Drugplain

CLE DE PEAU BEAUTE PROTECTIVE FORTIFYING n 3200 mg/125mL

avobenzone, octinoxate, octocrylene, and oxybenzone · EMULSION · SHISEIDO AMERICAS CORPORATION

No Recall History
Plain English

This is a topical sunscreen product that contains multiple UV-filtering ingredients to help protect skin from the sun's rays. It is available over-the-counter and comes as an emulsion applied directly to the skin.

Key Facts

Brand Name
CLE DE PEAU BEAUTE PROTECTIVE FORTIFYING n
Generic Name
avobenzone, octinoxate, octocrylene, and oxybenzone
NDC Code (Product)
58411-454
Manufacturer
SHISEIDO AMERICAS CORPORATION
Strength
3200 mg/125mL
Dosage Form
EMULSION
Route
TOPICAL
Marketing Status
Application #
M020
Marketing Start
02/01/2019

Recall History

No Recall History

Side Effects Reported to FDA

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

rash1 reports
rash erythematous1 reports
rash pruritic1 reports
urticaria1 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 For sunscreen use: 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 a.m. – 2 p.m. wear long-sleeve shirts, pants, hats, and sunglasses children under 6 months: Ask a 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 a doctor if rash occurs Keep out of reach of children. If product is swallowed, get medical help or contact a Poison Control Center right away.

Frequently Asked Questions

What is CLE DE PEAU BEAUTE PROTECTIVE FORTIFYING n used for?

This is a topical sunscreen product that contains multiple UV-filtering ingredients to help protect skin from the sun's rays. It is available over-the-counter and comes as an emulsion applied directly to the skin.

Is CLE DE PEAU BEAUTE PROTECTIVE FORTIFYING n a controlled substance?

CLE DE PEAU BEAUTE PROTECTIVE FORTIFYING n is not classified as a controlled substance by the DEA.

What is the generic name for CLE DE PEAU BEAUTE PROTECTIVE FORTIFYING n?

The generic name for CLE DE PEAU BEAUTE PROTECTIVE FORTIFYING n is avobenzone, octinoxate, octocrylene, and oxybenzone. There are 11 other brand versions of avobenzone, octinoxate, octocrylene, and oxybenzone.

What is the NDC code for CLE DE PEAU BEAUTE PROTECTIVE FORTIFYING n 3200 mg/125mL?

The NDC (National Drug Code) for CLE DE PEAU BEAUTE PROTECTIVE FORTIFYING n 3200 mg/125mL is 58411-454, listed by SHISEIDO AMERICAS CORPORATION.

Product NDC

58411-454

Package NDC

58411-454-10

Other CLE DE PEAU BEAUTE PROTECTIVE FORTIFYING n Dosages

Other Avobenzone, 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)