FIRST AID BEAUTY FAB ULTRA REPAIR RESCUE BARRIER BALM SKIN PROTECTANT- dimethicone cream

First Aid Beauty FAB Ultra Repair Rescue Barrier Balm Skin Protectant by

Drug Labeling and Warnings

First Aid Beauty FAB Ultra Repair Rescue Barrier Balm Skin Protectant by is a Otc medication manufactured, distributed, or labeled by The Procter & Gamble Manufacturing Company. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

SPL UNCLASSIFIED SECTION

Drug Facts

Active ingredients

Dimethicone 1%

Purpose

Skin Protectant

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.

WARNINGS

For external use only

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

Do not get into eyes.

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

Do not use on

• deep puncture wounds
• animal bites
• serious burns

Directions

Apply as needed

INACTIVE INGREDIENT

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

Questions:

888-FAB-3063

SPL UNCLASSIFIED SECTION

MADE IN USA

FIRST AID BEAUTY LTD

NEWTON, MA 02458

WWW.FIRSTAIDBEAUTY.COM

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)

INGREDIENTS AND APPEARANCE

FIRST AID BEAUTY FAB ULTRA REPAIR RESCUE BARRIER BALM SKIN PROTECTANT 
dimethicone cream

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 84126-045
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
DIMETHICONE (UNII: 92RU3N3Y1O) (DIMETHICONE - UNII:92RU3N3Y1O)	DIMETHICONE	1 g  in 100 g

Inactive Ingredients
Ingredient Name	Strength
PENTAERYTHRITYL TETRA-DI-T-BUTYL HYDROXYHYDROCINNAMATE (UNII: 255PIF62MS)
DICAPRYLYL CARBONATE (UNII: 609A3V1SUA)
LAURYL LAURATE (UNII: GPW77G0937)
BEHENYL ALCOHOL (UNII: 9G1OE216XY)
SORBITAN PALMITATE (UNII: 77K6Z421KU)
CARBOMER HOMOPOLYMER, UNSPECIFIED TYPE (UNII: 0A5MM307FC)
HYDROGENATED SOYBEAN LECITHIN (UNII: H1109Z9J4N)
LINOLEIC ACID (UNII: 9KJL21T0QJ)
GLYCERYL DIOLEATE (UNII: Z3MP1W91CW)
PROPANEDIOL (UNII: 5965N8W85T)
CETYL PALMITATE (UNII: 5ZA2S6B08X)
SORBITAN OLEATE (UNII: 06XEA2VD56)
SODIUM PHYTATE (UNII: 88496G1ERL)
CENTELLA ASIATICA TRITERPENOIDS (UNII: 4YS74Q4G4J)
ALOE BARBADENSIS LEAF JUICE (UNII: ZY81Z83H0X)
C12-16 ALCOHOLS (UNII: S4827SZE3L)
HYDROXYACETOPHENONE (UNII: G1L3HT4CMH)
TROMETHAMINE (UNII: 023C2WHX2V)
PENTYLENE GLYCOL (UNII: 50C1307PZG)
ETHYLHEXYLGLYCERIN (UNII: 147D247K3P)
OATMEAL (UNII: 8PI54V663Y)
PALMITIC ACID (UNII: 2V16EO95H1)
CETEARYL ALCOHOL (UNII: 2DMT128M1S)
TRIOLEIN (UNII: O05EC62663)
CAPRYLYL GLYCOL (UNII: 00YIU5438U)
PHENOXYETHANOL (UNII: HIE492ZZ3T)
WATER (UNII: 059QF0KO0R)
GLYCERIN (UNII: PDC6A3C0OX)
GLYCERYL STEARATE (UNII: 230OU9XXE4)
CAPRYLIC/CAPRIC TRIGLYCERIDE (UNII: C9H2L21V7U)
CERAMIDE NP (UNII: 4370DF050B)
BUTYLENE GLYCOL (UNII: 3XUS85K0RA)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 84126-045-63	1 in 1 CARTON	12/01/2024
1		63.7 g in 1 TUBE; Type 0: Not a Combination Product
2	NDC: 84126-045-10	1 in 1 CARTON	12/01/2024
2		10 g in 1 TUBE; Type 0: Not a Combination Product
3	NDC: 84126-045-30	1 in 1 CARTON	12/01/2024
3		30 g in 1 TUBE; Type 0: Not a Combination Product

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC Monograph Drug	M016	12/01/2024

Labeler - The Procter & Gamble Manufacturing Company (004238200)