OTC - ACTIVE INGREDIENT SECTION
ACTIVE INGREDIENTS: OCTINOXATE 5.00% [] TITANIUM DIOXIDE 2.00%
ACTIVE INGREDIENTS: OCTINOXATE 5.00% [] TITANIUM DIOXIDE 2.00%
INACTIVE INGREDIENTS: OCTYLDODECANOL [] SYNTHETIC BEESWAX [] COPERNICIA CERIFERA (CARNAUBA) WAX [] SILICA [] HYDROGENATED POLYISOBUTENE [] SIMMONDSIA CHINENSIS (JOJOBA) SEED OIL [] TOCOPHEROL [] ASCORBYL PALMITATE [] POLYBUTENE [] PVP/HEXADECENE COPOLYMER [] ALUMINA [] STEARIC ACID [] [+/-(MAY CONTAIN) TITANIUM DIOXIDE (CI 77891) [] IRON OXIDES (CI 77491, CI 77492, CI 77499) [] CHROMIUM OXIDE GREENS (CI 77288)]
WARNING: KEEP OUT OF EYES. STOP USE IF IRRITATION OCCURS. KEEP OUT OF REACH OF CHILDREN.
PRINCIPAL DISPLAY PANEL
MAC
STUDIO FINISH CONCEALER
SPF 35
NET WT. 7 g/ 0.24 oz
MAKE UP ART COSMETICS
TORONTO, ONTARIO, CANADA,M5V 1R7
| NDC | Effective | Action | Document | Indexing SPL | Related label |
|---|---|---|---|---|---|
| 40046-0048-1 | 2020-01-31 | C162847 | 48780-1 | 9d75b9d0-cdcc-f424-e053-dadaa90a57ce | 951163a3-b22f-4027-97ed-946aceb43762 |
| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|---|---|---|---|---|---|
| 40046-0048-1 | STUDIO FINISH CONCEALERSPF 35 | 1 in 1 CARTON | PASTE | 1 | 1 | |
| 40046-0048-2 | STUDIO FINISH CONCEALERSPF 35 | 7 g in 1 JAR | PASTE | 7 | 1 |
| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|---|---|---|---|
| 40046-0048 | STUDIO FINISH CONCEALER SPF 35 (OCTINOXATE, TITANIUM DIOXIDE) PASTE [MAKEUP ART COSMETICS] | 1 | Legacy NDC, 2 package rows | 20110829_951163a3-b22f-4027-97ed-946aceb43762.zip |
| Ingredient | Type | UNII | SPL version | Uploaded |
|---|---|---|---|---|
| OCTINOXATE | ACTIVE INGREDIENT | 4Y5P7MUD51 | 1 | |
| TITANIUM DIOXIDE | ACTIVE INGREDIENT | 15FIX9V2JP | 1 | |
| OCTINOXATE | ACTIVE MOIETY | 4Y5P7MUD51 | 1 | |
| TITANIUM DIOXIDE | ACTIVE MOIETY | 15FIX9V2JP | 1 | |
| ALPHA-TOCOPHEROL | INACTIVE INGREDIENT | H4N855PNZ1 | 1 | |
| ALUMINUM OXIDE | INACTIVE INGREDIENT | LMI26O6933 | 1 | |
| ASCORBYL PALMITATE | INACTIVE INGREDIENT | QN83US2B0N | 1 | |
| CARNAUBA WAX | INACTIVE INGREDIENT | R12CBM0EIZ | 1 | |
| CHROMIC OXIDE | INACTIVE INGREDIENT | X5Z09SU859 | 1 | |
| FERRIC OXIDE RED | INACTIVE INGREDIENT | 1K09F3G675 | 1 | |
| HYDROGENATED POLYBUTENE (1300 MW) | INACTIVE INGREDIENT | 7D1YQ9Y5EZ | 1 | |
| JOJOBA OIL | INACTIVE INGREDIENT | 724GKU717M | 1 | |
| OCTYLDODECANOL | INACTIVE INGREDIENT | 461N1O614Y | 1 | |
| POLYBUTENE (1400 MW) | INACTIVE INGREDIENT | 1NA5AO9GH7 | 1 | |
| SILICON DIOXIDE | INACTIVE INGREDIENT | ETJ7Z6XBU4 | 1 | |
| STEARIC ACID | INACTIVE INGREDIENT | 4ELV7Z65AP | 1 | |
| YELLOW WAX | INACTIVE INGREDIENT | 2ZA36H0S2V | 1 |
Every source-derived product name is available through these pages.
| Product NDC | Package NDC |
|---|---|
| 40046-0048 | 40046-0048-2, 40046-0048-1 |
Every source-derived ingredient row is available through these pages.
| Name | UNII | Kind |
|---|---|---|
| OCTINOXATE | 4Y5P7MUD51 | ACTIB |
| TITANIUM DIOXIDE | 15FIX9V2JP | ACTIB |
| OCTYLDODECANOL | 461N1O614Y | IACT |
| YELLOW WAX | 2ZA36H0S2V | IACT |
| CARNAUBA WAX | R12CBM0EIZ | IACT |
| SILICON DIOXIDE | ETJ7Z6XBU4 | IACT |
| HYDROGENATED POLYBUTENE (1300 MW) | 7D1YQ9Y5EZ | IACT |
| JOJOBA OIL | 724GKU717M | IACT |
| ALPHA-TOCOPHEROL | H4N855PNZ1 | IACT |
| ASCORBYL PALMITATE | QN83US2B0N | IACT |
| POLYBUTENE (1400 MW) | 1NA5AO9GH7 | IACT |
| ALUMINUM OXIDE | LMI26O6933 | IACT |
| STEARIC ACID | 4ELV7Z65AP | IACT |
| FERRIC OXIDE RED | 1K09F3G675 | IACT |
| CHROMIC OXIDE | X5Z09SU859 | IACT |
Inactive Ingredient Database values describe FDA-listed use contexts. The match method and ambiguity count are shown because ingredient names, routes, and dosage forms are not always unique. Browse recovered IID releases and source provenance.
| DailyMed ingredient | IID ingredient | UNII | Dosage form / route | Potency | Maximum daily exposure | Match |
|---|---|---|---|---|---|---|
| FERRIC OXIDE RED | FERRIC OXIDE RED | 1K09F3G675 | SUSPENSION, EXTENDED RELEASE / ORAL | 2.7 mg | ||
| CARNAUBA WAX | CARNAUBA WAX | R12CBM0EIZ | TABLET, EXTENDED RELEASE / ORAL | 2150 mg | ||
| ALPHA-TOCOPHEROL | .ALPHA.-TOCOPHEROL | H4N855PNZ1 | SYSTEM / TOPICAL | 0.1 mg | ||
| SILICON DIOXIDE | SILICON DIOXIDE | ETJ7Z6XBU4 | GEL / VAGINAL | 8 %w/w | ||
| SILICON DIOXIDE | SILICON DIOXIDE | ETJ7Z6XBU4 | GRANULE, DELAYED RELEASE / ORAL | 3.2 mg | ||
| CARNAUBA WAX | CARNAUBA WAX | R12CBM0EIZ | GUM, CHEWING / BUCCAL | 10 mg | ||
| POLYBUTENE (1400 MW) | POLYBUTENE (1400 MW) | 1NA5AO9GH7 | SYSTEM / TRANSDERMAL | 17.87 mg | ||
| ALPHA-TOCOPHEROL | .ALPHA.-TOCOPHEROL | H4N855PNZ1 | TABLET, FILM COATED / ORAL | 246 mg | ||
| STEARIC ACID | STEARIC ACID | 4ELV7Z65AP | TABLET, FILM COATED, EXTENDED RELEASE / ORAL | 120 mg | ||
| STEARIC ACID | STEARIC ACID | 4ELV7Z65AP | TABLET / ORAL | 336 mg | ||
| STEARIC ACID | STEARIC ACID | 4ELV7Z65AP | SHAMPOO / TOPICAL | 9.7 %w/w | ||
| YELLOW WAX | YELLOW WAX | 2ZA36H0S2V | TABLET, EXTENDED RELEASE / ORAL | 0.01 mg | ||
| FERRIC OXIDE RED | FERRIC OXIDE RED | 1K09F3G675 | TABLET, EXTENDED RELEASE / ORAL | 7 mg | ||
| STEARIC ACID | STEARIC ACID | 4ELV7Z65AP | TABLET, COATED / ORAL | 42.4 mg | ||
| ALPHA-TOCOPHEROL | .ALPHA.-TOCOPHEROL | H4N855PNZ1 | FILM, SOLUBLE / BUCCAL | 0.07 mg | ||
| STEARIC ACID | STEARIC ACID | 4ELV7Z65AP | SOLUTION / TOPICAL | NA | ||
| SILICON DIOXIDE | SILICON DIOXIDE | ETJ7Z6XBU4 | TABLET, COATED / ORAL | 176 mg | ||
| ALUMINUM OXIDE | ALUMINUM OXIDE | LMI26O6933 | SPONGE / TOPICAL | NA | ||
| SILICON DIOXIDE | SILICON DIOXIDE | ETJ7Z6XBU4 | GRANULE, FOR SUSPENSION, EXTENDED RELEASE / ORAL | NA | ||
| SILICON DIOXIDE | SILICON DIOXIDE | ETJ7Z6XBU4 | CAPSULE, COATED, EXTENDED RELEASE / ORAL | NA | ||
| STEARIC ACID | STEARIC ACID | 4ELV7Z65AP | CAPSULE / ORAL | 90 mg | ||
| SILICON DIOXIDE | SILICON DIOXIDE | ETJ7Z6XBU4 | TABLET, CHEWABLE / ORAL | 254 mg | ||
| SILICON DIOXIDE | SILICON DIOXIDE | ETJ7Z6XBU4 | GRANULE, FOR SOLUTION / ORAL | 1.8 mg/120ml | ||
| OCTYLDODECANOL | OCTYLDODECANOL | 461N1O614Y | CREAM / TOPICAL | 160 mg | ||
| FERRIC OXIDE RED | FERRIC OXIDE RED | 1K09F3G675 | TABLET, ORALLY DISINTEGRATING / ORAL | 2 mg | ||
| SILICON DIOXIDE | SILICON DIOXIDE | ETJ7Z6XBU4 | GRANULE / ORAL | 5000 mg | ||
| ASCORBYL PALMITATE | ASCORBYL PALMITATE | QN83US2B0N | SYSTEM / TOPICAL | 0.04 mg | ||
| FERRIC OXIDE RED | FERRIC OXIDE RED | 1K09F3G675 | CAPSULE / ORAL | 5 mg | ||
| FERRIC OXIDE RED | FERRIC OXIDE RED | 1K09F3G675 | CAPSULE, EXTENDED RELEASE / ORAL | 5 mg | ||
| STEARIC ACID | STEARIC ACID | 4ELV7Z65AP | IMPLANT / SUBCUTANEOUS | 1.04 mg | ||
| POLYBUTENE (1400 MW) | POLYBUTENE (1400 MW) | 1NA5AO9GH7 | FILM, EXTENDED RELEASE / TRANSDERMAL | NA | ||
| STEARIC ACID | STEARIC ACID | 4ELV7Z65AP | OINTMENT / TOPICAL | 15 %w/w | ||
| STEARIC ACID | STEARIC ACID | 4ELV7Z65AP | TABLET / BUCCAL | 6 mg | ||
| STEARIC ACID | STEARIC ACID | 4ELV7Z65AP | AEROSOL, FOAM / VAGINAL | 4 %w/w | ||
| SILICON DIOXIDE | SILICON DIOXIDE | ETJ7Z6XBU4 | TABLET, ORALLY DISINTEGRATING, DELAYED RELEASE / ORAL | 69 mg | ||
| SILICON DIOXIDE | SILICON DIOXIDE | ETJ7Z6XBU4 | FILM, SOLUBLE / ORAL | 2 mg | ||
| YELLOW WAX | YELLOW WAX | 2ZA36H0S2V | CAPSULE / ORAL | 44 mg | ||
| ALPHA-TOCOPHEROL | .ALPHA.-TOCOPHEROL | H4N855PNZ1 | TABLET, EXTENDED RELEASE / ORAL | 4 mg | ||
| STEARIC ACID | STEARIC ACID | 4ELV7Z65AP | TABLET, CHEWABLE / ORAL | 180 mg | ||
| SILICON DIOXIDE | SILICON DIOXIDE | ETJ7Z6XBU4 | TABLET, ORALLY DISINTEGRATING / ORAL | 68 mg | ||
| SILICON DIOXIDE | SILICON DIOXIDE | ETJ7Z6XBU4 | TABLET, FOR SUSPENSION / ORAL | 220 mg | ||
| YELLOW WAX | YELLOW WAX | 2ZA36H0S2V | TABLET, COATED / ORAL | 213.7 mg | ||
| SILICON DIOXIDE | SILICON DIOXIDE | ETJ7Z6XBU4 | CAPSULE, EXTENDED RELEASE / ORAL | 168 mg | ||
| SILICON DIOXIDE | SILICON DIOXIDE | ETJ7Z6XBU4 | GEL / NASAL | 20 mg | ||
| OCTYLDODECANOL | OCTYLDODECANOL | 461N1O614Y | CREAM / VAGINAL | 13.5 %w/w | ||
| ALPHA-TOCOPHEROL | .ALPHA.-TOCOPHEROL | H4N855PNZ1 | CAPSULE / ORAL | 16 mg | ||
| SILICON DIOXIDE | SILICON DIOXIDE | ETJ7Z6XBU4 | TABLET, FILM COATED / ORAL | 166 mg | ||
| STEARIC ACID | STEARIC ACID | 4ELV7Z65AP | AEROSOL, FOAM / TOPICAL | 8 %w/w | ||
| SILICON DIOXIDE | SILICON DIOXIDE | ETJ7Z6XBU4 | TABLET / SUBLINGUAL | 10 mg | ||
| CARNAUBA WAX | CARNAUBA WAX | R12CBM0EIZ | TABLET, FILM COATED, EXTENDED RELEASE / ORAL | 140 mg | ||
| STEARIC ACID | STEARIC ACID | 4ELV7Z65AP | CREAM / TOPICAL | 190 mg | ||
| SILICON DIOXIDE | SILICON DIOXIDE | ETJ7Z6XBU4 | TABLET, DELAYED RELEASE / ORAL | 1190 mg | ||
| STEARIC ACID | STEARIC ACID | 4ELV7Z65AP | CAPSULE, EXTENDED RELEASE / ORAL | 64 mg | ||
| SILICON DIOXIDE | SILICON DIOXIDE | ETJ7Z6XBU4 | CAPSULE, DELAYED RELEASE / ORAL | 40 mg | ||
| SILICON DIOXIDE | SILICON DIOXIDE | ETJ7Z6XBU4 | CREAM / VAGINAL | 51 mg | ||
| FERRIC OXIDE RED | FERRIC OXIDE RED | 1K09F3G675 | CREAM / TOPICAL | NA | ||
| STEARIC ACID | STEARIC ACID | 4ELV7Z65AP | CREAM / VAGINAL | 1088 mg | ||
| FERRIC OXIDE RED | FERRIC OXIDE RED | 1K09F3G675 | CAPSULE, COATED PELLETS / ORAL | 2 mg | ||
| FERRIC OXIDE RED | FERRIC OXIDE RED | 1K09F3G675 | CAPSULE, DELAYED RELEASE / ORAL | 14 mg | ||
| SILICON DIOXIDE | SILICON DIOXIDE | ETJ7Z6XBU4 | TAMPON / VAGINAL | NA |
OpenFDA label data provides additional search and identifier links. DailyMed’s Structured Product Label is the canonical label on FDA.report. Matching records are deduplicated before they are shown below.
| Brand | Generic | Manufacturer | SPL set ID | Effective date | Available safety fields | Join |
|---|---|---|---|---|---|---|
| c0ed0ee1-0b8a-4e11-aec8-dfc9d6b56ab4 | 951163a3-b22f-4027-97ed-946aceb43762 | 2011-08-26 | Warnings | c0ed0ee1-0b8a-4e11-aec8-dfc9d6b56ab4 951163a3-b22f-4027-97ed-946aceb43762 |
Adverse event summaries are temporarily unavailable. Other product information remains available.