CLARINS EXTRA-FIRMING DAY WRINKLE LIFTING SPF 15 - homosalate, octisalate, avobenzone and octocrylene lotion 
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 Ingredients

Active Ingredients                       Purpose
HOMOSALATE 10%               Sunscreen
OCTISALATE 5%                     Sunscreen
AVOBENZONE 3%                   Sunscreen
OCTOCRYLENE 2.7%               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.

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:

AQUA/WATER . GLYCERIN . CETEARYL ALCOHOL . DIMETHICONE . OLUS/VEGETABLE OIL . PENTAERYTHRITYL DISTEARATE . HYDROXYETHYL ACRYLATE/SODIUM ACRYLOYLDIMETHYL TAURATE COPOLYMER . CETEARYL GLUCOSIDE . PARFUM/FRAGRANCE . POTASSIUM CETYL PHOSPHATE . CAPRYLYL GLYCOL . AVENA SATIVA (OAT) KERNEL EXTRACT . BUTYLENE GLYCOL .DISODIUM EDTA .HYDROGENATED VEGETABLE OIL . TOCOPHERYL ACETATE . XANTHAN GUM . DIETHYLHEXYL ADIPATE . DEHYDROACETIC ACID . SODIUM HYALURO - NATE . CANDELILLA CERA/EUPHORBIA CERIFERA (CANDELILLA) WAX .TOCOPHEROL .MUSA SAPIENTUM (BANANA) FRUIT EXTRACT . PENTYLENE GLYCOL .THYMUS CITRIODORUS FLOWER/LEAF EXTRACT . SODIUM BENZOATE . DECARBOXY CARNOSINE HCL .THERMUS THERMOPHILLUS FERMENT .HELIANTHUS ANNUUS (SUNFLOWER) SEED OIL . HUMULUS LUPULUS (HOPS) EXTRACT . PHENOXYETHANOL . LAPSANA COMMUNIS FLOWER/LEAF/STEM EXTRACT .BOCOA PROUACENSIS EXTRACT .POTASSIUM SORBATE .CAMELLIA SINENSIS LEAF EXTRACT .RHODIOLA ROSEA ROOT EXTRACT . SODIUM LAURYL SULFATE . CI 15985/YELLOW 6 . CI 14700/RED 4.

Purpose

Sunscreen

Description

Extra-Firming Day Lotion  All skin types - SPF 15  A powerful wrinkle lifting formula resulting from Clarins unrivalled skin care expertise. The ideal day care for youthful-looking skin and for women in their 40s. A lightweight, fluid texture with added UV protection provides a matte finish that allows for easy make-up application.  - A strengthened "lifting" effect. Smoothes features on application thanks to the combination of hyaluronic acid and oat sugars.  - Firmer skin, the appearance of wrinkles is reduced. Reinforces skin elasticity for more toned skin (extracts of lemon thyme, green banana and bocoa).  Allergy tested,non-comedogenic. 6 patents application.  CLARINS PARIS - 92200 Neuilly 95300 Pontoise - France Made in France  18 M  ref. 10681 9

AGE CONTROL  CLARINS PARIS  SPF 15  Extra-Firming Day Wrinkle lifting lotion All skin types WITH PLANT EXTRACTS CLARINS S.A. 4, rue Berteaux-Dumas - 92200 Neuilly - France - Tel. : 01.47.38.12.12  www.clarins.com

Extra-Firming Day  Early wrinkle correcting lotion SPF 15 -  All skin types       You're 40 and you still have smooth, firm skin...  With Extra-Firming Day, now enhanced by recent advances from Clarins Research, discover the firming, anti-wrinkle skin care chosen by thousands of women across the world.    Firmer skin, the appearance of wrinkles is reduced.  A Clarins innovation, Extra-Firming Day is formulated with extratcts of organic lemon thyme, green banana and bocoa which act on all factors responsible for skin firmness and:  - encourage the synthesis of collagen fibres essential for skin tone and density,  - ensure reinforced protection of elastic fibres which give skin its suppleness,   - preserve the connections between fibres and cells.   The result: the appearance of wrinkles is visibly reduced, facial contours are reshaped and features are younger-looking.  An immediate "lifting" effect.  Oat sugars instantly smooth away fine lines while hyaluronic acid replenishes skin.  The light weight, fluid texture leaves skin velvety-soft with a matte finish allowing for easy make-up application.  Anti-pollution and SPF15 protection.  Allergy tested, non-comedogenic, 6 patent applications.

CLARINS PARIS  SPF 15  Extra-Firming Day Wrinkle lifting lotion All skin types.  Apply every morning before sun exposure to face and neck.  See insert.  CLARINS CANADA INC. 815 Desserte est - Autoroute Chomedey LAVAL (QUEBEC) H7W5N4   18M  ref. 10681 9   CLARINS PARIS - 92200 Neuilly 95300 Pontoise - France  Made in France   50mL 1.7 Oz. Net Wt.

Extra-Firming Day Lotion  All skin types - SPF 15  www.clarins.com  WITH PLANT EXTRACTS

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

CLARINS  AGE CONTROL  CLARINS PARIS  SPF 15  Extra-Firming Day  Wrinkle lifting lotion  All skin types  e 50 mL  1.7 Oz. Net Wt.  CLARINS CANADA Inc. 815 Desserte est  Autoroute Chomedey  LAVAL (QUEBEC) H7W5N4

Product Package Insert Label 1

Clarins Extra-Firming Day Wrinkle Insert 1

Product Package Insert Label 2

Clarins Extra-Firming Day Wrinkle Insert 2

Product Package Inner Label

Clarins Extra-Firming Day Wrinkle Inner Label

Product Outer Package Label 1

Clarins Extra-Firming Day Wrinkle Outer Package 1

Product Outer Package Label 2

Clarins Extra-Firming Day Wrinkle Outer Package 2

Product Outer Package Label 3

Clarins Extra-Firming Day Wrinkle Outer Package 3

CLARINS EXTRA-FIRMING DAY WRINKLE LIFTING SPF 15 
homosalate, octisalate, avobenzone, octocrylene lotion
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:58668-0681
Route of AdministrationTOPICALDEA Schedule    
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
HOMOSALATE (HOMOSALATE) HOMOSALATE10 mL  in 100 mL
OCTISALATE (OCTISALATE) OCTISALATE5 mL  in 100 mL
AVOBENZONE (AVOBENZONE) AVOBENZONE3 mL  in 100 mL
OCTOCRYLENE (OCTOCRYLENE) OCTOCRYLENE2.7 mL  in 100 mL
Inactive Ingredients
Ingredient NameStrength
WATER 
GLYCERIN 
CETOSTEARYL ALCOHOL 
DIMETHICONE 
CORN OIL 
PENTAERYTHRITYL DISTEARATE 
SODIUM ACRYLATE/SODIUM ACRYLOYLDIMETHYLTAURATE COPOLYMER (4000000 MW) 
CETEARYL GLUCOSIDE 
POTASSIUM CETYL PHOSPHATE 
CAPRYLYL GLYCOL 
OAT 
BUTYLENE GLYCOL 
EDETATE DISODIUM 
XANTHAN GUM 
DIETHYLHEXYL ADIPATE 
DEHYDROACETIC ACID 
HYALURONATE SODIUM 
CANDELILLA WAX 
TOCOPHEROL 
BANANA 
PENTYLENE GLYCOL 
SODIUM BENZOATE 
SUNFLOWER OIL 
HOPS 
PHENOXYETHANOL 
LAPSANA COMMUNIS FLOWERING TOP 
POTASSIUM SORBATE 
GREEN TEA LEAF 
SEDUM ROSEUM ROOT 
SODIUM LAURYL SULFATE 
FD&C YELLOW NO. 6 
FD&C RED NO. 4 
Packaging
#Item CodePackage Description
1NDC:58668-0681-11 in 1 CARTON
150 mL in 1 TUBE
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph finalpart35211/07/2011
Labeler - Laboratoires Clarins S.A. (503972197)
Establishment
NameAddressID/FEIBusiness Operations
Laboratoires Clarins S.A.503972197manufacture

Revised: 12/2011
 
Laboratoires Clarins S.A.