DYNASHIELD- zinc oxide cream 
Dynarex Corporation

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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1195, 1196

Active Ingredient

Zinc Oxide 1.8%

Purpose

​Skin Protectant

Uses

Warnings

For External Use Only

When using this product

  • Do not get in 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

Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center (1-800-222-1222) right away.

Directions

Other Information

Inactive Ingredients

Glycerin, Cetostearyl Alcohol, Cetyl Alcohol, White Soft Paraffin, Mineral Oil, Lanolin, Cetomacrogol 1000, Aloe Vera Leaf, Methyl Paraben, Propyl Paraben, Perfume Lavander Oil, Alpha Tocopherol, Trolamine, Vitamin A Acetate, Cholecalciferol (Vitamin D3), FD&C Yellow No. 5 (Tartrazine), Water

1195 Label

1195 IN MASTER

1196 Label

1196 IN MASTER

DYNASHIELD 
zinc oxide cream
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:67777-407
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
ZINC OXIDE (UNII: SOI2LOH54Z) (ZINC OXIDE - UNII:SOI2LOH54Z) ZINC OXIDE1.8 g  in 100 g
Inactive Ingredients
Ingredient NameStrength
VITAMIN A ACETATE (UNII: 3LE3D9D6OY)  
FD&C YELLOW NO. 5 (UNII: I753WB2F1M)  
LAVENDER OIL (UNII: ZBP1YXW0H8)  
ALPHA-TOCOPHEROL (UNII: H4N855PNZ1)  
ALOE VERA LEAF (UNII: ZY81Z83H0X)  
TROLAMINE (UNII: 9O3K93S3TK)  
WATER (UNII: 059QF0KO0R)  
LANOLIN (UNII: 7EV65EAW6H)  
CETETH-20 (UNII: I835H2IHHX)  
MINERAL OIL (UNII: T5L8T28FGP)  
METHYLPARABEN (UNII: A2I8C7HI9T)  
PROPYLPARABEN (UNII: Z8IX2SC1OH)  
GLYCERIN (UNII: PDC6A3C0OX)  
CETYL ALCOHOL (UNII: 936JST6JCN)  
CETOSTEARYL ALCOHOL (UNII: 2DMT128M1S)  
CHOLECALCIFEROL (UNII: 1C6V77QF41)  
WHITE PETROLATUM (UNII: B6E5W8RQJ4)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:67777-407-015 g in 1 PACKET; Type 0: Not a Combination Product05/23/2018
2NDC:67777-407-0215 g in 1 PACKET; Type 0: Not a Combination Product05/23/2018
3NDC:67777-407-1024 in 1 CASE10/01/2014
3NDC:67777-407-03114 g in 1 TUBE; Type 0: Not a Combination Product
4NDC:67777-407-1112 in 1 CASE10/01/2014
4NDC:67777-407-04427.5 g in 1 JAR; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph finalM01610/01/2014
Labeler - Dynarex Corporation (008124539)
Registrant - Dynarex Corporation (008124539)

Revised: 5/2023
Document Id: fb453512-061e-cf41-e053-6294a90a3187
Set id: 59fd865c-b81d-43ad-8fa0-c37ca0557769
Version: 8
Effective Time: 20230509
 
Dynarex Corporation