FDA.reportPublic FDA data

KISSABLE - Oatmeal daily moisturizing lotion (8 oz.)

Manufacturer
BRANDS INTERNATIONAL
Effective date
2023-02-22
Label type
HUMAN OTC DRUG LABEL
Version
3
Source
full-release
Hydrated at
2026-05-31 23:54:13

Label at a glance#

ProductOatmeal Daily Moisturizing 8oz.
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

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

Uses

  • 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.

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.

Do not use on

  • Deep or puncture wounds
  • Animal bites
  • Serious burns

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, Isopropyl Myristate, Glycerin, Cetyl Alcohol, Mineral Oil, Fragrance, DMDM Hydantoin, Stearyl Alcohol, Carbomer, Sodium Hydroxide, Aloe Vera Leaf, Vitamin E, Isopropyl Myristate.

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

44

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYSPL version
891710dimethicone 1.3 % Topical LotionPSN3
891710dimethicone 13 MG/ML Topical LotionSCD3
891710dimethicone 1.3 % Topical LotionSY3

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
50157-612-222025-01-30C16284748780-12cef2736-b435-d83d-e063-dadaa90ab31fKISSABLE - Oatmeal daily moisturizing lotion (8 oz.)

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
50157-612-22Oatmeal Daily Moisturizing 8oz.227 g in 1 BOTTLELOTION2273

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
50157-612OATMEAL DAILY MOISTURIZING 8OZ. (DIMETHICONE) LOTION [BRANDS INTERNATIONAL]31 package rows20230223_f550d584-3a8d-8c5d-e053-2995a90a00fa.zip

Products#

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

DailyMed product names page 1 of 1 · 16 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
50157-61250157-612-22

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 15 matching rows.

Name, UNII, Kind table
NameUNIIKind
VITAMIN E POLYETHYLENE GLYCOL SUCCINATEO03S90U1F2IACT
WATER059QF0KO0RIACT
.BETA.-ELEOSTEARIC ACIDLA17B88161IACT
MINERAL OILT5L8T28FGPIACT
GLYCERYL MONOSTEARATE230OU9XXE4IACT
ISOPROPYL MYRISTATE0RE8K4LNJSIACT
CARBOMER 1342809Y72KV36IACT
SODIUM HYDROXIDE55X04QC32IIACT
PROPYLPARABENZ8IX2SC1OHIACT
STEARYL ALCOHOL2KR89I4H1YIACT
ALOE VERA LEAFZY81Z83H0XIACT
CETYL ALCOHOL936JST6JCNIACT
DMDM HYDANTOINBYR0546TOWIACT
EDETATE DISODIUM ANHYDROUS8NLQ36F6MMIACT
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
f550d1b7-7198-919a-e053-2a95a90a95b2f550d584-3a8d-8c5d-e053-2995a90a00fa2023-02-22WarningsExact identifier
spl id: f550d1b7-7198-919a-e053-2a95a90a95b2
spl set id: f550d584-3a8d-8c5d-e053-2995a90a00fa

Reported adverse events (FAERS/openFDA)#

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