FDA.reportPublic FDA data

Skin Repair Cream

Manufacturer
Gentell LLC
Effective date
2026-08-19
Label type
HUMAN OTC DRUG LABEL
Version
1
Source
daily-update
Hydrated at
2026-08-21 02:01:58

Label at a glance#

ProductClaravie Skin Repair Cream
Active ingredientDIMETHICONE
Label structure10 sections

Indications and uses

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

Dosage and administration

Apply as needed

Storage and handling

Store between 59°F-86°F (15°C-30C)

Label contents#

Full prescribing information#

Active Ingredients

OTC - ACTIVE INGREDIENT SECTION

Dimethicone 1.5%

Purpose

OTC - PURPOSE SECTION

Skin Protectant

Uses

INDICATIONS & USAGE SECTION

Temporarily protects and helps relieve chafed chapped or cracked skin

Helps protect from the drying effects of wind and cold weather

Warnings

WARNINGS SECTION

For external use only

When using this product

do not use near or get into the 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 or puncture wounds

animal bites

serious burns

Keep out of reach of children

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

In case of accidental ingestion contact a physician or Poison Control Center right away.

Directions

INSTRUCTIONS FOR USE SECTION

Apply as needed

Other Information

STORAGE AND HANDLING SECTION

Store between 59°F-86°F (15°C-30C)

Inactive Ingredients

INACTIVE INGREDIENT SECTION

Water, Propylene Glycol, Ceteary| Alcohol, Glycerin, Glyceryl Monostearate, Stearic Acid, PEG-100 Stearate, Carbomer, Olive Oil, Corn Oil, Canola Oil, Niacinamide, Alpha - Tocopherol Acetate, Vitamin A Palmitate, Cholecalciferol, Edetate Disodium, Aloe Vera Extract, Citrus Medica Limonum (Lemon) Peel Oil, Orange Oil, Lavender Oil, Sodium Hydroxide Ethylhexylglycerin, Phenoxyethanol, Pyridoxine HCI Fragrance, FD&C Blue No, 1, FD&C Red No. 40, FD&C Yellow No. 6

DOSAGE & ADMINISTRATION SECTION

Apply as needed.

Skin Repair Cream

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Skin Repair Cream

Skin Repair CreamSkin Repair Cream

Product Linked Resources#

Resource, Code type, Value table
ResourceCode typeValueEquivalent identifiersSource image
BarcodeEAN-130361554011172GTIN-13: 0361554011172
EAN-13: 0361554011172
GTIN-12: 361554011172
UPC-A: 361554011172
GTIN storage (14 digits): 00361554011172		Skin Repair Cream 4oz.jpg

Products#

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

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

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
61554-30361554-303-11

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 28 matching rows.

Name, UNII, Kind table
NameUNIIKind
DIMETHICONE92RU3N3Y1OACTIB
WATER059QF0KO0RIACT
PROPYLENE GLYCOL6DC9Q167V3IACT
CETEARYL ALCOHOL2DMT128M1SIACT
GLYCERINPDC6A3C0OXIACT
GLYCERYL MONOSTEARATE230OU9XXE4IACT
STEARIC ACID4ELV7Z65APIACT
PEG-100 STEARATEYD01N1999RIACT
CARBOMER0A5MM307FCIACT
OLIVE OIL6UYK2W1W1EIACT
CORN OIL8470G57WFMIACT
CANOLA OIL331KBJ17RKIACT
NIACINAMIDE25X51I8RD4IACT
ALPHA-TOCOPHEROL ACETATE9E8X80D2L0IACT
VITAMIN A PALMITATE1D1K0N0VVCIACT
CHOLECALCIFEROL1C6V77QF41IACT
EDETATE DISODIUM7FLD91C86KIACT
ALOE VERA LEAFZY81Z83H0XIACT
CITRUS LIMON (LEMON) PEEL OILI9GRO824LLIACT
ORANGE OILAKN3KSD11BIACT
LAVENDER OILZBP1YXW0H8IACT
SODIUM HYDROXIDE55X04QC32IIACT
ETHYLHEXYLGLYCERIN147D247K3PIACT
PHENOXYETHANOLHIE492ZZ3TIACT
PYRIDOXINE HCL68Y4CF58BVIACT
FRAGRANCE LEMON ORC2001060K1725A7G95IACT
FD&C RED NO. 40WZB9127XOAIACT
FD&C YELLOW NO. 6H77VEI93A8IACT

Source Document#

Source XML

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
Claravie Skin Repair CreamDIMETHICONEGentell LLC596ae269-172e-aef5-e063-6394a90a4e2a2026-08-19WarningsExact identifier
ndc (package): 61554-303-11
ndc (product): 61554-303
ndc11 (package): 61554030311
spl id: 596ae269-172f-aef5-e063-6394a90a4e2a
spl set id: 596ae269-172e-aef5-e063-6394a90a4e2a

Reported adverse events (FAERS/openFDA)#

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