barrier cream

barrier cream
SPL v3
SPL
SPL Set ID bc6a2736-faa6-46d3-af9b-a70f0762e9ce
Route
topical
Published
Effective Date 2026-01-26
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
zinc oxide (100 mg)
Inactive Ingredients
medium-chain triglycerides coconut oil yellow wax candelilla wax jojoba oil tocopherol olea europaea leaf orange peel wax astaxanthin bentonite cetearyl olivate sorbitan olivate propolis wax lavender oil rosemary aloe vera whole st. john's wort chamomile licorice calendula officinalis flower manuka oil peppermint oil

Identifiers & Packaging

Marketing Status
otc monograph drug active Since 2022-01-01

Purpose

Skin protectant

Description

Zinc Oxide (Non-nano) 10%


Medication Information

Warnings
  • For external use only
  • Avoid contact with eyes. Rinse with water to remove.
Uses
  • Temporarily protects the skin and prevents chafing, blisters and irritation and helps seal out wetness.
  • Helps prevent and helps relieve minor skin irritation and itching due to rashes, chafed, chapped, cracked, or windburned skin.
Purpose

Skin protectant

Directions

Apply liberally, directly on skin as needed. Safe to apply to prosthetics, protective equipment, etc.

Other Information

store product between 45 to 100F

Gently warm or knead product as needed to soften before use.

Inactive Ingredients

*Caprylic/Capric Triglyceride (Fractionated Coconut Oil), *Cocos Nucifera (Coconut) Oil, *Cera Alba (beeswax), **Euphorbia Cerifera (candelilla) wax, *Simmondsia Chinensis (Jojoba) Seed Oil, Tocopherol, Olea Europaea (Olive) Leaf Extract, Citrus Aurantium Dulcis Peel Cera, Astaxanthin, Bentonite, Cetearyl Olivate, Sorbitan Olivate, *Propolis, *Lavandula Angustifolia (Lavender) Oil, *Rosmarinus Officinalis (Rosemary) Leaf Extract,*Aloe barbadensis,*St. John's wort (Hypericum perforatum),*Chamomile (Matricaria chamomilla L), *Licorice Root (Glycyrrhiza glabra), *Calendula Officinalis Flower Extract, **Leptospermum scoparium (Manuka) Oil, *Mentha Piperita (Peppermint) Oil *Organic

Description

Zinc Oxide (Non-nano) 10%

Questions?

Call 888-805-1507 or visit www.avasol.com

Section 50565-1

Keep out of reach of children.

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

Section 50570-1

Do not use:

  • if allergic to ingredients.
  • on deep or puncture wounds
  • on animal bites •on serious burns.
  • Test small area first.
Section 51945-4

Active Ingredients

Zinc Oxide (Non-nano) 10%

Stop Use and Ask A Doctor
  • Condition worsens
  • symptoms last for more than 7 days or clear up and occur again within a few days

Structured Label Content

Warnings
  • For external use only
  • Avoid contact with eyes. Rinse with water to remove.
Uses
  • Temporarily protects the skin and prevents chafing, blisters and irritation and helps seal out wetness.
  • Helps prevent and helps relieve minor skin irritation and itching due to rashes, chafed, chapped, cracked, or windburned skin.
Purpose

Skin protectant

Directions

Apply liberally, directly on skin as needed. Safe to apply to prosthetics, protective equipment, etc.

Other Information (Other information)

store product between 45 to 100F

Gently warm or knead product as needed to soften before use.

Inactive Ingredients (Inactive ingredients)

*Caprylic/Capric Triglyceride (Fractionated Coconut Oil), *Cocos Nucifera (Coconut) Oil, *Cera Alba (beeswax), **Euphorbia Cerifera (candelilla) wax, *Simmondsia Chinensis (Jojoba) Seed Oil, Tocopherol, Olea Europaea (Olive) Leaf Extract, Citrus Aurantium Dulcis Peel Cera, Astaxanthin, Bentonite, Cetearyl Olivate, Sorbitan Olivate, *Propolis, *Lavandula Angustifolia (Lavender) Oil, *Rosmarinus Officinalis (Rosemary) Leaf Extract,*Aloe barbadensis,*St. John's wort (Hypericum perforatum),*Chamomile (Matricaria chamomilla L), *Licorice Root (Glycyrrhiza glabra), *Calendula Officinalis Flower Extract, **Leptospermum scoparium (Manuka) Oil, *Mentha Piperita (Peppermint) Oil *Organic

Questions?

Call 888-805-1507 or visit www.avasol.com

Section 50565-1 (50565-1)

Keep out of reach of children.

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

Section 50570-1 (50570-1)

Do not use:

  • if allergic to ingredients.
  • on deep or puncture wounds
  • on animal bites •on serious burns.
  • Test small area first.
Section 51945-4 (51945-4)

Active Ingredients

Zinc Oxide (Non-nano) 10%

Stop Use and Ask A Doctor (Stop use and ask a doctor)
  • Condition worsens
  • symptoms last for more than 7 days or clear up and occur again within a few days

Advanced Ingredient Data


Raw Label Data

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