FDA.reportPublic FDA data

First Aid Beauty FAB Ultra Repair Cream Skin Protectant Summer Grapefruit

Manufacturer
The Procter & Gamble Manufacturing Company
Effective date
2026-06-29
Label type
HUMAN OTC DRUG LABEL
Version
1
Source
monthly-update
Hydrated at
2026-07-17 21:37:13

Label at a glance#

ProductFirst Aid Beauty FAB Ultra Repair Skin Protectant Summer Grapefruit
Active ingredientOATMEAL
Label structure10 sections

Indications and uses

Temporarily protects and helps relieve minor skin irritation and itching due to eczema, rashes, poison ivy, oak or sumac, insect bites

Dosage and administration

Apply as needed

Label contents#

Full prescribing information#

SPL UNCLASSIFIED SECTION

Drug Facts

Active ingredients

OTC - ACTIVE INGREDIENT SECTION

Colloidal Oatmeal 0.5%

Purpose

OTC - PURPOSE SECTION

Skin Protectant

Uses

INDICATIONS & USAGE SECTION

  • Temporarily protects and helps relieve minor skin irritation and itching due to eczema, rashes, poison ivy, oak or sumac, insect bites

Warnings

WARNINGS SECTION

For external use only.

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.

OTC - WHEN USING SECTION

Do not get into eyes.

OTC - STOP USE SECTION

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

Directions

DOSAGE & ADMINISTRATION SECTION

Apply as needed

INACTIVE INGREDIENT SECTION

Water, stearic acid, glycerin, C12-15 alkyl benzoate, caprylic/capric triglyceride, glyceryl stearate, glyceryl stearate SE, cetearyl alcohol, butyrospermum parkii (shea) butter, dimethicone, butyrospermum parkii (shea) butter, squalene, phenoxyethanol, caprylyl glycol. xanthan gum, citrus paradisi, citrus aurantium dulcis (orange) peel oil, allantoin, sodium hydroxide, tetrasodium EDTA, citrus paradisi (grapefruit) peel oil, ceramide NP, citrus citrus paradisi (grapefruit) peel extract, ethyl 2-methylbutyrate, michelia alba flower oil, tocopherol

Questions:

OTC - QUESTIONS SECTION

888-FAB-3063

PRINCIPAL DISPLAY PANEL - 14.0 oz (396.8 g)

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

First Aid Beauty

FAB

Ultra Repair® Cream

Intense Hydration

Skin Protectant Colloidal Oatmeal

Summer Grapefruit

Net Wt. 14.0 oz (396.8 g)

FABFAB

Product Linked Resources#

Resource, Code type, Value table
ResourceCode typeValueEquivalent identifiersSource image
BarcodeEAN-130810160801801GTIN-13: 0810160801801
EAN-13: 0810160801801
GTIN-12: 810160801801
UPC-A: 810160801801
GTIN storage (14 digits): 00810160801801		FAB.jpg

Products#

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

DailyMed product names page 1 of 1 · 27 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
84126-28184126-281-39

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 25 matching rows.

Name, UNII, Kind table
NameUNIIKind
CETEARYL ALCOHOL2DMT128M1SIACT
TOCOPHEROLR0ZB2556P8IACT
GLYCERYL STEARATE SEFCZ5MH785IIACT
MICHELIA ALBA FLOWER OIL8QDN200R1SIACT
CITRUS PARADISI (GRAPEFRUIT) PEEL OILYR377U58W9IACT
SQUALANEGW89575KF9IACT
DIMETHICONE92RU3N3Y1OIACT
TETRASODIUM EDTAMP1J8420LUIACT
C12-15 ALKYL BENZOATEA9EJ3J61HQIACT
CAPRYLYL GLYCOL00YIU5438UIACT
PHENOXYETHANOLHIE492ZZ3TIACT
BUTYROSPERMUM PARKII (SHEA) BUTTERK49155WL9YIACT
WATER059QF0KO0RIACT
GLYCERINPDC6A3C0OXIACT
OATMEAL8PI54V663YACTIB
ALLANTOIN344S277G0ZIACT
GLYCERYL STEARATE230OU9XXE4IACT
CAPRYLIC/CAPRIC TRIGLYCERIDEC9H2L21V7UIACT
STEARIC ACID4ELV7Z65APIACT
XANTHAN GUMTTV12P4NEEIACT
CITRUS AURANTIUM DULCIS (ORANGE) PEEL OILAKN3KSD11BIACT
CERAMIDE NP4370DF050BIACT
GRAPEFRUIT PEEL3582N05Q44IACT
ETHYL 2-METHYLBUTYRATEL1T4AB29DSIACT
SODIUM HYDROXIDE55X04QC32IIACT

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
First Aid Beauty FAB Ultra Repair Skin Protectant Summer GrapefruitCOLLOIDAL OATMEALThe Procter & Gamble Manufacturing Company55664a0f-7d46-f002-e063-6394a90a2dc72026-06-29WarningsExact identifier
ndc (package): 84126-281-39
ndc (product): 84126-281
ndc11 (package): 84126028139
spl id: 55666249-d633-206e-e063-6394a90a03dc
spl set id: 55664a0f-7d46-f002-e063-6394a90a2dc7

Reported adverse events (FAERS/openFDA)#

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