YVES SAINT LAURENT ALL HOURS FOUNDATION BROAD SPECTRUM SPF 20 SUNSCREEN LUMINOUS MATTE FOUNDATION- octinoxate and titanium dioxide lotion

Yves Saint Laurent All Hours Foundation Broad Spectrum SPF 20 Sunscreen Luminous Matte Foundation by

Drug Labeling and Warnings

Yves Saint Laurent All Hours Foundation Broad Spectrum SPF 20 Sunscreen Luminous Matte Foundation 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

Octinoxate 6.7%

Titanium dioxide 3.6%

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

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 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, dimethicone, isododecane, alcohol denat., trimethylsiloxysilicate, butylene glycol, PEG-10 dimethicone, synthetic fluorphlogopite, perlite, disteardimonium hectorite, nylon-12, HDI/trimethylol hexyllactone crosspolymer, aluminum hydroxide, isopropyl lauroyl sarcosinate, diisopropyl sebacate, bis-PEG/PPG-14/14 dimethicone,magnesium sulfate, phenoxyethanol, disodium stearoyl glutamate, aluminum hydroxide, dipentaerythrityl tetrahydroxystearate/tetraisostearate, silica silylate, glycerin, tocopherol, caprylic/capric triglyceride, hydrogen dimethicone, silica, BHT, jasminum officinale (jasmine) flower extract, benzyl alcohol, sodium hyaluronate, phenethyl alcohol, linalool, sodium carrageenan, citrus limon (lemon) peel extract, jania rubens extract, fragrance; may contain: iron oxides, titanium dioxide

PRINCIPAL DISPLAY PANEL

INGREDIENTS AND APPEARANCE

YVES SAINT LAURENT ALL HOURS FOUNDATION BROAD SPECTRUM SPF 20 SUNSCREEN LUMINOUS MATTE FOUNDATION 
octinoxate and titanium dioxide lotion

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 49967-712
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
OCTINOXATE (UNII: 4Y5P7MUD51) (OCTINOXATE - UNII:4Y5P7MUD51)	OCTINOXATE	67 mg  in 1 mL
TITANIUM DIOXIDE (UNII: 15FIX9V2JP) (TITANIUM DIOXIDE - UNII:15FIX9V2JP)	TITANIUM DIOXIDE	11 mg  in 1 mL

Inactive Ingredients
Ingredient Name	Strength
WATER (UNII: 059QF0KO0R)
DIMETHICONE (UNII: 92RU3N3Y1O)
ISODODECANE (UNII: A8289P68Y2)
ALCOHOL (UNII: 3K9958V90M)
TRIMETHYLSILOXYSILICATE (M/Q 0.6-0.8) (UNII: 5041RX63GN)
BUTYLENE GLYCOL (UNII: 3XUS85K0RA)
MAGNESIUM POTASSIUM ALUMINOSILICATE FLUORIDE (UNII: YK3DC63Y5M)
PEG-10 DIMETHICONE (600 CST) (UNII: 8PR7V1SVM0)
PERLITE (UNII: 0SG101ZGK9)
DISTEARDIMONIUM HECTORITE (UNII: X687XDK09L)
NYLON-12 (UNII: 446U8J075B)
HEXAMETHYLENE DIISOCYANATE/TRIMETHYLOL HEXYLLACTONE CROSSPOLYMER (UNII: WB5K9Y35Y9)
ISOPROPYL LAUROYL SARCOSINATE (UNII: LYR06W430J)
DIISOPROPYL SEBACATE (UNII: J8T3X564IH)
BIS-PEG/PPG-14/14 DIMETHICONE (UNII: X2I70H0QJE)
MAGNESIUM SULFATE, UNSPECIFIED FORM (UNII: DE08037SAB)
PHENOXYETHANOL (UNII: HIE492ZZ3T)
DISODIUM STEAROYL GLUTAMATE (UNII: 45ASM2L11M)
DIPENTAERYTHRITYL TETRAHYDROXYSTEARATE/TETRAISOSTEARATE (UNII: 230K0823CE)
GLYCERIN (UNII: PDC6A3C0OX)
TOCOPHEROL (UNII: R0ZB2556P8)
MEDIUM-CHAIN TRIGLYCERIDES (UNII: C9H2L21V7U)
HYDROGEN DIMETHICONE (13 CST) (UNII: 4QGR4P2YOI)
SILICON DIOXIDE (UNII: ETJ7Z6XBU4)
BUTYLATED HYDROXYTOLUENE (UNII: 1P9D0Z171K)
JASMINUM OFFICINALE FLOWER (UNII: 0Q8K841432)
BENZYL ALCOHOL (UNII: LKG8494WBH)
HYALURONATE SODIUM (UNII: YSE9PPT4TH)
PHENYLETHYL ALCOHOL (UNII: ML9LGA7468)
LINALOOL, (+/-)- (UNII: D81QY6I88E)
CARRAGEENAN (UNII: 5C69YCD2YJ)
LEMON PEEL (UNII: 72O054U628)
FERRIC OXIDE RED (UNII: 1K09F3G675)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 49967-712-01	1 in 1 CARTON	07/25/2022
1		25 mL in 1 BOTTLE; Type 0: Not a Combination Product
2	NDC: 49967-712-02	4.2 mL in 1 PACKAGE; Type 0: Not a Combination Product	07/25/2022

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC Monograph Drug	M020	07/25/2022

Labeler - L'Oreal USA Products Inc (002136794)

Establishment
Name	Address	ID/FEI	Business Operations
SICOS ET CIE		276993581	manufacture(49967-712) , pack(49967-712)

Establishment
Name	Address	ID/FEI	Business Operations
Socoplan		276221405	pack(49967-712)