MAYBELLINE NEW YORK FIT ME FOUNDATION DEWY PLUS SMOOTH SPF 18 SUNSCREEN- octinoxate lotion

Maybelline New York Fit Me Foundation Dewy Plus Smooth SPF 18 Sunscreen by

Drug Labeling and Warnings

Maybelline New York Fit Me Foundation Dewy Plus Smooth SPF 18 Sunscreen by is a Otc medication manufactured, distributed, or labeled by L'Oreal USA Products Inc, L'Oreal USA, Inc.. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

Active ingredient

Octinoxate 7%

Purpose

Sunscreen

Use

• helps prevent sunburn

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

• protect the product in this container from excessive heat and direct sun

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

PRINCIPAL DISPLAY PANEL

PRINCIPAL DISPLAY PANEL

INGREDIENTS AND APPEARANCE

MAYBELLINE NEW YORK FIT ME FOUNDATION DEWY PLUS SMOOTH SPF 18 SUNSCREEN 
octinoxate lotion

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 49967-969
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
OCTINOXATE (UNII: 4Y5P7MUD51) (OCTINOXATE - UNII:4Y5P7MUD51)	OCTINOXATE	70 mg  in 1 mL

Inactive Ingredients
Ingredient Name	Strength
WATER (UNII: 059QF0KO0R)
DIMETHICONE (UNII: 92RU3N3Y1O)
GLYCERIN (UNII: PDC6A3C0OX)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 49967-969-01	30 mL in 1 BOTTLE, GLASS; Type 0: Not a Combination Product	09/01/2010

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph not final	part352	09/01/2010

Labeler - L'Oreal USA Products Inc (002136794)

Establishment
Name	Address	ID/FEI	Business Operations
L'Oreal USA, Inc.		624244349	manufacture(49967-969)