Drugplain

Zinc Oxide 20% 20 g/100mL

Sunscreen SPF 50 · LOTION · The Soleil Group, LLC

4 Recalls on Record
Plain English

Zinc Oxide 20% is a lotion containing sunscreen spf 50 at 20 g/100mL, taken topical. Manufactured by The Soleil Group, LLC.

Key Facts

Brand Name
Zinc Oxide 20%
Generic Name
Sunscreen SPF 50
NDC Code (Product)
69630-004
Manufacturer
The Soleil Group, LLC
Strength
20 g/100mL
Dosage Form
LOTION
Route
TOPICAL
Marketing Status
Application #
M020
Marketing Start
10/09/2025

Recall History

4 Recalls on Record
Class II10/31/2025

Blossom Pharmaceuticals

cGMP deviations

OngoingVoluntary: Firm initiated
Class II10/31/2025

Blossom Pharmaceuticals

cGMP deviations

OngoingVoluntary: Firm initiated
Class II10/31/2025

Blossom Pharmaceuticals

cGMP deviations

OngoingVoluntary: Firm initiated
Class II01/08/2025

Johnson, S C and Son, Inc

Failed stability specifications: during routine stability monitoring quality concerns were identified. Physical separation for ingredients was observed.

OngoingVoluntary: Firm initiated

Side Effects Reported to FDA

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

drug ineffective506 reports
macular degeneration453 reports
off label use313 reports
pyrexia303 reports
nausea284 reports
pain280 reports
malaise259 reports
weight decreased235 reports
therapeutic product effect incomplete213 reports
headache201 reports

Full Prescribing Information

Source: FDA Drug Label (SPL)For healthcare professionals

Indications & Usage

Uses ■ Dries the oozing and weeping of poison • ivy • oak • sumac ■ Helps treat and prevent diaper rash ■ Protects chafed skin due to diaper rash and helps seal out wetness

Dosage & Administration

Directions ■ For poison ivy, oak & sumac: apply as needed ■ For Diaper Rash Change wet and soiled diapers promptly Cleanse the diaper area and allow to dry Apply ointment liberally as often as necessary, with each diaper change, especially at bed time or anytime when exposure to wet diapers may be prolonged

Warnings

Warnings For external use only

Frequently Asked Questions

What is Zinc Oxide 20% used for?

Zinc Oxide 20% contains Sunscreen SPF 50. It is a lotion taken topical. Consult your doctor for specific uses.

Is Zinc Oxide 20% a controlled substance?

Zinc Oxide 20% is not classified as a controlled substance by the DEA.

What is the generic name for Zinc Oxide 20%?

The generic name for Zinc Oxide 20% is Sunscreen SPF 50. There are 8 other brand versions of Sunscreen SPF 50.

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

The NDC (National Drug Code) for Zinc Oxide 20% 20 g/100mL is 69630-004, listed by The Soleil Group, LLC.

Product NDC

69630-004

Package NDC

69630-004-01

Other Zinc Oxide 20% Dosages

Other Sunscreen Brands

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

Data from openFDA · Public domain (CC0 1.0)