OTC - ACTIVE INGREDIENT SECTION
ACTIVE INGREDIENTS: OCTINOXATE 7.00% [] TITANIUM DIOXIDE 2.00%
ACTIVE INGREDIENTS: OCTINOXATE 7.00% [] TITANIUM DIOXIDE 2.00%
INACTIVE INGREDIENTS: WATER [] CYCLOPENTASILOXANE [] GLYCERIN [] BUTYLENE GLYCOL [] OCTYLDODECYL NEOPENTANOATE [] PEG/PPG-18/18 DIMETHICONE [] POLYMETHYLSILSESQUIOXANE [] ISOSTEARIC ACID [] C4-24 ALKYL DIMETHICONE/DIVINYLDIMETHICONE CROSSPOLYMER [] ISONONYL ISONONANOATE [] TAMARINDUS INDICA SEED EXTRACT [] TOCOPHEROL [] TOCOPHERYL ACETATE [] SODIUM HYALURONATE [] HABERLEA RHODOPENSIS LEAF EXTRACT [] BUTYROSPERMUM PARKII (SHEA BUTTER) [] YEAST EXTRACT\FAEX\EXTRAIT DE LEVURE [] QUERCUS SUBER BARK EXTRACT [] PHYTANTRIOL [] DEXTRIN PALMITATE [] DEXTRIN PALMITATE/ETHYLHEXANOATE [] CELLULOSE GUM [] TETRAHEXYLDECYL ASCORBATE [] XANTHAN GUM [] DIMETHICONE [] METHICONE [] PROPYLENE CARBONATE [] SODIUM CHLORIDE [] PALMITIC ACID [] POLYGLYCERYL-4 ISOSTEARATE [] CETYL PEG/PPG-10/1 DIMETHICONE [] HEXYL LAURATE [] POLYMETHYL METHACRYLATE [] OCTYLDODECYL PCA [] DISTEARDIMONIUM HECTORITE [] STEARIC ACID [] CAPRYLYL GLYCOL [] DIPROPYLENE GLYCOL [] PHENOXYETHANOL [] ALUMINUM STEARATE [] HEXYLENE GLYCOL [] [+/- MICA [] TITANIUM DIOXIDE (CI 77891) [] IRON OXIDES (CI 77491, CI 77492, CI 77499) [] CHROMIUM OXIDE GREENS (CI 77288)]
WARNING: KEEP OUR OF EYES. STOP USE IF IRRITATION OCCURS.
KEEP OUT OF REACH OF CHILDREN.
PRINCIPAL DISPLAY PANEL:
MAC
STUDIO SCULPT
SPF 15 FOUNDATION
40 ML/ 1.3 US FL OZ
DISTR BY MAKE-UP ART COSMETICS
TORONTO, ONTARIO
CANADA
| NDC | Effective | Action | Document | Indexing SPL | Related label |
|---|---|---|---|---|---|
| 40046-0032-1 | 2020-01-31 | C162847 | 48780-1 | 9d75b9d0-0ed4-f424-e053-dadaa90a57ce | 21045130-f8d5-465d-8628-c6053e95bc55 |
| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|---|---|---|---|---|---|
| 40046-0032-1 | STUDIO SCULPTSPF 15 FOUNDATION | 1 in 1 CARTON | LIQUID | 1 | 1 | |
| 40046-0032-2 | STUDIO SCULPTSPF 15 FOUNDATION | 40 mL in 1 TUBE | LIQUID | 40 | 1 |
| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|---|---|---|---|
| 40046-0032 | STUDIO SCULPT SPF 15 FOUNDATION (OCTINOXATE, TITANIUM DIOXIDE) LIQUID [MAKE UP ART COSMETICS] | 1 | Legacy NDC, 2 package rows | 20110301_21045130-f8d5-465d-8628-c6053e95bc55.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, DL- | INACTIVE INGREDIENT | WR1WPI7EW8 | 1 | |
| ALPHA-TOCOPHEROL, DL- | INACTIVE INGREDIENT | 7QWA1RIO01 | 1 | |
| BUTYLENE GLYCOL | INACTIVE INGREDIENT | 3XUS85K0RA | 1 | |
| CYCLOMETHICONE 5 | INACTIVE INGREDIENT | 0THT5PCI0R | 1 | |
| FERRIC OXIDE RED | INACTIVE INGREDIENT | 1K09F3G675 | 1 | |
| FERRIC OXIDE YELLOW | INACTIVE INGREDIENT | EX438O2MRT | 1 | |
| GLYCERIN | INACTIVE INGREDIENT | PDC6A3C0OX | 1 | |
| HYALURONATE SODIUM | INACTIVE INGREDIENT | YSE9PPT4TH | 1 | |
| ISOSTEARIC ACID | INACTIVE INGREDIENT | X33R8U0062 | 1 | |
| PHENOXYETHANOL | INACTIVE INGREDIENT | HIE492ZZ3T | 1 | |
| SHEA BUTTER | INACTIVE INGREDIENT | K49155WL9Y | 1 | |
| TAMARINDUS INDICA SEED | INACTIVE INGREDIENT | 6AHP8A7OML | 1 | |
| WATER | INACTIVE INGREDIENT | 059QF0KO0R | 1 |
Every source-derived product name is available through these pages.
| Product NDC | Package NDC |
|---|---|
| 40046-0032 | 40046-0032-2, 40046-0032-1 |
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 |
|---|---|---|---|---|---|---|
| ALPHA-TOCOPHEROL, DL- | .ALPHA.-TOCOPHEROL, DL- | 7QWA1RIO01 | POWDER, FOR SUSPENSION / ORAL | NA | ||
| FERRIC OXIDE RED | FERRIC OXIDE RED | 1K09F3G675 | CAPSULE, DELAYED RELEASE / ORAL | 14 mg | ||
| GLYCERIN | GLYCERIN | PDC6A3C0OX | EMULSION / INTRAVENOUS | 2.2 %w/v | ||
| GLYCERIN | GLYCERIN | PDC6A3C0OX | SYRUP / ORAL | 16734 mg | ||
| GLYCERIN | GLYCERIN | PDC6A3C0OX | DROPS / NASAL | 10 mg/1ml | ||
| GLYCERIN | GLYCERIN | PDC6A3C0OX | JELLY / VAGINAL | NA | ||
| GLYCERIN | GLYCERIN | PDC6A3C0OX | SOLUTION / RESPIRATORY (INHALATION) | 5 %w/w | ||
| GLYCERIN | GLYCERIN | PDC6A3C0OX | SUSPENSION, EXTENDED RELEASE / ORAL | 2000 mg | ||
| GLYCERIN | GLYCERIN | PDC6A3C0OX | TABLET, FILM COATED / ORAL | 1.55 mg | ||
| FERRIC OXIDE RED | FERRIC OXIDE RED | 1K09F3G675 | TABLET, DELAYED RELEASE / ORAL | 37 mg | ||
| GLYCERIN | GLYCERIN | PDC6A3C0OX | CAPSULE, LIQUID FILLED / ORAL | 185 mg | ||
| GLYCERIN | GLYCERIN | PDC6A3C0OX | INJECTION, SOLUTION / INTRAVENOUS | 15 %w/v | ||
| FERRIC OXIDE YELLOW | FERRIC OXIDE YELLOW | EX438O2MRT | TABLET, FILM COATED / ORAL | 6 mg | ||
| FERRIC OXIDE RED | FERRIC OXIDE RED | 1K09F3G675 | TABLET, ORALLY DISINTEGRATING, DELAYED RELEASE / ORAL | 0.15 mg | ||
| HYALURONATE SODIUM | HYALURONATE SODIUM | YSE9PPT4TH | GEL / TOPICAL | 463 mg | ||
| FERRIC OXIDE RED | FERRIC OXIDE RED | 1K09F3G675 | TABLET, ORALLY DISINTEGRATING / ORAL | 2 mg | ||
| GLYCERIN | GLYCERIN | PDC6A3C0OX | SPONGE / TOPICAL | 2 %w/w | ||
| GLYCERIN | GLYCERIN | PDC6A3C0OX | SOLUTION, CONCENTRATE / ORAL | 200 mg/1ml | ||
| GLYCERIN | GLYCERIN | PDC6A3C0OX | LIQUID / ORAL | 2400 mg | ||
| FERRIC OXIDE RED | FERRIC OXIDE RED | 1K09F3G675 | POWDER, FOR SUSPENSION / ORAL | 1 mg | ||
| BUTYLENE GLYCOL | BUTYLENE GLYCOL | 3XUS85K0RA | SYSTEM / TOPICAL | 1400 mg | ||
| HYALURONATE SODIUM | HYALURONATE SODIUM | YSE9PPT4TH | INJECTION, SUSPENSION / INTRAVITREAL | 23 mg | ||
| GLYCERIN | GLYCERIN | PDC6A3C0OX | PASTE / ORAL | 3822 mg | ||
| ISOSTEARIC ACID | ISOSTEARIC ACID | X33R8U0062 | OINTMENT / TOPICAL | NA | ||
| FERRIC OXIDE YELLOW | FERRIC OXIDE YELLOW | EX438O2MRT | POWDER, FOR SUSPENSION / ORAL | 3 mg | ||
| GLYCERIN | GLYCERIN | PDC6A3C0OX | CAPSULE / ORAL | 3487 mg | ||
| ALPHA-TOCOPHEROL, DL- | .ALPHA.-TOCOPHEROL, DL- | 7QWA1RIO01 | SYSTEM / TRANSDERMAL | 0.14 mg | ||
| FERRIC OXIDE YELLOW | FERRIC OXIDE YELLOW | EX438O2MRT | TABLET, ORALLY DISINTEGRATING / ORAL | 2 mg | ||
| ALPHA-TOCOPHEROL, DL- | .ALPHA.-TOCOPHEROL, DL- | 7QWA1RIO01 | SOLUTION, CONCENTRATE / INTRAVENOUS | 0.08 %w/v | ||
| FERRIC OXIDE YELLOW | FERRIC OXIDE YELLOW | EX438O2MRT | TABLET, CHEWABLE / ORAL | 14 mg | ||
| GLYCERIN | GLYCERIN | PDC6A3C0OX | INJECTION, SOLUTION / INTRAMUSCULAR | 15 %w/v | ||
| PHENOXYETHANOL | PHENOXYETHANOL | HIE492ZZ3T | GEL / TOPICAL | 14 mg | ||
| PHENOXYETHANOL | PHENOXYETHANOL | HIE492ZZ3T | AEROSOL / TOPICAL | 1.05 %w/w | ||
| GLYCERIN | GLYCERIN | PDC6A3C0OX | INJECTION, SUSPENSION / SUBCUTANEOUS | 1.6 %w/v | ||
| GLYCERIN | GLYCERIN | PDC6A3C0OX | SUSPENSION / AURICULAR (OTIC) | 0.05 %w/w | ||
| GLYCERIN | GLYCERIN | PDC6A3C0OX | JELLY / TOPICAL | NA | ||
| FERRIC OXIDE YELLOW | FERRIC OXIDE YELLOW | EX438O2MRT | CAPSULE / ORAL | 14 mg | ||
| GLYCERIN | GLYCERIN | PDC6A3C0OX | OINTMENT / TOPICAL | NA | ||
| FERRIC OXIDE YELLOW | FERRIC OXIDE YELLOW | EX438O2MRT | TABLET / ORAL | 24 mg | ||
| GLYCERIN | GLYCERIN | PDC6A3C0OX | PASTE, DENTIFRICE / DENTAL | 18 %w/w | ||
| GLYCERIN | GLYCERIN | PDC6A3C0OX | GUM, CHEWING / BUCCAL | 230 mg | ||
| ALPHA-TOCOPHEROL, DL- | .ALPHA.-TOCOPHEROL, DL- | 7QWA1RIO01 | TABLET, CHEWABLE / ORAL | 0.02 mg | ||
| FERRIC OXIDE YELLOW | FERRIC OXIDE YELLOW | EX438O2MRT | CAPSULE, COATED, EXTENDED RELEASE / ORAL | NA | ||
| FERRIC OXIDE RED | FERRIC OXIDE RED | 1K09F3G675 | TABLET / SUBLINGUAL | 1 mg | ||
| GLYCERIN | GLYCERIN | PDC6A3C0OX | SYSTEM / TOPICAL | 18144 mg | ||
| FERRIC OXIDE RED | FERRIC OXIDE RED | 1K09F3G675 | TABLET, FILM COATED, EXTENDED RELEASE / ORAL | 3.6 mg | ||
| ALPHA-TOCOPHEROL, DL- | .ALPHA.-TOCOPHEROL, DL- | 7QWA1RIO01 | TABLET / ORAL | 0.12 mg | ||
| GLYCERIN | GLYCERIN | PDC6A3C0OX | TABLET / PERIODONTAL | 0.53 mg | ||
| GLYCERIN | GLYCERIN | PDC6A3C0OX | INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION / INTRAVENOUS | 225 mg | ||
| PHENOXYETHANOL | PHENOXYETHANOL | HIE492ZZ3T | LOTION / TOPICAL | 1 %w/w | ||
| ISOSTEARIC ACID | ISOSTEARIC ACID | X33R8U0062 | CREAM / TOPICAL | 100 mg | ||
| FERRIC OXIDE RED | FERRIC OXIDE RED | 1K09F3G675 | TABLET / BUCCAL | 0.4 mg | ||
| FERRIC OXIDE YELLOW | FERRIC OXIDE YELLOW | EX438O2MRT | FILM / BUCCAL | 0.27 mg | ||
| GLYCERIN | GLYCERIN | PDC6A3C0OX | CONCENTRATE / ORAL | 1800 mg | ||
| GLYCERIN | GLYCERIN | PDC6A3C0OX | TABLET / ORAL | 42 mg | ||
| ISOSTEARIC ACID | ISOSTEARIC ACID | X33R8U0062 | GEL / TOPICAL | 20 mg | ||
| GLYCERIN | GLYCERIN | PDC6A3C0OX | GEL / TOPICAL | 500 mg | ||
| PHENOXYETHANOL | PHENOXYETHANOL | HIE492ZZ3T | CREAM, AUGMENTED / TOPICAL | 10 mg | ||
| GLYCERIN | GLYCERIN | PDC6A3C0OX | INJECTION / SUBCUTANEOUS | 450 mg | ||
| CYCLOMETHICONE 5 | CYCLOMETHICONE 5 | 0THT5PCI0R | AEROSOL, FOAM / TOPICAL | 144 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 |
|---|---|---|---|---|---|---|
| 5a09d299-9c80-4b6b-bdeb-4ffe9f290c77 | 21045130-f8d5-465d-8628-c6053e95bc55 | 2010-02-28 | Warnings | 5a09d299-9c80-4b6b-bdeb-4ffe9f290c77 21045130-f8d5-465d-8628-c6053e95bc55 |
Adverse event summaries are temporarily unavailable. Other product information remains available.