LANCOME PARIS TEINT IDOLE ULTRA 24H MAKEUP BROAD SPECTRUM SPF 15 SUNSCREEN- octinoxate liquid

Lancome Paris Teint Idole Ultra 24H Makeup Broad Spectrum SPF 15 Sunscreen by

Drug Labeling and Warnings

Lancome Paris Teint Idole Ultra 24H Makeup Broad Spectrum SPF 15 Sunscreen by is a Otc medication manufactured, distributed, or labeled by L'Oreal USA Products Inc, SICOS ET CIE, BPS60, Socoplan. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

Active ingredient

Octinoxate 3%

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

Flammable until dry.

Do not use near fire, flame, or heat.

Do not use

on damaged or broken skin

When using this product

keep out of eyes. Rinse with wate 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:

●  shake well

●  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

water, cyclohexasiloxane, alcohol denat., isododecane, butylene glycol, acrylates/polytrimethylsiloxymethacrylate copolymer, nylon-12, PEG-10 dimethicone, isohexadecane, silica, perlite, aluminum hydroxide, magnesium sulfate, disodium stearoyl glutamate, cetyl PEG/PPG-10/1 dimethicone; may contain: titanium dioxide, iron oxides

Questions or comments?

1-800-LANCOME

(1-800-526-2663)

Monday - Friday

(9 a.m. - 5 p.m. EST)

PRINCIPAL DISPLAY PANEL

INGREDIENTS AND APPEARANCE

LANCOME PARIS TEINT IDOLE ULTRA 24H MAKEUP BROAD SPECTRUM SPF 15 SUNSCREEN 
octinoxate liquid

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 49967-956
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
OCTINOXATE (UNII: 4Y5P7MUD51) (OCTINOXATE - UNII:4Y5P7MUD51)	OCTINOXATE	30 mg  in 1 mL

Inactive Ingredients
Ingredient Name	Strength
WATER (UNII: 059QF0KO0R)
CYCLOMETHICONE 6 (UNII: XHK3U310BA)
ALCOHOL (UNII: 3K9958V90M)
ISODODECANE (UNII: A8289P68Y2)
BUTYLENE GLYCOL (UNII: 3XUS85K0RA)
NYLON-12 (UNII: 446U8J075B)
PEG-10 DIMETHICONE (600 CST) (UNII: 8PR7V1SVM0)
ISOHEXADECANE (UNII: 918X1OUF1E)
SILICON DIOXIDE (UNII: ETJ7Z6XBU4)
PERLITE (UNII: 0SG101ZGK9)
ALUMINUM HYDROXIDE (UNII: 5QB0T2IUN0)
MAGNESIUM SULFATE, UNSPECIFIED FORM (UNII: DE08037SAB)
DISODIUM STEAROYL GLUTAMATE (UNII: 45ASM2L11M)
CETYL PEG/PPG-10/1 DIMETHICONE (HLB 3) (UNII: G300307ZXP)
TITANIUM DIOXIDE (UNII: 15FIX9V2JP)
FERRIC OXIDE RED (UNII: 1K09F3G675)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 49967-956-01	1 in 1 CARTON	07/01/2016
1		30 mL in 1 BOTTLE; Type 0: Not a Combination Product
2	NDC: 49967-956-02	1 in 1 CARTON	07/01/2016
2		10 mL in 1 BOTTLE; Type 0: Not a Combination Product
3	NDC: 49967-956-03	1 in 1 CARTON	07/01/2016
3		5 mL in 1 BOTTLE; Type 0: Not a Combination Product
4	NDC: 49967-956-04	110 mL in 1 BOTTLE; Type 0: Not a Combination Product	07/01/2016
5	NDC: 49967-956-05	1.6 mL in 1 PACKET; Type 0: Not a Combination Product	07/01/2016
6	NDC: 49967-956-06	1 in 1 CARTON	06/01/2019
6		15 mL in 1 BOTTLE; 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	07/01/2016

Labeler - L'Oreal USA Products Inc (002136794)

Establishment
Name	Address	ID/FEI	Business Operations
SICOS ET CIE		276993581	manufacture(49967-956) , pack(49967-956)

Establishment
Name	Address	ID/FEI	Business Operations
Laboratoires Biocosm SARL		288479491	pack(49967-956)

Establishment
Name	Address	ID/FEI	Business Operations
Socoplan		276221405	pack(49967-956)