Drug Facts

Drug Labeling and Warnings

Drug Details [pdf]

YVES SAINT LAURENT LE TEINT TOUCHE ECLAT SUNSCREEN ILLUMINATING FOUNDATION SPF 19- octinoxate lotion 
L'Oreal USA Products Inc

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

Octinoxate 7%

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 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
  

Purpose

Sunscreen

Inactive ingredients

water, cyclopentasiloxane, glycerin, dimethicone, PEG-10 dimethicone, sorbitol, bis-PEG/PPG-14/14 dimethicone, dimethicone/polyglycerin-3 crosspolymer, sodium chloride, phenoxyethanol, caprylyl glycol, disteardimonium hectorite, disodium stearoyl glutamate, ethylhexylglycerin, fragrance, aluminum hydroxide, ascorbyl palmitate, dipropylene glycol, isotridecyl isononanoate; may contain: titanium dioxide, iron oxides, bismuth oxychloride

YVES SAINT LAURENT LE TEINT TOUCHE ECLAT SUNSCREEN ILLUMINATING FOUNDATION SPF 19 
octinoxate lotion

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 49967-065
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
Octinoxate (UNII: 4Y5P7MUD51) (Octinoxate - UNII:4Y5P7MUD51)	Octinoxate	70 mg  in 1 mL

Inactive Ingredients
Ingredient Name	Strength
WATER (UNII: 059QF0KO0R)
CYCLOMETHICONE 5 (UNII: 0THT5PCI0R)
GLYCERIN (UNII: PDC6A3C0OX)
DIMETHICONE (UNII: 92RU3N3Y1O)
PEG-10 DIMETHICONE (600 CST) (UNII: 8PR7V1SVM0)
SORBITOL (UNII: 506T60A25R)
BIS-PEG/PPG-14/14 DIMETHICONE (UNII: X2I70H0QJE)
SODIUM CHLORIDE (UNII: 451W47IQ8X)
PHENOXYETHANOL (UNII: HIE492ZZ3T)
CAPRYLYL GLYCOL (UNII: 00YIU5438U)
DISTEARDIMONIUM HECTORITE (UNII: X687XDK09L)
DISODIUM STEAROYL GLUTAMATE (UNII: 45ASM2L11M)
ETHYLHEXYLGLYCERIN (UNII: 147D247K3P)
ALUMINUM HYDROXIDE (UNII: 5QB0T2IUN0)
ASCORBYL PALMITATE (UNII: QN83US2B0N)
DIPROPYLENE GLYCOL (UNII: E107L85C40)
ISOTRIDECYL ISONONANOATE (UNII: WEF51750MT)
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: 49967-065-01	1 in 1 CARTON	06/01/2012	06/01/2015
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	06/01/2012	06/01/2015

Labeler - L'Oreal USA Products Inc (002136794)

Establishment
Name	Address	ID/FEI	Business Operations
SICOS ET CIE		276993581	manufacture(49967-065)

Revised: 8/2019

Document Id: 3929e010-fbeb-46ba-b58f-7bb879e1fee9

34390-5

Set id: 8e396ea8-992d-4068-a5da-ce89642db08a

Version: 2

Effective Time: 20190826