FDA.reportPublic FDA data

Body Seal Ultra Reparing

Manufacturer
Skin Ps Brands
Effective date
2022-06-07
Label type
HUMAN OTC DRUG LABEL
Version
6
Source
legacy-cache
Hydrated at
2026-08-01 21:59:57

Label at a glance#

ProductBody Seal Ultra Reparing
Active ingredientOATMEAL
Label structure7 sections

Indications and uses

Temporarily protects and helps relieve minor skin irritations and itching due to eczema rashes

Dosage and administration

Apply directly to affected areas of skin

Label contents#

Full prescribing information#

Active Ingredient

OTC - ACTIVE INGREDIENT SECTION

Colloidal Oatmeal 1.0%

Purpose

OTC - PURPOSE SECTION

Skin Protectant

Uses

INDICATIONS & USAGE SECTION

Temporarily protects and helps relieve minor skin irritations and itching due to

  • eczema
  • rashes

Warnings

WARNINGS SECTION

For External Use Only

When using this product

OTC - WHEN USING SECTION

Avoid contact with eyes

Stop Use and ask a doctor if

OTC - STOP USE SECTION

  • Condition worsens
  • symptom last more than 7 days or clear up and occur again within a few days
Keep Out of reach of children

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

  If swallowed, get medical help or contact a Poison Control Center right away

Directions

DOSAGE & ADMINISTRATION SECTION

Apply directly to affected areas of skin

Other Information

OTHER SAFETY INFORMATION

  Store in a cool, dry place

Inactive Ingredients

INACTIVE INGREDIENT SECTION

Dimethicone,Water, Dimethicone, Butylene Glycol, Glycerin, Cetyl Alcohol, Glyceryl Stearate SE, Helianthus Annuus (Sunflower) Seed Oil, Niacinamide, Oryza Sativa (Rice) Bran Oil, Avena Sativa (Oat) Kernel Flour, Potassium Cetyl Phosphate, 1,2-Hexandiol, Caprylyl Glycol, Aluminum Starch Octenylsuccinate, Carbomer, Vitis Vinifera (Grape) Seed Oil, Hydrogenated Palm Glycerides, Aminomethyl Propanol, Sodium PCA, Hordeum Distichon (Barley) Extract, Panthenol, Tocopheryl Acetate, Phellodendron Amurense Bark Extract, Santalum Album (Sandalwood) Extract, Caprylic/Capric Triglyceride, Hydrogenated Phosphatidylcholine, Dipotassium Glycyrrhizate, Aloe Barbadensis Leaf Juice, Butyrospermum Parkii (Shea ) Butter, Pentylene Glycol, Squalane, Ceramide NP, Sodium Hyaluronate.

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Body SealUCBody SealUC

Products#

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

DailyMed product names page 1 of 1 · 35 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
73318-418073318-4180-1, 73318-4180-2

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 34 matching rows.

Name, UNII, Kind table
NameUNIIKind
OATMEAL8PI54V663YACTIB
DIMETHICONE92RU3N3Y1OIACT
WATER059QF0KO0RIACT
BUTYLENE GLYCOL3XUS85K0RAIACT
GLYCERINPDC6A3C0OXIACT
CETYL ALCOHOL936JST6JCNIACT
GLYCERYL STEARATE SEFCZ5MH785IIACT
SUNFLOWER SEED OIL GLYCERETH-8 ESTERS358X17CAT0IACT
NIACINAMIDE25X51I8RD4IACT
RICE BRAN OILLZO6K1506AIACT
OAT KERNEL OIL3UVP41R77RIACT
POTASSIUM CETYL PHOSPHATE03KCY6P7UTIACT
1,2-HEXANEDIOLTR046Y3K1GIACT
CAPRYLYL GLYCOL00YIU5438UIACT
ALUMINUM STARCH OCTENYLSUCCINATEI9PJ0O6294IACT
CARBOMER 9804Q93RCW27EIACT
GRAPE SEED OIL930MLC8XGGIACT
HYDROGENATED PALM GLYCERIDESYCZ8EM144QIACT
AMINOMETHYLPROPANOLLU49E6626QIACT
SODIUM PYRROLIDONE CARBOXYLATE469OTG57A2IACT
BARLEY5PWM7YLI7RIACT
PANTHENOLWV9CM0O67ZIACT
.ALPHA.-TOCOPHEROL ACETATE9E8X80D2L0IACT
PHELLODENDRON AMURENSE BARKPBG27B754GIACT
SANDALWOOD3641YW25N2IACT
MEDIUM-CHAIN TRIGLYCERIDESC9H2L21V7UIACT
HYDROGENATED SOYBEAN PHOSPHATIDYLCHOLINEQHQ97HF0PYIACT
GLYCYRRHIZINATE DIPOTASSIUMCA2Y0FE3FXIACT
ALOE VERA LEAFZY81Z83H0XIACT
SHEA BUTTERK49155WL9YIACT
PENTYLENE GLYCOL50C1307PZGIACT
SQUALANEGW89575KF9IACT
ceramide NP4370DF050BIACT
HYALURONATE SODIUMYSE9PPT4THIACT

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
2712d642-3952-4ac5-afa3-5f2721e34156bc6da44b-deaf-490b-b275-434769621a7d2022-06-07WarningsExact identifier
spl id: 2712d642-3952-4ac5-afa3-5f2721e34156
spl set id: bc6da44b-deaf-490b-b275-434769621a7d

Reported adverse events (FAERS/openFDA)#

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