Tinted Lip Cream SPF 15 9.28 mg/100mg

ZINC OXIDE · CREAM · COSMAX USA, CORPORATION

No Recall History

Plain English

Tinted Lip Cream SPF 15 is a cream containing zinc oxide at 9.28 mg/100mg, taken topical. Manufactured by COSMAX USA, CORPORATION.

Key Facts

Brand Name: Tinted Lip Cream SPF 15
Generic Name: ZINC OXIDE
NDC Code (Product): 68577-169
Manufacturer: COSMAX USA, CORPORATION
Strength: 9.28 mg/100mg
Dosage Form: CREAM
Route: TOPICAL
Marketing Status
Application #: M020
Marketing Start: 01/01/2024

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

Warnings

Warnings For external use only Do not use on damaged or broken skin Keep out of reach of children . If swallowed, get medical help or contact a Poison Control Center right away.

Frequently Asked Questions

What is Tinted Lip Cream SPF 15 used for?

Tinted Lip Cream SPF 15 contains ZINC OXIDE. It is a cream taken topical. Consult your doctor for specific uses.

Is Tinted Lip Cream SPF 15 a controlled substance?

Tinted Lip Cream SPF 15 is not classified as a controlled substance by the DEA.

What is the generic name for Tinted Lip Cream SPF 15?

The generic name for Tinted Lip Cream SPF 15 is ZINC OXIDE. There are 12 other brand versions of ZINC OXIDE.

What is the NDC code for Tinted Lip Cream SPF 15 9.28 mg/100mg?

The NDC (National Drug Code) for Tinted Lip Cream SPF 15 9.28 mg/100mg is 68577-169, listed by COSMAX USA, CORPORATION.

Product NDC

68577-169

Package NDC

68577-169-00

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)