MAYBELLINE NEW YORK FIT ME FOUNDATION DEWY PLUS SMOOTH SPF 18 SUNSCREEN- octinoxate lotion 
L'Oreal USA Products Inc

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Drug Facts

Active ingredient

Octinoxate 7%

Purpose

Sunscreen

Use

Skin Cancer/Skin Aging Alert:

Spending time in the sun increases your risk of skin cancer and early skin aging. This product has been shown only to help prevent sunburn, not skin cancer or early skin aging.

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

Other information

Inactive ingredients

water, cyclopentasiloxane, dimethicone, glycerin, isotridecyl isononanoate, PEG-9 polydimethylsiloxyethyl dimethicone, disteardimonium hectorite, dimethicone/polyglycerin-3 crosspolymner, sodium chloride, PEG-10 dimethicone, phenoxyethanol, methylparaben, disodium stearoyl glutamate chlorphenesin, disodium, EDTA, acrylates copolymer, propylparaben, fragrance, tocopherol ascorbyl palmitate, aluminum hydroxide, butylparaben PEG-9, ethylparaben, dipropylene glycol, alphaisomethyl ionone; may contain: titanium dioxide, iron oxides

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MAYBELLINE NEW YORK FIT ME FOUNDATION DEWY PLUS SMOOTH SPF 18 SUNSCREEN 
octinoxate lotion
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:49967-969
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
OCTINOXATE (UNII: 4Y5P7MUD51) (OCTINOXATE - UNII:4Y5P7MUD51) OCTINOXATE70 mg  in 1 mL
Inactive Ingredients
Ingredient NameStrength
WATER (UNII: 059QF0KO0R)  
DIMETHICONE (UNII: 92RU3N3Y1O)  
GLYCERIN (UNII: PDC6A3C0OX)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:49967-969-0130 mL in 1 BOTTLE, GLASS; Type 0: Not a Combination Product09/01/2010
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC Monograph DrugM02009/01/2010
Labeler - L'Oreal USA Products Inc (002136794)
Establishment
NameAddressID/FEIBusiness Operations
L'Oreal USA, Inc.624244349manufacture(49967-969)

Revised: 12/2023
Document Id: 8ec56f5f-3741-475d-9c6d-8b68224b56bb
Set id: 52e169b7-3560-489e-b7ab-1fea01466c0c
Version: 3
Effective Time: 20231228
 
L'Oreal USA Products Inc