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

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

Drug Labeling and Warnings

Touche Eclat Le Teint Radiance Awakening Foundation Octinoxate Sunscreen Broad Spectrum SPF 22 by is a Otc medication manufactured, distributed, or labeled by BPS 60. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

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:

INGREDIENTS AND APPEARANCE

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

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 70581-002
Route of Administration	TOPICAL, TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
OCTINOXATE (UNII: 4Y5P7MUD51) (OCTINOXATE - UNII:4Y5P7MUD51)	OCTINOXATE	68 mg  in 1 mL

Inactive Ingredients
Ingredient Name	Strength
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 Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 70581-002-01	1 in 1 BOX	04/09/2016
1		125 mL in 1 PACKAGE; 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	04/09/2016

Labeler - BPS 60 (272259304)

Establishment
Name	Address	ID/FEI	Business Operations
BPS 60		272259304	pack(70581-002)