FDA.reportPublic FDA data

Dermasil Sensitive

Manufacturer
Rise International Group LLC | Kingkey Daily Chemical Co., Ltd.
Effective date
2014-01-13
Label type
HUMAN OTC DRUG LABEL
Version
8
Source
legacy-cache
Hydrated at
2026-08-02 01:37:35

Label at a glance#

ProductDermasil Sensitive
Active ingredientdimethicone
Label structure10 sections

Indications and uses

Temporarily protects and helps relieve chapped or cracked skin. Helps protect from the drying effects of wind and cold weather.

Dosage and administration

Apply as needed

Label contents#

Full prescribing information#

SPL UNCLASSIFIED SECTION

Dermasil® Labs has developed Dermasil® OTC Sensitive Skin Formula, a powerful sensitive skin treatment and skin protectant. This lotion contains four systems to control and provide long-lasting relief from severe dry skin:

  • Occlusives to block moisture loss from the skin's surface
  • Humectant to bind water in the skin's outermost layers
  • Skin Lipids to enhance the skin's natural ability to retain moisture
  • EFA's an important component of the skin's moisture barrier

Indications:

SPL UNCLASSIFIED SECTION

Suitable for sensitive skin, and control of symptoms such as chapping, cracking, flaking, roughness, redness, soreness, and the itching associated with dry skin.

Drug Facts

Active Ingredient

OTC - ACTIVE INGREDIENT SECTION

Dimethicone 1%

Purpose

OTC - PURPOSE SECTION

Skin protectant

Uses

INDICATIONS & USAGE SECTION

  • Temporarily protects and helps relieve chapped or cracked skin.
  • Helps protect from the drying effects of wind and cold weather.

Warnings

WARNINGS SECTION

  • For external use only.
  • 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 - 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.

Directions

DOSAGE & ADMINISTRATION SECTION

  • Apply as needed

Inactive Ingredients

INACTIVE INGREDIENT SECTION

Water (Aqua), Petrolatum, Mineral Oil (Parraffinum Liquidum), Glycerin, Stearic Acid, Glycol Stearate, Glyceryl Stearate, PEG-40 Stearate, Cetyl Alcohol, Sodium Hydroxide, Phenoxyethanol, Methylisothiazolinone, Iodopropynyl Butylcarbamate, Magnesium Aluminum Silicate, Allantoin, Helianthus Annuus (Sunflower) Seed Oil, Cetyl Acetate, Acetylated Lanolin Alcohol, Carbomer, Disodium EDTA, Lecithin, Borago Officinalis Seed Oil, Cholesterol, Ascorbyl Palmitate, Prunus Amygdalus Dulcis (Sweet Almond) Oil, Ethylene Brassylate, Santalum Album (Sandalwood) Oil, Rosa Damascena Extract, Vanilla Planifolia Fruit Extract.

Questions/Comments? 1-800-282-1813

OTC - QUESTIONS SECTION

FigureFigureCruelty-Free. No Animal Testing.
Please Recycle This Bottle.

www.riseintlgroup.com
RISE INTERNATIONAL GROUP LLC
Lodi, NJ 07644. Made in China
©RISE INTERNATIONAL GROUP LLC

Principal Display Panel - Bottle Label Dermasil 8oz

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Dermasil®
LABS
Pharmaceutical Research
Controls Even Severe Dry Skin
Skin Lipid & EFA Treatment
Hypo-Allergenic
Dermasil ®
Sensitive Skin Treatment
LOTION
8 FL.OZ. (1/2 PINT, 237 ml)

Principal Display Panel - Bottle Label Dermasil 8oz
Principal Display Panel - Bottle Label Dermasil 8oz

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
67143-3102-22024-11-18C16284748780-19855e2a2-3c2d-60a7-e053-dbdaa90a05bd41717ae2-b729-4970-b32a-8c2ada32e5b9
67143-3102-32024-11-18C16284748780-19855e2a2-3c2d-60a7-e053-dbdaa90a05bd41717ae2-b729-4970-b32a-8c2ada32e5b9
67143-3102-52024-11-18C16284748780-19855e2a2-3c2d-60a7-e053-dbdaa90a05bd41717ae2-b729-4970-b32a-8c2ada32e5b9
67143-3102-22019-11-27C16284748780-19855e2a2-3c2d-60a7-e053-dbdaa90a05bd41717ae2-b729-4970-b32a-8c2ada32e5b9
67143-3102-32019-11-27C16284748780-19855e2a2-3c2d-60a7-e053-dbdaa90a05bd41717ae2-b729-4970-b32a-8c2ada32e5b9
67143-3102-52019-11-27C16284748780-19855e2a2-3c2d-60a7-e053-dbdaa90a05bd41717ae2-b729-4970-b32a-8c2ada32e5b9

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIISPL versionUploaded
dimethiconeACTIVE INGREDIENT92RU3N3Y1O8
dimethiconeACTIVE MOIETY92RU3N3Y1O8
ALLANTOININACTIVE INGREDIENT344S277G0Z8
ALMOND OILINACTIVE INGREDIENT66YXD4DKO98
ASCORBYL PALMITATEINACTIVE INGREDIENTQN83US2B0N8
BORAGE OILINACTIVE INGREDIENTF8XAG1755S8
CARBOMER HOMOPOLYMER TYPE CINACTIVE INGREDIENT4Q93RCW27E8
CETYL ALCOHOLINACTIVE INGREDIENT936JST6JCN8
CETYL OLEATEINACTIVE INGREDIENT78K2L26L8N8
CHOLESTEROLINACTIVE INGREDIENT97C5T2UQ7J8
EDETATE DISODIUMINACTIVE INGREDIENT7FLD91C86K8
GLYCERININACTIVE INGREDIENTPDC6A3C0OX8
GLYCERYL MONOSTEARATEINACTIVE INGREDIENT230OU9XXE48
GLYCOL STEARATEINACTIVE INGREDIENT0324G66D0E8
IODOPROPYNYL BUTYLCARBAMATEINACTIVE INGREDIENT603P14DHEB8
LANOLININACTIVE INGREDIENT7EV65EAW6H8
LECITHIN, SOYBEANINACTIVE INGREDIENT1DI56QDM628
MAGNESIUMINACTIVE INGREDIENTI38ZP9992A8
METHYLISOTHIAZOLINONEINACTIVE INGREDIENT229D0E1QFA8
MINERAL OILINACTIVE INGREDIENTT5L8T28FGP8
PEG-40 STEARATEINACTIVE INGREDIENTECU18C66Q78
PETROLATUMINACTIVE INGREDIENT4T6H12BN9U8
PHENOXYETHANOLINACTIVE INGREDIENTHIE492ZZ3T8
ROSA DAMASCENA FLOWERINACTIVE INGREDIENTJWB78P295A8
SANDALWOOD OILINACTIVE INGREDIENTX7X01WMQ5F8
SODIUM HYDROXIDEINACTIVE INGREDIENT55X04QC32I8
STEARIC ACIDINACTIVE INGREDIENT4ELV7Z65AP8
SUNFLOWER OILINACTIVE INGREDIENT3W1JG795YI8
VANILLAINACTIVE INGREDIENTQ74T35078H8
WATERINACTIVE INGREDIENT059QF0KO0R8

Products#

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

DailyMed product names page 1 of 1 · 30 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
67143-310267143-3102-2, 67143-3102-3, 67143-3102-5

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 29 matching rows.

Name, UNII, Kind table
NameUNIIKind
dimethicone92RU3N3Y1OACTIB
WATER059QF0KO0RIACT
PETROLATUM4T6H12BN9UIACT
MINERAL OILT5L8T28FGPIACT
GLYCERINPDC6A3C0OXIACT
STEARIC ACID4ELV7Z65APIACT
GLYCOL STEARATE0324G66D0EIACT
GLYCERYL MONOSTEARATE230OU9XXE4IACT
PEG-40 STEARATEECU18C66Q7IACT
CETYL ALCOHOL936JST6JCNIACT
PHENOXYETHANOLHIE492ZZ3TIACT
MAGNESIUMI38ZP9992AIACT
IODOPROPYNYL BUTYLCARBAMATE603P14DHEBIACT
ALLANTOIN344S277G0ZIACT
SUNFLOWER OIL3W1JG795YIIACT
CETYL OLEATE78K2L26L8NIACT
LANOLIN7EV65EAW6HIACT
CARBOMER HOMOPOLYMER TYPE C4Q93RCW27EIACT
METHYLISOTHIAZOLINONE229D0E1QFAIACT
EDETATE DISODIUM7FLD91C86KIACT
LECITHIN, SOYBEAN1DI56QDM62IACT
BORAGE OILF8XAG1755SIACT
CHOLESTEROL97C5T2UQ7JIACT
ASCORBYL PALMITATEQN83US2B0NIACT
ALMOND OIL66YXD4DKO9IACT
SANDALWOOD OILX7X01WMQ5FIACT
ROSA DAMASCENA FLOWERJWB78P295AIACT
VANILLAQ74T35078HIACT
SODIUM HYDROXIDE55X04QC32IIACT

Source Document#

Source XML

Inactive ingredient matches#

Inactive Ingredient Database values describe FDA-listed use contexts. The match method and ambiguity count are shown because ingredient names, routes, and dosage forms are not always unique. Browse recovered IID releases and source provenance.

Inactive ingredient links page 1 of 9 · 492 matching rows.

DailyMed ingredient, IID ingredient, UNII table
DailyMed ingredientIID ingredientUNIIDosage form / routePotencyMaximum daily exposureMatch
LANOLINLANOLIN7EV65EAW6HSHAMPOO / TOPICAL2 %w/wExact identifier — unii candidate
9 equally ranked IID candidates
EDETATE DISODIUMEDETATE DISODIUM7FLD91C86KGEL / TRANSDERMAL1 mgExact identifier — unii candidate
77 equally ranked IID candidates
SODIUM HYDROXIDESODIUM HYDROXIDE55X04QC32IINJECTION, POWDER, FOR SOLUTION / RECTALADJ PHExact identifier — unii candidate
174 equally ranked IID candidates
CHOLESTEROLCHOLESTEROL97C5T2UQ7JOINTMENT / TOPICAL5 %w/wExact identifier — unii candidate
10 equally ranked IID candidates
GLYCERINGLYCERINPDC6A3C0OXSUSPENSION / AURICULAR (OTIC)0.05 %w/wExact identifier — unii candidate
75 equally ranked IID candidates
SODIUM HYDROXIDESODIUM HYDROXIDE55X04QC32IINJECTION, SUSPENSION / INTRAMUSCULARADJ PHExact identifier — unii candidate
174 equally ranked IID candidates
EDETATE DISODIUMEDETATE DISODIUM7FLD91C86KSOLUTION / NASAL100 mg/100mlExact identifier — unii candidate
77 equally ranked IID candidates
EDETATE DISODIUMEDETATE DISODIUM7FLD91C86KDROPS / AURICULAR (OTIC)0.05 %w/wExact identifier — unii candidate
77 equally ranked IID candidates
SODIUM HYDROXIDESODIUM HYDROXIDE55X04QC32IENEMA / RECTAL0.44 %v/vExact identifier — unii candidate
174 equally ranked IID candidates
SODIUM HYDROXIDESODIUM HYDROXIDE55X04QC32IINJECTION / INTRA-ARTICULARADJ PHExact identifier — unii candidate
174 equally ranked IID candidates
SODIUM HYDROXIDESODIUM HYDROXIDE55X04QC32ISOLUTION / INTRAOCULARADJ PHExact identifier — unii candidate
174 equally ranked IID candidates
STEARIC ACIDSTEARIC ACID4ELV7Z65APTABLET, ORALLY DISINTEGRATING / ORAL10 mgExact identifier — unii candidate
26 equally ranked IID candidates
STEARIC ACIDSTEARIC ACID4ELV7Z65APPOWDER, FOR SUSPENSION / ORAL1203 mg/5mlExact identifier — unii candidate
26 equally ranked IID candidates
MINERAL OILMINERAL OILT5L8T28FGPCAPSULE / ORAL120 mgExact identifier — unii candidate
30 equally ranked IID candidates
SODIUM HYDROXIDESODIUM HYDROXIDE55X04QC32IINJECTION, SUSPENSION / SUBCUTANEOUSADJ PHExact identifier — unii candidate
174 equally ranked IID candidates
SODIUM HYDROXIDESODIUM HYDROXIDE55X04QC32IINJECTION / INTRADERMALADJ PHExact identifier — unii candidate
174 equally ranked IID candidates
SODIUM HYDROXIDESODIUM HYDROXIDE55X04QC32ISUSPENSION, EXTENDED RELEASE / INTRASYNOVIALADJ PHExact identifier — unii candidate
174 equally ranked IID candidates
GLYCERYL MONOSTEARATEGLYCERYL MONOSTEARATE230OU9XXE4AEROSOL, FOAM / TOPICAL3.27 %w/wExact identifier — unii candidate
21 equally ranked IID candidates
LANOLINLANOLIN7EV65EAW6HOINTMENT / OPHTHALMIC3 %w/wExact identifier — unii candidate
9 equally ranked IID candidates
EDETATE DISODIUMEDETATE DISODIUM7FLD91C86KSOLUTION/ DROPS / OPHTHALMIC0.13 %w/vExact identifier — unii candidate
77 equally ranked IID candidates
CETYL ALCOHOLCETYL ALCOHOL936JST6JCNAEROSOL, FOAM / TOPICAL82 mgExact identifier — unii candidate
20 equally ranked IID candidates
SODIUM HYDROXIDESODIUM HYDROXIDE55X04QC32IMOUTHWASH / BUCCAL2 mg/1mlExact identifier — unii candidate
174 equally ranked IID candidates
SODIUM HYDROXIDESODIUM HYDROXIDE55X04QC32IINJECTION / INTRAVITREALADJ PHExact identifier — unii candidate
174 equally ranked IID candidates
EDETATE DISODIUMEDETATE DISODIUM7FLD91C86KSOLUTION / INTRAVENOUS0.05 %w/vExact identifier — unii candidate
77 equally ranked IID candidates
SODIUM HYDROXIDESODIUM HYDROXIDE55X04QC32IINJECTION, SOLUTION / SUBMUCOSALADJ PHExact identifier — unii candidate
174 equally ranked IID candidates
STEARIC ACIDSTEARIC ACID4ELV7Z65APTABLET, EXTENDED RELEASE / ORAL200 mgExact identifier — unii candidate
26 equally ranked IID candidates
SODIUM HYDROXIDESODIUM HYDROXIDE55X04QC32IINJECTION, POWDER, FOR SOLUTION / PARENTERALADJ PHExact identifier — unii candidate
174 equally ranked IID candidates
GLYCERINGLYCERINPDC6A3C0OXINJECTION / INTRAVENOUS33750 mgExact identifier — unii candidate
75 equally ranked IID candidates
SODIUM HYDROXIDESODIUM HYDROXIDE55X04QC32ITABLET, DELAYED RELEASE / ORAL4 mgExact identifier — unii candidate
174 equally ranked IID candidates
SODIUM HYDROXIDESODIUM HYDROXIDE55X04QC32ISOLUTION / INTRAVENOUS2.78 %w/vExact identifier — unii candidate
174 equally ranked IID candidates
GLYCERINGLYCERINPDC6A3C0OXINJECTION, POWDER, LYOPHILIZED, FOR SOLUTION / INTRAVENOUS225 mgExact identifier — unii candidate
75 equally ranked IID candidates
EDETATE DISODIUMEDETATE DISODIUM7FLD91C86KAEROSOL, FOAM / TOPICAL0.05 %w/wExact identifier — unii candidate
77 equally ranked IID candidates
GLYCERINGLYCERINPDC6A3C0OXTABLET, COATED / ORAL1 mgExact identifier — unii candidate
75 equally ranked IID candidates
EDETATE DISODIUMEDETATE DISODIUM7FLD91C86KLOTION / TOPICAL22 mgExact identifier — unii candidate
77 equally ranked IID candidates
EDETATE DISODIUMEDETATE DISODIUM7FLD91C86KLIQUID / ORAL0.5 mg/1mlExact identifier — unii candidate
77 equally ranked IID candidates
GLYCERINGLYCERINPDC6A3C0OXSPRAY, METERED / NASAL13 mgExact identifier — unii candidate
75 equally ranked IID candidates
SODIUM HYDROXIDESODIUM HYDROXIDE55X04QC32ICAPSULE, LIQUID FILLED / ORAL1.5 mgExact identifier — unii candidate
174 equally ranked IID candidates
GLYCERINGLYCERINPDC6A3C0OXCAPSULE, COATED / ORAL14.21 mgExact identifier — unii candidate
75 equally ranked IID candidates
SODIUM HYDROXIDESODIUM HYDROXIDE55X04QC32ISOLUTION / TOPICAL39 mgExact identifier — unii candidate
174 equally ranked IID candidates
SODIUM HYDROXIDESODIUM HYDROXIDE55X04QC32ISUSPENSION, EXTENDED RELEASE / SUBCUTANEOUSNAExact identifier — unii candidate
174 equally ranked IID candidates
SODIUM HYDROXIDESODIUM HYDROXIDE55X04QC32ISOLUTION / IONTOPHORESISADJ PHExact identifier — unii candidate
174 equally ranked IID candidates
SODIUM HYDROXIDESODIUM HYDROXIDE55X04QC32ISOLUTION / AURICULAR (OTIC)0.8 %w/wExact identifier — unii candidate
174 equally ranked IID candidates
PETROLATUMPETROLATUM4T6H12BN9USOAP / TOPICAL0.85 %w/wExact identifier — unii candidate
18 equally ranked IID candidates
PETROLATUMPETROLATUM4T6H12BN9UCAPSULE / VAGINALNAExact identifier — unii candidate
18 equally ranked IID candidates
SODIUM HYDROXIDESODIUM HYDROXIDE55X04QC32IINJECTION, POWDER, LYOPHILIZED, FOR SOLUTION / PARENTERALADJ PHExact identifier — unii candidate
174 equally ranked IID candidates
EDETATE DISODIUMEDETATE DISODIUM7FLD91C86KSOLUTION / OPHTHALMIC4 mgExact identifier — unii candidate
77 equally ranked IID candidates
SODIUM HYDROXIDESODIUM HYDROXIDE55X04QC32ISOLUTION / IRRIGATIONADJ PHExact identifier — unii candidate
174 equally ranked IID candidates
STEARIC ACIDSTEARIC ACID4ELV7Z65APSOAP / TOPICAL6 %w/wExact identifier — unii candidate
26 equally ranked IID candidates
GLYCERYL MONOSTEARATEGLYCERYL MONOSTEARATE230OU9XXE4LIQUID / TOPICAL1 %w/wExact identifier — unii candidate
21 equally ranked IID candidates
GLYCERINGLYCERINPDC6A3C0OXSOLUTION / DENTAL15 %w/vExact identifier — unii candidate
75 equally ranked IID candidates
MINERAL OILMINERAL OILT5L8T28FGPOINTMENT / OPHTHALMIC59.5 %w/wExact identifier — unii candidate
30 equally ranked IID candidates
SODIUM HYDROXIDESODIUM HYDROXIDE55X04QC32IEMULSION / TOPICAL0.2 %w/wExact identifier — unii candidate
174 equally ranked IID candidates
EDETATE DISODIUMEDETATE DISODIUM7FLD91C86KINJECTION, SOLUTION / INTRAMUSCULAR4 mgExact identifier — unii candidate
77 equally ranked IID candidates
SODIUM HYDROXIDESODIUM HYDROXIDE55X04QC32IINJECTION, POWDER, FOR SOLUTION / INTRATUMORADJ PHExact identifier — unii candidate
174 equally ranked IID candidates
CETYL ALCOHOLCETYL ALCOHOL936JST6JCNTABLET, EXTENDED RELEASE / ORAL132 mgExact identifier — unii candidate
20 equally ranked IID candidates
SODIUM HYDROXIDESODIUM HYDROXIDE55X04QC32IINJECTION / INTRAVASCULARADJ PHExact identifier — unii candidate
174 equally ranked IID candidates
SODIUM HYDROXIDESODIUM HYDROXIDE55X04QC32IINJECTION / PARENTERALADJ PHExact identifier — unii candidate
174 equally ranked IID candidates
CHOLESTEROLCHOLESTEROL97C5T2UQ7JINJECTABLE, LIPOSOMAL / INFILTRATION0.47 %w/vExact identifier — unii candidate
10 equally ranked IID candidates
EDETATE DISODIUMEDETATE DISODIUM7FLD91C86KGEL / OPHTHALMIC396 mgExact identifier — unii candidate
77 equally ranked IID candidates
LECITHIN, SOYBEANSOYBEAN LECITHIN1DI56QDM62TABLET, FILM COATED / ORAL0.33 mgExact identifier — unii candidate
7 equally ranked IID candidates

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
24868239-2556-48de-8fb2-0aa9b58be8e741717ae2-b729-4970-b32a-8c2ada32e5b92024-11-15WarningsExact identifier
spl set id: 41717ae2-b729-4970-b32a-8c2ada32e5b9

Reported adverse events (FAERS/openFDA)#

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