YVES SAINT LAURENT TOUCHE ECLAT LE TEINT RADIANCE AWAKENING FOUNDATION BROAD SPECTRUM SPF 22 SUNSCREEN- 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 6.8%

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, cyclopentasiloxane, glycerin, dimethicone, isododecane, PEG-10 dimethicone, sorbitol, bis-PEG/PPG-14/14 dimethicone, synthetic fluorphlogopite, sodium chloride, silica, dimethicone/polyglycerin-3 crosspolymer, phenoxyethanol, methyl methacrylate crosspolymer, capryly glycol, disodium stearoyl glutamate, disteardimonium hectorite, silica silylate, tocopheryl acetate, ethylhexylglycerin, fragrance, aluminum hydroxide, ascorbyl palmitate, ethylhexyl hydroxystearate, triethoxycaprylylsilane, dipropylene glycol, ruscus aculeatus root extract, BHT, tocopherol, sodium citrate, isopropyl alcohol ; may contain : titanium dioxide, iron oxides, bismuth oxychloride

image of a carton

YVES SAINT LAURENT TOUCHE ECLAT LE TEINT RADIANCE AWAKENING FOUNDATION BROAD SPECTRUM SPF 22 SUNSCREEN 
octinoxate lotion
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:49967-787
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
OCTINOXATE (UNII: 4Y5P7MUD51) (OCTINOXATE - UNII:4Y5P7MUD51) OCTINOXATE68 mg  in 1 mL
Inactive Ingredients
Ingredient NameStrength
WATER (UNII: 059QF0KO0R)  
CYCLOMETHICONE 5 (UNII: 0THT5PCI0R)  
GLYCERIN (UNII: PDC6A3C0OX)  
DIMETHICONE (UNII: 92RU3N3Y1O)  
ISODODECANE (UNII: A8289P68Y2)  
PEG-10 DIMETHICONE (600 CST) (UNII: 8PR7V1SVM0)  
SORBITOL (UNII: 506T60A25R)  
BIS-PEG/PPG-14/14 DIMETHICONE (UNII: X2I70H0QJE)  
SODIUM CHLORIDE (UNII: 451W47IQ8X)  
SILICON DIOXIDE (UNII: ETJ7Z6XBU4)  
PHENOXYETHANOL (UNII: HIE492ZZ3T)  
DISODIUM STEAROYL GLUTAMATE (UNII: 45ASM2L11M)  
DISTEARDIMONIUM HECTORITE (UNII: X687XDK09L)  
.ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)  
ETHYLHEXYLGLYCERIN (UNII: 147D247K3P)  
ALUMINUM HYDROXIDE (UNII: 5QB0T2IUN0)  
ASCORBYL PALMITATE (UNII: QN83US2B0N)  
ETHYLHEXYL HYDROXYSTEARATE (UNII: B7I80BVV5E)  
TRIETHOXYCAPRYLYLSILANE (UNII: LDC331P08E)  
DIPROPYLENE GLYCOL (UNII: E107L85C40)  
RUSCUS ACULEATUS ROOT (UNII: ZW12V95I1Q)  
BUTYLATED HYDROXYTOLUENE (UNII: 1P9D0Z171K)  
TOCOPHEROL (UNII: R0ZB2556P8)  
SODIUM CITRATE (UNII: 1Q73Q2JULR)  
ISOPROPYL ALCOHOL (UNII: ND2M416302)  
TITANIUM DIOXIDE (UNII: 15FIX9V2JP)  
FERRIC OXIDE RED (UNII: 1K09F3G675)  
BISMUTH OXYCHLORIDE (UNII: 4ZR792I587)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:49967-787-011 in 1 CARTON07/01/201508/08/2023
130 mL in 1 BOTTLE, PUMP; Type 0: Not a Combination Product
2NDC:49967-787-021 in 1 CARTON07/01/201508/08/2023
210 mL in 1 BOTTLE; Type 0: Not a Combination Product
3NDC:49967-787-031 mL in 1 PACKET; Type 0: Not a Combination Product07/01/201508/08/2023
4NDC:49967-787-04125 mL in 1 BOTTLE; Type 0: Not a Combination Product07/01/201508/08/2023
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph not finalpart35207/01/201508/08/2023
Labeler - L'Oreal USA Products Inc (002136794)
Establishment
NameAddressID/FEIBusiness Operations
Sicos et Cie276993581manufacture(49967-787) , pack(49967-787)
Establishment
NameAddressID/FEIBusiness Operations
BPS60272259304pack(49967-787)
Establishment
NameAddressID/FEIBusiness Operations
Socoplan276221405pack(49967-787)

Revised: 1/2023
 
L'Oreal USA Products Inc