FDA.reportPublic FDA data

Simply Firm Eye - Non-Surgical Face Lift

Manufacturer
CarePluss Pharma S.A. de C.V.
Effective date
2013-04-23
Label type
HUMAN OTC DRUG LABEL
Version
2
Source
full-release
Hydrated at
2026-05-31 22:35:15

Label at a glance#

ProductSimply Firm Eye - Non-Surgical Face Lift
Active ingredientDIMETHICONE
Label structure8 sections

Label contents#

Full prescribing information#

OTC - ACTIVE INGREDIENT SECTION

Active Ingredient                 Purpose

Dimethicone 1% ........ skin protectant

OTC - PURPOSE SECTION

Uses: protects from minor skin irritations.

  • temporarily protects injured or exposed skin
  • slows the loss of water of the skin by forming a barrier on the skin's surface
  • enhances the appearance of dry or damaged skin
  • increases the water content of the top layers of the skin
  • is a lubricant for the surface of the skin
  • gives skin a soft and smooth appearance

WARNINGS SECTION

Warnings: For external use only

  • when using this product skin irritation may occur
  • some medicines may interact with dimethicone, however, no specific interactions are known at this time

Do not use

  • if you are allergic to any ingredients listed
  • if you have sensitive skin and/or are sensitive to Dimethicone
  • do not use if you are pregnant, planning to become pregnant, or breast feeding
  • if you have an open wound, burn, damaged or irritaed skin

When using this product

  • skin irritation may occur, characterized by redness, burning, itching, peeling, or possibly swelling
  • should irritation occur lesson frequency of use
  • avoid unnecessary sun exposure and use a 45 SPF sun screen when going outside

Stop use and ask a doctor

  • if any of these severe side effects occur: allergic reaction, irritation become severe i.e. persistant rash, hives, itching, burning, difficulty breathing, swelling

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 immediately.

INDICATIONS & USAGE SECTION

Directions:

  • cleanse gently
  • apply SIMPLY FIRM BODY
  • massage into desired area using long upward strokes
  • start with a single application, gradually increase to as many applications as desired
  • when going outside be sure to use a 45 SPF SUN SCREEN applicable to the area
  • if excessive irritation or sensitivity develops stop use of product and contact a physician

INACTIVE INGREDIENT SECTION

Other ingredients: Water, Almond Oil, Glycerin, Cetearyl alcohol, Cetearteh-12, Mineral Oil, L-Carnitine, DMAE bitartrate, Sodium Ascorbyl Fosphate, Carbomer, Green Tea extract, Coffe Berry extract, Trietanolamine, Sodium Lauryl Sulphate, Vitamin C, Pepermint Oil, Menthol, Almond scent, Green Tea scent, Coco scent, EDTA disodium.

DOSAGE & ADMINISTRATION SECTION

2 fl oz / 60 mL

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

label imagelabel image

DailyMed Pharmacologic Classes#

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

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
777d68c6-a5ab-e06c-d314-677b0b9af0c8Product name220240508
08c722ec-780f-bb7b-8f14-3d4f7bf0e098Product name220240205
e2f276e5-439f-b432-b5e5-b0cfa993da69Product name320220609
4585a4fb-0028-3d95-020c-9b1c40bf15e0Product name120140508

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
51439-001-012019-11-27C16284748780-19855d018-e3a5-cd31-e053-dbdaa90ab51adfa588ae-1f3a-4a8f-be0f-027b0938fb11

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
51439-001-01Simply Firm Eye - Non-Surgical Face Lift60 mg in 1 TUBEGEL602

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
51439-001SIMPLY FIRM EYE - NON-SURGICAL FACE LIFT (DIMETHICONE GEL) GEL [CAREPLUSS PHARMA S.A. DE C.V.]2Legacy NDC, 1 package rows20130423_dfa588ae-1f3a-4a8f-be0f-027b0938fb11.zip

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIISPL versionUploaded
DIMETHICONEACTIVE INGREDIENT92RU3N3Y1O2
DIMETHICONEACTIVE MOIETY92RU3N3Y1O2
ALMONDINACTIVE INGREDIENT3Z252A2K9G2
ALMOND OILINACTIVE INGREDIENT66YXD4DKO92
ASCORBIC ACIDINACTIVE INGREDIENTPQ6CK8PD0R2
BUTYLATED HYDROXYANISOLEINACTIVE INGREDIENTREK4960K2U2
BUTYLATED HYDROXYTOLUENEINACTIVE INGREDIENT1P9D0Z171K2
CARBOMER HOMOPOLYMER TYPE A (ALLYL PENTAERYTHRITOL CROSSLINKED)INACTIVE INGREDIENTF68VH75CJC2
CETEARETH-12INACTIVE INGREDIENT7V4MR24V5P2
CETYL ALCOHOLINACTIVE INGREDIENT936JST6JCN2
COCONUTINACTIVE INGREDIENT3RT3536DHY2
COFFEE BEANINACTIVE INGREDIENTJFH385Y7442
DEANOLINACTIVE INGREDIENT2N6K9DRA242
EDETIC ACIDINACTIVE INGREDIENT9G34HU7RV02
GLYCERININACTIVE INGREDIENTPDC6A3C0OX2
GREEN TEA LEAFINACTIVE INGREDIENTW2ZU1RY8B02
LEVOCARNITINEINACTIVE INGREDIENT0G389FZZ9M2
LIME (CITRUS)INACTIVE INGREDIENT8CZS5469542
METHYLPARABENINACTIVE INGREDIENTA2I8C7HI9T2
MINERAL OILINACTIVE INGREDIENTT5L8T28FGP2
MINTINACTIVE INGREDIENTFV98Z8GITP2
PEPPERMINT OILINACTIVE INGREDIENTAV092KU4JH2
POMEGRANATE SEED OILINACTIVE INGREDIENT0UI45XV0T62
PROPYLPARABENINACTIVE INGREDIENTZ8IX2SC1OH2
SODIUM ASCORBYL PHOSPHATEINACTIVE INGREDIENT836SJG51DR2
SODIUM DODECYLBENZENESULFONATEINACTIVE INGREDIENT554127163Y2
SUNFLOWER OILINACTIVE INGREDIENT3W1JG795YI2
TROLAMINEINACTIVE INGREDIENT9O3K93S3TK2
VITIS VINIFERA SEEDINACTIVE INGREDIENTC34U15ICXA2
WATERINACTIVE INGREDIENT059QF0KO0R2

Products#

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

DailyMed product names page 1 of 1 · 31 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
51439-00151439-001-01

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
ALMOND OIL66YXD4DKO9IACT
GLYCERINPDC6A3C0OXIACT
CETYL ALCOHOL936JST6JCNIACT
CETEARETH-127V4MR24V5PIACT
MINERAL OILT5L8T28FGPIACT
LEVOCARNITINE0G389FZZ9MIACT
DEANOL2N6K9DRA24IACT
SODIUM ASCORBYL PHOSPHATE836SJG51DRIACT
GREEN TEA LEAFW2ZU1RY8B0IACT
COFFEE BEANJFH385Y744IACT
TROLAMINE9O3K93S3TKIACT
SODIUM DODECYLBENZENESULFONATE554127163YIACT
ASCORBIC ACIDPQ6CK8PD0RIACT
PEPPERMINT OILAV092KU4JHIACT
MINTFV98Z8GITPIACT
ALMOND3Z252A2K9GIACT
COCONUT3RT3536DHYIACT
LIME (CITRUS)8CZS546954IACT
EDETIC ACID9G34HU7RV0IACT
METHYLPARABENA2I8C7HI9TIACT
PROPYLPARABENZ8IX2SC1OHIACT
BUTYLATED HYDROXYTOLUENE1P9D0Z171KIACT
BUTYLATED HYDROXYANISOLEREK4960K2UIACT
SUNFLOWER OIL3W1JG795YIIACT
VITIS VINIFERA SEEDC34U15ICXAIACT
POMEGRANATE SEED OIL0UI45XV0T6IACT
CARBOMER HOMOPOLYMER TYPE A (ALLYL PENTAERYTHRITOL CROSSLINKED)F68VH75CJCIACT

Source Document#

Source XML · Source PDF

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 7 · 418 matching rows.

DailyMed ingredient, IID ingredient, UNII table
DailyMed ingredientIID ingredientUNIIDosage form / routePotencyMaximum daily exposureMatch
METHYLPARABENMETHYLPARABENA2I8C7HI9TJELLY / TOPICAL420 mgExact identifier — unii candidate
79 equally ranked IID candidates
GLYCERINGLYCERINPDC6A3C0OXGUM, CHEWING / BUCCAL230 mgExact identifier — unii candidate
75 equally ranked IID candidates
EDETIC ACIDEDETIC ACID9G34HU7RV0INJECTION, SOLUTION / SUBCUTANEOUS2 mgExact identifier — unii candidate
13 equally ranked IID candidates
METHYLPARABENMETHYLPARABENA2I8C7HI9TSOLUTION / INTRAVENOUS0.13 %w/vExact identifier — unii candidate
79 equally ranked IID candidates
METHYLPARABENMETHYLPARABENA2I8C7HI9TSOLUTION / IONTOPHORESIS0.1 %w/vExact identifier — unii candidate
79 equally ranked IID candidates
GLYCERINGLYCERINPDC6A3C0OXEMULSION / INTRAVENOUS2.2 %w/vExact identifier — unii candidate
75 equally ranked IID candidates
CETYL ALCOHOLCETYL ALCOHOL936JST6JCNTABLET, EXTENDED RELEASE / ORAL132 mgExact identifier — unii candidate
20 equally ranked IID candidates
METHYLPARABENMETHYLPARABENA2I8C7HI9TTABLET / ORAL1.8 mgExact identifier — unii candidate
79 equally ranked IID candidates
METHYLPARABENMETHYLPARABENA2I8C7HI9TCREAM, AUGMENTED / TOPICAL2 mgExact identifier — unii candidate
79 equally ranked IID candidates
MINERAL OILMINERAL OILT5L8T28FGPTABLET, COATED / ORAL1.5 mgExact identifier — unii candidate
30 equally ranked IID candidates
METHYLPARABENMETHYLPARABENA2I8C7HI9TSUSPENSION / AURICULAR (OTIC)NAExact identifier — unii candidate
79 equally ranked IID candidates
METHYLPARABENMETHYLPARABENA2I8C7HI9TSHAMPOO, SUSPENSION / TOPICAL0.15 %w/wExact identifier — unii candidate
79 equally ranked IID candidates
ASCORBIC ACIDASCORBIC ACIDPQ6CK8PD0RAEROSOL, METERED / RESPIRATORY (INHALATION)0.1 %w/wExact identifier — unii candidate
25 equally ranked IID candidates
GLYCERINGLYCERINPDC6A3C0OXSOLUTION / ORAL32400 mgExact identifier — unii candidate
75 equally ranked IID candidates
CARBOMER HOMOPOLYMER TYPE A (ALLYL PENTAERYTHRITOL CROSSLINKED)CARBOMER HOMOPOLYMER TYPE A (ALLYL PENTAERYTHRITOL CROSSLINKED)F68VH75CJCGEL / TOPICAL8 mgExact identifier — unii candidate
5 equally ranked IID candidates
CETYL ALCOHOLCETYL ALCOHOL936JST6JCNAEROSOL, FOAM / VAGINAL0.75 %w/wExact identifier — unii candidate
20 equally ranked IID candidates
METHYLPARABENMETHYLPARABENA2I8C7HI9TCONCENTRATE / ORAL12 mgExact identifier — unii candidate
79 equally ranked IID candidates
PROPYLPARABENPROPYLPARABENZ8IX2SC1OHINJECTION / INTRAMUSCULAR6 mgExact identifier — unii candidate
68 equally ranked IID candidates
GLYCERINGLYCERINPDC6A3C0OXINJECTION / INTRADERMAL1.6 %w/vExact identifier — unii candidate
75 equally ranked IID candidates
METHYLPARABENMETHYLPARABENA2I8C7HI9TGEL / TOPICAL24 mgExact identifier — unii candidate
79 equally ranked IID candidates
GLYCERINGLYCERINPDC6A3C0OXSOAP / TOPICAL0.76 %w/wExact identifier — unii candidate
75 equally ranked IID candidates
GLYCERINGLYCERINPDC6A3C0OXINJECTION, POWDER, LYOPHILIZED, FOR SOLUTION / INTRAVENOUS225 mgExact identifier — unii candidate
75 equally ranked IID candidates
BUTYLATED HYDROXYANISOLEBUTYLATED HYDROXYANISOLEREK4960K2UTABLET, ORALLY DISINTEGRATING / ORAL2 mgExact identifier — unii candidate
24 equally ranked IID candidates
PROPYLPARABENPROPYLPARABENZ8IX2SC1OHFILM, SOLUBLE / BUCCAL1 mgExact identifier — unii candidate
68 equally ranked IID candidates
METHYLPARABENMETHYLPARABENA2I8C7HI9TDROPS / NASAL26 mgExact identifier — unii candidate
79 equally ranked IID candidates
TROLAMINETROLAMINE9O3K93S3TKCREAM / TOPICAL1 %w/wExact identifier — unii candidate
22 equally ranked IID candidates
BUTYLATED HYDROXYANISOLEBUTYLATED HYDROXYANISOLEREK4960K2USUPPOSITORY / VAGINAL1 mgExact identifier — unii candidate
24 equally ranked IID candidates
METHYLPARABENMETHYLPARABENA2I8C7HI9TINJECTION, SOLUTION / INTRAVENOUS45 mgExact identifier — unii candidate
79 equally ranked IID candidates
TROLAMINETROLAMINE9O3K93S3TKSHAMPOO / TOPICAL3.7 %w/wExact identifier — unii candidate
22 equally ranked IID candidates
METHYLPARABENMETHYLPARABENA2I8C7HI9TINJECTION / SOFT TISSUE0.15 %w/vExact identifier — unii candidate
79 equally ranked IID candidates
BUTYLATED HYDROXYANISOLEBUTYLATED HYDROXYANISOLEREK4960K2USUPPOSITORY / RECTAL1 mgExact identifier — unii candidate
24 equally ranked IID candidates
PEPPERMINT OILPEPPERMINT OILAV092KU4JHPOWDER / SUBLINGUAL1 mgExact identifier — unii candidate
21 equally ranked IID candidates
METHYLPARABENMETHYLPARABENA2I8C7HI9TSUSPENSION / TOPICAL0.24 %w/vExact identifier — unii candidate
79 equally ranked IID candidates
BUTYLATED HYDROXYTOLUENEBUTYLATED HYDROXYTOLUENE1P9D0Z171KLOTION / TOPICAL1000 mgExact identifier — unii candidate
32 equally ranked IID candidates
BUTYLATED HYDROXYTOLUENEBUTYLATED HYDROXYTOLUENE1P9D0Z171KSUPPOSITORY / RECTAL1 mgExact identifier — unii candidate
32 equally ranked IID candidates
ASCORBIC ACIDASCORBIC ACIDPQ6CK8PD0RCAPSULE / ORAL7 mgExact identifier — unii candidate
25 equally ranked IID candidates
METHYLPARABENMETHYLPARABENA2I8C7HI9TINJECTION / INTRADERMAL1 mgExact identifier — unii candidate
79 equally ranked IID candidates
PROPYLPARABENPROPYLPARABENZ8IX2SC1OHSUSPENSION, EXTENDED RELEASE / ORAL4 mgExact identifier — unii candidate
68 equally ranked IID candidates
PROPYLPARABENPROPYLPARABENZ8IX2SC1OHINJECTION, SOLUTION / INTRAMUSCULAR5 mgExact identifier — unii candidate
68 equally ranked IID candidates
PROPYLPARABENPROPYLPARABENZ8IX2SC1OHAEROSOL, FOAM / TOPICAL0.04 %w/wExact identifier — unii candidate
68 equally ranked IID candidates
METHYLPARABENMETHYLPARABENA2I8C7HI9TINJECTION / INTRAVENOUS95 mgExact identifier — unii candidate
79 equally ranked IID candidates
BUTYLATED HYDROXYANISOLEBUTYLATED HYDROXYANISOLEREK4960K2UINJECTION, POWDER, FOR SOLUTION / INTRAVENOUSNAExact identifier — unii candidate
24 equally ranked IID candidates
METHYLPARABENMETHYLPARABENA2I8C7HI9TSOLUTION / RESPIRATORY (INHALATION)0.03 %w/wExact identifier — unii candidate
79 equally ranked IID candidates
MINERAL OILMINERAL OILT5L8T28FGPOINTMENT / AURICULAR (OTIC)NAExact identifier — unii candidate
30 equally ranked IID candidates
PROPYLPARABENPROPYLPARABENZ8IX2SC1OHINJECTION, SUSPENSION / SUBCUTANEOUS0.02 %w/vExact identifier — unii candidate
68 equally ranked IID candidates
GLYCERINGLYCERINPDC6A3C0OXSOLUTION/ DROPS / AURICULAR (OTIC)25 mgExact identifier — unii candidate
75 equally ranked IID candidates
GLYCERINGLYCERINPDC6A3C0OXSPRAY / NASAL22.3 mg/1mlExact identifier — unii candidate
75 equally ranked IID candidates
METHYLPARABENMETHYLPARABENA2I8C7HI9TINJECTION / PERIDURAL1 mgExact identifier — unii candidate
79 equally ranked IID candidates
TROLAMINETROLAMINE9O3K93S3TKGEL / TOPICAL6 mgExact identifier — unii candidate
22 equally ranked IID candidates
PROPYLPARABENPROPYLPARABENZ8IX2SC1OHPOWDER, FOR SUSPENSION / ORAL8 mgExact identifier — unii candidate
68 equally ranked IID candidates
PROPYLPARABENPROPYLPARABENZ8IX2SC1OHSUSPENSION/ DROPS / OPHTHALMIC0.01 %w/wExact identifier — unii candidate
68 equally ranked IID candidates
BUTYLATED HYDROXYTOLUENEBUTYLATED HYDROXYTOLUENE1P9D0Z171KTABLET / ORAL3 mgExact identifier — unii candidate
32 equally ranked IID candidates
GLYCERINGLYCERINPDC6A3C0OXSOLUTION / TOPICAL1971 mgExact identifier — unii candidate
75 equally ranked IID candidates
CETYL ALCOHOLCETYL ALCOHOL936JST6JCNSUSPENSION / OPHTHALMIC0.5 %w/vExact identifier — unii candidate
20 equally ranked IID candidates
PROPYLPARABENPROPYLPARABENZ8IX2SC1OHINJECTION / INTRAVENOUS6 mgExact identifier — unii candidate
68 equally ranked IID candidates
METHYLPARABENMETHYLPARABENA2I8C7HI9TSUSPENSION, EXTENDED RELEASE / ORAL40 mgExact identifier — unii candidate
79 equally ranked IID candidates
TROLAMINETROLAMINE9O3K93S3TKEMULSION / TOPICAL0.5 %w/wExact identifier — unii candidate
22 equally ranked IID candidates
EDETIC ACIDEDETIC ACID9G34HU7RV0CREAM / TOPICAL0.5 %w/wExact identifier — unii candidate
13 equally ranked IID candidates
BUTYLATED HYDROXYTOLUENEBUTYLATED HYDROXYTOLUENE1P9D0Z171KSOLUTION / ORAL14 mgExact identifier — unii candidate
32 equally ranked IID candidates
PROPYLPARABENPROPYLPARABENZ8IX2SC1OHGEL / TOPICAL4 mgExact identifier — unii candidate
68 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
d12e00d9-1373-4c8e-accc-8c24c2dbd14ddfa588ae-1f3a-4a8f-be0f-027b0938fb112013-04-23WarningsExact identifier
spl id: d12e00d9-1373-4c8e-accc-8c24c2dbd14d
spl set id: dfa588ae-1f3a-4a8f-be0f-027b0938fb11

Reported adverse events (FAERS/openFDA)#

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