Label: PURE FINISH MINERAL POWDER FOUNDATION SPF 20 PURE FINISH 8- titanium dioxide powder
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Contains inactivated NDC Code(s)
NDC Code(s): 67938-1397-1, 67938-1397-2 - Packager: Elizabeth Arden, Inc
- Category: HUMAN OTC DRUG LABEL
- DEA Schedule: None
- Marketing Status: OTC monograph final
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.
Drug Label Information
Updated January 11, 2011
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- Official Label (Printer Friendly)
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DESCRIPTION
For all skin types. Mediun/full coverage. Pure, luminous finish. Pure minerals. Pure comfort. Pure perfection. This microlight mineral makeup is ultra blendable and buildable. SPF 20 sun protection. Fragrance free. Talc free. Oil free. Freshly ground for ultimate purity. Clinically and dermatologist tested. Sensititve skin tested.
- INDICATIONS AND USAGE
- WARNINGS
- OTC - ACTIVE INGREDIENT
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INACTIVE INGREDIENT
Other Ingredients: Mica, Dimethicon, Nylon-12, Zinc Stearate, Silica, Methicon, Squalane, Magnesium Myristate, Sea Salt/Maris Sal/Sel Marin, Aloe Barbadensis Leaf Jucie, Silk Powder/Serica/Poudre de Soice, Ascorbyl Palmitate, Retinyl Palmitate, Tocopherol, Alumina, Oryza Sative (Rice) Starch, Butylparaben, Methylparaben, Propylparaben, Sodium Dehydroacetate. [May Contain/Peut Contenir (+/-) Bismuth Oxychloride (CI 77163), Carmine (CI 75470), Iron Oxides (CI 77491, CI 77492, CI 77499), Titanium Dioxide (CI 77891).]
- DOSAGE & ADMINISTRATION
- OTC - KEEP OUT OF REACH OF CHILDREN
- OTC - PURPOSE
- OTC - WHEN USING
- PACKAGE LABEL.PRINCIPAL DISPLAY PANEL
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INGREDIENTS AND APPEARANCE
PURE FINISH MINERAL POWDER FOUNDATION SPF 20 PURE FINISH 8
titanium dioxide powderProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:67938-1397 Route of Administration TOPICAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength TITANIUM DIOXIDE (UNII: 15FIX9V2JP) (TITANIUM DIOXIDE - UNII:15FIX9V2JP) TITANIUM DIOXIDE 0.358 g in 8.33 g Inactive Ingredients Ingredient Name Strength MICA (UNII: V8A1AW0880) DIMETHICONE (UNII: 92RU3N3Y1O) ZINC STEARATE (UNII: H92E6QA4FV) SILICON DIOXIDE (UNII: ETJ7Z6XBU4) SQUALANE (UNII: GW89575KF9) MAGNESIUM MYRISTATE (UNII: Z1917F0578) SEA SALT (UNII: 87GE52P74G) STARCH, RICE (UNII: 4DGK8B7I3S) ALUMINUM OXIDE (UNII: LMI26O6933) METHYLPARABEN (UNII: A2I8C7HI9T) SODIUM DEHYDROACETATE (UNII: 8W46YN971G) ALOE VERA LEAF (UNII: ZY81Z83H0X) PROPYLPARABEN (UNII: Z8IX2SC1OH) VITAMIN A PALMITATE (UNII: 1D1K0N0VVC) ASCORBYL PALMITATE (UNII: QN83US2B0N) BUTYLPARABEN (UNII: 3QPI1U3FV8) ALPHA-TOCOPHEROL (UNII: H4N855PNZ1) Product Characteristics Color BROWN (Pure Finish 8) Score Shape Size Flavor Imprint Code Contains Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:67938-1397-1 1 in 1 BOX 1 NDC:67938-1397-2 8.33 g in 1 CONTAINER Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC monograph final part352 09/20/2010 Labeler - Elizabeth Arden, Inc (849222187)
