Drugplain

Zinc Oxide 20 g/100g

Skin Protectant · OINTMENT · BluePoint Laboratories

10 Recalls on Record
Plain English

Zinc Oxide is a ointment containing skin protectant at 20 g/100g, taken topical. Manufactured by BluePoint Laboratories.

Key Facts

Brand Name
Zinc Oxide
Generic Name
Skin Protectant
NDC Code (Product)
68001-533
Manufacturer
BluePoint Laboratories
Strength
20 g/100g
Dosage Form
OINTMENT
Route
TOPICAL
Marketing Status
Application #
M016
Marketing Start
03/24/2022

Recall History

10 Recalls on Record
Class II10/10/2025

CA BOTANA International, Inc.

CGMP Deviations

OngoingVoluntary: Firm initiated
Class II03/12/2025

KABANA SKIN CARE

cGMP deviations

OngoingVoluntary: Firm initiated
Class II12/14/2017

SHISEIDO AMERICA INC.

GMP Deviations: manufacturing of API material did not meet GMP and quality requirements.

TerminatedVoluntary: Firm initiated
Class II08/18/2023

HUMANRACE

Subpotent Drug: Product does not contain SPF that is declared on the label.

OngoingVoluntary: Firm initiated
Class II09/24/2013

W.S. Badger Company Inc.

Microbial Contamination of Non-Sterile Products; Selected lots of Badger Baby and Kids Sunscreen Lotion were recalled due to microbial contamination.

TerminatedVoluntary: Firm initiated
Class II10/31/2025

Blossom Pharmaceuticals

cGMP deviations

OngoingVoluntary: Firm initiated
Class I09/30/2021

Beiersdorf Inc

Chemical contamination; presence of benzene

TerminatedVoluntary: Firm initiated
Class II08/18/2023

HUMANRACE

Subpotent Drug: Product does not contain SPF that is declared on the label.

OngoingVoluntary: Firm initiated
Class II10/10/2025

CA BOTANA International, Inc.

CGMP Deviations

OngoingVoluntary: Firm initiated
Class II03/12/2025

KABANA SKIN CARE

cGMP deviations

OngoingVoluntary: Firm initiated

Side Effects Reported to FDA

FDA FAERS database · These are reported events, not confirmed side effects

drug ineffective508 reports
macular degeneration453 reports
off label use313 reports
pyrexia307 reports
nausea285 reports
pain284 reports
malaise262 reports
weight decreased237 reports
therapeutic product effect incomplete213 reports
headache201 reports

Full Prescribing Information

Source: FDA Drug Label (SPL)For healthcare professionals

Indications & Usage

Uses Helps treat and prevent diaper rash Protects chaged skin or minor skin irritation due to diaper rash and helps seal out wetness

Dosage & Administration

Directions apply cream liberally as often as necessary change wet and soiled diapers promptly cleanse the diaper area, and allow to dry apply cream with each diaper change, especially at bedtime or anytime when exposure to wet diapers may be prolonged

Warnings

Warnings For external use only

Frequently Asked Questions

What is Zinc Oxide used for?

Zinc Oxide contains Skin Protectant. It is a ointment taken topical. Consult your doctor for specific uses.

Is Zinc Oxide a controlled substance?

Zinc Oxide is not classified as a controlled substance by the DEA.

What is the generic name for Zinc Oxide?

The generic name for Zinc Oxide is Skin Protectant. There are 12 other brand versions of Skin Protectant.

What is the NDC code for Zinc Oxide 20 g/100g?

The NDC (National Drug Code) for Zinc Oxide 20 g/100g is 68001-533, listed by BluePoint Laboratories.