Drug Facts

Drug Labeling and Warnings

Drug Details [pdf]

YVES SAINT LAURENT TEINT RESIST LONG WEAR ENDLESS COMFORT TRANSFER RESISTANT FOUNDATION SPF 10- titanium dioxide lotion 
Sicos Et Cie (Lancome)

Disclaimer: Most OTC drugs are not reviewed and approved by FDA, however they may be marketed if they comply with applicable regulations and policies. FDA has not evaluated whether this product complies.

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Drug Facts

ACTIVE INGREDIENT

Titanium dioxide 6.03%

USES

HELPS PREVENT SUNBURN. HIGHER SPF GIVES MORE SUN PROTECTION.

DIRECTIONS

SHAKE WELL BEFORE USE. APPLY BEFORE SUN EXPOSURE.

WARNINGS

FOR EXTERNAL USE ONLY. AVOID CONTACT WITH EYES. DISCONTINUE IF SIGNS OF IRRITATION OR RASH APPEAR. KEEP OUT OF REACH OF CHILDREN.

When using this product

avoid contact with eyes.

Discontinue use if

signs of irritation or rash appear

Keep out of reach

of children.

Inactive ingredients

water, cyclohexasiloxane, nylon-12, isododecane, alcohol denat., cyclopentasiloxane, PEG-10 dimethicone, cetyl PEG/PPG-10/1 dimethicone, PEG-20, polyglyceryl-4 isostearate, disteardimonium dectorite, magnesium sulfate, disodium stearoyl gltamate, HDI/trimethylol hexyllactone crosspolymer, methylparaben, acrylaes copolymer, fragrance, butylparaben, tocopherol, aluminum hydroxide, alumina, silica, glylcerin; may conain: titanium dioxide, iron oxides

YVES SAINT LAURENT TEINT RESIST LONG WEAR ENDLESS COMFORT TRANSFER RESISTANT FOUNDATION SPF 10 
titanium dioxide lotion

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 51150-409
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
Titanium Dioxide (UNII: 15FIX9V2JP) (Titanium Dioxide - UNII:15FIX9V2JP)	Titanium Dioxide	60.3 mg  in 1 mL

Inactive Ingredients
Ingredient Name	Strength
WATER (UNII: 059QF0KO0R)
CYCLOMETHICONE 6 (UNII: XHK3U310BA)
NYLON-12 (UNII: 446U8J075B)
ISODODECANE (UNII: A8289P68Y2)
ALCOHOL (UNII: 3K9958V90M)
CYCLOMETHICONE 5 (UNII: 0THT5PCI0R)
PEG-10 DIMETHICONE (600 CST) (UNII: 8PR7V1SVM0)
CETYL PEG/PPG-10/1 DIMETHICONE (HLB 2) (UNII: V2W71V8T0X)
POLYETHYLENE GLYCOL 9000 (UNII: V146K8QJ07)
POLYGLYCERYL-4 ISOSTEARATE (UNII: 820DPX33S7)
DISTEARDIMONIUM HECTORITE (UNII: X687XDK09L)
MAGNESIUM SULFATE, UNSPECIFIED FORM (UNII: DE08037SAB)
DISODIUM STEAROYL GLUTAMATE (UNII: 45ASM2L11M)
HEXAMETHYLENE DIISOCYANATE/TRIMETHYLOL HEXYLLACTONE CROSSPOLYMER (UNII: WB5K9Y35Y9)
METHYLPARABEN (UNII: A2I8C7HI9T)
BUTYL ACRYLATE/METHYL METHACRYLATE/METHACRYLIC ACID COPOLYMER (18000 MW) (UNII: JZ1374NL9E)
BUTYLPARABEN (UNII: 3QPI1U3FV8)
TOCOPHEROL (UNII: R0ZB2556P8)
ALUMINUM HYDROXIDE (UNII: 5QB0T2IUN0)
ALUMINUM OXIDE (UNII: LMI26O6933)
SILICON DIOXIDE (UNII: ETJ7Z6XBU4)
GLYCERIN (UNII: PDC6A3C0OX)
FERROUS OXIDE (UNII: G7036X8B5H)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 51150-409-01	1 in 1 CARTON	03/01/2011	06/01/2014
1		30 mL in 1 BOTTLE, PUMP; 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	03/01/2011	06/01/2014

Labeler - Sicos Et Cie (Lancome) (276993581)

Establishment
Name	Address	ID/FEI	Business Operations
Sicos Et Cie (Lancome)		276993581	manufacture(51150-409)

Revised: 8/2019

Document Id: 054159c0-1c93-4e55-bff1-7ee0dac4181a

34390-5

Set id: 2f439b8c-865f-45b5-bc67-e1130048db4e

Version: 4

Effective Time: 20190827