Maybelline New York Fit Dewy Plus Smooth Normal to Dry Broad Spectrum SPF 18 Sunscreen

OCTINOXATE TOPICAL HUMAN OTC DRUG

Maybelline New York Fit Dewy Plus Smooth Normal to Dry Broad Spectrum SPF 18 Sunscreen is an FDA drug label for the active ingredient OCTINOXATE manufactured by L'Oreal USA Products Inc administered by TOPICAL. This page reproduces the FDA-approved indications and usage, dosage, contraindications, warnings, and adverse reactions exactly as published in the drug label. Data source: openFDA (U.S. FDA), label effective 20231228.

Generic name
OCTINOXATE
Manufacturer
L'Oreal USA Products Inc
Product type
HUMAN OTC DRUG
Route
TOPICAL
Dosage form
N/A
NDC
82046-648
Application
M020
Label effective
20231228

Active ingredients

Active ingredient Octinoxate 7%

Indications & Usage

Use helps prevent sunburn

Dosage & Administration

Directions For sunscreen use: ● apply liberally 15 minutes before sun exposure ● reapply at least every 2 hours ● use a water resistant sunscreen if swimming or sweating ● children under 6 months of age: Ask a doctor 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 ● children under 6 months of age: Ask a doctor

Contraindications

Not available.

Warnings

Warnings For external use only

Adverse Reactions

Not available.

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