CLARINS UV PLUS HP SPF 40 DAY SCREEN HIGH PROTECTION- 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 SPF 40 Day Screen High Protection

Active Ingredient                                                                     Purpose
TITANIUM DIOXIDE 8.1%                                                       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. 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 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 - POLYGLYCERYL-3 POLYDIMETHYLSILOXYETHYL DIMETHICONE - CORN STATCH MODIFIED - ALCOHOL - ALUMINUM HYDROXIDE - STEARIC ACID - SODIUM CHLORIDE - PEG/PPG-18/18 DIMETHICONE - PHENOXYETHANOL - PEG/PPG-20/15 DIMETHICONE - TOCOPHERYL ACETATE - FRAGRANCE - HYDROXYPROPYLTRIMONIUM MALTODEEXTRIN CROSSPOLYMER - DISODIUM EDTA - BUTYLENE GLYCOL - GLYCERIN - PENTYLENE GLYCOL - CUCUMIS MELO (MELON) FRUIT EXTRACT - BIOSACCHARIDE GUM-4 - THERMUS THERMOPHILLUS FERMENT - LAPSANA COMMUNIS FLOWER/LEAF/STEM EXTRACT - CAMELLIA SINENSIS LEAF EXTRACT - POTASSIUM SORBATE - RHODIOLA ROSEA ROOT EXTRACT - SODIUM LAURYL SULFATE - BENZYL SALICYLATE - GERANIOL - CITRONELLOL - BENZYL BENZOATE - BUTYLPHENYL METHYLPROPIONAL - HYDROXYISOHEXYL 3-CYCLOHEXENE CARBOXALDEHYDE - LIMONENE - HEXYL CINNAMAL - LINALOOL.

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 skin looking smooth, soft and matte. 100% mineral screen. Apply over regular day care.

Anti-oxidative stress. Formulated with an age-fighting antioxidant obtained from cantaloupe melon extract.

Allergy and ophthalmologist tested, non-comedogenic.

www.clarins.com

CLARINS PARIS - 92200 Neuilly France

95300 Pontoise

Made In France - Patent application

18 M   ref. 12872 9

CLARINS PARIS

UV PLUS HP

Ecran Multi-Protection

SPF 40

Anti-pollution UVA-UVB/Oil-free

Day Screen High Protection

- Contains SPF 40 for high sun protection. Shake well before use. 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. 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 INGREDIENTS: TITANIUM DIOXIDE 8.1 %.

18 M ref. 12872 9

CLARINS PARIS - 92200 Neuilly France

95300 Pontoise

Made in France

50 mL     1.7 Fl. Oz.


"CLARINS: effective, serious treatments, ensuring maximum results with the highest quality ingredients." Jacques Courtin Clarins

www.clarins.com

100% MINERAL SCREEN

CLARINS PARIS

UV PLUS HP

Ecran Multi-Protection

SPF 40
Anti-pollution
UVA-UVB/Oil-free

Day Screen High Protection

e 50 mL   1.7 Fl. Oz.

WITH PLANT EXTRACTS                CLARINS-PARIS

CLARINS PARIS - 92200 Neuilly France

95300 Pontoise

Made In France - Patent application

18 M   ref. 12872 9

Clarins UVPlus HP DayScreenProtection Inner

Clarins UVPlus HP DayScreenProtection Outer

CLARINS UV PLUS HP SPF 40 DAY SCREEN HIGH PROTECTION 
titanium dioxide solution
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:58668-2872
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
TITANIUM DIOXIDE (UNII: 15FIX9V2JP) (TITANIUM DIOXIDE - UNII:15FIX9V2JP) TITANIUM DIOXIDE81 mg  in 1 mL
Inactive Ingredients
Ingredient NameStrength
CYCLOMETHICONE 5 (UNII: 0THT5PCI0R)  
WATER (UNII: 059QF0KO0R)  
ALCOHOL (UNII: 3K9958V90M)  
ALUMINUM HYDROXIDE (UNII: 5QB0T2IUN0)  
STEARIC ACID (UNII: 4ELV7Z65AP)  
SODIUM CHLORIDE (UNII: 451W47IQ8X)  
PHENOXYETHANOL (UNII: HIE492ZZ3T)  
EDETATE DISODIUM (UNII: 7FLD91C86K)  
BUTYLENE GLYCOL (UNII: 3XUS85K0RA)  
GLYCERIN (UNII: PDC6A3C0OX)  
PENTYLENE GLYCOL (UNII: 50C1307PZG)  
MUSKMELON (UNII: ZV095H5633)  
GREEN TEA LEAF (UNII: W2ZU1RY8B0)  
POTASSIUM SORBATE (UNII: 1VPU26JZZ4)  
SODIUM LAURYL SULFATE (UNII: 368GB5141J)  
BENZYL SALICYLATE (UNII: WAO5MNK9TU)  
GERANIOL (UNII: L837108USY)  
.BETA.-CITRONELLOL, (R)- (UNII: P01OUT964K)  
BENZYL BENZOATE (UNII: N863NB338G)  
BUTYLPHENYL METHYLPROPIONAL (UNII: T7540GJV69)  
HYDROXYISOHEXYL 3-CYCLOHEXENE CARBOXALDEHYDE (UNII: QUE43B9Z2Q)  
.ALPHA.-HEXYLCINNAMALDEHYDE (UNII: 7X6O37OK2I)  
LINALOOL, (+/-)- (UNII: D81QY6I88E)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:58668-2872-11 in 1 PACKAGE09/30/201012/31/2016
150 mL in 1 BOTTLE; Type 0: Not a Combination Product
2NDC:58668-2872-230 mL in 1 BOTTLE; Type 0: Not a Combination Product09/30/201012/31/2016
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph not finalpart35209/30/201012/31/2016
Labeler - Laboratoires Clarins S.A. (266317555)
Establishment
NameAddressID/FEIBusiness Operations
Laboratoires Clarins S.A.266317555manufacture(58668-2872)

Revised: 12/2016
 
Laboratoires Clarins S.A.