LANCOME PARIS TEINT IDOLE ULTRA CUSHION BROAD SPECTRUM SPF 50 SUNSCREEN- octinoxate and titanium dioxide liquid

Lancome Paris Teint Idole Ultra Cushion Broad Spectrum SPF 50 Sunscreen by

Drug Labeling and Warnings

Lancome Paris Teint Idole Ultra Cushion Broad Spectrum SPF 50 Sunscreen by is a Otc medication manufactured, distributed, or labeled by L'Oreal USA Products Inc, SICOS ET CIE. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

Active ingredients

Octinoxate 5%

Titanium dioxide 10.59%

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 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

water, cyclopentasiloxane, isononyl isononanoate, alcohol denat., phenyl trimethicone, PEG-10 dimethicone, glycerin, bis-PEG/PPG-14/14 dimethicone, citrus aurantium dulcis (orange) fruit water, mentha piperita (peppermint) extract, RNA, zea mays (corn) kernel extract, rosa centifolia flower extract, sorbitol, saccharum officinarum (sugar cane) extract, vaccinium myrtillus fruit extract, talc, arginine, pyridoxine HCL, alumina, aluminum hydroxide, phenylalanine, magnesium sulfate, mannitol, ascorbyl glycoside, nylon-12, tryrosine, disodium adenosine triphosphate, disodium stearoyl glutamate, propylene glycol, acer saccharum (sugar maple) extract, citrus limon (lemon) fruit extract, maltitol, gentiana lutea root extract, pentylene glycol, disteardimonium hectorite, histidine HCL, ethylhexyl hydroxystearate, BHT, pentaerythrityl tetra-di-t-butyl hydroxyhydroxcinnamate, sorbic acid, phenoxyethanol, fragrance, linalool, eugenol, alpha-isomethyl ionone, hexyl cinnamal, benzyl alcohol, benzyl salicylate; may contain: titanium dioxide, bismuth oxychloride, 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 CUSHION BROAD SPECTRUM SPF 50 SUNSCREEN 
octinoxate and titanium dioxide liquid

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 49967-423
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
OCTINOXATE (UNII: 4Y5P7MUD51) (OCTINOXATE - UNII:4Y5P7MUD51)	OCTINOXATE	50 mg  in 1 g
TITANIUM DIOXIDE (UNII: 15FIX9V2JP) (TITANIUM DIOXIDE - UNII:15FIX9V2JP)	TITANIUM DIOXIDE	105.9 mg  in 1 g

Inactive Ingredients
Ingredient Name	Strength
WATER (UNII: 059QF0KO0R)
CYCLOMETHICONE 5 (UNII: 0THT5PCI0R)
ISONONYL ISONONANOATE (UNII: S4V5BS6GCX)
ALCOHOL (UNII: 3K9958V90M)
PHENYL TRIMETHICONE (UNII: DR0K5NOJ4R)
GLYCERIN (UNII: PDC6A3C0OX)
BIS-PEG/PPG-14/14 DIMETHICONE (UNII: X2I70H0QJE)
ORANGE (UNII: 5EVU04N5QU)
MENTHA PIPERITA (UNII: 79M2M2UDA9)
SACCHAROMYCES CEREVISIAE RNA (UNII: J17GBZ5VGX)
CORN (UNII: 0N8672707O)
ROSA CENTIFOLIA FLOWER (UNII: CS4TE8FF7O)
SORBITOL (UNII: 506T60A25R)
SUGARCANE (UNII: 81H2R5AOH3)
BILBERRY (UNII: 9P2U39H18W)
TALC (UNII: 7SEV7J4R1U)
ARGININE (UNII: 94ZLA3W45F)
PYRIDOXINE HYDROCHLORIDE (UNII: 68Y4CF58BV)
ALUMINUM OXIDE (UNII: LMI26O6933)
ALUMINUM HYDROXIDE (UNII: 5QB0T2IUN0)
PHENYLALANINE (UNII: 47E5O17Y3R)
MAGNESIUM SULFATE, UNSPECIFIED FORM (UNII: DE08037SAB)
MANNITOL (UNII: 3OWL53L36A)
ASCORBYL LACTOSIDE (UNII: NJ3O2X7MF4)
NYLON-12 (UNII: 446U8J075B)
TYROSINE (UNII: 42HK56048U)
ADENOSINE TRIPHOSPHATE DISODIUM (UNII: 5L51B4DR1G)
DISODIUM STEAROYL GLUTAMATE (UNII: 45ASM2L11M)
PROPYLENE GLYCOL (UNII: 6DC9Q167V3)
ACER SACCHARUM BARK/SAP (UNII: Z120VL0KAC)
LEMON (UNII: 24RS0A988O)
MALTITOL (UNII: D65DG142WK)
GENTIANA LUTEA ROOT (UNII: S72O3284MS)
PENTYLENE GLYCOL (UNII: 50C1307PZG)
DISTEARDIMONIUM HECTORITE (UNII: X687XDK09L)
HISTIDINE MONOHYDROCHLORIDE (UNII: 1D5Q932XM6)
ETHYLHEXYL HYDROXYSTEARATE (UNII: B7I80BVV5E)
BUTYLATED HYDROXYTOLUENE (UNII: 1P9D0Z171K)
PENTAERYTHRITOL TETRAKIS(3-(3,5-DI-TERT-BUTYL-4-HYDROXYPHENYL)PROPIONATE) (UNII: 255PIF62MS)
SORBIC ACID (UNII: X045WJ989B)
PHENOXYETHANOL (UNII: HIE492ZZ3T)
LINALOOL, (+/-)- (UNII: D81QY6I88E)
EUGENOL (UNII: 3T8H1794QW)
ISOMETHYL-.ALPHA.-IONONE (UNII: 9XP4LC555B)
.ALPHA.-HEXYLCINNAMALDEHYDE (UNII: 7X6O37OK2I)
BENZYL ALCOHOL (UNII: LKG8494WBH)
BENZYL SALICYLATE (UNII: WAO5MNK9TU)
BISMUTH OXYCHLORIDE (UNII: 4ZR792I587)
FERRIC OXIDE RED (UNII: 1K09F3G675)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 49967-423-01	1 in 1 CARTON	06/01/2016
1		13 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	06/01/2016

Labeler - L'Oreal USA Products Inc (002136794)

Establishment
Name	Address	ID/FEI	Business Operations
SICOS ET CIE		276993581	manufacture(49967-423)