WARNING
KEEP OUT OF EYES. STOP USE IF IRRITATION OCCURS. KEEP OUT OF REACH OF CHILDREN.
KEEP OUT OF EYES. STOP USE IF IRRITATION OCCURS. KEEP OUT OF REACH OF CHILDREN.
OCTINOXATE 5.00%, TITANIUM DIOXIDE 2.90%
DI-PPG-3-MYRISTYL ETHER ADIPATE, PHENYL TRIMETHICONE, SILICA, HDI/TRIMETHYLOL HEXYLLACTONE CROSSPOLYMER, DIMETHICONE, TRIBEHENIN, C20-40 ALCOHOLS, ISONONYL ISONONANOATE, OZOKERITE, ALOE BARBADENSIS LEAF EXTRACT, TOCOPHERYL ACETATE, ASCORBYL PALMITATE, RETINYL PALMITATE, LECITHIN, ALUMINUM STEARATE, TRIMETHYLSILOXYSILICATE, SORBITAN LAURATE, PROPYLENE GLYCOL LAURATE, PROPYLENE GLYCOL STEARATE, POLYSORBATE 20, STEARIC ACID [+/- TITANIUM DIOXIDE (CI 77891), IRON OXIDES (CI 77491, CI 77492, CI 77499)] <ILN29118>
DIST. BY/PAR: MAKE-UP ART COSMETICS
TORONTO, ONTARIO, CANADA M5V 1R7, LONDON W1K 3BQ.
| NDC | Effective | Action | Document | Indexing SPL | Related label |
|---|---|---|---|---|---|
| 40046-0057-1 | 2019-11-13 | C162847 | 48780-1 | 97449f38-b8f1-f6ea-e053-dbdaa90aa703 | STUDIO STICK FOUNDATION SPF 15 |
| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|---|---|---|---|---|---|
| 40046-0057-1 | STUDIO FOUNDATION SPF 15 | 9 g in 1 TUBE | STICK | 9 | 1 | |
| 40046-0057-1 | STUDIO FOUNDATION SPF 15 | 1 in 1 CARTON | STICK | 1 | 1 |
| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|---|---|---|---|
| 40046-0057 | STUDIO FOUNDATION SPF 15 (OCTINOXATE AND TITANIUM DIOXIDE) STICK [MAKEUP ART COSMETICS] | 1 | Legacy NDC, 2 package rows | 20120828_ce99fd56-33cc-4ef7-bfe5-8a057d884229.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 ACETATE | INACTIVE INGREDIENT | 9E8X80D2L0 | 1 | |
| ALOE VERA LEAF | INACTIVE INGREDIENT | ZY81Z83H0X | 1 | |
| ALUMINUM STEARATE | INACTIVE INGREDIENT | U6XF9NP8HM | 1 | |
| ASCORBYL PALMITATE | INACTIVE INGREDIENT | QN83US2B0N | 1 | |
| DI-PPG-3 MYRISTYL ETHER ADIPATE | INACTIVE INGREDIENT | T32481VTXW | 1 | |
| DIMETHICONE | INACTIVE INGREDIENT | 92RU3N3Y1O | 1 | |
| FERRIC OXIDE RED | INACTIVE INGREDIENT | 1K09F3G675 | 1 | |
| FERRIC OXIDE YELLOW | INACTIVE INGREDIENT | EX438O2MRT | 1 | |
| FERROSOFERRIC OXIDE | INACTIVE INGREDIENT | XM0M87F357 | 1 | |
| ISONONYL ISONONANOATE | INACTIVE INGREDIENT | S4V5BS6GCX | 1 | |
| PHENYL TRIMETHICONE | INACTIVE INGREDIENT | DR0K5NOJ4R | 1 | |
| POLYSORBATE 20 | INACTIVE INGREDIENT | 7T1F30V5YH | 1 | |
| PROPYLENE GLYCOL MONOLAURATE | INACTIVE INGREDIENT | 668Z5835Z3 | 1 | |
| PROPYLENE GLYCOL STEARATE | INACTIVE INGREDIENT | MZM1I680W0 | 1 | |
| SILICON DIOXIDE | INACTIVE INGREDIENT | ETJ7Z6XBU4 | 1 | |
| SORBITAN MONOLAURATE | INACTIVE INGREDIENT | 6W9PS8B71J | 1 | |
| STEARIC ACID | INACTIVE INGREDIENT | 4ELV7Z65AP | 1 | |
| TRIBEHENIN | INACTIVE INGREDIENT | 8OC9U7TQZ0 | 1 | |
| VITAMIN A PALMITATE | INACTIVE INGREDIENT | 1D1K0N0VVC | 1 |
Every source-derived product name is available through these pages.
| Product NDC | Package NDC |
|---|---|
| 40046-0057 | 40046-0057-1 |
Every source-derived ingredient row is available through these pages.
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 |
|---|---|---|---|---|---|---|
| FERROSOFERRIC OXIDE | FERROSOFERRIC OXIDE | XM0M87F357 | TABLET, FILM COATED / ORAL | 0.2 mg | ||
| FERRIC OXIDE YELLOW | FERRIC OXIDE YELLOW | EX438O2MRT | TABLET, CHEWABLE / ORAL | 14 mg | ||
| SILICON DIOXIDE | SILICON DIOXIDE | ETJ7Z6XBU4 | TAMPON / VAGINAL | NA | ||
| FERRIC OXIDE RED | FERRIC OXIDE RED | 1K09F3G675 | CREAM / TOPICAL | NA | ||
| SORBITAN MONOLAURATE | SORBITAN MONOLAURATE | 6W9PS8B71J | CREAM / TOPICAL | 0.5 %w/w | ||
| ASCORBYL PALMITATE | ASCORBYL PALMITATE | QN83US2B0N | CAPSULE / ORAL | 12 mg | ||
| FERRIC OXIDE YELLOW | FERRIC OXIDE YELLOW | EX438O2MRT | CAPSULE / ORAL | 14 mg | ||
| SILICON DIOXIDE | SILICON DIOXIDE | ETJ7Z6XBU4 | FILM, EXTENDED RELEASE / TRANSDERMAL | 49 mg | ||
| SILICON DIOXIDE | SILICON DIOXIDE | ETJ7Z6XBU4 | TABLET / BUCCAL | 3 mg | ||
| SILICON DIOXIDE | SILICON DIOXIDE | ETJ7Z6XBU4 | TABLET, CHEWABLE / ORAL | 254 mg | ||
| FERRIC OXIDE YELLOW | FERRIC OXIDE YELLOW | EX438O2MRT | CAPSULE, EXTENDED RELEASE / ORAL | 7 mg | ||
| SORBITAN MONOLAURATE | SORBITAN MONOLAURATE | 6W9PS8B71J | SPRAY, METERED / NASAL | 1 mg | ||
| .ALPHA.-TOCOPHEROL ACETATE | .ALPHA.-TOCOPHEROL ACETATE | 9E8X80D2L0 | CAPSULE / ORAL | 2 mg | ||
| POLYSORBATE 20 | POLYSORBATE 20 | 7T1F30V5YH | SUPPOSITORY / VAGINAL | NA | ||
| SILICON DIOXIDE | SILICON DIOXIDE | ETJ7Z6XBU4 | CAPSULE, EXTENDED RELEASE / ORAL | 168 mg | ||
| PROPYLENE GLYCOL STEARATE | PROPYLENE GLYCOL MONOSTEARATE | MZM1I680W0 | CREAM / VAGINAL | 140 mg | ||
| STEARIC ACID | STEARIC ACID | 4ELV7Z65AP | SHAMPOO / TOPICAL | 9.7 %w/w | ||
| ALUMINUM STEARATE | ALUMINUM STEARATE | U6XF9NP8HM | OINTMENT / TOPICAL | 0.01 %w/w | ||
| SILICON DIOXIDE | SILICON DIOXIDE | ETJ7Z6XBU4 | GRANULE, FOR SOLUTION / ORAL | 1.8 mg/120ml | ||
| SORBITAN MONOLAURATE | SORBITAN MONOLAURATE | 6W9PS8B71J | SUSPENSION / ORAL | 2.5 mg/5ml | ||
| SILICON DIOXIDE | SILICON DIOXIDE | ETJ7Z6XBU4 | POWDER, FOR SUSPENSION / ORAL | 2553 mg | ||
| SORBITAN MONOLAURATE | SORBITAN MONOLAURATE | 6W9PS8B71J | TABLET / ORAL | 800 mg | ||
| STEARIC ACID | STEARIC ACID | 4ELV7Z65AP | SOAP / TOPICAL | 6 %w/w | ||
| FERROSOFERRIC OXIDE | FERROSOFERRIC OXIDE | XM0M87F357 | TABLET, DELAYED RELEASE / ORAL | 6 mg | ||
| FERRIC OXIDE RED | FERRIC OXIDE RED | 1K09F3G675 | TABLET, FILM COATED / ORAL | 3 mg | ||
| SILICON DIOXIDE | SILICON DIOXIDE | ETJ7Z6XBU4 | CAPSULE, COATED PELLETS / ORAL | 69 mg | ||
| FERRIC OXIDE YELLOW | FERRIC OXIDE YELLOW | EX438O2MRT | FILM / BUCCAL | 0.27 mg | ||
| FERRIC OXIDE RED | FERRIC OXIDE RED | 1K09F3G675 | TABLET, EXTENDED RELEASE / ORAL | 7 mg | ||
| SILICON DIOXIDE | SILICON DIOXIDE | ETJ7Z6XBU4 | TABLET, DELAYED RELEASE PARTICLES / ORAL | 170 mg | ||
| PROPYLENE GLYCOL MONOLAURATE | PROPYLENE GLYCOL MONOLAURATE | 668Z5835Z3 | TABLET / ORAL | 20 mg | ||
| FERRIC OXIDE RED | FERRIC OXIDE RED | 1K09F3G675 | TABLET / BUCCAL | 0.4 mg | ||
| SORBITAN MONOLAURATE | SORBITAN MONOLAURATE | 6W9PS8B71J | GEL / TOPICAL | 1 %w/w | ||
| FERRIC OXIDE YELLOW | FERRIC OXIDE YELLOW | EX438O2MRT | POWDER, FOR SUSPENSION / ORAL | 3 mg | ||
| SILICON DIOXIDE | SILICON DIOXIDE | ETJ7Z6XBU4 | SUSPENSION / ORAL | 400 mg | ||
| POLYSORBATE 20 | POLYSORBATE 20 | 7T1F30V5YH | SHAMPOO / TOPICAL | 8 %w/w | ||
| SILICON DIOXIDE | SILICON DIOXIDE | ETJ7Z6XBU4 | CAPSULE / RESPIRATORY (INHALATION) | NA | ||
| FERRIC OXIDE YELLOW | FERRIC OXIDE YELLOW | EX438O2MRT | CAPSULE, COATED / ORAL | 0.01 mg | ||
| POLYSORBATE 20 | POLYSORBATE 20 | 7T1F30V5YH | SOAP / TOPICAL | 0.02 %w/w | ||
| FERROSOFERRIC OXIDE | FERROSOFERRIC OXIDE | XM0M87F357 | TABLET / ORAL | 2 mg | ||
| POLYSORBATE 20 | POLYSORBATE 20 | 7T1F30V5YH | CLOTH / TOPICAL | NA | ||
| FERRIC OXIDE YELLOW | FERRIC OXIDE YELLOW | EX438O2MRT | TABLET, COATED / ORAL | 1 mg | ||
| FERRIC OXIDE RED | FERRIC OXIDE RED | 1K09F3G675 | CAPSULE, COATED / ORAL | 0.12 mg | ||
| SORBITAN MONOLAURATE | SORBITAN MONOLAURATE | 6W9PS8B71J | EMULSION / ORAL | NA | ||
| STEARIC ACID | STEARIC ACID | 4ELV7Z65AP | TABLET / ORAL | 336 mg | ||
| POLYSORBATE 20 | POLYSORBATE 20 | 7T1F30V5YH | INJECTION / INTRAVENOUS | 30 mg | ||
| FERRIC OXIDE RED | FERRIC OXIDE RED | 1K09F3G675 | TABLET, ORALLY DISINTEGRATING / ORAL | 2 mg | ||
| SILICON DIOXIDE | SILICON DIOXIDE | ETJ7Z6XBU4 | CREAM / VAGINAL | 51 mg | ||
| SILICON DIOXIDE | SILICON DIOXIDE | ETJ7Z6XBU4 | TABLET / SUBLINGUAL | 10 mg | ||
| SILICON DIOXIDE | SILICON DIOXIDE | ETJ7Z6XBU4 | GRANULE / ORAL | 5000 mg | ||
| PROPYLENE GLYCOL MONOLAURATE | PROPYLENE GLYCOL MONOLAURATE | 668Z5835Z3 | CAPSULE / ORAL | 2115 mg | ||
| SILICON DIOXIDE | SILICON DIOXIDE | ETJ7Z6XBU4 | FILM, SOLUBLE / ORAL | 2 mg | ||
| FERRIC OXIDE RED | FERRIC OXIDE RED | 1K09F3G675 | TABLET, CHEWABLE / ORAL | 2 mg | ||
| STEARIC ACID | STEARIC ACID | 4ELV7Z65AP | TABLET, ORALLY DISINTEGRATING / ORAL | 10 mg | ||
| ASCORBYL PALMITATE | ASCORBYL PALMITATE | QN83US2B0N | SUPPOSITORY / RECTAL | 16 mg | ||
| POLYSORBATE 20 | POLYSORBATE 20 | 7T1F30V5YH | TAMPON / VAGINAL | 64.8 mg | ||
| FERROSOFERRIC OXIDE | FERROSOFERRIC OXIDE | XM0M87F357 | TABLET, EXTENDED RELEASE / ORAL | 8 mg | ||
| POLYSORBATE 20 | POLYSORBATE 20 | 7T1F30V5YH | CREAM / TOPICAL | 108 mg | ||
| PROPYLENE GLYCOL MONOLAURATE | PROPYLENE GLYCOL MONOLAURATE | 668Z5835Z3 | FILM, EXTENDED RELEASE / TRANSDERMAL | NA | ||
| SILICON DIOXIDE | SILICON DIOXIDE | ETJ7Z6XBU4 | CAPSULE, COATED / ORAL | 3 mg | ||
| SILICON DIOXIDE | SILICON DIOXIDE | ETJ7Z6XBU4 | SUSPENSION, EXTENDED RELEASE / ORAL | 70 mg |
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 |
|---|---|---|---|---|---|---|
| 6ac61092-2d20-45fd-a03b-e3be163388b1 | ce99fd56-33cc-4ef7-bfe5-8a057d884229 | 2012-08-16 | Warnings | 6ac61092-2d20-45fd-a03b-e3be163388b1 ce99fd56-33cc-4ef7-bfe5-8a057d884229 |
Adverse event summaries are temporarily unavailable. Other product information remains available.