first aid beauty fab ultra repair rescue barrier balm skin protectant

first aid beauty fab ultra repair rescue barrier balm skin protectant
SPL v5
SPL
SPL Set ID 276c68d4-e273-4e48-e063-6294a90ab16f
Route
topical
Published
Effective Date 2026-02-01
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
dimethicone (1 g)
Inactive Ingredients
glyceryl dibehenate sorbitan palmitate pentaerythrityl tetra-di-t-butyl hydroxyhydrocinnamate dicaprylyl carbonate lauryl laurate behenyl alcohol carbomer hydrogenated soybean lecithin linoleic acid glyceryl dioleate cetyl palmitate sorbitan oleate sodium phytate centella asiatica triterpenoids aloe barbadensis leaf juice c12-16 alcohols hydroxyacetophenone tromethamine pentylene glycol ethylhexylglycerin oatmeal palmitic acid cetearyl alcohol triolein caprylyl glycol phenoxyethanol water glycerin glyceryl stearate caprylic/capric triglyceride ceramide np butylene glycol glycine soja (soybean) sterols

Identifiers & Packaging

Marketing Status
otc monograph drug completed Since 2024-12-01 Until 2026-12-01

Purpose

Skin Protectant

Description

Drug Facts


Medication Information

Warnings and Precautions

For external use only

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.
Purpose

Skin Protectant

Directions

Apply as needed

Description

Drug Facts

Section 42229-5

Drug Facts

Section 50565-1

Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center right away.

Section 50566-9

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

Section 50567-7

Do not get into eyes.

Section 50570-1

Do not use on

  • deep puncture wounds
  • animal bites
  • serious burns
Section 51727-6

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:

888-FAB-3063

Active Ingredients

Dimethicone 1%

Principal Display Panel 63.7 G (2.25 Oz)

First Aid Beauty

FAB

Ultra Repair®

Rescue Barrier Balm

Skin Protectant

with 1% Dimethicone

Net Wt. 63.7 g (2.25 oz)


Structured Label Content

Warnings and Precautions (34071-1)

For external use only

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.
Purpose

Skin Protectant

Directions

Apply as needed

Section 42229-5 (42229-5)

Drug Facts

Section 50565-1 (50565-1)

Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center right away.

Section 50566-9 (50566-9)

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

Section 50567-7 (50567-7)

Do not get into eyes.

Section 50570-1 (50570-1)

Do not use on

  • deep puncture wounds
  • animal bites
  • serious burns
Section 51727-6 (51727-6)

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:

888-FAB-3063

Active Ingredients (Active ingredients)

Dimethicone 1%

Principal Display Panel 63.7 G (2.25 Oz) (PRINCIPAL DISPLAY PANEL - 63.7 g (2.25 oz))

First Aid Beauty

FAB

Ultra Repair®

Rescue Barrier Balm

Skin Protectant

with 1% Dimethicone

Net Wt. 63.7 g (2.25 oz)


Advanced Ingredient Data


Raw Label Data

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