CLARINS EVERLASTING CUSHION LONG-WEARING AND HYDRATING FOUNDATION BROAD SPECTRUM SPF 50 TINT 108 TESTER REFILL WITH SPONGE- 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 and Hydrating Foundation Broad Spectrum SPF 50 Tint 108 - Tester refill with sponge

Package Labeling:

Label

Drug Facts

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

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC:58668-9915
Route of Administration	TOPICAL

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

Ingredient Name	Strength
Inactive Ingredients
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)
ENSULIZOLE (UNII: 9YQ9DI1W42)
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)
.ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)
DISTEARDIMONIUM HECTORITE (UNII: X687XDK09L)
TRIETHOXYCAPRYLYLSILANE (UNII: LDC331P08E)
ADENOSINE (UNII: K72T3FS567)
PALMITOYL PROLINE (UNII: I49727TDYF)
CHENOPODIUM QUINOA SEED (UNII: OO4K72NZ2X)
MAGNESIUM PALMITOYL GLUTAMATE (UNII: DH37YM1F48)
SODIUM PALMITOYL SARCOSINATE (UNII: 7297LY09YF)
CERAMIDE NP (UNII: 4370DF050B)
PALMITIC ACID (UNII: 2V16EO95H1)
HYDROGENATED SOYBEAN LECITHIN (UNII: H1109Z9J4N)
LAPSANA COMMUNIS FLOWERING TOP (UNII: T9B77O7PZA)
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)
MICA (UNII: V8A1AW0880)
SILICON DIOXIDE (UNII: ETJ7Z6XBU4)
FERRIC OXIDE RED (UNII: 1K09F3G675)
FERRIC OXIDE YELLOW (UNII: EX438O2MRT)
FERROSOFERRIC OXIDE (UNII: XM0M87F357)

#	Item Code	Package Description	Marketing Start Date	Marketing End Date
Packaging
1	NDC:58668-9915-1	13 mL in 1 CASE; Type 0: Not a Combination Product	03/08/2017	12/15/2019

Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
OTC monograph not final	part352	03/08/2017	12/15/2019

Labeler - Laboratoires Clarins (266317555)

Revised: 11/2021

Document Id: d0557af2-0f28-63c7-e053-2a95a90a8055

Set id: 4b70fbb7-4a2f-4b88-a668-223b9168b8b8

Version: 4

Effective Time: 20211109

Laboratoires Clarins