LANCOME PARIS TEINT MIRACLE LIT FROM WITHIN MAKEUP BROAD SPECTRUM SPF 15 SUNSCREEN- octinoxate liquid

Lancome Paris Teint Miracle Lit From Within Makeup Broad Spectrum SPF 15 Sunscreen by

Drug Labeling and Warnings

Lancome Paris Teint Miracle Lit From Within 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. 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 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:

● 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, cyclopentasiloxane, alcohol denat., phenyl trimethicone, glycerin, PEG-10 dimethicone, bis-PEG/PPG-14/14 dimethicone, PEG/PPG/polybutylene glycol-8/5/3 glycerin, rosa gallica flower extract, talc, dimethicone, dimethicone/polyglycerin-3 crosspolymer, methicone, alumina, aluminum hydroxide, magnesium sulfate, disodium stearoyl glutamate, ethylhexyl hydroxystearate, polyethylene glycol, tocopheryl acetate; may contain: red 28 lake, red 7, mica, titanium dioxide, blue 1 lake, 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 MIRACLE LIT FROM WITHIN MAKEUP BROAD SPECTRUM SPF 15 SUNSCREEN 
octinoxate liquid

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 49967-506
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 5 (UNII: 0THT5PCI0R)
ALCOHOL (UNII: 3K9958V90M)
PHENYL TRIMETHICONE (UNII: DR0K5NOJ4R)
GLYCERIN (UNII: PDC6A3C0OX)
PEG-10 DIMETHICONE (600 CST) (UNII: 8PR7V1SVM0)
BIS-PEG/PPG-14/14 DIMETHICONE (UNII: X2I70H0QJE)
STANNIC OXIDE (UNII: KM7N50LOS6)
ROSA GALLICA FLOWER (UNII: X8W61WUV70)
TALC (UNII: 7SEV7J4R1U)
DIMETHICONE (UNII: 92RU3N3Y1O)
METHICONE (20 CST) (UNII: 6777U11MKT)
ALUMINUM OXIDE (UNII: LMI26O6933)
ALUMINUM HYDROXIDE (UNII: 5QB0T2IUN0)
MAGNESIUM SILICATE (UNII: 9B9691B2N9)
DISODIUM STEAROYL GLUTAMATE (UNII: 45ASM2L11M)
ETHYLHEXYL HYDROXYSTEARATE (UNII: B7I80BVV5E)
.ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)
LINALOOL, (+/-)- (UNII: D81QY6I88E)
LIMONENE, (+)- (UNII: GFD7C86Q1W)
HYDROXYISOHEXYL 3-CYCLOHEXENE CARBOXALDEHYDE (UNII: QUE43B9Z2Q)
BUTYLPHENYL METHYLPROPIONAL (UNII: T7540GJV69)
.ALPHA.-HEXYLCINNAMALDEHYDE (UNII: 7X6O37OK2I)
D&C RED NO. 7 (UNII: ECW0LZ41X8)
MICA (UNII: V8A1AW0880)
TITANIUM DIOXIDE (UNII: 15FIX9V2JP)
BISMUTH OXYCHLORIDE (UNII: 4ZR792I587)
FERRIC OXIDE RED (UNII: 1K09F3G675)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 49967-506-01	1 in 1 CARTON	04/01/2011
1		30 mL in 1 BOTTLE; Type 0: Not a Combination Product
2	NDC: 49967-506-02	1 in 1 CARTON	04/01/2011
2		10 mL in 1 BOTTLE; Type 0: Not a Combination Product
3	NDC: 49967-506-03	110 mL in 1 BOTTLE; Type 0: Not a Combination Product	04/01/2011

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph not final	part352	04/01/2011

Labeler - L'Oreal USA Products Inc (002136794)

Establishment
Name	Address	ID/FEI	Business Operations
SICOS ET CIE		276993581	manufacture(49967-506) , pack(49967-506)

Establishment
Name	Address	ID/FEI	Business Operations
Laboratoires Biocosm SARL		288479491	pack(49967-506)