CLARINS SUNSCREEN HIGH PROTECTION SPF 30- octocrylene, octinoxate, titanium dioxide and ensulizole cream 
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                           Purpose

OCTOCRYLENE 9%                       Sunscreen

OCTINOXATE 7.5%                        Sunscreen

TITANIUM DIOXIDE 3.24%              Sunscreen

ENSULIZOLE 3%                            Sunscreen

Uses:
- helps prevent sunburn
- higher SPF gives more sunburn protection
- for skin highly sensitive to sunburn
- retains SPF after 40 minutes of activity in water

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
- reapply as needed or after towel drying, swimming
- 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: WATER - CYCLOMETHICONE - ISOHEXADECANE - BUTYLENE GLYCOL - CYCLOPENTASILOXANE - TROMETHAMINE - VP/EICOSENE COPOLYMER - C14-22 ALCOHOLS - POTASSIUM CETYL PHOSPHATE - ALUMINUM STARCH OCTENYLSUCCINATE - ALOE BARBADENSIS LEAF JUICE - MANNITOL - SODIUM POLYACRYLATE - DIPHENYL DIMETHICONE - FRAGRANCE - C12-20 ALKYL GLUCOSIDE - ALUMINUM HYDROXIDE - STEARIC ACID - GLYCERIN - TOCOPHERYL ACETATE - DISODIUM EDTAXANTHAN GUM - CYCLODEXTRIN - PISUM SATIVUM (PEA) EXTRACT - CASSIA ALATA LEAF EXTRACT - YEAST EXTRACT - DEXTRIN - HYDROLYZED ADANSONIA DIGITATA EXTRACT - OLEA EUROPAEA (OLIVE) LEAF EXTRACT - PLATANUS OCCIDENTALIS BARK EXTRACT - CITRIC ACID - PHENOXYETHANOL - POTASSIUM SORBATE - SODIUM BENZOATE - BHT.

Clarins Sunscreen Cream High Protection Sun-Sensitive Skin Insert

Clarins Sunscreen Cream High Protection Sun-Sensitive Skin Inner

"CLARINS: effective,
serious treatments,
ensuring maximum
results with the highest
quality ingredients."
J.C.C.

C

ADVANCED SUN PROTECTION

SUN DAMAGE CONTROL FORMULA

CLARINS PARIS

30 SPF

Sunscreen Cream
High Protection

For Sun-Sensitive Skin
    Water-Resistant

125 mL       4.4 Oz. Net Wt.

WITH PLANT EXTRACTS CLARINS-PARIS WITH PLANT EXTRACTS CLARINS-PARIS


CLARINS PARIS - 92200 Neuilly France - 95300 Pontoise
Made in France - Brevet FR et marques deposes
                    French patent application
                            www.clarins.com

                               ref. 14411  9

Clarins Sunscreen Cream High Protection Sun-Sensitive Skin Outer

CLARINS SUNSCREEN HIGH PROTECTION SPF 30 
octocrylene, octinoxate, titanium dioxide, ensulizole cream
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:58668-4411
Route of AdministrationTOPICALDEA Schedule    
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
OCTOCRYLENE (OCTOCRYLENE) OCTOCRYLENE90 mg  in 1 mL
OCTINOXATE (OCTINOXATE) OCTINOXATE75 mg  in 1 mL
TITANIUM DIOXIDE (TITANIUM DIOXIDE) TITANIUM DIOXIDE32.4 mg  in 1 mL
ENSULIZOLE (ENSULIZOLE) ENSULIZOLE30 mg  in 1 mL
Inactive Ingredients
Ingredient NameStrength
WATER 
CYCLOMETHICONE 
ISOHEXADECANE 
BUTYLENE GLYCOL 
CYCLOMETHICONE 5 
TROMETHAMINE 
POTASSIUM CETYL PHOSPHATE 
ALUMINUM STARCH OCTENYLSUCCINATE 
MANNITOL 
ALUMINUM HYDROXIDE 
STEARIC ACID 
GLYCERIN 
EDETATE DISODIUM 
XANTHAN GUM 
YEAST 
CITRIC ACID MONOHYDRATE 
PHENOXYETHANOL 
POTASSIUM SORBATE 
SODIUM BENZOATE 
BUTYLATED HYDROXYTOLUENE 
Packaging
#Item CodePackage Description
1NDC:58668-4411-11 in 1 PACKAGE
1125 mL in 1 TUBE
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph not finalpart35208/05/201008/16/2013
Labeler - Laboratoires Clarins S.A. (503972197)
Establishment
NameAddressID/FEIBusiness Operations
Laboratoires Clarins S.A.503972197manufacture(58668-4411)

Revised: 08/2013
Document Id: 25a3776a-fe04-4ed8-a7c8-4da29a990f16
Set id: a8a013c8-dd1f-4e87-9ff1-f3feb64c5694
Version: 4
Effective Time: 20130828
 
Laboratoires Clarins S.A.