2-IN-1 POWDER MAKE-UP SPF-15

2 IN 1 POWDER MAKE-UP SPF 15- octinoxate titanium dioxide powder
JAFRA COSMETICS INTERNATIONAL

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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SUNSCREEN ACTIVE INGREDIENT (SPF 15):
OCTINOXATE, TITANIUM DIOXIDE/CI77891

PURPOSE: SUNSCREEN

OTHER INGREDIENTS: TALC, HYDROGENATED LECITHIN, DIMETHICONE, OCTYLDODECYL LACTATE, METHYL METHACRYLATE CROSSPOLYMER, SILICA, ZINC STEARATE, OCTYLDODECYL STEAROYL STEARATE, METHYLPARABEN, DIISOSTEAROYL POLYGLYCERYL-3 DIISOSTEARATE, PROPYLPARABEN, SODIUM PCA, TOCOPHERYL ACETATE, TRIMETHYLSILOXYAMODIMETHICONE, MICA, DIAZOLIDINYL UREA [MAY CONTAIN, +/-: IRON OXIDES/CI 77491/CI 77492/CI 77499]

CONTAINS SPF 15 TO HELP SHIELD AGAINST HARMFUL UV RAYS.

TO USE: APPLY WITH THE SPONGE FOR A LONG-LASTING VELVETY MATTE FINISH OR A POWDER BRUSH FOR A SHEER AND NATURAL FINISH.

DISCONTINUE USE IF IRRITATION OCCURS.

KEEP OUT OF REACH OF CHILDREN.

JAFRA

TWO-IN-ONE POWDER MAKEUP SPF 15

2-In-1 Powder M-U SPF-15_ART_BOX-FR_12g_20120502 2-In-1 Powder M-U SPF-15_ART_LBL_12g_20120502

2 IN 1 POWDER MAKE-UP SPF 15
octinoxate titanium dioxide powder

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC:68828-057
Route of Administration	TOPICAL

Ingredient Name	Basis of Strength	Strength
Active Ingredient/Active Moiety
OCTINOXATE (UNII: 4Y5P7MUD51) (OCTINOXATE - UNII:4Y5P7MUD51)	OCTINOXATE	5 g in 100 g
TITANIUM DIOXIDE (UNII: 15FIX9V2JP) (TITANIUM DIOXIDE - UNII:15FIX9V2JP)	TITANIUM DIOXIDE	3.25 g in 100 g

Ingredient Name	Strength
Inactive Ingredients
TALC (UNII: 7SEV7J4R1U)
HYDROGENATED SOYBEAN LECITHIN (UNII: H1109Z9J4N)
DIMETHICONE (UNII: 92RU3N3Y1O)
OCTYLDODECYL LACTATE (UNII: 8JKW8M5W35)
METHYL METHACRYLATE (UNII: 196OC77688)
SILICON DIOXIDE (UNII: ETJ7Z6XBU4)
ZINC STEARATE (UNII: H92E6QA4FV)
OCTYLDODECYL STEAROYL STEARATE (UNII: 3D47Q6D93C)
METHYLPARABEN (UNII: A2I8C7HI9T)
POLYGLYCERYL-3 DIISOSTEARATE (UNII: 46P231IQV8)
PROPYLPARABEN (UNII: Z8IX2SC1OH)
TRIMETHYLSILOXYSILICATE (M/Q 0.66) (UNII: 5041RX63GN)
MICA (UNII: V8A1AW0880)
DIAZOLIDINYL UREA (UNII: H5RIZ3MPW4)
SODIUM PYRROLIDONE CARBOXYLATE (UNII: 469OTG57A2)
ALPHA-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)
FERRIC OXIDE RED (UNII: 1K09F3G675)
FERRIC OXIDE YELLOW (UNII: EX438O2MRT)
FERROSOFERRIC OXIDE (UNII: XM0M87F357)

#	Item Code	Package Description
Packaging
1	NDC:68828-057-21	1 in 1 BOX
1	NDC:68828-057-25	12 g in 1 JAR

Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
OTC monograph not final	part352	04/24/2012

Labeler - JAFRA COSMETICS INTERNATIONAL (041676479)

Registrant - JAFRA COSMETICS INTERNATIONAL (041676479)

Name	Address	ID/FEI	Business Operations
Establishment
Jafra Manufacturing, S.A. de C.V.		814732061	manufacture