CLARINS UV PLUS HP DAYSCREEN HIGH PROTECTION TINT - MEDIUM SPF 40  - titanium dioxide liquid 
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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Active Ingredient:

Active Ingredient                      Purpose
TITANIUM DIOXIDE 7%       Sunscreen

Uses:

- helps prevent sunburn  - higher SPF gives more sunburn protection

Warnings:

For external use only

When using this product:

- keep out of eyes. Rinse with water to remove

Stop use and ask a doctor if:

- rash or irritation develops and lasts

Keep out of reach of children

Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center right away.

Directions:

- apply liberally before sun exposure  - do not use on infants under 6 months of age.

Other Information:

Sun alert: Limiting sun exposure, wearing protective clothing, and using sunscreens may reduce the risks of skin aging, skin cancer and other harmful effects of the sun.

Inactive Ingredients:

CYCLOPENTASILOXANE - WATER - TITANIUM DIOXIDE - POLYGLYCERYL-3 POLYDIMETHYLSILOXYETHYL - DIMETHICONE - IRON OXIDES - ALCOHOL - CETYL PEG/PPG-10/1 DIMETHICONE.HEXYL LAURATE - POLYGLYCERYL- 4 ISOSTEARATE - ALUMINUM HYDROXIDE - STEARIC ACID - ALUMINUM STARCH OCTENYLSUCCINATE - SODIUM CHLORIDE - PEG/PPG-18/18 DIMETHICONE - PHENOXYETHANOL - PEG/PPG-20/15 DIMETHICONE - ISOPROPYL TITANIUM TRIISOST EARATE - TOCOPHERYL ACETATE - MICA - FRAGRANCE - HYDROXYPROPYLTRIMONIUM MALTODEXTRIN CROSSPOLYMER - DISODIUM EDTA - BUTYLENE GLYCOL - SILICA - 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.

Purpose

Sunscreen

Description:

Day Screen High Protection SPF 40 UVA-UVB/Oil-free Triple protection against UVA-UVB rays, free radicals and pollution from an ultra-lightweight texture that leaves the skin smooth, soft and matte. A sheer tinted colour evens and illuminates the complexion. 100% mineral screen. Apply over regular day care.  Anti-oxidative stress. Formulated with an age-fighting antioxidant obtained from cantaloupe melon extract.  Dermatologist and ophthalmologist tested, non-comedogenic.  www.clarins.com  [S2503A/04]  CLARINS PARIS - 92200 Neuilly  95300 Pontoise - France  Made in France  18 M ref. 12911 9

100% MINERAL SCREEN  CLARINS  PARIS  UV PLUS HP  Multi-Protection  SPF 40  Anti-pollution  UVA-UVB/Oil-free  Day Screen High Protection Tint  WITH PLANT EXTRACTS

Day Screen High Protection SPF 40 UVA-UVB/Oil-free Triple protection against UVA-UVB rays, free radicals and pollution. The silky, ultra-lightweight texture is suitable for use with all skin care and make-up products. A 100% mineral sunscreen and a high performance anti- pollution complex UV PLUS HP contains a 100% mineral screen to help protect against the signs of photo-ageing and the appearance of sun-induced age spots. UV PLUS HP is formulated for even the most sensitive skin and Clarins Anti-Pollution Complex* helps protect skin from the harmful effects of pollution.  A high performance antioxidant: cantaloupe melon extract This plant ingredient is both a powerful antioxidant and anti- ageing enzyme that is protected by an innovative micro encapsulating process, ensuring optimal effectiveness when applied.  Cantaloupe melon benefits  Cantaloupe melon was first presented as a gourmet delicacy in the 15th century. A treasure from the region of Provence in France, the cantaloupe melon extract chosen by Clarins Research is obtained from organic farming and contains an exceptional concentration of superoxide dismutase, an enzyme with antioxidant benefits that neutralizes the harmful effects of free radicals.  UV PLUS HP exists in 4 versions: transparent, and 3 sheer tints to suit all skin tones.  *2 patent applications.  Allergy and ophthalmologist tested, non-comedogenic.

CLARINS PARIS  UV PLUS HP  Multi-Protection MEDIUM SPF 40 Anti-pollution UVA-UVB/Oil-free Day Screen High Protection Tint  - Contains SPF 40 for high sun protection. Shake well before use. WARNING: for external use only. When using this product: keep out of eyes. Rinsewithwater to remove. Stop use and ask a doctor if rash or irritation develops and lasts. Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center immediately. Directions: apply liberally before sun exposure and as needed. Do not use on infants under 6 months of age.  ACTIVE INGREDIENT: TITANIUM DIOXIDE 7%. 18 M  ref. 12911 9  CLARINS PARIS - 92200 Neuilly  95300 Pontoise - France  Made in France  50 mL 1.7 Fl. Oz.

Day Screen High Protection SPF 40 UVA-UVB/Oil-free  www.clarins.com  "CLARINS: effective, serious treatments, ensuring maximum results with the highest quality ingredients."  WITH PLANT EXTRACTS  CLARINS-PARIS

CLARINS  100% MINERAL SCREEN  CLARINS PARIS  UV PLUS HP  Multi-Protection MEDIUM SPF 40 Anti-pollution UVA-UVB/Oil-free Day Screen High Protection Tint e 50 mL  1.7 Fl. Oz.  CLARINS PARIS - 92200 Neuilly  95300 Pontoise - France  Made in France  18 M  ref. 12911  9

Product Package Insert 1

Clarins UV Plus Medium Insert

Product Package Insert 2

Clarins UV Plus Medium Insert 2

Product Package Inner Label

Clarins UV Medium Bottle

Product Package Outer Label 1

Clarins UV Medium 1

Product Package Outer Label 2

Clarins UV Medium 2


CLARINS UV PLUS HP DAYSCREEN HIGH PROTECTION TINT - MEDIUM SPF 40 
titanium dioxide liquid
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:58668-2911
Route of AdministrationTOPICALDEA Schedule    
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
TITANIUM DIOXIDE (TITANIUM) TITANIUM DIOXIDE7 mL  in 100 mL
Inactive Ingredients
Ingredient NameStrength
CYCLOMETHICONE 5 
WATER 
TITANIUM DIOXIDE 
DIMETHICONE 
ALCOHOL 
HEXYL LAURATE 
POLYGLYCERYL-4 ISOSTEARATE 
ALUMINUM HYDROXIDE 
STEARIC ACID 
ALUMINUM STARCH OCTENYLSUCCINATE 
SODIUM CHLORIDE 
PHENOXYETHANOL 
MICA 
EDETATE DISODIUM 
BUTYLENE GLYCOL 
SILICON DIOXIDE 
GLYCERIN 
PENTYLENE GLYCOL 
BENZYL SALICYLATE 
MUSKMELON 
GERANIOL 
.BETA.-CITRONELLOL, (R)- 
BENZYL BENZOATE 
BUTYLPHENYL METHYLPROPIONAL 
HYDROXYISOHEXYL 3-CYCLOHEXENE CARBOXALDEHYDE 
LAPSANA COMMUNIS FLOWERING TOP 
.ALPHA.-HEXYLCINNAMALDEHYDE 
LINALOOL, (+/-)- 
GREEN TEA LEAF 
POTASSIUM SORBATE 
SEDUM ROSEUM ROOT 
SODIUM LAURYL SULFATE 
Product Characteristics
Color    Score    
ShapeSize
FlavorImprint Code
Contains    
Packaging
#Item CodePackage DescriptionMultilevel Packaging
1NDC:58668-2911-11 BOTTLE ( BOTTLE) in 1 PACKAGEcontains a BOTTLE
150 mL in 1 BOTTLEThis package is contained within the PACKAGE (58668-2911-1)

Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph finalpart35212/02/2011

Labeler - Laboratoires Clarins S.A (503972197)
Establishment
NameAddressID/FEIOperations
Laboratoires Clarins S.A503972197manufacture

Revised: 12/2011 Laboratoires Clarins S.A