LANCOME PARIS NUDE MIRACLE BROAD SPECTRUM SPF 15 SUNSCREEN- octinoxate liquid

Lancome Paris Nude Miracle Broad Spectrum SPF 15 Sunscreen by

Drug Labeling and Warnings

Lancome Paris Nude Miracle Broad Spectrum SPF 15 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 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

cyclohexasiloxane, dimethicone, isododecane, alcohol denat., vinyl dimethicone/methicone silsesquioxane crosspolymer, phenyl trimethicone, PEG-10 dimethicone, disteardimonium hectorite, rosa canina fruit oil, tin oxide, ruscus aculeatus root extract, water, silica silylate, aluminum hydroxide, magnesium silicate, disodium stearoyl glutamate, propylene carbonate, synthetic fluophlogopite, tocopheryl acetate, fragrance, linalool, limonene, hydroxyisohexyl 3-cyclohexene carboxaldehyde, butylphenyl methylpropional, hexyl cinnamal; 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 NUDE MIRACLE BROAD SPECTRUM SPF 15 SUNSCREEN 
octinoxate liquid

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 49967-636
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
CYCLOMETHICONE 6 (UNII: XHK3U310BA)
DIMETHICONE (UNII: 92RU3N3Y1O)
ISODODECANE (UNII: A8289P68Y2)
ALCOHOL (UNII: 3K9958V90M)
PHENYL TRIMETHICONE (UNII: DR0K5NOJ4R)
PEG-14 DIMETHICONE (UNII: G7DL1Y4G26)
DISTEARDIMONIUM HECTORITE (UNII: X687XDK09L)
ROSA CANINA FRUIT OIL (UNII: CR7307M3QZ)
STANNIC OXIDE (UNII: KM7N50LOS6)
RUSCUS ACULEATUS ROOT (UNII: ZW12V95I1Q)
WATER (UNII: 059QF0KO0R)
ALUMINUM HYDROXIDE (UNII: 5QB0T2IUN0)
MAGNESIUM SILICATE (UNII: 9B9691B2N9)
DISODIUM STEAROYL GLUTAMATE (UNII: 45ASM2L11M)
PROPYLENE CARBONATE (UNII: 8D08K3S51E)
.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)
TITANIUM DIOXIDE (UNII: 15FIX9V2JP)
FERRIC OXIDE RED (UNII: 1K09F3G675)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 49967-636-01	1 in 1 CARTON	01/01/2014
1		30 mL in 1 BOTTLE; Type 0: Not a Combination Product
2	NDC: 49967-636-02	1 mL in 1 PACKET; Type 0: Not a Combination Product	01/01/2014
3	NDC: 49967-636-03	100 mL in 1 BOTTLE; Type 0: Not a Combination Product	01/01/2014

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph not final	part352	01/01/2014

Labeler - L'Oreal USA Products Inc (002136794)

Establishment
Name	Address	ID/FEI	Business Operations
SICOS ET CIE		276993581	manufacture(49967-636)