CLARINS HIGH PROTECTION SUNSCREEN FOR SUN-SENSITIVE AREAS SPF 30 - titanium dioxide and zinc oxide stick 
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.

----------

Active Ingredients

Active Ingredients                                    Purpose
TITANIUM DIOXIDE            10.4%           Sunscreen
ZINC OXIDE                         3.8%            Sunscreen

Use:

helps prevent sunburn

Warnings:

Keep out of eyes

Stop use:

if skin rash occurs

Keep out of reach of children

Keep out of reach of children.

Directions:

• apply liberally before sun exposure and as needed • do not use on infants under 6 months of age

Inactive Ingredients:

RICINUS COMMUNIS (CASTOR) SEED OIL . OCTYLDODECANOL . CAPRYLIC/CAPRIC TRIGLYCERIDE . HELIANTHUS ANNUUS (SUNFLOWER) SEED WAX . HYDROGENATED POLYISOBUTENE . HELIANTHUS ANNUUS (SUNFLOWER) SEED OIL . BUTYROSPERMUM PARKII (SHEA) BUT - TER . COPERNICIA CERIFERA (CARNAUBA) WAX . OZOKERITE . POLYGLYCERYL-2 DIPOLYHYDROXYSTEARATE . POLYGLYCERYL-3 DIISOSTEARATE . MANGIFERA INDICA (MANGO) SEED OIL . ALUMINA . STEARIC ACID .TOCOPHERYL ACETATE . FRAGRANCE . DIETHYLHEXYL ADIPATE . TOCOPHEROL . CENTELLA ASIATICA EXTRACT . BHT . CITRIC ACID.

Description

Sunscreen Stick  For Sun-Sensitive Areas  100% mineral screen SPF 30 Comfortable, high level protection for sun-sensitive areas like the nose, lips and ears. Ideal for water sports, winter skiing and intense sunlight. Apply well before sun exposure. Renew application at least every two hours. Allergy tested.  www.clarins.com  "CLARINS: effective, serious treatments, ensuring maximum results with the highest quality ingredients." Jacques Courtin Clarins  Sunscreen Stick For Sun-Sensitive Areas 100% mineral screen SPF 30  CLARINS PARIS - 92200 Neuilly 95300 Pontoise - France  Made in France  12 M ref. 14311  9

CLARINS PARIS  30 SPF  HIGH PROTECTION UVB / UVA  Sunscreen Stick For Sun-Sensitive Areas  100% mineral screen  • WARNINGS: for external use only. Keep out of eyes. Stop use if skin rash occurs. Keep out of reach of children. Directions: apply liberally before sun exposure and as needed. Do not use on infants under 6 months of age. Allergy tested. ACTIVE INGREDIENTS: TITANIUM DIOXIDE 10.4% . ZINC OXIDE 3.8%  12 M ref. 14311  9  CLARINS PARIS - 92200 Neuilly 95300 Pontoise - France  Made in France  8 g  0.28 Oz. Net Wt.

www.clarins.com  CLARINS  SUN DAMAGE CONTROL CARE  MULTI CELLULAR PROTECTION  CLARINS  PARIS  30 SPF HIGH PROTECTION UVB / UVA  Sunscreen Stick For Sun-Sensitive Areas  100% mineral screen  e 8 g  0.28 Oz. Net Wt.  WITH PLANT EXTRACTS  CLARINS-PARIS  OC 500738 - VO

Product Inner Package Label

Clarins 30 SPF Sunscreen Stick Inner Label

Product Outer Package Label

Clarins 30 SPF Sunscreen Stick Outer LabelClarins30SPFSunscreenStick_OuterLabel2

CLARINS HIGH PROTECTION SUNSCREEN FOR SUN-SENSITIVE AREAS SPF 30 
titanium dioxide, zinc oxide stick
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:58668-4311
Route of AdministrationTOPICALDEA Schedule    
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
TITANIUM DIOXIDE (TITANIUM) TITANIUM DIOXIDE10.4 g  in 100 g
ZINC OXIDE (ZINC) ZINC OXIDE3.8 g  in 100 g
Inactive Ingredients
Ingredient NameStrength
CASTOR OIL 
OCTYLDODECANOL 
MEDIUM-CHAIN TRIGLYCERIDES 
HELIANTHUS ANNUUS SEED WAX 
SUNFLOWER OIL 
SHEA BUTTER 
CARNAUBA WAX 
CERESIN 
MANGO SEED OIL 
ALUMINUM OXIDE 
STEARIC ACID 
DIETHYLHEXYL ADIPATE 
TOCOPHEROL 
CENTELLA ASIATICA 
BUTYLATED HYDROXYTOLUENE 
CITRIC ACID MONOHYDRATE 
Packaging
#Item CodePackage Description
1NDC:58668-4311-11 in 1 CARTON
18 g in 1 PACKAGE
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph finalpart35210/18/2011
Labeler - Laboratoires Clarins S.A. (503972197)
Establishment
NameAddressID/FEIBusiness Operations
Laboratoires Clarins S.A.503972197manufacture

Revised: 10/2011
 
Laboratoires Clarins S.A.