First Aid Beauty FAB Ultra Repair Rescue Barrier Balm Skin Protectant Dimethicone 1 g/100g Cream, 30 g
Other active recalls for Dimethicone (different manufacturers) — 1 · tap to view
🆔 Identity & classification
Where does this data come from?
🏭 Manufacturer & labeler
Where does this data come from?
🩺 Clinical
This is a topical cream containing dimethicone, a silicone-based ingredient commonly used in skin protectant products. Dimethicone functions as a water-repellent barrier on the skin surface and is typically included in over-the-counter products meant to help protect and soften skin. The product is marketed as an OTC monograph drug, meaning it follows established FDA guidelines for skin protectants rather than being individually reviewed.
Patient education
Supplement & herbal interactions
Some supplements/herbs that may interact with Dimethicone — tap one for details:
Where does this data come from?
Ask a licensed pharmacist directly — free, answered by our team.
🧪 Inactive Ingredients / Excipients
Inactive ingredients, also called excipients, are components of the drug product other than the active ingredient. They may include fillers, dyes, coatings, preservatives, flavors, or other formulation ingredients.
💡 Tap an ingredient (hover on desktop) to see what it is and why it’s used.
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UNII RUE8E6T4NB
Aloe vera leaf juice is a clear gel extracted from aloe vera plant leaves. It's used in medicines as a lubricant, emollient, and preservative to soothe skin contact and help keep the product stable.
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UNII 9G1OE216XY
Docosanol is a waxy, fatty alcohol derived from plant sources. It acts as an emollient and thickener in topical medicines, helping to soften the skin and improve product texture and stability.
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UNII 3XUS85K0RA
Butylene glycol is a clear liquid derived from petroleum or plants that acts as a humectant, solvent, and preservative booster in medicines. It helps keep formulations stable, dissolve active ingredients, and maintain moisture in topical products.
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UNII S4827SZE3L
A mixture of fatty alcohols derived from plant or petroleum sources with 12 to 16 carbon atoms. Used as an emulsifier and thickening agent to help blend water and oil components and give the product its desired texture.
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UNII C9H2L21V7U
A fat derived from coconut or palm oil containing shorter fatty acid chains. It serves as a solvent and carrier to help dissolve or suspend active ingredients, improving absorption and stability in liquid formulations.
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UNII 00YIU5438U
Caprylyl glycol is a clear liquid derived from coconut oil. In medicines, it acts as a humectant to retain moisture, a preservative booster to prevent microbial growth, and a solvent to help dissolve or mix other ingredients.
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UNII 0A5MM307FC
A synthetic polymer that absorbs water and forms a thick, gel-like substance. In medicines, it works as a thickener and stabilizer to improve texture and help ingredients stay mixed together in creams, gels, and lotions.
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UNII 4YS74Q4G4J
A plant extract from Centella asiatica containing natural compounds called triterpenoids. It's used as an active ingredient in some formulations for its purported skin-supporting properties, though it functions as a botanical additive rather than a structural component of the medicine.
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UNII 4370DF050B
Ceramide NP is a waxy, lipid-based substance that mimics natural skin oils. It's used in topical formulations as an emollient and skin-conditioning agent to help soften, smooth, and protect the skin barrier.
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UNII 2DMT128M1S
A waxy solid derived from plant or animal sources. It acts as an emulsifier to blend oil and water components, and also thickens the medicine to give it the right texture and consistency.
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UNII 5ZA2S6B08X
Cetyl palmitate is a waxy substance made from natural fats. It works as a binder and thickener to help hold the medicine together and control how it dissolves in your body.
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UNII 609A3V1SUA
A silky liquid derived from caprylic acid that acts as an emollient and solvent in formulations. It helps dissolve active ingredients and improves the spreadability and feel of lotions, creams, and topical products.
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UNII 147D247K3P
Ethylhexylglycerin is a synthetic preservative used to prevent bacteria and mold from growing in medicines and personal care products. It helps keep the product safe and stable throughout its shelf life.
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UNII PDC6A3C0OX
Glycerin is a clear, thick liquid derived from plant oils or fats. It acts as a humectant to retain moisture, a sweetener, and a solvent in medications.
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UNII R8WTH25YS2
Glyceryl dibehenate is a wax-like substance made from behenate fatty acids and glycerol. It functions as a binder and release-control agent in tablets and capsules, helping hold ingredients together and regulate how quickly the medicine dissolves and releases in your body.
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UNII Z3MP1W91CW
A fatty substance derived from glycerin and oleic acid. It acts as an emulsifier to help blend oil and water-based ingredients, and may serve as a lubricant or thickening agent in the formulation.
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UNII 230OU9XXE4
A waxy substance made from glycerin and stearic acid that acts as an emulsifier to blend oily and watery ingredients together. It also helps thicken and stabilize the medicine's texture.
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UNII PL360EPO9J
Soy sterol is a plant-derived fat extracted from soybeans. It's used as an emulsifier and stabilizer to help keep oil and water mixed together and maintain the medicine's texture and consistency.
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UNII H1109Z9J4N
A natural emulsifier derived from soybean oil. It helps mix oil and water-based ingredients together, ensuring even distribution of active ingredients throughout the medicine.
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UNII G1L3HT4CMH
A synthetic compound used in medicines as a preservative and antimicrobial agent. It helps prevent bacterial and fungal growth, extending the product's shelf life.
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UNII GPW77G0937
Lauryl laurate is a synthetic oily compound made from lauric acid and lauryl alcohol. It acts as an emollient and lubricant in medicines, helping to soften formulations and reduce friction during manufacturing and use.
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UNII 9KJL21T0QJ
Linoleic acid is an omega-6 fatty acid derived from plant oils. It serves as an emulsifier and skin conditioning agent in topical formulations, helping ingredients mix smoothly and improving product texture.
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UNII 8PI54V663Y
Oatmeal is ground oat grain used as a natural filler and texture agent in medicines. It absorbs moisture, adds bulk to the formulation, and may help create a soothing base in topical products.
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UNII 2V16EO95H1
Palmitic acid is a saturated fatty acid derived from plant and animal sources. It serves as an emulsifier and lubricant in medicines, helping ingredients mix smoothly and preventing sticking during manufacturing.
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UNII 255PIF62MS
A synthetic antioxidant compound used to prevent oils and fats in medications from breaking down or becoming rancid during storage. It helps maintain the medicine's stability and shelf life.
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UNII 50C1307PZG
Pentylene glycol is a humectant and preservative helper derived from petroleum or plant sources. It draws moisture into the product and helps prevent bacterial growth, keeping medicines stable during storage.
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UNII HIE492ZZ3T
Phenoxyethanol is a synthetic preservative and antimicrobial agent used to prevent bacterial and fungal growth in medicines and cosmetic products, extending shelf life and maintaining product safety.
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UNII 88496G1ERL
Sodium phytate is a plant-derived salt used in medications as a chelating agent and preservative. It helps stabilize formulations and may improve how the body absorbs certain minerals in the medicine.
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UNII 06XEA2VD56
Sorbitan oleate is an emulsifier derived from sorbitol and oleic acid. It helps mix oil and water-based ingredients together and keeps them from separating in the medicine.
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UNII 77K6Z421KU
Sorbitan monopalmitate is an emulsifier made from sorbitol, a natural sugar alcohol, combined with palmitic acid. It helps mix oil and water ingredients together in medications and keeps them evenly blended throughout the product's shelf life.
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UNII O05EC62663
A natural oil derived from glycerin and oleic acid. It acts as a lubricant and emollient in medicines, helping ingredients mix smoothly and improving how the product flows during manufacturing and application.
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UNII 023C2WHX2V
Tromethamine is a chemical buffer that helps maintain the proper acidity level in liquid medicines. It neutralizes acids and stabilizes the solution so the medication remains effective and safe throughout its shelf life.
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UNII 059QF0KO0R
Water is a liquid solvent that dissolves and mixes ingredients together in liquid medicines, syrups, and injections. It helps distribute the active drug evenly throughout the product.
33 inactive ingredients listed in the exact product block matched to this NDC.
Label-section wording can be broader than the structured product block and may mention additional formulation ingredients.
Where does this data come from?
ingredient classCode="IACT" elements from the exact product block matched by this NDC. Label-section narrative from DailyMed / the openFDA label index is shown separately when available.Inactive ingredient FAQ
Are inactive ingredients the same for every manufacturer?
Why might an inactive ingredient be missing?
Can inactive ingredients matter?
💲 Pricing
A drug doesn't have one price. Each row is a different public payment system, and none is what you'd pay at the counter — that depends on your insurance. The ⓘ on each row explains what it measures.
| Price system | Per g | Per package |
|---|---|---|
| Retail pharmacies payNADAC · weekly | Not in the retail survey — common for institutional, discontinued, or low-volume packs. | |
| Medicaid paysCMS SDUD · 12 mo | No recent Medicaid claims on file for this NDC — rare and low-volume NDCs are suppressed in the public data. | |
| Medicare drug plans payPart D · quarterly | No Part D plan price is available for this NDC in our data. | |
Where does this data come from?
🔁 Therapeutic equivalents
| Product | Labeler | Pack | NADAC/unit | TE | Status | Price vs. this |
|---|---|---|---|---|---|---|
| Quad Wash 1 g/100g 67777-0225-02 | Dynarex | 24 tubes | — | — | FDA listed | — |
| First Aid Beauty FAB Ultra Repair Rescue Barrier Balm Skin Protectant 1 g/100gthis 84126-0045-30 | The | 30 g | — | — | FDA listed | — |
Where does this data come from?
⏳ Availability & generic status
We did not find an FDA-approved generic match for this exact strength, form and route.
Where does this data come from?
🔬 Reported adverse events (FAERS)
Top reported reactions
Reporter sex
Serious outcomes
Where does this data come from?
📦 Packaging — all sizes for this product
| Package NDC | Description | Marketing start | Status |
|---|---|---|---|
| 84126-0045-01 | 1 TUBE in 1 CARTON (84126-045-01) / 63.7 g in 1 TUBE | 2026-02-01 | Active |
| 84126-0045-02 | 2 g in 1 POUCH (84126-045-02) | 2024-12-01 | Active |
| 84126-0045-10 | 10 g in 1 TUBE (84126-045-10) | 2024-12-01 | Active |
| 84126-0045-30 You're viewing this | 30 g in 1 TUBE (84126-045-30) | 2024-12-01 | Active |
| 84126-0045-63 | 63.7 g in 1 TUBE (84126-045-63) | 2024-12-01 | Active |
Pack size FAQ
What quantity is in NDC 84126-0045-30?
What is the difference between NDC 84126-0045-30 and NDC 84126-0045-01?
What NDC number is used to bill for this package of First Aid Beauty FAB Ultra Repair Rescue Barrier Balm Skin Protectant Dimethicone 1 g/100g Cream?
🧭 About this NDC listing & data coverage
What data is (and isn’t) available for this NDC — tap to expand
| NDC identity (package / product / labeler codes) | ✓ Available |
| Labeler | ✓ Available |
| Product & package description | ✓ Available |
| Marketing category & status | ✓ Available |
| Active ingredient / dosage form / route | ✓ Available |
| FDA label (SPL via DailyMed) | ✓ Available |
| Package photos | ✓ Available |
| Inactive ingredients (structured) | ✓ Available |
| NADAC pharmacy acquisition price (CMS) | — Not published for this NDC CMS publishes NADAC only for NDCs reported in its retail-pharmacy survey. |
| Orange Book / therapeutic-equivalence data | — Not published for this NDC Applies only to products approved under an NDA/ANDA; many listings are out of scope. |
| HCPCS J-code billing crosswalk | — Not published for this NDC Most self-administered / retail products have no J-code — that is normal. |
| Medicaid utilization (CMS SDUD) | — Not published for this NDC CMS reports utilization only for NDCs with Medicaid claims above its privacy threshold. |
Questions about this listing
Is this NDC FDA-approved?
Why is there no price listed?
Is the NDC printed on the package the same as the 11-digit billing NDC?
What do the three segments of this NDC mean?
Is this package still being marketed?
Does this product come in other package sizes?
Who lists this product with the FDA?
Do I need a prescription for this product?
Where does this data come from?
📄 FDA label — Drug Facts FDA SPL
🎯 Indications and Usage ▾
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 ▾
Directions Apply as needed
⚠️ 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
🧪 Active Ingredient ▾
Active ingredients Dimethicone 1%
🧪 Inactive Ingredients ▾
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
🎯 Purpose ▾
Purpose Skin Protectant