RENEW SKIN REPAIR- otc skin protectant drug products cream 
Dermarite Industries LLC

Disclaimer: Most OTC drugs are not reviewed and approved by FDA, however they may be marketed if they comply with applicable regulations and policies. FDA has not evaluated whether this product complies.

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DRUG LISTING: RENEW SKIN REPAIR CREAM

Active Ingredient:

Dimethicone 1.5%

Purpose:

Skin Protectant

Uses:

Temporarily protects and helps relieve chapped or cracked skin. Benificial for face, hands, body, and legs.

Warnings:

Warnings:

Directions:

Apply cream liberally as needed.

Other Information:

Inactive Infredients:

Water, Olea Europaea(Olive) Oil, Zea Mays (Corn) Oil, Canola Oil, Stearic Acid, glyceryl Stearate, PEG-100 Stearate, Propylene Glycol, Triethanolamine, Aloe Barbadensis Leaf Juice, Glycerin, Butylparaben, Ethylparaben, Isobutylparaben, methylparaben, Phenoxyethanol, propylparaben, Citrus Aurantium Dulcis (orange) Peel Oil, Anthemis Nobilis Flower Oil, Lavandula Officinalis (lavender) Oil, Fragrance, Cetearyl Alcohol, Carbomer, Ascorbyl Palmitate, Disodium EDTA, Tocopheryl Acetate, Niacinamide, Retinyl Palmitate, Cholecalciferol, Pyridoxine HCL

Questions?

Call 1-800-337-6296 Mon-Fri 9AM-5PM EST.

Package Label Principal Display Panel

328005 gr4oz

RENEW SKIN REPAIR 
otc skin protectant drug products cream
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:61924-405
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
DIMETHICONE (UNII: 92RU3N3Y1O) (DIMETHICONE - UNII:92RU3N3Y1O) DIMETHICONE0.015 g  in 100 g
Inactive Ingredients
Ingredient NameStrength
ALOE VERA LEAF (UNII: ZY81Z83H0X)  
ASCORBYL PALMITATE (UNII: QN83US2B0N)  
BUTYLPARABEN (UNII: 3QPI1U3FV8)  
CANOLA OIL (UNII: 331KBJ17RK)  
CARBOMER 940 (UNII: 4Q93RCW27E)  
CETOSTEARYL ALCOHOL (UNII: 2DMT128M1S)  
CHOLECALCIFEROL (UNII: 1C6V77QF41)  
ETHYLPARABEN (UNII: 14255EXE39)  
GLYCERIN (UNII: PDC6A3C0OX)  
GLYCERYL MONOSTEARATE (UNII: 230OU9XXE4)  
ISOBUTYLPARABEN (UNII: 0QQJ25X58G)  
METHYLPARABEN (UNII: A2I8C7HI9T)  
NIACINAMIDE (UNII: 25X51I8RD4)  
OLIVE OIL (UNII: 6UYK2W1W1E)  
PEG-100 STEARATE (UNII: YD01N1999R)  
PHENOXYETHANOL (UNII: HIE492ZZ3T)  
PROPYLENE GLYCOL (UNII: 6DC9Q167V3)  
PROPYLPARABEN (UNII: Z8IX2SC1OH)  
PYRIDOXINE HYDROCHLORIDE (UNII: 68Y4CF58BV)  
VITAMIN A PALMITATE (UNII: 1D1K0N0VVC)  
STEARIC ACID (UNII: 4ELV7Z65AP)  
.ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)  
TROLAMINE (UNII: 9O3K93S3TK)  
EDETATE DISODIUM (UNII: 7FLD91C86K)  
WATER (UNII: 059QF0KO0R)  
CORN OIL (UNII: 8470G57WFM)  
Product Characteristics
ColorwhiteScore    
ShapeSize
FlavorImprint Code
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:61924-405-27793 g in 1 BAG; Type 0: Not a Combination Product03/03/2011
2NDC:61924-405-04113 g in 1 TUBE; Type 0: Not a Combination Product03/03/2011
3NDC:61924-405-32907 g in 1 BOTTLE, PUMP; Type 0: Not a Combination Product03/03/2011
4NDC:61924-405-055 g in 1 PACKET; Type 0: Not a Combination Product03/03/2011
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph finalpart34703/03/2011
Labeler - Dermarite Industries LLC (883925562)
Registrant - Dermarite Industries LLC (883925562)
Establishment
NameAddressID/FEIBusiness Operations
Dermarite Industries LLC883925562manufacture(61924-405)

Revised: 1/2020
Document Id: 9c598909-7909-e69a-e053-2995a90a1402
Set id: 871cd64d-c3a5-4be9-a8fc-ce8bc28a5f71
Version: 6
Effective Time: 20200117
 
Dermarite Industries LLC