CLARINS UV PLUS HP BROAD SPECTRUM SPF 40 SUNSCREEN MULTI-PROTECTION TINT MEDIUM- titanium dioxide solution
Laboratoires Clarins S.A.

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 UV PLUS HP Broad Spectrum SPF 40 Sunscreen Multi-Protection Tint MEDIUM

Drug Facts

Active Ingredient

TITANIUM DIOXIDE 7%

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 me dical 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 in creases 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 sun screen if swimming or sweating

Other Information:

• protect this product from excessive heat and direct sun

Questions or Comments?

Call 1-866-252-7467
Monday-Friday, 8 a.m. to 5 p.m.

CLARINS PARIS - 92200 Neuilly
95300 Pontoise - France

Made in France

www.clarins.com

Inactive Ingredients

CYCLOPENTASILOXANE . AQUA/ WATER/EAU . ALUMINUM STARCH OCTENYLSUCCINATE . POLYGLYCERYL-3 POLYDIMETHYLSILOXYETHYL DIMETHICONE .ALCOHOL .ALUMINUM HYDROXIDE .STEARIC ACID .CI 77491/ CI 77492/CI 77499/IRON OXIDES . SODIUM CHLORIDE . PEG/PPG-18/18 DIMETHICONE . CI 77891/TITANIUM DIOXIDE . PHENOXYETHANOL . PEG/PPG-20/15 DIMETHICONE . CETYL PEG/PPG-10/1 DIMETHICONE . HEXYL LAURATE . POLYGLYCERYL-4 ISOSTEARATE . MICA . TOCOPHERYL ACETATE.PARFUM/FRAGRANCE.HYDROXYPROPYLTRIMONIUM MALTODEXTRIN CROSSPOLYMER . DISODIUM EDTA . BUTYLENE GLYCOL . ISOPROPYL TITANIUM TRIISOSTEARATE. GLYCERIN.PENTYLENE GLYCOL.BENZYL SALICYLATE.CUCUMIS MELO (MELON) FRUIT EXTRACT .GERANIOL .BIOSACCHARIDE GUM-4 .CITRONELLOL .THERMUS THERMOPHILLUS FERMENT . BENZYL BENZOATE . BUTYLPHENYL METHYLPROPIONAL . HYDROXYISOHEXYL 3-CYCLOHEXENE CARBOXALDEHYDE .LAPSANA COMMUNIS FLOWER/LEAF/STEM EXTRACT . LIMONENE .HEXYL CINNAMAL .LINALOOL .CAMELLIA SINENSIS LEAF EXTRACT .POTASSIUM SORBATE . RHODIOLA ROSEA ROOT EXTRACT . SODIUM LAURYL SULFATE. [S2503A/02]

CLARINS UV PLUS HP Broad Spectrum SPF 40 Sunscreen Multi-Protection Tint

OuterPackage

Insert

Bottle

CLARINS UV PLUS HP BROAD SPECTRUM SPF 40 SUNSCREEN MULTI-PROTECTION TINT MEDIUM
titanium dioxide solution

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC:58668-2911
Route of Administration	TOPICAL

Ingredient Name	Basis of Strength	Strength
Active Ingredient/Active Moiety
TITANIUM DIOXIDE (UNII: 15FIX9V2JP) (TITANIUM DIOXIDE - UNII:15FIX9V2JP)	TITANIUM DIOXIDE	70 mg in 1 mL

Ingredient Name	Strength
Inactive Ingredients
CYCLOMETHICONE 5 (UNII: 0THT5PCI0R)
WATER (UNII: 059QF0KO0R)
ALUMINUM STARCH OCTENYLSUCCINATE (UNII: I9PJ0O6294)
DIMETHICONE (UNII: 92RU3N3Y1O)
ALCOHOL (UNII: 3K9958V90M)
ALUMINUM HYDROXIDE (UNII: 5QB0T2IUN0)
STEARIC ACID (UNII: 4ELV7Z65AP)
FERRIC OXIDE RED (UNII: 1K09F3G675)
FERRIC OXIDE YELLOW (UNII: EX438O2MRT)
FERROSOFERRIC OXIDE (UNII: XM0M87F357)
SODIUM CHLORIDE (UNII: 451W47IQ8X)
PEG/PPG-18/18 DIMETHICONE (UNII: 9H0AO7T794)
PHENOXYETHANOL (UNII: HIE492ZZ3T)
PEG/PPG-20/15 DIMETHICONE (UNII: 06R6X77P9C)
CETYL PEG/PPG-10/1 DIMETHICONE (HLB 2) (UNII: V2W71V8T0X)
HEXYL LAURATE (UNII: 4CG9F9W01Q)
MICA (UNII: V8A1AW0880)
.ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)
MALTODEXTRIN (UNII: 7CVR7L4A2D)
EDETATE SODIUM (UNII: MP1J8420LU)
BUTYLENE GLYCOL (UNII: 3XUS85K0RA)
ISOPROPYL TITANIUM TRIISOSTEARATE (UNII: 949E3KBJ1I)
GLYCERIN (UNII: PDC6A3C0OX)
PENTYLENE GLYCOL (UNII: 50C1307PZG)
CUCUMIS MELO VAR. CANTALUPENSIS WHOLE (UNII: HUU66O04OX)
GERANIOL (UNII: L837108USY)
.BETA.-CITRONELLOL, (R)- (UNII: P01OUT964K)
THERMUS THERMOPHILUS (UNII: 415H64SACF)
BENZYL BENZOATE (UNII: N863NB338G)
BUTYLPHENYL METHYLPROPIONAL (UNII: T7540GJV69)
HYDROXYISOHEXYL 3-CYCLOHEXENE CARBOXALDEHYDE (UNII: QUE43B9Z2Q)
LAPSANA COMMUNIS WHOLE (UNII: UXH42V064J)
LIMONENE, (+)- (UNII: GFD7C86Q1W)
.ALPHA.-HEXYLCINNAMALDEHYDE (UNII: 7X6O37OK2I)
LINALOOL, (+)- (UNII: F4VNO44C09)
CAMELLIA SINENSIS WHOLE (UNII: C5M4585ZBZ)
POTASSIUM SORBATE (UNII: 1VPU26JZZ4)
RHODIOLA ROSEA ROOT (UNII: 3S5ITS5ULN)
SODIUM LAURYL SULFATE (UNII: 368GB5141J)

#	Item Code	Package Description	Marketing Start Date	Marketing End Date
Packaging
1	NDC:58668-2911-1	50 mL in 1 BOTTLE; Type 0: Not a Combination Product	10/25/2012	04/30/2018

Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
OTC monograph not final	part352	10/25/2012	04/30/2018

Labeler - Laboratoires Clarins S.A. (266317555)

Registrant - Laboratoires Clarins S.A. (266317555)

Name	Address	ID/FEI	Business Operations
Establishment
Laboratoires Clarins S.A.		266317555	manufacture(58668-2911)

Revised: 3/2019

Document Id: 853fddf5-7ac3-b5df-e053-2a91aa0a69ee

Set id: 1de678eb-e44b-48b9-9d77-07eb4423602f

Version: 7

Effective Time: 20190329

Laboratoires Clarins S.A.