ZINC OXIDE 40%- diaper rash skin cream 
BRANDS INTERNATIONAL

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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Zinc Oxide 40% Diaper Rash Cream

Active Ingredient

Zinc oxide 40%

Purpose

Skin Protectant

Uses

Warnings

For external use only

When using this product

do not get into 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

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

Directions

Other Information

Inactive Ingredients

Sunflower oil, Castor Oil, Sunflower seed wax, polyhydroxystearic acid, shea butter, coconut oil, theobroma cacao seed butter, calophyllum seed oil, tocopherol, zea mays corn starch

Questions and comments?

1-888-880-6888

Label

1

ZINC OXIDE 40% 
diaper rash skin cream
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:50157-477
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
ZINC OXIDE (UNII: SOI2LOH54Z) (ZINC OXIDE - UNII:SOI2LOH54Z) ZINC OXIDE40 g  in 100 mL
Inactive Ingredients
Ingredient NameStrength
COCONUT OIL (UNII: Q9L0O73W7L)  
SHEA BUTTER (UNII: K49155WL9Y)  
COCOA BUTTER (UNII: 512OYT1CRR)  
CALOPHYLLUM TACAMAHACA SEED OIL (UNII: 05G85L61OE)  
STARCH, CORN (UNII: O8232NY3SJ)  
SUNFLOWER OIL (UNII: 3W1JG795YI)  
POLYHYDROXYSTEARIC ACID (2300 MW) (UNII: YXH47AOU0F)  
CASTOR OIL (UNII: D5340Y2I9G)  
HELIANTHUS ANNUUS SEED WAX (UNII: 42DG15CHXV)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:50157-477-18118 mL in 1 TUBE; Type 0: Not a Combination Product09/20/2022
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph finalM01609/20/2022
Labeler - BRANDS INTERNATIONAL (243748238)
Establishment
NameAddressID/FEIBusiness Operations
BRANDS INTERNATIONAL243748238manufacture(50157-477)

Revised: 9/2022
Document Id: e91ff69e-84b8-ead0-e053-2995a90a752d
Set id: e9201a26-46b3-477f-e053-2995a90a5e0e
Version: 1
Effective Time: 20220920
 
BRANDS INTERNATIONAL