YVES SAINT LAURENT FOREVER YOUTH LIBERATOR BROAD SPECTRUM SPF 15 SUNSCREEN FLUID- avobenzone, octisalate and octocrylene lotion

Yves Saint Laurent Forever Youth Liberator Broad Spectrum SPF 15 Sunscreen Fluid by

Drug Labeling and Warnings

Yves Saint Laurent Forever Youth Liberator Broad Spectrum SPF 15 Sunscreen Fluid 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

Avobenzone 2.1%

Octisalate 3.5%

Octocrylene 4.9%

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 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, dimethicone, cyclohexasiloxane, mineral oil, pentaerythrityl tetraethylhexanoate, glyceryl stearate, alcohol denat., polyglyceryl-3 methylglucose distearate, silica, rhamnose, hydroxyethylpiperazine ethane sulfonic acid, hydroxypropyl tetrahydropyrantriol, phenoxyethanol, propylene glycol, PEG-8 isostearate, polysilicone-11, ammonium polyacryloyldimethyl taurate, octyldodecanol, dimethiconol, methylparaben, capryloyl salicylic acid, sorbitan palmitate, glycine soja (soybean) oil, tocopherol, acrylamide/sodium acryloyldimethyltaurate copolymer, cholesterol, disodum stearoyl glutamate, dimethyl isosorbide, ethylparaben, acrylates copolymer, isohexadecane, triethanolamine, sodium hyaluronate, xanthan gum, disodium EDTA, polysorbate 80, linalool, alpha-isomethyl ionone, chondrus crispus (carrageenan), limonene, geraniol, citronellol, coumarin, yellow 5, red 4, benzyl alcohol, blue 1, fragrance

PRINCIPAL DISPLAY PANEL

INGREDIENTS AND APPEARANCE

YVES SAINT LAURENT FOREVER YOUTH LIBERATOR BROAD SPECTRUM SPF 15 SUNSCREEN FLUID 
avobenzone, octisalate and octocrylene lotion

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 49967-135
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
AVOBENZONE (UNII: G63QQF2NOX) (AVOBENZONE - UNII:G63QQF2NOX)	AVOBENZONE	21 mg  in 1 mL
OCTISALATE (UNII: 4X49Y0596W) (OCTISALATE - UNII:4X49Y0596W)	OCTISALATE	35 mg  in 1 mL
OCTOCRYLENE (UNII: 5A68WGF6WM) (OCTOCRYLENE - UNII:5A68WGF6WM)	OCTOCRYLENE	49 mg  in 1 mL

Inactive Ingredients
Ingredient Name	Strength
WATER (UNII: 059QF0KO0R)
GLYCERIN (UNII: PDC6A3C0OX)
DIMETHICONE (UNII: 92RU3N3Y1O)
CYCLOMETHICONE 6 (UNII: XHK3U310BA)
MINERAL OIL (UNII: T5L8T28FGP)
PENTAERYTHRITYL TETRAETHYLHEXANOATE (UNII: XJ7052W897)
GLYCERYL MONOSTEARATE (UNII: 230OU9XXE4)
ALCOHOL (UNII: 3K9958V90M)
SILICON DIOXIDE (UNII: ETJ7Z6XBU4)
RHAMNOSE (UNII: QN34XC755A)
HYDROXYETHYLPIPERAZINE ETHANE SULFONIC ACID (UNII: RWW266YE9I)
HYDROXYPROPYL TETRAHYDROPYRANTRIOL (UNII: 4U3GMG1OT1)
PHENOXYETHANOL (UNII: HIE492ZZ3T)
PROPYLENE GLYCOL (UNII: 6DC9Q167V3)
PEG-8 ISOSTEARATE (UNII: 526U509I14)
DIMETHICONE/VINYL DIMETHICONE CROSSPOLYMER (SOFT PARTICLE) (UNII: 9E4CO0W6C5)
OCTYLDODECANOL (UNII: 461N1O614Y)
METHYLPARABEN (UNII: A2I8C7HI9T)
CAPRYLOYL SALICYLIC ACID (UNII: 5F7PJF6AA4)
SORBITAN MONOPALMITATE (UNII: 77K6Z421KU)
SOYBEAN OIL (UNII: 241ATL177A)
TOCOPHEROL (UNII: R0ZB2556P8)
CHOLESTEROL (UNII: 97C5T2UQ7J)
DISODIUM STEAROYL GLUTAMATE (UNII: 45ASM2L11M)
DIMETHYL ISOSORBIDE (UNII: SA6A6V432S)
ETHYLPARABEN (UNII: 14255EXE39)
ISOHEXADECANE (UNII: 918X1OUF1E)
TROLAMINE (UNII: 9O3K93S3TK)
HYALURONATE SODIUM (UNII: YSE9PPT4TH)
XANTHAN GUM (UNII: TTV12P4NEE)
EDETATE DISODIUM (UNII: 7FLD91C86K)
POLYSORBATE 80 (UNII: 6OZP39ZG8H)
LINALOOL, (+/-)- (UNII: D81QY6I88E)
ISOMETHYL-.ALPHA.-IONONE (UNII: 9XP4LC555B)
CHONDRUS CRISPUS CARRAGEENAN (UNII: UE856F2T78)
LIMONENE, (+)- (UNII: GFD7C86Q1W)
GERANIOL (UNII: L837108USY)
.BETA.-CITRONELLOL, (R)- (UNII: P01OUT964K)
COUMARIN (UNII: A4VZ22K1WT)
FD&C YELLOW NO. 5 (UNII: I753WB2F1M)
FD&C RED NO. 4 (UNII: X3W0AM1JLX)
BENZYL ALCOHOL (UNII: LKG8494WBH)
FD&C BLUE NO. 1 (UNII: H3R47K3TBD)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 49967-135-01	1 in 1 CARTON	02/01/2012
1		50 mL in 1 BOTTLE; Type 0: Not a Combination Product

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph not final	part352	02/01/2012

Labeler - L'Oreal USA Products Inc (002136794)

Establishment
Name	Address	ID/FEI	Business Operations
SICOS ET CIE		276993581	manufacture(49967-135)