Label: ILLUMINATING FINISH- titanium dioxide, octinoxate powder
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Contains inactivated NDC Code(s)
NDC Code(s): 64141-007-01, 64141-007-02 - Packager: Bobbi Brown Professional Cosmetics Inc.
- Category: HUMAN OTC DRUG LABEL
- DEA Schedule: None
- Marketing Status: OTC monograph not 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 September 1, 2010
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ACTIVE INGREDIENT
ACTIVE INGREDIENTS: TITANIUM DIOXIDE 6.30% [] OCTINOXATE 3.00%
INACTIVE INGREDIENTS:
TALC [] SILICA [] ZINC STEARATE [] OCTYLDODECYL STEAROYL STEARATE [] HYDROGENATED COCO-GLYCERIDES [] NELUMBIUM SPECIOSUM FLOWER EXTRACT [] TRIETHOXYCAPRYLYLSILANE [] PROPYLENE GLYCOL DICAPRYLATE/DICAPRATE [] DIMETHICONE [] CAPRYLYL GLYCOL [] HEXYLENE GLYCOL [] PENTAERYTHRITYL TETRA-DI-T-BUTYL HYDROXYHYDROCINNAMATE [] DEHYDROACETIC ACID [] [+/- BISMUTH OXYCHLORIDE (CI 77163) [] IRON OXIDES (CI 77491, CI 77492, CI 77499) [] YELLOW 5 LAKE (CI 19140) [] YELLOW 6 LAKE (CI 15985) [] TITANIUM DIOXIDE (CI 77891) [] MICA [] RED 30 LAKE (CI 73360)]
- WHEN USING
- WARNINGS
- PRINCIPAL DISPLAY PANEL
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INGREDIENTS AND APPEARANCE
ILLUMINATING FINISH COMPACT FOUNDATION SPF 12
titanium dioxide, octinoxate powderProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:64141-007 Route of Administration TOPICAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength TITANIUM DIOXIDE (UNII: 15FIX9V2JP) (TITANIUM DIOXIDE - UNII:15FIX9V2JP) TITANIUM DIOXIDE 6.3 g in 100 g OCTINOXATE (UNII: 4Y5P7MUD51) (OCTINOXATE - UNII:4Y5P7MUD51) OCTINOXATE 3.0 g in 100 g Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:64141-007-01 1 in 1 CARTON 1 NDC:64141-007-02 13 g in 1 CASE Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC monograph not final part352 07/01/2010 Labeler - Bobbi Brown Professional Cosmetics Inc. (627131279) Establishment Name Address ID/FEI Business Operations ESTEE LAUDER COSMETICS, LTD 205952385 manufacture Establishment Name Address ID/FEI Business Operations ESTEE LAUDER N.V. 370151326 manufacture Establishment Name Address ID/FEI Business Operations Len-Ron Manufacturing Division of Aramis Inc. 809771152 manufacture Establishment Name Address ID/FEI Business Operations Aramis Inc. 042918826 manufacture Establishment Name Address ID/FEI Business Operations Northtec Bristol 949264774 manufacture, relabel, repack Establishment Name Address ID/FEI Business Operations Northtec Keystone 618107429 manufacture, relabel, repack Establishment Name Address ID/FEI Business Operations Estee Lauder Pennsylvania Distribution Center 2 828534516 manufacture, relabel, repack Establishment Name Address ID/FEI Business Operations Estee Lauder Cosmetics, Ltd. 255175580 manufacture Establishment Name Address ID/FEI Business Operations Estee Lauder Cosmetics, Ltd 253616536 manufacture Establishment Name Address ID/FEI Business Operations Estee Lauder Cosmetics Distribution Center 208579636 repack, relabel Establishment Name Address ID/FEI Business Operations Estee Lauder Kabushiki Kaisha 712808195 relabel, repack Establishment Name Address ID/FEI Business Operations Whitman Laboratories Ltd. 216866277 manufacture Establishment Name Address ID/FEI Business Operations Aveda Corporation 071352058 manufacture Establishment Name Address ID/FEI Business Operations Intercos 338578473 manufacture
