CLARINS EVERLASTING CUSHION LONG WEARING AND HYDRATING FOUNDATION BROAD SPECTRUM SPF 50 108 RETAIL REFILL WITH SPONGE- ensulizole, titanium dioxide emulsion

CLARINS EVERLASTING CUSHION LONG WEARING and HYDRATING FOUNDATION BROAD SPECTRUM SPF 50 108 Retail refill with sponge by

Drug Labeling and Warnings

CLARINS EVERLASTING CUSHION LONG WEARING and HYDRATING FOUNDATION BROAD SPECTRUM SPF 50 108 Retail refill with sponge by is a Otc medication manufactured, distributed, or labeled by LABORATOIRES CLARINS. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

Drug Facts

Active Ingredients:

ENSULIZOLE: 2.7 %

TITANIUM DIOXIDE: 6.2 %

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 product is swallowed, get medical help or contact a Poison Control Center right away.

Directions:

apply liberally 15 minutes before sun exposure.
apply to all skin exposed to the sun.
children under 6 months: Ask a doctor.
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 broad spectrum SPF 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.
reapply at least every 2 hours.
use a water resistant sunscreen if swimming or sweating.

Inactive Ingredients:

AQUA/WATER/EAU . CYCLOPENTASILOXANE . PHENYL TRIMETHICONE . CYCLOHEXASILOXANE . BUTYLENE GLYCOL . DIPENTAERYTHRITYL HEXA C5-9 ACID ESTERS . TRIETHYLHEXANOIN . CETYL PEG/PPG-10/1 DIMETHICONE . GLICERIN . DIMETHICONE . NIACINAMIDE . TROMETHAMINE . 1,2-HEXANEDIOL . SORBITAN SESQUIOLEATE . STEARIC ACID . DIMETHICONE/PEG-10/15 CROSSPOLYMER . NYLON-12 . PEG-30 DIPOLYHYDROXYSTEARATE . SODIUM CHLORIDE . ZINC STEARATE . ALUMINUM HYDROXIDE . DISTEARYLDIMONIUM CHLORIDE . PARFUM/FRAGRANCE . TOCOPHERYL ACETATE . BIS-VINYL DIMETHICONE/DIMETHICONE COPOLYMER . DISTEARDIMONIUM HECTORITE . TRIETHOXYCAPRYLYLSILANE . ADENOSINE . PALMITOYL PROLINE . TRIETHOXYSILYLETHYL POLYDIMETHYLSILOXYETHYL HEXYL DIMETHICONE . CHENOPODIUM QUINOA SEED EXTRACT . MAGNESIUM PALMITOYL GLUTAMATE . SODIUM PALMITOYL SARCOSINATE . CERAMIDE 3 . PALMITIC ACID . HYDROGENATED LECITHIN . LAPSANA COMMUNIS FLOWER/ LEAF/STEM EXTRACT . DIPROPYLENE GLYCOL . GLYCERETH-20 . CAMELLIA SINENSIS LEAF EXTRACT . PEG-10 RAPESEED STEROL . GLYCERYL STEARATE . SODIUM BENZOATE . PHENOXYETHANOL.
+/-MAY CONTAIN/PEUT CONTENIR : MICA . SILICA . CI 77891/TITANIUM DIOXIDE . CI 77491/CI 77492/CI 77499/IRON OXIDES. [MS3256A2]

Other information:

protect this product from excessive heat and direct sun.

Questions or comments?

Call 1-866-252-7467 (In the US) Monday-Friday 8 a.m. to 5 p.m.

Package Labeling: (

58668-1727-0)

Package Labeling: (

58668-1727-1)

INGREDIENTS AND APPEARANCE

CLARINS EVERLASTING CUSHION LONG WEARING AND HYDRATING FOUNDATION BROAD SPECTRUM SPF 50 108 RETAIL REFILL WITH SPONGE 
ensulizole, titanium dioxide emulsion

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 58668-1727
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
ENSULIZOLE (UNII: 9YQ9DI1W42) (ENSULIZOLE - UNII:9YQ9DI1W42)	ENSULIZOLE	27 mg  in 1 mL
TITANIUM DIOXIDE (UNII: 15FIX9V2JP) (TITANIUM DIOXIDE - UNII:15FIX9V2JP)	TITANIUM DIOXIDE	62 mg  in 1 mL

Inactive Ingredients
Ingredient Name	Strength
WATER (UNII: 059QF0KO0R)
CYCLOMETHICONE 5 (UNII: 0THT5PCI0R)
PHENYL TRIMETHICONE (UNII: DR0K5NOJ4R)
CYCLOMETHICONE 6 (UNII: XHK3U310BA)
BUTYLENE GLYCOL (UNII: 3XUS85K0RA)
DIPENTAERYTHRITYL HEXA C5-9 ACID ESTERS (UNII: D818OLQ51Z)
TRIETHYLHEXANOIN (UNII: 7K3W1BIU6K)
GLYCERIN (UNII: PDC6A3C0OX)
DIMETHICONE (UNII: 92RU3N3Y1O)
NIACINAMIDE (UNII: 25X51I8RD4)
TROMETHAMINE (UNII: 023C2WHX2V)
1,2-HEXANEDIOL (UNII: TR046Y3K1G)
SORBITAN SESQUIOLEATE (UNII: 0W8RRI5W5A)
STEARIC ACID (UNII: 4ELV7Z65AP)
NYLON-12 (UNII: 446U8J075B)
PEG-30 DIPOLYHYDROXYSTEARATE (UNII: 9713Q0S7FO)
SODIUM CHLORIDE (UNII: 451W47IQ8X)
ZINC STEARATE (UNII: H92E6QA4FV)
ALUMINUM HYDROXIDE (UNII: 5QB0T2IUN0)
DISTEARYLDIMONIUM CHLORIDE (UNII: OM9573ZX3X)
DISTEARDIMONIUM HECTORITE (UNII: X687XDK09L)
TRIETHOXYCAPRYLYLSILANE (UNII: LDC331P08E)
ADENOSINE (UNII: K72T3FS567)
PALMITOYL PROLINE (UNII: I49727TDYF)
MAGNESIUM PALMITOYL GLUTAMATE (UNII: DH37YM1F48)
SODIUM PALMITOYL SARCOSINATE (UNII: 7297LY09YF)
CERAMIDE 3 (UNII: 4370DF050B)
PALMITIC ACID (UNII: 2V16EO95H1)
HYDROGENATED SOYBEAN LECITHIN (UNII: H1109Z9J4N)
DIPROPYLENE GLYCOL (UNII: E107L85C40)
GLYCERETH-20 (UNII: GJ57297I4F)
GREEN TEA LEAF (UNII: W2ZU1RY8B0)
PEG-10 RAPESEED STEROL (UNII: 258O76T85M)
GLYCERYL MONOSTEARATE (UNII: 230OU9XXE4)
SODIUM BENZOATE (UNII: OJ245FE5EU)
PHENOXYETHANOL (UNII: HIE492ZZ3T)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 58668-1727-0	1 in 1 BOX	08/01/2018
1		13 mL in 1 JAR; Type 0: Not a Combination Product
2	NDC: 58668-1727-1	1 in 1 BOX	08/01/2018
2		13 mL in 1 JAR; 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	08/01/2018

Labeler - LABORATOIRES CLARINS (266317555)