OS-01 Lip SPF BS SPF15 5.5 g/100g

Zinc Oxide · CREAM · ONESKIN INC.

No Recall History

Plain English

OS-01 Lip SPF BS SPF15 is a cream containing zinc oxide at 5.5 g/100g, taken topical. Manufactured by ONESKIN INC..

Key Facts

Brand Name: OS-01 Lip SPF BS SPF15
Generic Name: Zinc Oxide
NDC Code (Product): 84451-004
Manufacturer: ONESKIN INC.
Strength: 5.5 g/100g
Dosage Form: CREAM
Route: TOPICAL
Marketing Status
Application #: M020
Marketing Start: 05/07/2025

Recall History

No Recall History

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 • Helps prevent sunburn • If used as directed with other sun protection measures (see Directions), decreases the risk of skin cancer and early skin aging caused by the sun.

Dosage & Administration

Directions: • Apply liberally 15 minutes before sun exposure. • Reapply at least every 2 hours • Use a water-resistant sunscreen If swimming or sweating. • Children under 8 months of age: Ask a Doctor. • Sun Probation Measures: Spending time in the sun increases your risk of skin cancer and early skin aging. To decrease this risk, regularly use a sunscreen with a Broad Spectrum SPF value of 15 or higher and other sun protection measures including: • Limit time in the sun. especially from 10 a.m. - 2 p.m. • Wear long-sleeved shirts, pants, hats, and sunglasses

Warnings

Warnings For external use only

Frequently Asked Questions

What is OS-01 Lip SPF BS SPF15 used for?

OS-01 Lip SPF BS SPF15 contains Zinc Oxide. It is a cream taken topical. Consult your doctor for specific uses.

Is OS-01 Lip SPF BS SPF15 a controlled substance?

OS-01 Lip SPF BS SPF15 is not classified as a controlled substance by the DEA.

What is the generic name for OS-01 Lip SPF BS SPF15?

The generic name for OS-01 Lip SPF BS SPF15 is Zinc Oxide. There are 12 other brand versions of Zinc Oxide.

What is the NDC code for OS-01 Lip SPF BS SPF15 5.5 g/100g?

The NDC (National Drug Code) for OS-01 Lip SPF BS SPF15 5.5 g/100g is 84451-004, listed by ONESKIN INC..

Product NDC

84451-004

Package NDC

84451-004-02

Other Zinc 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)