LANCOME PARIS TEINT IDOLE ULTRA MAKEUP BROAD SPECTRUM SPF 21- octinoxate and titanium dioxide stick

Lancome Paris Teint Idole Ultra Makeup Broad Spectrum SPF 21 by

Drug Labeling and Warnings

Lancome Paris Teint Idole Ultra Makeup Broad Spectrum SPF 21 by is a Otc medication manufactured, distributed, or labeled by L'Oreal USA Products Inc, Kolmar Laboratories, Inc., L'Oreal USA, Inc.. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

Active ingredients

Octinoxate 2%

Titanium dioxide 1.9%

Purpose

Sunscreen

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

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

● 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 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

cyclohexasiloxane, phenyl trimethicone, isohexadecane, polyethylene, methyl methacrylate crosspolymer, aluminum calcium sodium silicate, cyclopentasiloxane, arachidyl propionate, tambourissa trichophylla leaf extract, perlite, aluminum hydroxide, disodium stearoyl glutamate, isopropyl titanium triisostearate, lauroyl lysine; may contain: mica, titanium dioxide, iron oxides, ferric ammonium ferrocyanide

Questions or comments?

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PRINCIPAL DISPLAY PANEL

INGREDIENTS AND APPEARANCE

LANCOME PARIS TEINT IDOLE ULTRA MAKEUP BROAD SPECTRUM SPF 21 
octinoxate and titanium dioxide stick

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 49967-269
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
OCTINOXATE (UNII: 4Y5P7MUD51) (OCTINOXATE - UNII:4Y5P7MUD51)	OCTINOXATE	20 mg  in 1 g
TITANIUM DIOXIDE (UNII: 15FIX9V2JP) (TITANIUM DIOXIDE - UNII:15FIX9V2JP)	TITANIUM DIOXIDE	19 mg  in 1 g

Inactive Ingredients
Ingredient Name	Strength
PERLITE (UNII: 0SG101ZGK9)
ALUMINUM HYDROXIDE (UNII: 5QB0T2IUN0)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 49967-269-01	1 in 1 CARTON	12/01/2015
1		9 g in 1 CONTAINER; Type 0: Not a Combination Product

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph not final	part352	12/01/2015

Labeler - L'Oreal USA Products Inc (002136794)

Establishment
Name	Address	ID/FEI	Business Operations
Kolmar Laboratories, Inc.		001535103	manufacture(49967-269)

Establishment
Name	Address	ID/FEI	Business Operations
L'Oreal USA, Inc.		185931458	manufacture(49967-269)