CLARINS SUNSCREEN SOOTHING PROGRESSIVE TANNING- octocrylene, octinoxate and titanium dioxide 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

Uses:
- helps prevent sunburn
- higher SPF gives more sunburn protection
- for skin that sunburns easily
- 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 - POTASSIUM CETYL PHOSPHATE - VP/EICOSENE COPOLYMER - C14-22 ALCOHOLS - ALOE BARBADENSIS LEAF JUICE - MANNITOL - DIPHENYL DIMETHICONE - FRAGRANCE - ALUMINUM HYDROXIDE - C12-20 ALKYL GLUCOSIDE - STEARIC ACID - GLYCERIN - ACRYLATES/C10-30 ALKYL ACRYLATE CROSSPOLYMER - TROMETHAMINE - TOCOPHERYL ACETATE - DISODIUM EDTA - XANTHAN 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 Soothing Progressive Tanning Insert

Clarins Sunscreen Soothing Progressive Tanning Inner

Clarins Sunscreen Soothing Progressive Tanning Outer

CLARINS SUNSCREEN SOOTHING PROGRESSIVE TANNING 
octocrylene, octinoxate, titanium dioxide cream
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:58668-4421
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
Inactive Ingredients
Ingredient NameStrength
WATER 
CYCLOMETHICONE 
ISOHEXADECANE 
BUTYLENE GLYCOL 
CYCLOMETHICONE 5 
POTASSIUM CETYL PHOSPHATE 
ALOE VERA LEAF 
MANNITOL 
ALUMINUM HYDROXIDE 
STEARIC ACID 
GLYCERIN 
TROMETHAMINE 
EDETATE DISODIUM 
XANTHAN GUM 
PLATANUS OCCIDENTALIS POLLEN 
CITRIC ACID MONOHYDRATE 
PHENOXYETHANOL 
POTASSIUM SORBATE 
SODIUM BENZOATE 
BUTYLATED HYDROXYTOLUENE 
Packaging
#Item CodePackage Description
1NDC:58668-4421-11 in 1 PACKAGE
1200 mL in 1 BOTTLE
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(58668-4421)

Revised: 08/2013
 
Laboratoires Clarins S.A.