CLARINS EVERLASTING CUSHION LONG WEARING AND HYDRATING FOUNDATION BROAD SPECTRUM SPF 50 103 RETAIL- ensulizole, titanium dioxide

United States - English - NLM (National Library of Medicine)

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Active ingredient:
ENSULIZOLE (UNII: 9YQ9DI1W42) (ENSULIZOLE - UNII:9YQ9DI1W42), TITANIUM DIOXIDE (UNII: 15FIX9V2JP) (TITANIUM DIOXIDE - UNII:15FIX9V2JP)
Available from:
LABORATOIRES CLARINS
Administration route:
TOPICAL
Prescription type:
OTC DRUG
Therapeutic indications:
• 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.
Authorization status:
OTC monograph not final
Authorization number:
58668-1720-0

CLARINS EVERLASTING CUSHION LONG WEARING AND HYDRATING FOUNDATION

BROAD SPECTRUM SPF 50 103 RETAIL- 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

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

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: (58668-1720-0)

CLARINS EVERLASTING CUSHION LONG WEARING AND HYDRATING

FOUNDATION BROAD SPECTRUM SPF 50 103 RETAIL

ensulizole, titanium dioxide emulsion

Product Information

Product T ype

HUMAN OTC DRUG

Ite m Code (Source )

NDC:58 6 6 8 -1720

Route of Administration

TOPICAL

Active Ingredient/Active Moiety

Ingredient Name

Basis of Strength

Stre ng th

ENSULIZO LE (UNII: 9 YQ9 DI1W42) (ENSULIZOLE - UNII:9 YQ9 DI1W42)

ENSULIZOLE

27 mg in 1 mL

TITANIUM DIO XIDE (UNII: 15FIX9 V2JP) (TITANIUM DIOXIDE - UNII:15FIX9 V2JP)

TITANIUM DIOXIDE

6 2 mg in 1 mL

Inactive Ingredients

Ingredient Name

Stre ng th

WATER (UNII: 0 59 QF0 KO0 R)

CYCLO METHICO NE 5 (UNII: 0 THT5PCI0 R)

PHENYL TRIMETHICO NE (UNII: DR0 K5NOJ4R)

CYCLO METHICO NE 6 (UNII: XHK3U310 BA)

BUTYLENE GLYCO L (UNII: 3XUS8 5K0 RA)

DIPENTAERYTHRITYL HEXA C5-9 ACID ESTERS (UNII: D8 18 OLQ51Z)

LABORATOIRES CLARINS

TRIETHYLHEXANO IN (UNII: 7K3W1BIU6 K)

GLYCERIN (UNII: PDC6 A3C0 OX)

DIMETHICO NE (UNII: 9 2RU3N3Y1O)

NIACINAMIDE (UNII: 25X51I8 RD4)

TRO METHAMINE (UNII: 0 23C2WHX2V)

1,2 -HEXANEDIO L (UNII: TR0 46 Y3K1G)

SO RBITAN SESQ UIO LEATE (UNII: 0 W8 RRI5W5A)

STEARIC ACID (UNII: 4ELV7Z6 5AP)

NYLO N-12 (UNII: 446 U8 J0 75B)

PEG-3 0 DIPO LYHYDRO XYSTEARATE (UNII: 9 713Q0 S7FO)

SO DIUM CHLO RIDE (UNII: 451W47IQ8 X)

ZINC STEARATE (UNII: H9 2E6 QA4FV)

ALUMINUM HYDRO XIDE (UNII: 5QB0 T2IUN0 )

DISTEARYLDIMO NIUM CHLO RIDE (UNII: OM9 573ZX3X)

DISTEARDIMO NIUM HECTO RITE (UNII: X6 8 7XDK0 9 L)

TRIETHO XYCAPRYLYLSILANE (UNII: LDC331P0 8 E)

ADENO SINE (UNII: K72T3FS56 7)

PALMITO YL PRO LINE (UNII: I49 727TDYF)

MAGNESIUM PALMITO YL GLUTAMATE (UNII: DH37YM1F48 )

SO DIUM PALMITO YL SARCO SINATE (UNII: 729 7LY0 9 YF)

CERAMIDE 3 (UNII: 4370 DF0 50 B)

PALMITIC ACID (UNII: 2V16 EO9 5H1)

HYDRO GENATED SO YBEAN LECITHIN (UNII: H110 9 Z9 J4N)

DIPRO PYLENE GLYCO L (UNII: E10 7L8 5C40 )

GLYCERETH-2 0 (UNII: GJ5729 7I4F)

GREEN TEA LEAF (UNII: W2ZU1RY8 B0 )

PEG-10 RAPESEED STERO L (UNII: 258 O76 T8 5M)

GLYCERYL MO NO STEARATE (UNII: 230 OU9 XXE4)

SO DIUM BENZO ATE (UNII: OJ245FE5EU)

PHENO XYETHANO L (UNII: HIE49 2ZZ3T)

Packag ing

#

Item Code

Package Description

Marketing Start Date

Marketing End Date

1

NDC:58 6 6 8 -1720 -0

1 in 1 BOX

0 8 /0 1/20 18

1

13 mL in 1 JAR; Type 0 : No t a Co mbinatio n Pro duct

Marketing Information

Marke ting Cate gory

Application Numbe r or Monograph Citation

Marke ting Start Date

Marke ting End Date

OTC mo no graph no t final

pa rt352

0 8 /0 1/20 18

Labeler -

LABORAT OIRES CLARINS (266317555)

Revised: 12/2019

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