LANCOME PARIS CITY MIRACLE BROAD SPECTRUM SPF 50 SUNSCREEN CC- homosalate, octisalate, octocrylene and titanium dioxide cream

Lancome Paris City Miracle Broad Spectrum SPF 50 Sunscreen CC by

Drug Labeling and Warnings

Lancome Paris City Miracle Broad Spectrum SPF 50 Sunscreen CC 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

Homosalate 10%

Octisalate 5%

Octocrylene 5%

Titanium dioxide 1.6%

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:

● 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, glycerin, alcohol denat., dicaprylyl ether, polyglyceryl-4 isostearate, ascorbyl glucoside, silica, nylon-12, tribehenin, disteardimonium hectorite, butylene glycol, rosa canina fruit oil, PEG-30 dipolyhydroxystearate, saccharomyces/xylinum/black tea ferment, sodium chloride, aluminum hydroxide, adenosine, disodium stearoyl glutamate, butyrospermum parkii (shea butter) seedcake extract, phenoxyethanol, fragrance, linalool, geraniol, limonene, hydroxyisohexyl 3-cyclohexene carboxaldehyde, citronellol, butylphenyl methylpropional, hexyl cinnamal, benzyl alcohol; 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 CITY MIRACLE BROAD SPECTRUM SPF 50 SUNSCREEN CC 
homosalate, octisalate, octocrylene and titanium dioxide cream

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 49967-578
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
HOMOSALATE (UNII: V06SV4M95S) (HOMOSALATE - UNII:V06SV4M95S)	HOMOSALATE	100 mg  in 1 mL
OCTISALATE (UNII: 4X49Y0596W) (OCTISALATE - UNII:4X49Y0596W)	OCTISALATE	50 mg  in 1 mL
OCTOCRYLENE (UNII: 5A68WGF6WM) (OCTOCRYLENE - UNII:5A68WGF6WM)	OCTOCRYLENE	50 mg  in 1 mL
TITANIUM DIOXIDE (UNII: 15FIX9V2JP) (TITANIUM DIOXIDE - UNII:15FIX9V2JP)	TITANIUM DIOXIDE	16 mg  in 1 mL

Inactive Ingredients
Ingredient Name	Strength
WATER (UNII: 059QF0KO0R)
GLYCERIN (UNII: PDC6A3C0OX)
ALCOHOL (UNII: 3K9958V90M)
DICAPRYLYL ETHER (UNII: 77JZM5516Z)
POLYGLYCERYL-4 ISOSTEARATE (UNII: 820DPX33S7)
ASCORBYL GLUCOSIDE (UNII: 2V52R0NHXW)
SILICON DIOXIDE (UNII: ETJ7Z6XBU4)
NYLON-12 (UNII: 446U8J075B)
TRIBEHENIN (UNII: 8OC9U7TQZ0)
DISTEARDIMONIUM HECTORITE (UNII: X687XDK09L)
BUTYLENE GLYCOL (UNII: 3XUS85K0RA)
ROSA CANINA FRUIT OIL (UNII: CR7307M3QZ)
SODIUM CHLORIDE (UNII: 451W47IQ8X)
ALUMINUM HYDROXIDE (UNII: 5QB0T2IUN0)
ADENOSINE (UNII: K72T3FS567)
DISODIUM STEAROYL GLUTAMATE (UNII: 45ASM2L11M)
SHEA BUTTER (UNII: K49155WL9Y)
PHENOXYETHANOL (UNII: HIE492ZZ3T)
LINALOOL, (+/-)- (UNII: D81QY6I88E)
GERANIOL (UNII: L837108USY)
LIMONENE, (+)- (UNII: GFD7C86Q1W)
HYDROXYISOHEXYL 3-CYCLOHEXENE CARBOXALDEHYDE (UNII: QUE43B9Z2Q)
.BETA.-CITRONELLOL, (R)- (UNII: P01OUT964K)
BUTYLPHENYL METHYLPROPIONAL (UNII: T7540GJV69)
.ALPHA.-HEXYLCINNAMALDEHYDE (UNII: 7X6O37OK2I)
BENZYL ALCOHOL (UNII: LKG8494WBH)
FERRIC OXIDE RED (UNII: 1K09F3G675)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 49967-578-01	1 in 1 CARTON	01/01/2015
1		30 mL in 1 TUBE; Type 0: Not a Combination Product
2	NDC: 49967-578-02	1 in 1 CARTON	01/01/2015
2		10 mL in 1 TUBE; Type 0: Not a Combination Product
3	NDC: 49967-578-03	1 in 1 CARTON	01/01/2015
3		5 mL in 1 TUBE; Type 0: Not a Combination Product
4	NDC: 49967-578-04	1 mL in 1 PACKET; Type 0: Not a Combination Product	01/01/2015

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

Labeler - L'Oreal USA Products Inc (002136794)

Establishment
Name	Address	ID/FEI	Business Operations
SICOS ET CIE		276993581	manufacture(49967-578)