YVES SAINT LAURENT TOUCHE ECLAT ALL IN ONE GLOW INSTANT COMPLEXION ENHANCER BROAD SPECTRUM SPF 23 SUNSCREEN- octinoxate lotion

Yves Saint Laurent Touche Eclat All in One Glow Instant Complexion Enhancer Broad Spectrum SPF 23 Sunscreen by

Drug Labeling and Warnings

Yves Saint Laurent Touche Eclat All in One Glow Instant Complexion Enhancer Broad Spectrum SPF 23 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.

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

water, glycerin, caprylyl methicone, propanediol, dimethicone, dimethicone/PEG-10/15 crosspolymer, sodium chloride, phenoxyethanol, propylene glycol, chlorphenesin, triethoxysilylethyl polydimethylsiloxyethyl dimethicone, isopropyl titanium triisostearate, tocopheryl acetate, fragrance, disodium EDTA, alumina, dipropylene glycol, calendula officinalis flower extract, ruscus aculeatus root exract, sodium hyaluronate, sodium citrate, BHT, benzyl alcohol, tocopherol; may contain: titanium dioxide, iron oxides, bismuth oxychloride

PRINCIPAL DISPLAY PANEL

INGREDIENTS AND APPEARANCE

YVES SAINT LAURENT TOUCHE ECLAT ALL IN ONE GLOW INSTANT COMPLEXION ENHANCER BROAD SPECTRUM SPF 23 SUNSCREEN 
octinoxate lotion

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 49967-406
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)
GLYCERIN (UNII: PDC6A3C0OX)
CAPRYLYL TRISILOXANE (UNII: Q95M2P1KJL)
PROPANEDIOL (UNII: 5965N8W85T)
DIMETHICONE (UNII: 92RU3N3Y1O)
SODIUM CHLORIDE (UNII: 451W47IQ8X)
PHENOXYETHANOL (UNII: HIE492ZZ3T)
PROPYLENE GLYCOL (UNII: 6DC9Q167V3)
CHLORPHENESIN (UNII: I670DAL4SZ)
ISOPROPYL TITANIUM TRIISOSTEARATE (UNII: 949E3KBJ1I)
.ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)
EDETATE DISODIUM (UNII: 7FLD91C86K)
ALUMINUM OXIDE (UNII: LMI26O6933)
DIPROPYLENE GLYCOL (UNII: E107L85C40)
CALENDULA OFFICINALIS FLOWER (UNII: P0M7O4Y7YD)
RUSCUS ACULEATUS ROOT (UNII: ZW12V95I1Q)
HYALURONATE SODIUM (UNII: YSE9PPT4TH)
SODIUM CITRATE (UNII: 1Q73Q2JULR)
BUTYLATED HYDROXYTOLUENE (UNII: 1P9D0Z171K)
BENZYL ALCOHOL (UNII: LKG8494WBH)
TOCOPHEROL (UNII: R0ZB2556P8)
TITANIUM DIOXIDE (UNII: 15FIX9V2JP)
FERRIC OXIDE RED (UNII: 1K09F3G675)
BISMUTH OXYCHLORIDE (UNII: 4ZR792I587)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 49967-406-01	1 in 1 CARTON	12/01/2017
1		30 mL in 1 TUBE; Type 0: Not a Combination Product
2	NDC: 49967-406-02	1 mL in 1 PACKET; Type 0: Not a Combination Product	12/01/2017

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph not final	part352	12/01/2017

Labeler - L'Oreal USA Products Inc (002136794)

Establishment
Name	Address	ID/FEI	Business Operations
SICOS ET CIE		276993581	manufacture(49967-406) , pack(49967-406)

Establishment
Name	Address	ID/FEI	Business Operations
Socoplan		276221405	pack(49967-406)