMed Pharmacologic Classes#

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

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
57337-100-01Oatmeal Skin Relief Calming .8oz227 g in 1 BOTTLELOTION2271

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
57337-100OATMEAL SKIN RELIEF CALMING . 8OZ (DIMETHICONE) LOTION [REJOICE INTERNATIONAL INC.]1Current NDC, Legacy NDC, 1 package rows20190308_8384dc52-ba36-da3d-e053-2a91aa0a4f40.zip

Products#

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

DailyMed product names page 1 of 1 · 20 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
57337-10057337-100-01

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
CETYL ALCOHOL936JST6JCNIACT
ISOPROPYL MYRISTATE0RE8K4LNJSIACT
LAURETH-7Z95S6G8201IACT
MAGNESIUM DISODIUM EDTANDT563S5VZIACT
POLYACRYLAMIDE (10000 MW)E2KR9C9V2IIACT
C13-14 ISOPARAFFINE4F12ROE70IACT
CETYL STEARATE06RI5UQA7LIACT
PEG-100 STEARATEYD01N1999RIACT
DMDM HYDANTOINBYR0546TOWIACT
METHYLPARABENA2I8C7HI9TIACT
WATER059QF0KO0RIACT
PETROLATUM4T6H12BN9UIACT
GLYCERINPDC6A3C0OXIACT
PROPYLENE GLYCOL6DC9Q167V3IACT
STEARYL ALCOHOL2KR89I4H1YIACT
DIMETHICONE92RU3N3Y1OACTIB
OAT KERNEL OIL3UVP41R77RIACT
DISTEARYLDIMONIUM CHLORIDEOM9573ZX3XIACT

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
Oatmeal Skin Relief Calming . 8ozDIMETHICONERejoice International Inc.8384dc52-ba36-da3d-e053-2a91aa0a4f402019-03-07WarningsExact identifier
ndc (package): 57337-100-01
ndc (product): 57337-100
ndc11 (package): 57337010001
spl id: 8384b028-7b9c-2a7b-e053-2a91aa0a342c
spl set id: 8384dc52-ba36-da3d-e053-2a91aa0a4f40

Reported adverse events (FAERS/openFDA)#

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