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

2 IN 1 POWDER MAKE-UP by

Drug Labeling and Warnings

2 IN 1 POWDER MAKE-UP by is a Otc medication manufactured, distributed, or labeled by JAFRA COSMETICS INTERNATIONAL, Jafra Manufacturing, S.A. de C.V.. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

ACTIVE INGREDIENT

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

PURPOSE

PURPOSE: SUNSCREEN

INACTIVE INGREDIENT

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]

INDICATIONS & USAGE

CONTAINS SPF 15 TO HELP SHIELD AGAINST HARMFUL UV RAYS.

DOSAGE & ADMINISTRATION

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

WARNINGS

DISCONTINUE USE IF IRRITATION OCCURS.

KEEP OUT OF REACH OF CHILDREN

KEEP OUT OF REACH OF CHILDREN.

PRINCIPAL DISPLAY PANEL

JAFRA

TWO-IN-ONE POWDER MAKEUP SPF 15

     

INGREDIENTS AND APPEARANCE

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

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
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

Inactive Ingredients
Ingredient Name	Strength
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)

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

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

Labeler - JAFRA COSMETICS INTERNATIONAL (041676479)

Registrant - JAFRA COSMETICS INTERNATIONAL (041676479)

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