Your browser does not support JavaScript! BRONZING DUO SPF 15 MINERAL COMPACT TINT 03 DARK (TITANIUM DIOXIDE) POWDER [LABORATOIRES CLARINS S.A.]
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BRONZING DUO SPF 15 MINERAL COMPACT TINT 03 DARK (titanium dioxide) powder
[Laboratoires Clarins S.A.]


Category DEA Schedule Marketing Status
HUMAN OTC DRUG LABEL OTC monograph final
NOTE: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.
Drug Label Sections

ACTIVE INGREDIENT

TITANIUM DIOXIDE :   8.4%

INACTIVE INGREDIENTS

TALC . ZINC STEARATE . ZEA MAYS (CORN) STARCH . OCTYLDODECYL STEAROYL STEARATE . DIMETHICONE . DIISOSTEARYL MALATE . PENTAERYTHRITYL TETRAISOSTEARATE . GLYCERIN . EMPETRUM NIGRUM FRUIT JUICE . SILICA . NYLON-12 . ASCORBYL PALMITATE . PARFUM/FRAGRANCE . TOCOPHEROL . HDI/TRIMETHYLOL HEXYLLACTONE  CROSSPOLYMER . AQUA/ WATER . BUTYLENE GLYCOL . RETINYL PALMITATE . BENZYL SALICYLATE . HYDROXYETHYL UREA . LIMONENE . CAMELLIA SINENSIS LEAF EXTRACT . BUTYLPHENYL METHYLPROPIONAL . PHENOXYETHANOL . POTASSIUM SORBATE . ALGIN . ACACIA SENEGAL GUM. ± /MAY CONTAIN/PEUT CONTENIR : [CI 77891/TITANIUM DIOXIDE . CI 77491/CI 77492/CI 77499/ IRON OXIDES . CI 77019/MICA . TIN OXIDE . ALUMINA . CI 19140/ YELLOW 5 LAKE]. [M2411A]

DIRECTIONS:

apply liberally.  Reapply as needed.

WARNING:

for external use only, not to be swallowed.  Avoid contact with eyes.

Discontinue use

if signs of irritation or rash appear.

Purpose

Sunscreen

This lightweight Bronzing Duo compact has two complementary shades that blend together for a natural-looking, sun-kissed complexion. Formulated with mineral and plant extracts that help protect and care for your skin. SPF 15.  Dermatologist tested.

03 dark  Bronzing Duo   CLARINS PARIS SPF 15 Mineral Powder Compact 100%Mineral Screen  e 10g  0.35 Oz. Net Wt.   MFD FOR CLARINS PARIS 92200 Neuilly  95300 Pontoise - France   Made in Italy Distrib. Canada:  CLARINS CANADA Inc. 815 Desserte est Autoroute Chomedey  ALVAL (QUEBEC) H7W 5N4    www.clarins.com

Bronzing Duo SPF 15 Mineral Powder Compact Tint 03 Dark 10g (58668-5371-1)



Bottom Label

Outer Package Dark

BRONZING DUO SPF 15 MINERAL COMPACT TINT 03 DARK 
titanium dioxide powder
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:58668-5371
Route of AdministrationTOPICALDEA Schedule    
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
TITANIUM DIOXIDE (TITANIUM DIOXIDE) TITANIUM DIOXIDE8.4 g  in 100 g
Inactive Ingredients
Ingredient NameStrength
TALC 
ZINC STEARATE 
STARCH, CORN 
OCTYLDODECYL STEAROYL STEARATE 
DIMETHICONE 
PENTAERYTHRITYL TETRAISOSTEARATE 
GLYCERIN 
EMPETRUM NIGRUM FRUIT JUICE 
SILICON DIOXIDE 
NYLON-12 
ASCORBYL PALMITATE 
TOCOPHEROL 
WATER 
BUTYLENE GLYCOL 
VITAMIN A PALMITATE 
BENZYL SALICYLATE 
HYDROXYETHYL UREA 
GREEN TEA LEAF 
BUTYLPHENYL METHYLPROPIONAL 
PHENOXYETHANOL 
POTASSIUM SORBATE  
ACACIA 
FERRIC OXIDE RED 
FERRIC OXIDE YELLOW 
FERROSOFERRIC OXIDE 
MICA 
STANNIC OXIDE 
ALUMINUM OXIDE 
FD&C YELLOW NO. 5 
Packaging
#Item CodePackage Description
1NDC:58668-5371-11 in 1 CARTON
110 g in 1 BOX
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph finalpart35204/24/2012
Labeler - Laboratoires Clarins S.A. (503972197)
Establishment
NameAddressID/FEIBusiness Operations
Laboratoires Clarins S.A.503972197manufacture

Revised: 04/2012
Document Id: acf873c3-38b0-4a5a-bc85-25e8b94d9d25
Set id: db3c5355-e30a-405a-a8d9-cded8b5b46a9
Version: 1
Effective Time: 20120424
 
Laboratoires Clarins S.A.

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