Active Ingredient
Octinoxate 7%
Maybelline New York Fit Dewy Plus Smooth Normal To Dry Broad Spectrum Spf 18 Sunscreen Lotion
FDA Label NDC 82046-648
Full FDA labeling including Indications, Dosage, Usage, and Precautions
Structured Product Label
The following Structured Product Label (SPL) was submitted to the FDA by L'oreal Usa Products Inc for the product Maybelline New York Fit Dewy Plus Smooth Normal To Dry Broad Spectrum Spf 18 Sunscreen (NDC 82046-648). This document serves as the official prescribing information, containing essential scientific data and clinical materials required for healthcare providers and patients.
This specific version of the label includes detailed information regarding active ingredient, purpose, use, warnings, do not use, when using this product, stop use and ask a doctor if, keep out of reach of children., and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.
Label Section Quick Index
Purpose
Sunscreen
Use
- helps prevent sunburn
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 swallowed, get medical help or contact a Poison Control Center right away.
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
Other Information
- protect the product in this container from excessive heat and direct sun
Inactive Ingredients
water, cyclopentasiloxane, dimethicone, glycerin, isotridectyl isononanoate, PEG-9 polydimethylsiloxyethyl dimethicone, disteardimonium hectorite, dimethicone/polyglycerin-3 crosspolymer, sodium chloride, phenoxyethanol, PEG-10 dimethicone, methylparaben, disodium stearoyl glutamate, silica silylate, chlorphenesin, fragrance, trisodium ethylenediamine disuccinate, tocopherol, ascorbyl palmitate, aluminum hydroxide, dipropylene glycol, BHT, alpha-isomethyl ionone; may contain: titanium dioxide, iron oxides
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