CLARINS EVERLASTING CUSHION LONG WEARING AND HYDRATING FOUNDATION BROAD SPECTRUM SPF 50 103 RETAIL REFILL WITH SPONGE- ensulizole, titanium dioxide emulsion 
LABORATOIRES CLARINS

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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CLARINS - EVERLASTING CUSHION LONG-WEARING & HYDRATING FOUNDATION - BROAD SPECTRUM SPF 50 - 103 Retail refill with sponge

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: (58668-1721-0)

Label2

Package Labeling: (58668-1721-1)

Label3

CLARINS EVERLASTING CUSHION LONG WEARING AND HYDRATING FOUNDATION BROAD SPECTRUM SPF 50 103 RETAIL REFILL WITH SPONGE 
ensulizole, titanium dioxide emulsion
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:58668-1721
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
ENSULIZOLE (UNII: 9YQ9DI1W42) (ENSULIZOLE - UNII:9YQ9DI1W42) ENSULIZOLE27 mg  in 1 mL
TITANIUM DIOXIDE (UNII: 15FIX9V2JP) (TITANIUM DIOXIDE - UNII:15FIX9V2JP) TITANIUM DIOXIDE62 mg  in 1 mL
Inactive Ingredients
Ingredient NameStrength
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 CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:58668-1721-01 in 1 BOX08/01/201812/15/2019
113 mL in 1 JAR; Type 0: Not a Combination Product
2NDC:58668-1721-11 in 1 BOX08/01/201812/15/2019
213 mL in 1 JAR; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph not finalpart35208/01/201812/15/2019
Labeler - LABORATOIRES CLARINS (266317555)

Revised: 11/2021
 
LABORATOIRES CLARINS