BENCHMARKS DERMA SHIELD- dimethicone aerosol 
STAR COLOUR LABORATORIES

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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Active Ingredient(s)

Dimethicone, 2.7%

Uses

Purpose

Skin protectant

Warnings

For external use only

Flammable:

Do not use on:

Directions

Inactive ingredients

Water, Propane, Butane, Palmitic acid, Palm Kernal acid, Isopropyl Myrisate, Glycerin, VP/VA Copolymer, Isobutane, Triethanolamine, Cetyl Alcohol, Cetearyl Alcohol, Ceteareth-20, Hydroxyethylcellulose, Perfluorianted Polyether, Aloe Barbadensis Leaf Juice, Tocopheryl Acetate, Lanolin, Tetrasodium EDTA, Propylene Glycol Diazolindinyl Urea, Methylparaben, Propylparaben, Sodium Benzoate, Potassium Sorbate, Citric Acid

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Derma Shield 2oz Aerosol USA

Outer label for Derma Shield 2oz Aerosol

Derma Shield 6oz Aerosol USA

Outer label for Derma Shield 6oz Aerosol

Derma Shield 17oz Aerosol USA

Outer label for Derma Shield 17oz Aerosol

BENCHMARKS DERMA SHIELD 
dimethicone aerosol
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:80905-001
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
DIMETHICONE (UNII: 92RU3N3Y1O) (DIMETHICONE - UNII:92RU3N3Y1O) DIMETHICONE2.7 g  in 100 g
Inactive Ingredients
Ingredient NameStrength
LANOLIN (UNII: 7EV65EAW6H)  
PROPYLPARABEN (UNII: Z8IX2SC1OH)  
POLYOXYL 20 CETOSTEARYL ETHER (UNII: YRC528SWUY)  
CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP)  
DIAZOLIDINYL UREA (UNII: H5RIZ3MPW4)  
GLYCERIN (UNII: PDC6A3C0OX)  
HYDROXYETHYL CELLULOSE (4000 MPA.S AT 1%) (UNII: ZYD53NBL45)  
METHYLPARABEN (UNII: A2I8C7HI9T)  
PALM KERNEL ACID (UNII: 79P21R4317)  
PROPYLENE GLYCOL (UNII: 6DC9Q167V3)  
SODIUM BENZOATE (UNII: OJ245FE5EU)  
COPOVIDONE K25-31 (UNII: D9C330MD8B)  
EDETATE SODIUM (UNII: MP1J8420LU)  
.ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)  
TROLAMINE (UNII: 9O3K93S3TK)  
ALOE VERA LEAF (UNII: ZY81Z83H0X)  
WATER (UNII: 059QF0KO0R)  
CETYL ALCOHOL (UNII: 936JST6JCN)  
ISOBUTANE (UNII: BXR49TP611)  
ISOPROPYL MYRISTATE (UNII: 0RE8K4LNJS)  
PALMITIC ACID (UNII: 2V16EO95H1)  
PERFLUOROPOLYMETHYLISOPROPYL ETHER (UNII: X6324K3MBW)  
POTASSIUM SORBATE (UNII: 1VPU26JZZ4)  
PROPANE (UNII: T75W9911L6)  
BUTANE (UNII: 6LV4FOR43R)  
Product Characteristics
ColorwhiteScore    
ShapeSize
FlavorImprint Code
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:80905-001-03482 g in 1 CAN; Type 0: Not a Combination Product10/09/2020
2NDC:80905-001-02170 g in 1 CAN; Type 0: Not a Combination Product10/09/2020
3NDC:80905-001-0157 g in 1 CAN; Type 0: Not a Combination Product10/09/2020
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph finalpart34710/09/2020
Labeler - STAR COLOUR LABORATORIES (215970015)
Establishment
NameAddressID/FEIBusiness Operations
STAR COLOUR LABORATORIES215970015manufacture(80905-001)

Revised: 10/2020
Document Id: a3f85945-4ab1-40bc-83aa-c157d3ba3427
Set id: a2d586e2-352e-4fea-a95e-85b089f1dda3
Version: 1
Effective Time: 20201009
 
STAR COLOUR LABORATORIES