Renew Dimethicone Skin Protectant

Manufacturer: Dermarite Industries LLC
Effective date: 2024-12-05
Label type: HUMAN OTC DRUG LABEL
Version: 6
Source: full-release
Hydrated at: 2026-06-01 00:41:01

Label at a glance#

ProductRenew Dimethicone Skin Protectant

Active ingredientDIMETHICONE

Label structure10 sections

Indications and uses

Forms a moisture barrier that prevents and helps treat effects associated with diaper rash from wetness, urine, or stool. Temporarily protects and helps relieve chapped or cracked skin.

Dosage and administration

Clean skin gently with mild skin cleanser. Pat dry or allow to air dry. Apply as necessary. If applying to perineal area, apply after each incontinent episode or diaper change to promote comfort and long lasting protection.

Contacts and useful links#

PhoneLabel contact1-800-37-6296

Label contents#

Full prescribing information#

Active Ingredient:

OTC - ACTIVE INGREDIENT SECTION

Dimethicone 5%

Purpose:

OTC - PURPOSE SECTION

Skin Protectant

Uses:

INDICATIONS & USAGE SECTION

Forms a moisture barrier that prevents and helps treat effects associated with diaper rash from wetness, urine, or stool.
Temporarily protects and helps relieve chapped or cracked skin.

Warnings:

WARNINGS SECTION

For external use only.
Avoid contact with eyes. In case of contact, flush thoroughly with water.
Stop use and ask a doctor if condition worsens or does not improve within 7 days.
Do not use on deep or punctured wounds.

Warnings:

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

Keep out of reach of children. In case of accidental ingestion contact physician or Poison Control Center right away.

Directions:

DOSAGE & ADMINISTRATION SECTION

Other Information:

OTHER SAFETY INFORMATION

Store at room temperature (59 ^o- 86 ^oF)

Inactive Ingredients:

INACTIVE INGREDIENT SECTION

Aloe Barbadensis Leaf Juice, Aluminum Stearate, Cera Alba, Cholecalciferol, Chloroxylenol, Corn Oil, Imidiazolidinyl Urea, Dicocoyl Pentaerythrityl Distearyl Citrate, Fragrance, Lanolin, Methylparaben, Mineral Oil, Paraffin wax, Petrolatum, Phenoxyethanol, Propylene Glycol, Propylparaben, Retinyl Palmitate, Sorbitan Sesquioleate, Tocopheryl Acetate, Water.

Questions?

OTC - QUESTIONS SECTION

Call 1-800-37-6296

Renew Skin Protectant Package Label Principal Display Panel

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Renew Dimethicone Skin Protectant tube labelRenew Dimethicone Skin Protectant 4ox box label

DailyMed Pharmacologic Classes#

Class, Version, Type table
Class	Version	Type	Effective
DIMETHICONE Pharmacologic Class Indexing	3	Indexing - Pharmacologic Class	20180813

DailyMed Product Concepts#

Product concept, Relation, Version table
Product concept	Relation	Version	Effective
59361619-24d9-b610-eca6-5a7f25ed5e03	Product name	5	20240909
5e18e798-5614-cf5c-0185-38b1cb77a093	Product name	2	20160822
ebc62596-fc97-4d03-9483-7ba095d25db7	Product name	1	20151210
60c52429-fcef-eb54-2387-43bc9e4f296b	Product name	1	20140508

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDC	Effective	Action	Document	Indexing SPL	Related label
61924-410-04	2026-01-29	C162847	48780-1	d6a99b39-ed3f-a426-e053-dadaa90af4c2	DRUG LISTING: Renew Dimethicone Skin Protectant
61924-410-05	2026-01-29	C162847	48780-1	d6a99b39-ed3f-a426-e053-dadaa90af4c2	DRUG LISTING: Renew Dimethicone Skin Protectant
61924-410-04	2024-12-06	C162847	48780-1	d6a99b39-ed3f-a426-e053-dadaa90af4c2	DRUG LISTING: Renew Dimethicone Skin Protectant
61924-410-05	2024-12-06	C162847	48780-1	d6a99b39-ed3f-a426-e053-dadaa90af4c2	DRUG LISTING: Renew Dimethicone Skin Protectant
61924-410-04	2022-01-28	C162847	48780-1	d6a99b39-ed3f-a426-e053-dadaa90af4c2	DRUG LISTING: Renew Dimethicone Skin Protectant
61924-410-05	2022-01-28	C162847	48780-1	d6a99b39-ed3f-a426-e053-dadaa90af4c2	DRUG LISTING: Renew Dimethicone Skin Protectant

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	Strength	SPL version
61924-410-04	Renew Dimethicone Skin Protectant	113 g in 1 TUBE	CREAM	113		6
61924-410-05	Renew Dimethicone Skin Protectant	5 g in 1 PACKET	CREAM	5		6

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
61924-410	RENEW DIMETHICONE SKIN PROTECTANT (SKIN PROTECTANT) CREAM [DERMARITE INDUSTRIES LLC]	6	Legacy NDC, 2 package rows	20241208_ae82d2b7-eb86-4bbe-825c-f7d7cd7610ad.zip

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
Ingredient	Type	UNII	SPL version
DIMETHICONE	ACTIVE INGREDIENT	92RU3N3Y1O	2
DIMETHICONE	ACTIVE MOIETY	92RU3N3Y1O	2
.ALPHA.-TOCOPHEROL ACETATE	INACTIVE INGREDIENT	9E8X80D2L0	2
Aloe Vera Leaf	INACTIVE INGREDIENT	ZY81Z83H0X	2
Ascorbyl Palmitate	INACTIVE INGREDIENT	QN83US2B0N	2
Butylparaben	INACTIVE INGREDIENT	3QPI1U3FV8	2
Canola Oil	INACTIVE INGREDIENT	331KBJ17RK	2
CARBOMER 940	INACTIVE INGREDIENT	4Q93RCW27E	2
CETOSTEARYL ALCOHOL	INACTIVE INGREDIENT	2DMT128M1S	2
Cholecalciferol	INACTIVE INGREDIENT	1C6V77QF41	2
Corn Oil	INACTIVE INGREDIENT	8470G57WFM	2
EDETATE DISODIUM	INACTIVE INGREDIENT	7FLD91C86K	2
Ethylparaben	INACTIVE INGREDIENT	14255EXE39	2
Glycerin	INACTIVE INGREDIENT	PDC6A3C0OX	2
GLYCERYL MONOSTEARATE	INACTIVE INGREDIENT	230OU9XXE4	2
Isobutylparaben	INACTIVE INGREDIENT	0QQJ25X58G	2
Methylparaben	INACTIVE INGREDIENT	A2I8C7HI9T	2
Niacinamide	INACTIVE INGREDIENT	25X51I8RD4	2
Olive Oil	INACTIVE INGREDIENT	6UYK2W1W1E	2
PEG-100 Stearate	INACTIVE INGREDIENT	YD01N1999R	2
Phenoxyethanol	INACTIVE INGREDIENT	HIE492ZZ3T	2
Propylene Glycol	INACTIVE INGREDIENT	6DC9Q167V3	2
Propylparaben	INACTIVE INGREDIENT	Z8IX2SC1OH	2
Pyridoxine Hydrochloride	INACTIVE INGREDIENT	68Y4CF58BV	2
Stearic Acid	INACTIVE INGREDIENT	4ELV7Z65AP	2
TROLAMINE	INACTIVE INGREDIENT	9O3K93S3TK	2
VITAMIN A PALMITATE	INACTIVE INGREDIENT	1D1K0N0VVC	2
Water	INACTIVE INGREDIENT	059QF0KO0R	2

Products#

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

DailyMed product names page 1 of 1 · 29 matching rows.

Renew Dimethicone Skin Protectant
Skin Protectant
ALOE VERA LEAF
ASCORBYL PALMITATE
BUTYLPARABEN
CANOLA OIL
CARBOMER 940
CETOSTEARYL ALCOHOL
CHOLECALCIFEROL
ETHYLPARABEN
GLYCERIN
GLYCERYL MONOSTEARATE
ISOBUTYLPARABEN
METHYLPARABEN
NIACINAMIDE
OLIVE OIL
PEG-100 STEARATE
PHENOXYETHANOL
PROPYLENE GLYCOL
PROPYLPARABEN
PYRIDOXINE HYDROCHLORIDE
VITAMIN A PALMITATE
STEARIC ACID
.ALPHA.-TOCOPHEROL ACETATE
TROLAMINE
EDETATE DISODIUM
WATER
CORN OIL
DIMETHICONE

NDC Codes#

Product NDC, Package NDC table
Product NDC	Package NDC
61924-410	61924-410-05, 61924-410-04

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 27 matching rows.

Name, UNII, Kind table
Name	UNII	Kind
ALOE VERA LEAF	ZY81Z83H0X	IACT
ASCORBYL PALMITATE	QN83US2B0N	IACT
BUTYLPARABEN	3QPI1U3FV8	IACT
CANOLA OIL	331KBJ17RK	IACT
CARBOMER 940	4Q93RCW27E	IACT
CETOSTEARYL ALCOHOL	2DMT128M1S	IACT
CHOLECALCIFEROL	1C6V77QF41	IACT
ETHYLPARABEN	14255EXE39	IACT
GLYCERIN	PDC6A3C0OX	IACT
GLYCERYL MONOSTEARATE	230OU9XXE4	IACT
ISOBUTYLPARABEN	0QQJ25X58G	IACT
METHYLPARABEN	A2I8C7HI9T	IACT
NIACINAMIDE	25X51I8RD4	IACT
OLIVE OIL	6UYK2W1W1E	IACT
PEG-100 STEARATE	YD01N1999R	IACT
PHENOXYETHANOL	HIE492ZZ3T	IACT
PROPYLENE GLYCOL	6DC9Q167V3	IACT
PROPYLPARABEN	Z8IX2SC1OH	IACT
PYRIDOXINE HYDROCHLORIDE	68Y4CF58BV	IACT
VITAMIN A PALMITATE	1D1K0N0VVC	IACT
STEARIC ACID	4ELV7Z65AP	IACT
.ALPHA.-TOCOPHEROL ACETATE	9E8X80D2L0	IACT
TROLAMINE	9O3K93S3TK	IACT
EDETATE DISODIUM	7FLD91C86K	IACT
WATER	059QF0KO0R	IACT
CORN OIL	8470G57WFM	IACT
DIMETHICONE	92RU3N3Y1O	ACTIB

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 · 524 matching rows.

DailyMed ingredient, IID ingredient, UNII table
DailyMed ingredient	IID ingredient	UNII	Dosage form / route	Potency	Maximum daily exposure	Match
Propylene Glycol	PROPYLENE GLYCOL	6DC9Q167V3	GEL / TOPICAL		4522 mg	Exact identifier — unii candidate 81 equally ranked IID candidates
EDETATE DISODIUM	EDETATE DISODIUM	7FLD91C86K	CAPSULE / ORAL		5 mg	Exact identifier — unii candidate 77 equally ranked IID candidates
CARBOMER 940	CARBOMER HOMOPOLYMER TYPE C (ALLYL PENTAERYTHRITOL CROSSLINKED)	4Q93RCW27E	LOTION / TOPICAL		300 mg	Exact identifier — unii candidate 9 equally ranked IID candidates
Propylparaben	PROPYLPARABEN	Z8IX2SC1OH	OINTMENT / OPHTHALMIC	0.01 %w/w		Exact identifier — unii candidate 68 equally ranked IID candidates
Glycerin	GLYCERIN	PDC6A3C0OX	SOLUTION, CONCENTRATE / ORAL	200 mg/1ml		Exact identifier — unii candidate 75 equally ranked IID candidates
Glycerin	GLYCERIN	PDC6A3C0OX	EMULSION / OPHTHALMIC		3 mg	Exact identifier — unii candidate 75 equally ranked IID candidates
Olive Oil	OLIVE OIL	6UYK2W1W1E	SOLUTION / ORAL	425 mg/1ml		Exact identifier — unii candidate 5 equally ranked IID candidates
Methylparaben	METHYLPARABEN	A2I8C7HI9T	SOLUTION / OPHTHALMIC	0.05 %w/w		Exact identifier — unii candidate 79 equally ranked IID candidates
Propylparaben	PROPYLPARABEN	Z8IX2SC1OH	POWDER, FOR SUSPENSION / ORAL		8 mg	Exact identifier — unii candidate 68 equally ranked IID candidates
Propylene Glycol	PROPYLENE GLYCOL	6DC9Q167V3	SWAB / TOPICAL	34.6 %w/w		Exact identifier — unii candidate 81 equally ranked IID candidates
GLYCERYL MONOSTEARATE	GLYCERYL MONOSTEARATE	230OU9XXE4	SUSPENSION / OPHTHALMIC	0.5 %w/v		Exact identifier — unii candidate 21 equally ranked IID candidates
Propylene Glycol	PROPYLENE GLYCOL	6DC9Q167V3	PASTE / DENTAL	0.5 %w/w		Exact identifier — unii candidate 81 equally ranked IID candidates
Methylparaben	METHYLPARABEN	A2I8C7HI9T	ENEMA / RECTAL	0.18 %w/v		Exact identifier — unii candidate 79 equally ranked IID candidates
Butylparaben	BUTYLPARABEN	3QPI1U3FV8	OINTMENT / TOPICAL	0.18 %w/w		Exact identifier — unii candidate 15 equally ranked IID candidates
Glycerin	GLYCERIN	PDC6A3C0OX	GUM, CHEWING / BUCCAL		230 mg	Exact identifier — unii candidate 75 equally ranked IID candidates
Ascorbyl Palmitate	ASCORBYL PALMITATE	QN83US2B0N	CREAM / TOPICAL	0.02 %w/w		Exact identifier — unii candidate 6 equally ranked IID candidates
Propylene Glycol	PROPYLENE GLYCOL	6DC9Q167V3	SYSTEM / TOPICAL		4200 mg	Exact identifier — unii candidate 81 equally ranked IID candidates
CETOSTEARYL ALCOHOL	CETOSTEARYL ALCOHOL	2DMT128M1S	OINTMENT / TOPICAL	1.2 %w/w		Exact identifier — unii candidate 9 equally ranked IID candidates
Methylparaben	METHYLPARABEN	A2I8C7HI9T	SYSTEM / TOPICAL		42 mg	Exact identifier — unii candidate 79 equally ranked IID candidates
Stearic Acid	STEARIC ACID	4ELV7Z65AP	TABLET, ORALLY DISINTEGRATING / ORAL		10 mg	Exact identifier — unii candidate 26 equally ranked IID candidates
Butylparaben	BUTYLPARABEN	3QPI1U3FV8	DROPS / ORAL	NA		Exact identifier — unii candidate 15 equally ranked IID candidates
EDETATE DISODIUM	EDETATE DISODIUM	7FLD91C86K	GEL / OPHTHALMIC		396 mg	Exact identifier — unii candidate 77 equally ranked IID candidates
EDETATE DISODIUM	EDETATE DISODIUM	7FLD91C86K	INJECTION / INTRALESIONAL	0.05 %w/v		Exact identifier — unii candidate 77 equally ranked IID candidates
EDETATE DISODIUM	EDETATE DISODIUM	7FLD91C86K	INJECTION / INTRA-ARTICULAR	0.05 %w/v		Exact identifier — unii candidate 77 equally ranked IID candidates
Ascorbyl Palmitate	ASCORBYL PALMITATE	QN83US2B0N	TABLET / ORAL	7.14 mg		Exact identifier — unii candidate 6 equally ranked IID candidates
Glycerin	GLYCERIN	PDC6A3C0OX	DOUCHE / VAGINAL	1 %w/w		Exact identifier — unii candidate 75 equally ranked IID candidates
TROLAMINE	TROLAMINE	9O3K93S3TK	LIQUID / TOPICAL	NA		Exact identifier — unii candidate 22 equally ranked IID candidates
Propylparaben	PROPYLPARABEN	Z8IX2SC1OH	CREAM, AUGMENTED / TOPICAL		2 mg	Exact identifier — unii candidate 68 equally ranked IID candidates
CARBOMER 940	CARBOMER HOMOPOLYMER TYPE C (ALLYL PENTAERYTHRITOL CROSSLINKED)	4Q93RCW27E	EMULSION / TOPICAL		6 mg	Exact identifier — unii candidate 9 equally ranked IID candidates
Methylparaben	METHYLPARABEN	A2I8C7HI9T	SUSPENSION / TOPICAL	0.24 %w/v		Exact identifier — unii candidate 79 equally ranked IID candidates
Glycerin	GLYCERIN	PDC6A3C0OX	LOTION / TOPICAL		3990 mg	Exact identifier — unii candidate 75 equally ranked IID candidates
Propylene Glycol	PROPYLENE GLYCOL	6DC9Q167V3	INJECTION, SOLUTION / SUBCUTANEOUS	1.4 %w/v		Exact identifier — unii candidate 81 equally ranked IID candidates
Propylene Glycol	PROPYLENE GLYCOL	6DC9Q167V3	JELLY / TOPICAL	20 %w/w		Exact identifier — unii candidate 81 equally ranked IID candidates
Methylparaben	METHYLPARABEN	A2I8C7HI9T	DROPS / OPHTHALMIC	0.01 %w/w		Exact identifier — unii candidate 79 equally ranked IID candidates
Methylparaben	METHYLPARABEN	A2I8C7HI9T	SOLUTION/ DROPS / OPHTHALMIC	0.05 %w/v		Exact identifier — unii candidate 79 equally ranked IID candidates
EDETATE DISODIUM	EDETATE DISODIUM	7FLD91C86K	GEL / TRANSDERMAL		1 mg	Exact identifier — unii candidate 77 equally ranked IID candidates
Butylparaben	BUTYLPARABEN	3QPI1U3FV8	TABLET, EXTENDED RELEASE / ORAL	0.01 mg		Exact identifier — unii candidate 15 equally ranked IID candidates
EDETATE DISODIUM	EDETATE DISODIUM	7FLD91C86K	INJECTION / SUBCUTANEOUS		6 mg	Exact identifier — unii candidate 77 equally ranked IID candidates
Propylene Glycol	PROPYLENE GLYCOL	6DC9Q167V3	SHAMPOO / TOPICAL	8 %w/w		Exact identifier — unii candidate 81 equally ranked IID candidates
Propylene Glycol	PROPYLENE GLYCOL	6DC9Q167V3	SUSPENSION / AURICULAR (OTIC)	10 %w/v		Exact identifier — unii candidate 81 equally ranked IID candidates
Glycerin	GLYCERIN	PDC6A3C0OX	OINTMENT / TOPICAL	NA		Exact identifier — unii candidate 75 equally ranked IID candidates
Propylparaben	PROPYLPARABEN	Z8IX2SC1OH	POWDER, FOR SOLUTION / ORAL		13 mg	Exact identifier — unii candidate 68 equally ranked IID candidates
Propylene Glycol	PROPYLENE GLYCOL	6DC9Q167V3	TABLET, DELAYED RELEASE / ORAL		36 mg	Exact identifier — unii candidate 81 equally ranked IID candidates
Methylparaben	METHYLPARABEN	A2I8C7HI9T	LOTION / TOPICAL		351 mg	Exact identifier — unii candidate 79 equally ranked IID candidates
Propylparaben	PROPYLPARABEN	Z8IX2SC1OH	SOLUTION / TOPICAL		24 mg	Exact identifier — unii candidate 68 equally ranked IID candidates
Methylparaben	METHYLPARABEN	A2I8C7HI9T	SUSPENSION / RECTAL		1808 mg	Exact identifier — unii candidate 79 equally ranked IID candidates
Methylparaben	METHYLPARABEN	A2I8C7HI9T	INJECTION / PERINEURAL		80 mg	Exact identifier — unii candidate 79 equally ranked IID candidates
Stearic Acid	STEARIC ACID	4ELV7Z65AP	TABLET, DELAYED RELEASE / ORAL		80 mg	Exact identifier — unii candidate 26 equally ranked IID candidates
Niacinamide	NIACINAMIDE	25X51I8RD4	INJECTION / INTRAMUSCULAR	2.5 %w/v		Exact identifier — unii candidate 4 equally ranked IID candidates
Butylparaben	BUTYLPARABEN	3QPI1U3FV8	SOLUTION / OPHTHALMIC	0.02 %w/w		Exact identifier — unii candidate 15 equally ranked IID candidates
Propylene Glycol	PROPYLENE GLYCOL	6DC9Q167V3	SOLUTION / AURICULAR (OTIC)	56.55 %w/v		Exact identifier — unii candidate 81 equally ranked IID candidates
Glycerin	GLYCERIN	PDC6A3C0OX	SOLUTION / DENTAL	15 %w/v		Exact identifier — unii candidate 75 equally ranked IID candidates
Methylparaben	METHYLPARABEN	A2I8C7HI9T	TABLET, COATED / ORAL	0.8 mg		Exact identifier — unii candidate 79 equally ranked IID candidates
Stearic Acid	STEARIC ACID	4ELV7Z65AP	LOTION / TOPICAL		80 mg	Exact identifier — unii candidate 26 equally ranked IID candidates
TROLAMINE	TROLAMINE	9O3K93S3TK	AEROSOL, METERED / RECTAL	ADJ PH		Exact identifier — unii candidate 22 equally ranked IID candidates
Stearic Acid	STEARIC ACID	4ELV7Z65AP	TABLET / SUBLINGUAL	9 mg		Exact identifier — unii candidate 26 equally ranked IID candidates
Propylene Glycol	PROPYLENE GLYCOL	6DC9Q167V3	SOLUTION/ DROPS / OPHTHALMIC	0.75 %w/v		Exact identifier — unii candidate 81 equally ranked IID candidates
Propylene Glycol	PROPYLENE GLYCOL	6DC9Q167V3	SUSPENSION / OPHTHALMIC	0.6 %w/v		Exact identifier — unii candidate 81 equally ranked IID candidates
Glycerin	GLYCERIN	PDC6A3C0OX	TABLET / ORAL		42 mg	Exact identifier — unii candidate 75 equally ranked IID candidates
Methylparaben	METHYLPARABEN	A2I8C7HI9T	FILM, SOLUBLE / BUCCAL		3 mg	Exact identifier — unii candidate 79 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
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
288a24b8-9c5d-df11-e063-6294a90a4bfc			ae82d2b7-eb86-4bbe-825c-f7d7cd7610ad	2024-12-05	Warnings	Exact identifier spl id: 288a24b8-9c5d-df11-e063-6294a90a4bfc spl set id: ae82d2b7-eb86-4bbe-825c-f7d7cd7610ad

Reported adverse events (FAERS/openFDA)#

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