WINTER SKIN PROTECTANT- zinc oxide, allantoin ointment 
Biomin 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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Winter + Skin Protectant

DRUG FACTS

Active Ingredients

Zinc Oxide 20.00%

Allantoin 2%

Purpose

Sunscreen

Skin Protectant

Uses:

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

Warnings:

For external use only.

Do not use

  • on damaged or broken skin.
  • Do not use deep or puncture wounds animal bites serious burns.

Stop use and ask a doctor 

  • If rash occurs conditions worsens symptoms last more than 7 days or clear up again within a few days.

When using this product

  • Keep out of eyes.
  • Rinse with water to remove.

Keep out of reach of children.

  • If swallowed, get medical help or contact a Poison Control Center right away.

Directions:

Inactive Ingredients:

Cocos Nucifera (Coconut) Oil, Cera Alba (Beeswax), Calendula Officinalis (Calendula Flower) Infused in Simmondsia Chinensis (Jojoba Oil), Tocopherol (Vitamin E)

Other Information:

Protect this product from excessive heat and direct sun.

Package Labeling:

Label

WINTER SKIN PROTECTANT 
zinc oxide, allantoin ointment
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:82177-001
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
ZINC OXIDE (UNII: SOI2LOH54Z) (ZINC CATION - UNII:13S1S8SF37) ZINC CATION200 mg  in 1 mL
ALLANTOIN (UNII: 344S277G0Z) (ALLANTOIN - UNII:344S277G0Z) ALLANTOIN20 mg  in 1 mL
Inactive Ingredients
Ingredient NameStrength
COCONUT OIL (UNII: Q9L0O73W7L)  
YELLOW WAX (UNII: 2ZA36H0S2V)  
CALENDULA OFFICINALIS FLOWER (UNII: P0M7O4Y7YD)  
JOJOBA OIL (UNII: 724GKU717M)  
TOCOPHEROL (UNII: R0ZB2556P8)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:82177-001-00120 mL in 1 JAR; Type 0: Not a Combination Product07/01/2022
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph finalpart34707/01/2022
Labeler - Biomin LLC. (105075828)

Revised: 6/2022
Document Id: e0787314-d07a-5418-e053-2a95a90a1b98
Set id: e0787c0a-b4a7-5302-e053-2995a90a0c85
Version: 1
Effective Time: 20220602
 
Biomin LLC.