Drugplain

Zinc Oxide 20 mg/100mL

Pacifica Ultra CC Cream Radiant Foundation SPF 30 Warm/Light · CREAM · Pacifica Beauty, LLC

10 Recalls on Record
Plain English

Zinc Oxide is a cream containing pacifica ultra cc cream radiant foundation spf 30 warm/light at 20 mg/100mL, taken topical. Manufactured by Pacifica Beauty, LLC.

Key Facts

Brand Name
Zinc Oxide
Generic Name
Pacifica Ultra CC Cream Radiant Foundation SPF 30 Warm/Light
NDC Code (Product)
61197-314
Manufacturer
Pacifica Beauty, LLC
Strength
20 mg/100mL
Dosage Form
CREAM
Route
TOPICAL
Marketing Status
Application #
M020
Marketing Start
04/01/2025

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 Pacifica Ultra CC Cream Radiant Foundation SPF 30 Warm/Light. It is a cream 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 Pacifica Ultra CC Cream Radiant Foundation SPF 30 Warm/Light. There are no other listed brand versions of Pacifica Ultra CC Cream Radiant Foundation SPF 30 Warm/Light.

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

The NDC (National Drug Code) for Zinc Oxide 20 mg/100mL is 61197-314, listed by Pacifica Beauty, LLC.

Product NDC

61197-314

Package NDC

61197-314-00

Not medical advice. Always consult your doctor or pharmacist before making any medication decisions.

Data from openFDA · Public domain (CC0 1.0)