OTC Medication Information: 2 IN 1 POWDER MAKE-UP SPF 15

2 IN 1 POWDER MAKE-UP SPF 15- octinoxate and 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.

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
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2-In-1 Powder M-U SPF-15_ART_BOX-BK_12g_20120502
(click image for full-size original)
2-In-1 Powder M-U SPF-15_ART_LBL_12g_20120502
(click image for full-size original)

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 DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
OCTINOXATE (OCTINOXATE) OCTINOXATE 5 g in 100 g
TITANIUM DIOXIDE (TITANIUM DIOXIDE) TITANIUM DIOXIDE 3.25 g in 100 g
Inactive Ingredients
Ingredient Name Strength
TALC
HYDROGENATED SOYBEAN LECITHIN
DIMETHICONE
OCTYLDODECYL LACTATE
METHYL METHACRYLATE
SILICON DIOXIDE
ZINC STEARATE
OCTYLDODECYL STEAROYL STEARATE
METHYLPARABEN
POLYGLYCERYL-3 DIISOSTEARATE
PROPYLPARABEN
TRIMETHYLSILOXYSILICATE (M/Q 0.66)
MICA
DIAZOLIDINYL UREA
SODIUM PYRROLIDONE CARBOXYLATE
ALPHA-TOCOPHEROL ACETATE
FERRIC OXIDE RED
FERRIC OXIDE YELLOW
FERROSOFERRIC OXIDE
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:68828-057-21 1 JAR (JAR) in 1 BOX contains a JAR (68828-057-25)
1 NDC:68828-057-25 12 g in 1 JAR This package is contained within the BOX (68828-057-21)
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 Operations
Jafra Manufacturing, S.A. de C.V. 814732061 manufacture

Revised: 05/2012 JAFRA COSMETICS INTERNATIONAL

Our database comes directly from the FDA’s central repository of drug labels and package inserts under the Structured Product Labeling standard. OTCLabels.com provides the full over the counter products subset of the FDA’s repository. Medication information provided here is not intended as a substitute for direct consultation with a qualified health professional.

Our database comes directly from the FDA's central repository of drug labels and package inserts under the Structured Product Labeling standard. OTCLabels.com provides the full over the counter products subset of the FDA's repository. Medication information provided here is not intended as a substitute for direct consultation with a qualified health professional.

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