YVES SAINT LAURENT LE TEINT ENCRE DE PEAU FUSION INK FOUNDATION BROAD SPECTRUM SPF 18 SUNSCREEN- octinoxate lotion

Yves Saint Laurent Le Teint Encre De Peau Fusion Ink Foundation Broad Spectrum SPF 18 Sunscreen by

Drug Labeling and Warnings

Yves Saint Laurent Le Teint Encre De Peau Fusion Ink Foundation Broad Spectrum SPF 18 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

Caution:

flammable until dry. Avoid fire, flame and heat during application.

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 before use

● apply generously 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

dimethicone, cyclohexasiloxane, isododecane, alcohol denat., vinyl dimethicone/methicone silsesquioxane crosspolymer, phenyl trimethicone, disteardimonium hectorite, PEG-10 dimethicone, synthetic fluorphlogopite, water, propylene carbonate, disodium stearoyl glutamate, silica silylate, fragrance, calophyllum inophyllum seed oil, aluminum hydroxide, benzyl alcohol; may contain: titanium dioxide, iron oxides

PRINCIPAL DISPLAY PANEL

INGREDIENTS AND APPEARANCE

YVES SAINT LAURENT LE TEINT ENCRE DE PEAU FUSION INK FOUNDATION BROAD SPECTRUM SPF 18 SUNSCREEN 
octinoxate lotion

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 49967-789
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
DIMETHICONE (UNII: 92RU3N3Y1O)
CYCLOMETHICONE 6 (UNII: XHK3U310BA)
ISODODECANE (UNII: A8289P68Y2)
ALCOHOL (UNII: 3K9958V90M)
VINYL DIMETHICONE/METHICONE SILSESQUIOXANE CROSSPOLYMER (UNII: 9NH1UDD2RR)
PHENYL TRIMETHICONE (UNII: DR0K5NOJ4R)
DISTEARDIMONIUM HECTORITE (UNII: X687XDK09L)
PEG-10 DIMETHICONE (600 CST) (UNII: 8PR7V1SVM0)
WATER (UNII: 059QF0KO0R)
PROPYLENE CARBONATE (UNII: 8D08K3S51E)
DISODIUM STEAROYL GLUTAMATE (UNII: 45ASM2L11M)
TAMANU OIL (UNII: JT3LVK84A1)
ALUMINUM HYDROXIDE (UNII: 5QB0T2IUN0)
BENZYL ALCOHOL (UNII: LKG8494WBH)
TITANIUM DIOXIDE (UNII: 15FIX9V2JP)
FERRIC OXIDE RED (UNII: 1K09F3G675)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 49967-789-01	1 in 1 CARTON	08/01/2014
1		25 mL in 1 BOTTLE; Type 0: Not a Combination Product
2	NDC: 49967-789-02	1 in 1 CARTON	08/01/2014
2		10 mL in 1 BOTTLE; Type 0: Not a Combination Product
3	NDC: 49967-789-03	0.27 mL in 1 PACKAGE; Type 0: Not a Combination Product	08/01/2014	11/30/2017

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph not final	part352	08/01/2014

Labeler - L'Oreal USA Products Inc (002136794)

Establishment
Name	Address	ID/FEI	Business Operations
Sicos et Cie		276993581	manufacture(49967-789)

Establishment
Name	Address	ID/FEI	Business Operations
Laboratoires Biocosm SARL		288479491	pack(49967-789)

Establishment
Name	Address	ID/FEI	Business Operations
Socoplan		276221405	pack(49967-789)