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.


Sunscreen Cream
High Protection SPF 30
For Sun-Sensitive Skin

Formulated to protect the most sensitive skin, this lightweight, comfortable cream helps prevent redness and irritation while promoting an even tan. Heat-resistant UVB-UVA filters.
Water-resistant.


Clarins Laboratories Innovation:
plants that help safeguard your skin's health and beauty
Thanks to the Phyto-Sunactyl 2 complex based on Senna, Olive Tree and Baobab, this sunscreen helps provide reinforced protection to preserve skin's youth and beauty.

Allergy tested.


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

ref. 14411  9

Advanced Sun Protection
Sun Damage Control Formula

CLARINS PARIS

Soins Solaires
Multi-Protection

Advanced Sun Protection
           Treatments

     with plant extracts

Advanced Sun Protection Treatments

- Does the effectiveness of a sun protection product depend on the SPF? The Sun Protection Factor (SPF) measures the level of protection against sunburn. But it only provides partial protection against premature skin aging and free radicals. This is why Clarins sun products contain an exclusive advanced sun protection complex, Phyto-Sunactyl 2* along with UVB-UVA filters.

- Besides sun protection, what else does Clarins Phyto-Sunactyl 2 complex provide? Enhanced beauty for today and for tomorrow… this exclusive Clarins complex is based on plant extracts which have a remarkable resistance to the effects of sun exposure: Senna, Plane Tree, Olive Tree, Baobab and Pea. As the guardian of your skin's health and beauty, the Phyto-Sunactyl 2 complex helps protect the skin's cells. Furthermore, Senna helps slow down damage caused by UV rays. The result: your skin is better protected against the formation of wrinkles, so it remains firmer and more youthful-looking longer.

- Is Advanced Sun Protection recommended for all skin types? It is ideal for sun-sensitive skin but is also recommended for skin that tans easily. Darker skin tones are just as susceptible to the sun's free radicals as any other. A lower SPF could be used as the season progresses without altering the quality of protection.

Clarins advice when you're in the sun

- To maintain a beautiful long-lasting tan, try one of Clarins Self Tanners.
- Use higher SPF products for the first few days. Be sure to avoid the intense rays at midday. Apply your sun protection at least a half hour before going out in the sun and remember to reapply frequently.
- Excess sun exposure is especially dangerous for children. Reapply their sun protection frequently and never leave them in direct sunlight for extended periods of time. Be sure they wear tee-shirts and a sun hat when outdoors. Children under 3 should not be exposed to the sun.
- After sun exposure, apply a Clarins After Sun Skin Soother in the evening Clarins Sun Guide contains tips on how to obtain a beautiful safe tan. Ask your Clarins Skin Care Specialist for your complimentary copy.

*Due to their specific textures and use, Sunscreen Spray Oil-Free Lotion SPF 15, Sunscreen Spray Radiant Oil SPF 6, and Sunscreen Control Stick SPF 30 do not contain the Phyto-Sunactyl 2 complex.
Allergy tested.

                                                www.clarins.com

Clarins Sunscreen Cream High Protection Sun-Sensitive Skin Insert

CLARINS PARIS

30 SPF

Sunscreen Cream
High Protection
For Sun-Sensitive Skin

-WARNINGS: For external use only. When using this product: keep out of eyes. 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 after 40 minutes of activity in water and as needed. Do not use on infants under 6 months of age. Allergy tested.

ACTIVE INGREDIENTS: OCTOCRYLENE 9% - OCTINOXATE
7.5% - TITANIUM DIOXIDE 3.24% - ENSULIZOLE 3%.

ref. 14411  9

Made in France - Marques déposées
CLARINS PARIS - 92200 Neuilly France
                 95300 Pontoise

125 mL                           4.4 Oz. Net Wt.

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) OCTOCRYLENE9 mL  in 100 mL
OCTINOXATE (OCTINOXATE) OCTINOXATE7.5 mL  in 100 mL
TITANIUM DIOXIDE (TITANIUM) TITANIUM DIOXIDE3.24 mL  in 100 mL
ENSULIZOLE (ENSULIZOLE) ENSULIZOLE3 mL  in 100 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 finalpart35208/05/2010
Labeler - Laboratoires Clarins S.A. (503972197)
Establishment
NameAddressID/FEIBusiness Operations
Laboratoires Clarins S.A.503972197manufacture

Revised: 08/2010
 
Laboratoires Clarins S.A.