TOUCHE ECLAT LE TEINT RADIANCE AWAKENING FOUNDATION OCTINOXATE SUNSCREEN BROAD SPECTRUM SPF 22- octinoxate cream 
BPS 60

----------

Touche Eclat Le Teint Radiance Awakening Foundation Octinoxate Sunscreen Broad Spectrum SPF 22

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, caprylyl glycol, disodium stearoyl glutamate, disteardimonium hectorite, silica siylate, tocopheryl acetate, ethyhexylglycerin, 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

Package Labeling:

Label7

TOUCHE ECLAT LE TEINT RADIANCE AWAKENING FOUNDATION OCTINOXATE SUNSCREEN BROAD SPECTRUM SPF 22 
octinoxate cream
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:70581-002
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)  
CAPRYLYL GLYCOL (UNII: 00YIU5438U)  
DISODIUM STEAROYL GLUTAMATE (UNII: 45ASM2L11M)  
DISTEARDIMONIUM HECTORITE (UNII: X687XDK09L)  
.ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)  
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)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:70581-002-011 in 1 BOX04/09/201601/30/2023
1125 mL in 1 PACKAGE; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC Monograph DrugM02004/09/201601/30/2023
Labeler - BPS 60 (272259304)
Establishment
NameAddressID/FEIBusiness Operations
BPS 60272259304pack(70581-002)

Revised: 12/2023
 
BPS 60