FDA.reportPublic FDA data

First Aid Beauty FAB Ultra Repair Cream Skin Protectant Cranberry Pomegranate

Manufacturer
The Procter & Gamble Manufacturing Company
Effective date
2026-03-19
Label type
HUMAN OTC DRUG LABEL
Version
4
Source
full-release
Hydrated at
2026-06-01 01:50:54

Label at a glance#

ProductFirst Aid Beauty FAB Ultra Repair Intense Hydration Skin Protectant Cranberry Pomegranate
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, squalene, phenoxyethanol, caprylyl glycol. xanthan gum, allantoin, sodium hydroxide, tetrasodium EDTA, chrysanthemum parthenium (feverfew) extract, triethyl citrate, camellia sinensis leaf extract, glycyrrhiza glabra (licorice) root extract, cinnamomum camphora linalooliferum wood extract, citrus limon (lemon) peel extract, punica granatum seed extract, rubus idaeus (raspberry) fruit extract, vaccinium macrocarpon (cranberry) seed oil, ceramide NP, ananas sativus (pineapple) fruit extract, citrus paradisi (grapefruit) peel extract, cucumis melo (melon) fruit extract, passiflora incarnata fruit extract, pimpinella anisum (anise) fruit extract, pyrus malus (apple) fruit extract, rosa damascene flower extract, Theobroma cacao (cocoa) extract, tsuga canadensis oil, vaccinium macrocarpon (cranberry) fruit extract, vanilla planifolia fruit extract

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

Cranberry Pomegranate Natural Infusion

Net Wt. 14.0 oz (396.8 g)

FABFAB

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYSPL version
1654149colloidal oatmeal 0.5 % Topical CreamPSN4
1654149colloidal oatmeal 5 MG/ML Topical CreamSCD4
1654149colloidal oatmeal 0.5 % Topical CreamSY4

DailyMed Pharmacologic Classes#

Class, Version, Type table
ClassVersionTypeEffective
OATMEAL Pharmacologic Class Indexing2Indexing - Pharmacologic Class20181113

Product Linked Resources#

Resource, Code type, Value table
ResourceCode typeValueEquivalent identifiersSource image
BarcodeEAN-130815517025459GTIN-13: 0815517025459
EAN-13: 0815517025459
GTIN-12: 815517025459
UPC-A: 815517025459
GTIN storage (14 digits): 00815517025459		FAB.jpg

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
69423-565-39First Aid Beauty FAB Ultra Repair Intense Hydration Skin Protectant Cranberry Pomegranate396.8 g in 1 JARCREAM396.84
69423-565-56First Aid Beauty FAB Ultra Repair Intense Hydration Skin Protectant Cranberry Pomegranate56 g in 1 TUBECREAM564

Products#

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

DailyMed product names page 1 of 2 · 41 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
69423-56569423-565-39, 69423-565-56

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 39 matching rows.

Name, UNII, Kind table
NameUNIIKind
MUSKMELONZV095H5633IACT
PASSIFLORA INCARNATA FRUITSF206I8G4PIACT
MENTHA PIPERITA LEAFA389O33LX6IACT
APPLEB423VGH5S9IACT
CRANBERRY SEED OIL73KDS3BW5EIACT
TANACETUM PARTHENIUM WHOLE6GE7Z0761KIACT
CETOSTEARYL ALCOHOL2DMT128M1SIACT
SQUALANEGW89575KF9IACT
DIMETHICONE92RU3N3Y1OIACT
EDETATE SODIUMMP1J8420LUIACT
GLYCERYL STEARATE SEFCZ5MH785IIACT
ALKYL (C12-15) BENZOATEA9EJ3J61HQIACT
GREEN TEA LEAFW2ZU1RY8B0IACT
CAPRYLYL GLYCOL00YIU5438UIACT
SODIUM HYDROXIDE55X04QC32IIACT
PHENOXYETHANOLHIE492ZZ3TIACT
SHEA BUTTERK49155WL9YIACT
GLYCYRRHIZA GLABRA2788Z9758HIACT
WATER059QF0KO0RIACT
GLYCERINPDC6A3C0OXIACT
OATMEAL8PI54V663YACTIB
ALLANTOIN344S277G0ZIACT
GLYCERYL MONOSTEARATE230OU9XXE4IACT
MEDIUM-CHAIN TRIGLYCERIDESC9H2L21V7UIACT
STEARIC ACID4ELV7Z65APIACT
XANTHAN GUMTTV12P4NEEIACT
PINEAPPLE2A88ZO081OIACT
CERAMIDE NP4370DF050BIACT
VANILLA BEANQ74T35078HIACT
RASPBERRY4N14V5R27WIACT
LEMON PEEL72O054U628IACT
TRIETHYL CITRATE8Z96QXD6UMIACT
CRANBERRY0MVO31Q3QSIACT
POMEGRANATE SEED7294Z34NS7IACT
GRAPEFRUIT PEEL3582N05Q44IACT
ANISE21C2F5E8REIACT
ROSA DAMASCENA FLOWERJWB78P295AIACT
COCOAD9108TZ9KGIACT
TSUGA CANADENSIS LEAF OILQ1S51LGQ0GIACT

Source Document#

Source XML

Older Hydrated Versions#

Version, Effective date, Source table
VersionEffective dateSourceHydrated
32025-12-18monthly-update2026-06-03 17:46:25

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 Intense Hydration Skin Protectant Cranberry PomegranateCOLLOIDAL OATMEALThe Procter & Gamble Manufacturing Companyf4464fb2-ba25-16f2-e053-2a95a90a04062026-03-19WarningsExact identifier
ndc (package): 69423-565-56
ndc (package): 69423-565-39
ndc (product): 69423-565
ndc11 (package): 69423056539
ndc11 (package): 69423056556
spl id: 4d668530-bf0a-cd08-e063-6294a90a0d1d
spl set id: f4464fb2-ba25-16f2-e053-2a95a90a0406

Reported adverse events (FAERS/openFDA)#

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