PRIME Prometics LipOil SPF 35 Soft Petal 13.5 mg/100mL

Zinc Oxide · OIL · COSMAX USA, CORP

No Recall History

Plain English

PRIME Prometics LipOil SPF 35 Soft Petal is a oil containing zinc oxide at 13.5 mg/100mL, taken topical. Manufactured by COSMAX USA, CORP.

Key Facts

Brand Name: PRIME Prometics LipOil SPF 35 Soft Petal
Generic Name: Zinc Oxide
NDC Code (Product): 68577-228
Manufacturer: COSMAX USA, CORP
Strength: 13.5 mg/100mL
Dosage Form: OIL
Route: TOPICAL
Marketing Status
Application #: M020
Marketing Start: 10/01/2025

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 Uses Helps prevent sunburn I 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 DIRECTIONS Apply generously and evenly 15 minutes before sun exposure Reapply at least every 2 hours Use water resistant sunscreen if swimming or sweating Sun Protection Measures . Spending time in the sun increases your risk of certain cancer and early aging. To decrease this risk, regularly use a sunscreen with Broad Spectrum SPF value of 15 or higher and other sun protection measures including: Limit in the sun, especially from 10 a.m. - 2 p.m. Wear long-sleeved shirts, pants, hats, and sunglasses Children under 6 months: Ask doctor.

Warnings

WARNINGS For external use only Do not use on damaged or broken skin When using this product keep out of eyes. Rinse with water to remove Stop use and ask doctor if rash occurs Keep out of reach of children . If product is swallowed, get medical help or contact Poison Control Center right away.

Frequently Asked Questions

What is PRIME Prometics LipOil SPF 35 Soft Petal used for?

PRIME Prometics LipOil SPF 35 Soft Petal contains Zinc Oxide. It is a oil taken topical. Consult your doctor for specific uses.

Is PRIME Prometics LipOil SPF 35 Soft Petal a controlled substance?

PRIME Prometics LipOil SPF 35 Soft Petal is not classified as a controlled substance by the DEA.

What is the generic name for PRIME Prometics LipOil SPF 35 Soft Petal?

The generic name for PRIME Prometics LipOil SPF 35 Soft Petal is Zinc Oxide. There are 12 other brand versions of Zinc Oxide.

What is the NDC code for PRIME Prometics LipOil SPF 35 Soft Petal 13.5 mg/100mL?

The NDC (National Drug Code) for PRIME Prometics LipOil SPF 35 Soft Petal 13.5 mg/100mL is 68577-228, listed by COSMAX USA, CORP.

Product NDC

68577-228

Package NDC

68577-228-01

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)