FDA.reportPublic FDA data

First Aid Beauty FAB Ultra Repair Rescue Barrier Balm Skin Protectant

Manufacturer
The Procter & Gamble Manufacturing Company
Effective date
2026-03-04
Label type
HUMAN OTC DRUG LABEL
Version
5
Source
full-release
Hydrated at
2026-06-01 01:48:59

Label at a glance#

ProductFirst Aid Beauty FAB Ultra Repair Rescue Barrier Balm Skin Protectant
Active ingredientDIMETHICONE
Label structure10 sections

Indications and uses

Helps prevent and temporarily protects and helps relieve chafed, chapped or cracked skin. Helps prevet and protect from the drying effects of wind and cold weather.

Dosage and administration

Apply as needed

Label contents#

Full prescribing information#

SPL UNCLASSIFIED SECTION

Drug Facts

Active ingredients

OTC - ACTIVE INGREDIENT SECTION

Dimethicone 1%

Purpose

OTC - PURPOSE SECTION

Skin Protectant

Uses

INDICATIONS & USAGE SECTION

  • Helps prevent and temporarily protects and helps relieve chafed, chapped or cracked skin.
  • Helps prevet and protect from the drying effects of wind and cold weather.

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

OTC - DO NOT USE SECTION

Do not use on

  • deep puncture wounds
  • animal bites
  • serious burns

Directions

DOSAGE & ADMINISTRATION SECTION

Apply as needed

INACTIVE INGREDIENT SECTION

WATER, BUTYLENE GLYCOL, CAPRYLIC/CAPRIC TRIGLYCERIDE, DICAPRYLYL CARBONATE, GLYCERIN, PENTYLENE GLYCOL, CETEARYL ALCOHOL, GLYCERYL STEARATE, LAURYL LAURATE, C12-16 ALCOHOLS, BEHENYL ALCOHOL, COLLOIDAL OATMEAL, GLYCERYL BEHENATE, POLYGLYCERYL-6 OCTASTEARATE, CETYL PALMITATE, SORBITAN PALMITATE, HYDROXYACETOPHENONE, PALMITIC ACID, PHENOXYETHANOL, CARBOMER, CAPRYLYL GLYCOL, HYDROGENATED LECITHIN, TROMETHAMINE, GLYCINE SOJA (SOYBEAN) STEROLS, LINOLEIC ACID, PHOSPHOLIPIDS, SORBITAN OLEATE, PENTAERYTHRITYL TETRA-DI-T-BUTYL HYDROXYHYDROCINNAMATE, ETHYLHEXYLGLYCERIN, SODIUM PHYTATE, TRIOLEIN, CERAMIDE NP, GLYCERYL DIOLEATE, CENTELLA ASIATICA EXTRACT, ALOE BARBADENSIS LEAF JUICE

Questions:

OTC - QUESTIONS SECTION

888-FAB-3063

PRINCIPAL DISPLAY PANEL - 63.7 g (2.25 oz)

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

First Aid Beauty

FAB

Ultra Repair®

Rescue Barrier Balm

Skin Protectant

with 1% Dimethicone

Net Wt. 63.7 g (2.25 oz)

FABFAB

DailyMed Pharmacologic Classes#

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

Product Linked Resources#

Resource, Code type, Value table
ResourceCode typeValueEquivalent identifiersSource image
BarcodeEAN-130810160800149GTIN-13: 0810160800149
EAN-13: 0810160800149
GTIN-12: 810160800149
UPC-A: 810160800149
GTIN storage (14 digits): 00810160800149		FAB.jpg

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
77dc03a4-fbfc-e6a3-fe95-285bbae40d75Product name220250814

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
84126-045-01First Aid Beauty FAB Ultra Repair Rescue Barrier Balm Skin Protectant1 in 1 CARTONCREAM15
84126-045-01First Aid Beauty FAB Ultra Repair Rescue Barrier Balm Skin Protectant63.7 g in 1 TUBECREAM63.75
84126-045-02First Aid Beauty FAB Ultra Repair Rescue Barrier Balm Skin Protectant2 g in 1 POUCHCREAM25
84126-045-10First Aid Beauty FAB Ultra Repair Rescue Barrier Balm Skin Protectant10 g in 1 TUBECREAM105
84126-045-30First Aid Beauty FAB Ultra Repair Rescue Barrier Balm Skin Protectant30 g in 1 TUBECREAM305
84126-045-63First Aid Beauty FAB Ultra Repair Rescue Barrier Balm Skin Protectant63.7 g in 1 TUBECREAM63.75

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
84126-04584126-045-63, 84126-045-10, 84126-045-30, 84126-045-02, 84126-045-01

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
GLYCERYL DIBEHENATER8WTH25YS2IACT
SORBITAN PALMITATE77K6Z421KUIACT
PENTAERYTHRITYL TETRA-DI-T-BUTYL HYDROXYHYDROCINNAMATE255PIF62MSIACT
DICAPRYLYL CARBONATE609A3V1SUAIACT
LAURYL LAURATEGPW77G0937IACT
BEHENYL ALCOHOL9G1OE216XYIACT
CARBOMER0A5MM307FCIACT
HYDROGENATED SOYBEAN LECITHINH1109Z9J4NIACT
LINOLEIC ACID9KJL21T0QJIACT
GLYCERYL DIOLEATEZ3MP1W91CWIACT
CETYL PALMITATE5ZA2S6B08XIACT
SORBITAN OLEATE06XEA2VD56IACT
SODIUM PHYTATE88496G1ERLIACT
CENTELLA ASIATICA TRITERPENOIDS4YS74Q4G4JIACT
ALOE BARBADENSIS LEAF JUICERUE8E6T4NBIACT
C12-16 ALCOHOLSS4827SZE3LIACT
HYDROXYACETOPHENONEG1L3HT4CMHIACT
TROMETHAMINE023C2WHX2VIACT
PENTYLENE GLYCOL50C1307PZGIACT
ETHYLHEXYLGLYCERIN147D247K3PIACT
OATMEAL8PI54V663YIACT
PALMITIC ACID2V16EO95H1IACT
CETEARYL ALCOHOL2DMT128M1SIACT
TRIOLEINO05EC62663IACT
CAPRYLYL GLYCOL00YIU5438UIACT
PHENOXYETHANOLHIE492ZZ3TIACT
WATER059QF0KO0RIACT
GLYCERINPDC6A3C0OXIACT
DIMETHICONE92RU3N3Y1OACTIB
GLYCERYL STEARATE230OU9XXE4IACT
CAPRYLIC/CAPRIC TRIGLYCERIDEC9H2L21V7UIACT
CERAMIDE NP4370DF050BIACT
BUTYLENE GLYCOL3XUS85K0RAIACT
GLYCINE SOJA (SOYBEAN) STEROLSPL360EPO9JIACT

Source Document#

Source XML

Older Hydrated Versions#

Version, Effective date, Source table
VersionEffective dateSourceHydrated
42025-12-18monthly-update2026-06-03 17:51:13

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 Rescue Barrier Balm Skin ProtectantDIMETHICONEThe Procter & Gamble Manufacturing Company276c68d4-e273-4e48-e063-6294a90ab16f2026-03-04WarningsExact identifier
ndc (package): 84126-045-30
ndc (package): 84126-045-01
ndc (package): 84126-045-10
ndc (package): 84126-045-63
ndc (package): 84126-045-02
ndc (product): 84126-045
ndc11 (package): 84126004530
ndc11 (package): 84126004502
ndc11 (package): 84126004510
ndc11 (package): 84126004501
ndc11 (package): 84126004563
spl id: 4c37b1d2-abaf-4a15-e063-6394a90a7970
spl set id: 276c68d4-e273-4e48-e063-6294a90ab16f

Reported adverse events (FAERS/openFDA)#

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