Drugplain

Image MD Restoring Lip Enhancer SPF15 30 g/1000g

sunscreen · CREAM · Swiss-American CDMO, LLC

No Recall History
Plain English

Image MD Restoring Lip Enhancer SPF15 is a cream containing sunscreen at 30 g/1000g, taken topical. Manufactured by Swiss-American CDMO, LLC.

Key Facts

Brand Name
Image MD Restoring Lip Enhancer SPF15
Generic Name
sunscreen
NDC Code (Product)
60232-3537
Manufacturer
Swiss-American CDMO, LLC
Strength
30 g/1000g
Dosage Form
CREAM
Route
TOPICAL
Marketing Status
Application #
M020
Marketing Start
03/17/2022

Recall History

No Recall History

Side Effects Reported to FDA

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

rash12 reports
acne10 reports
sunburn9 reports
dry skin8 reports
erythema8 reports
malignant melanoma8 reports
headache7 reports
off label use7 reports
application site erythema6 reports
pain6 reports

Full Prescribing Information

Source: FDA Drug Label (SPL)For healthcare professionals

Indications & Usage

Directions Apply liberally 15 minutes before sun exposure. Use a water-resistant sunscreen if swimming or sweating. Reapply at least every 2 hours. Sun Protection 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 of 15 or higher and other sun protection measures including: limit time in the sun, especially from 10 am to 2 pm. Wear long-sleeve shirts, pants, hats, and sunglasses. Children under 6 months: ask a physician.

Dosage & Administration

Directions Apply liberally 15 minutes before sun exposure. Use a water-resistant sunscreen if swimming or sweating. Reapply at least every 2 hours. Sun Protection 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 of 15 or higher and other sun protection measures including: limit time in the sun, especially from 10 am to 2 pm. Wear long-sleeve shirts, pants, hats, and sunglasses. Children under 6 months: ask a physician.

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. If swallowed get medical help or contact a Poison Control Center right away.

Frequently Asked Questions

What is Image MD Restoring Lip Enhancer SPF15 used for?

Image MD Restoring Lip Enhancer SPF15 contains sunscreen. It is a cream taken topical. Consult your doctor for specific uses.

Is Image MD Restoring Lip Enhancer SPF15 a controlled substance?

Image MD Restoring Lip Enhancer SPF15 is not classified as a controlled substance by the DEA.

What is the generic name for Image MD Restoring Lip Enhancer SPF15?

The generic name for Image MD Restoring Lip Enhancer SPF15 is sunscreen. There are 12 other brand versions of sunscreen.

What is the NDC code for Image MD Restoring Lip Enhancer SPF15 30 g/1000g?

The NDC (National Drug Code) for Image MD Restoring Lip Enhancer SPF15 30 g/1000g is 60232-3537, listed by Swiss-American CDMO, LLC.

Product NDC

60232-3537

Package NDC

60232-3537-0

Other Sunscreen Brands

See all →

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

Data from openFDA · Public domain (CC0 1.0)