BRONZING DUO SPF 15 MINERAL COMPACT TINT 02 MEDIUM- titanium dioxide powder

Bronzing Duo SPF 15 Mineral Compact Tint 02 Medium by

Drug Labeling and Warnings

Bronzing Duo SPF 15 Mineral Compact Tint 02 Medium by is a Otc medication manufactured, distributed, or labeled by Laboratoires Clarins S.A.. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

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

SPL UNCLASSIFIED SECTION

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.

PRINCIPAL DISPLAY PANEL

02 medium  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 02 Medium 10g (

58668-5361-1)

INGREDIENTS AND APPEARANCE

BRONZING DUO SPF 15 MINERAL COMPACT TINT 02 MEDIUM 
titanium dioxide powder

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 58668-5361
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
TITANIUM DIOXIDE (UNII: 15FIX9V2JP) (TITANIUM DIOXIDE - UNII:15FIX9V2JP)	TITANIUM DIOXIDE	8.4 g  in 100 g

Inactive Ingredients
Ingredient Name	Strength
TALC (UNII: 7SEV7J4R1U)
ZINC STEARATE (UNII: H92E6QA4FV)
STARCH, CORN (UNII: O8232NY3SJ)
OCTYLDODECYL STEAROYL STEARATE (UNII: 3D47Q6D93C)
DIMETHICONE (UNII: 92RU3N3Y1O)
PENTAERYTHRITYL TETRAISOSTEARATE (UNII: 9D7IK5483F)
GLYCERIN (UNII: PDC6A3C0OX)
EMPETRUM NIGRUM FRUIT JUICE (UNII: 349W2L66Q1)
SILICON DIOXIDE (UNII: ETJ7Z6XBU4)
NYLON-12 (UNII: 446U8J075B)
ASCORBYL PALMITATE (UNII: QN83US2B0N)
TOCOPHEROL (UNII: R0ZB2556P8)
WATER (UNII: 059QF0KO0R)
BUTYLENE GLYCOL (UNII: 3XUS85K0RA)
VITAMIN A PALMITATE (UNII: 1D1K0N0VVC)
BENZYL SALICYLATE (UNII: WAO5MNK9TU)
HYDROXYETHYL UREA (UNII: MBQ7DDQ7AR)
GREEN TEA LEAF (UNII: W2ZU1RY8B0)
BUTYLPHENYL METHYLPROPIONAL (UNII: T7540GJV69)
PHENOXYETHANOL (UNII: HIE492ZZ3T)
POTASSIUM SORBATE (UNII: 1VPU26JZZ4)
ACACIA (UNII: 5C5403N26O)
FERRIC OXIDE RED (UNII: 1K09F3G675)
FERRIC OXIDE YELLOW (UNII: EX438O2MRT)
FERROSOFERRIC OXIDE (UNII: XM0M87F357)
MICA (UNII: V8A1AW0880)
STANNIC OXIDE (UNII: KM7N50LOS6)
ALUMINUM OXIDE (UNII: LMI26O6933)
FD&C YELLOW NO. 5 (UNII: I753WB2F1M)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 58668-5361-1	1 in 1 CARTON
1		10 g in 1 BOX

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph final	part352	04/24/2012

Labeler - Laboratoires Clarins S.A. (503972197)

Establishment
Name	Address	ID/FEI	Business Operations
Laboratoires Clarins S.A.		503972197	manufacture