OTC - ACTIVE INGREDIENT SECTION
ACTIVE INGREDIENTS: OCTINOXATE 2.50% [] TITANIUM DIOXIDE 1.00%
ACTIVE INGREDIENTS: OCTINOXATE 2.50% [] TITANIUM DIOXIDE 1.00%
INACTIVE INGREDIENTS: WATER\AQUA\EAU [] CYCLOPENTASILOXANE [] PEG-10 DIMETHICONE [] BUTYLENE GLYCOL [] TRIMETHYLSILOXYSILICATE [] DIMETHICONE [] MAGNESIUM SULFATE [] LAMINARIA SACCHARINA EXTRACT [] ALGAE EXTRACT [] TOCOPHERYL ACETATE [] SODIUM HYALURONATE [] TOCOPHEROL [] LECITHIN [] HYDROGENATED LECITHIN [] XANTHAN GUM [] SORBITAN SESQUIOLEATE [] METHOXY AMODIMETHICONE/SILSESQUIOXANE COPOLYMER [] LAURETH-7 [] DIPROPYLENE GLYCOL [] DIMETHICONE/PEG-10/15 CROSSPOLYMER [] DIMETHICONE/PEG-10 CROSSPOLYMER [] PEG/PPG-18/18 DIMETHICONE [] DISTEARDIMONIUM HECTORITE [] SILICA [] DIMETHICONE CROSSPOLYMER [] TRIETHOXYCAPRYLYLSILANE [] PROPYLENE CARBONATE [] PENTAERYTHRITYL TETRA-DI-T-BUTYL HYDROXYHYDROCINNAMATE [] SORBIC ACID [] CHLOROXYLENOL [] PHENOXYETHANOL [] [+/- 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 FIX FLUID
SPF 15
1 FL OZ LIQ/ 30 ML
MAKEUP ART COSMETICS
TORONTO, ONTARIO, CANADA M5V 1R7
| NDC | Effective | Action | Document | Indexing SPL | Related label |
|---|---|---|---|---|---|
| 40046-0050-1 | 2019-10-29 | C162847 | 48780-1 | 960f7f55-c527-8e05-e053-dbdaa90a074a | 9f5c0b30-ab8a-4217-b2cc-68352d129d66 |
| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|---|---|---|---|---|---|
| 40046-0050-1 | STUDIO FIX FLUIDSPF 15 | 1 in 1 CARTON | LOTION | 1 | 1 | |
| 40046-0050-2 | STUDIO FIX FLUIDSPF 15 | 30 mL in 1 BOTTLE | LOTION | 30 | 1 |
| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|---|---|---|---|
| 40046-0050 | STUDIO FIX FLUID SPF 15 (OCTINOXATE, TITANIUM DIOXIDE) LOTION [MAKEUP ART COSMETICS] | 1 | Legacy NDC, 2 package rows | 20110829_9f5c0b30-ab8a-4217-b2cc-68352d129d66.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 | |
| ALPHA-TOCOPHEROL ACETATE | INACTIVE INGREDIENT | 9E8X80D2L0 | 1 | |
| BUTYLENE GLYCOL | INACTIVE INGREDIENT | 3XUS85K0RA | 1 | |
| CHLOROXYLENOL | INACTIVE INGREDIENT | 0F32U78V2Q | 1 | |
| CHROMIC OXIDE | INACTIVE INGREDIENT | X5Z09SU859 | 1 | |
| CYCLOMETHICONE 5 | INACTIVE INGREDIENT | 0THT5PCI0R | 1 | |
| DIMETHICONE | INACTIVE INGREDIENT | 92RU3N3Y1O | 1 | |
| DIPROPYLENE GLYCOL | INACTIVE INGREDIENT | E107L85C40 | 1 | |
| FERRIC OXIDE RED | INACTIVE INGREDIENT | 1K09F3G675 | 1 | |
| HYALURONATE SODIUM | INACTIVE INGREDIENT | YSE9PPT4TH | 1 | |
| HYDROGENATED SOYBEAN LECITHIN | INACTIVE INGREDIENT | H1109Z9J4N | 1 | |
| LAURETH-7 | INACTIVE INGREDIENT | Z95S6G8201 | 1 | |
| LECITHIN, SOYBEAN | INACTIVE INGREDIENT | 1DI56QDM62 | 1 | |
| MAGNESIUM SULFATE, UNSPECIFIED | INACTIVE INGREDIENT | DE08037SAB | 1 | |
| PENTAERYTHRITOL TETRAKIS(3-(3,5-DI-TERT-BUTYL-4-HYDROXYPHENYL)PROPIONATE) | INACTIVE INGREDIENT | 255PIF62MS | 1 | |
| PHENOXYETHANOL | INACTIVE INGREDIENT | HIE492ZZ3T | 1 | |
| PROPYLENE CARBONATE | INACTIVE INGREDIENT | 8D08K3S51E | 1 | |
| SEAWEED | INACTIVE INGREDIENT | 477TV3P5UX | 1 | |
| SILICON DIOXIDE | INACTIVE INGREDIENT | ETJ7Z6XBU4 | 1 | |
| SORBIC ACID | INACTIVE INGREDIENT | X045WJ989B | 1 | |
| SORBITAN SESQUIOLEATE | INACTIVE INGREDIENT | 0W8RRI5W5A | 1 | |
| TRIETHOXYCAPRYLYLSILANE | INACTIVE INGREDIENT | LDC331P08E | 1 | |
| TRIMETHYLSILANE | INACTIVE INGREDIENT | 9L70DJH2K0 | 1 | |
| WATER | INACTIVE INGREDIENT | 059QF0KO0R | 1 | |
| XANTHAN GUM | INACTIVE INGREDIENT | TTV12P4NEE | 1 |
Every source-derived product name is available through these pages.
| Product NDC | Package NDC |
|---|---|
| 40046-0050 | 40046-0050-2, 40046-0050-1 |
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 |
|---|---|---|---|---|---|---|
| PHENOXYETHANOL | PHENOXYETHANOL | HIE492ZZ3T | LOTION / TOPICAL | 1 %w/w | ||
| SORBITAN SESQUIOLEATE | SORBITAN SESQUIOLEATE | 0W8RRI5W5A | OINTMENT / TOPICAL | 75 mg | ||
| SILICON DIOXIDE | SILICON DIOXIDE | ETJ7Z6XBU4 | CAPSULE, COATED PELLETS / ORAL | 69 mg | ||
| XANTHAN GUM | XANTHAN GUM | TTV12P4NEE | GRANULE, FOR SUSPENSION / ORAL | 450 mg | ||
| SILICON DIOXIDE | SILICON DIOXIDE | ETJ7Z6XBU4 | POWDER / RESPIRATORY (INHALATION) | NA | ||
| PHENOXYETHANOL | PHENOXYETHANOL | HIE492ZZ3T | AEROSOL, FOAM / TOPICAL | 72 mg | ||
| DIPROPYLENE GLYCOL | DIPROPYLENE GLYCOL | E107L85C40 | FILM, EXTENDED RELEASE / TRANSDERMAL | 296 mg | ||
| SORBIC ACID | SORBIC ACID | X045WJ989B | EMULSION / OPHTHALMIC | 1 mg | ||
| XANTHAN GUM | XANTHAN GUM | TTV12P4NEE | SOLUTION / ORAL | 84 mg | ||
| SORBIC ACID | SORBIC ACID | X045WJ989B | TABLET, CHEWABLE / ORAL | NA | ||
| SILICON DIOXIDE | SILICON DIOXIDE | ETJ7Z6XBU4 | SUPPOSITORY / RECTAL | 14 mg | ||
| BUTYLENE GLYCOL | BUTYLENE GLYCOL | 3XUS85K0RA | SYSTEM / TOPICAL | 1400 mg | ||
| SORBIC ACID | SORBIC ACID | X045WJ989B | SOLUTION / OPHTHALMIC | 0.2 %w/v | ||
| SORBIC ACID | SORBIC ACID | X045WJ989B | AEROSOL, FOAM / TOPICAL | 6 mg | ||
| XANTHAN GUM | XANTHAN GUM | TTV12P4NEE | SUSPENSION, EXTENDED RELEASE / ORAL | 186.8 mg | ||
| XANTHAN GUM | XANTHAN GUM | TTV12P4NEE | TABLET / ORAL | 56 mg | ||
| SORBIC ACID | SORBIC ACID | X045WJ989B | CREAM / TOPICAL | 14 mg | ||
| CHLOROXYLENOL | CHLOROXYLENOL | 0F32U78V2Q | SOLUTION / AURICULAR (OTIC) | 0.1 %w/w | ||
| PROPYLENE CARBONATE | PROPYLENE CARBONATE | 8D08K3S51E | OINTMENT / TOPICAL | 3000 mg | ||
| DIPROPYLENE GLYCOL | DIPROPYLENE GLYCOL | E107L85C40 | SYSTEM / TRANSDERMAL | 6 mg | ||
| SILICON DIOXIDE | SILICON DIOXIDE | ETJ7Z6XBU4 | PASTE / DENTAL | 34 %w/w | ||
| SILICON DIOXIDE | SILICON DIOXIDE | ETJ7Z6XBU4 | GRANULE, FOR SUSPENSION / ORAL | 200 mg | ||
| SILICON DIOXIDE | SILICON DIOXIDE | ETJ7Z6XBU4 | TABLET, EXTENDED RELEASE / ORAL | 450 mg | ||
| HYDROGENATED SOYBEAN LECITHIN | HYDROGENATED SOYBEAN LECITHIN | H1109Z9J4N | CREAM / TOPICAL | 1.5 %w/w | ||
| SILICON DIOXIDE | SILICON DIOXIDE | ETJ7Z6XBU4 | TABLET, ORALLY DISINTEGRATING / ORAL | 68 mg | ||
| ALPHA-TOCOPHEROL | .ALPHA.-TOCOPHEROL | H4N855PNZ1 | SYSTEM / TOPICAL | 0.1 mg | ||
| SILICON DIOXIDE | SILICON DIOXIDE | ETJ7Z6XBU4 | GEL / NASAL | 20 mg | ||
| FERRIC OXIDE RED | FERRIC OXIDE RED | 1K09F3G675 | TABLET, EXTENDED RELEASE / ORAL | 7 mg | ||
| SILICON DIOXIDE | SILICON DIOXIDE | ETJ7Z6XBU4 | DROPS / ORAL | NA | ||
| FERRIC OXIDE RED | FERRIC OXIDE RED | 1K09F3G675 | SUSPENSION, EXTENDED RELEASE / ORAL | 2.7 mg | ||
| SILICON DIOXIDE | SILICON DIOXIDE | ETJ7Z6XBU4 | TAMPON / VAGINAL | NA | ||
| LECITHIN, SOYBEAN | SOYBEAN LECITHIN | 1DI56QDM62 | POWDER, FOR SUSPENSION / ORAL | 39 mg | ||
| SORBIC ACID | SORBIC ACID | X045WJ989B | TABLET / SUBLINGUAL | 0.16 mg | ||
| SILICON DIOXIDE | SILICON DIOXIDE | ETJ7Z6XBU4 | SUSPENSION, EXTENDED RELEASE / ORAL | 70 mg | ||
| SILICON DIOXIDE | SILICON DIOXIDE | ETJ7Z6XBU4 | GEL / VAGINAL | 8 %w/w | ||
| SILICON DIOXIDE | SILICON DIOXIDE | ETJ7Z6XBU4 | TABLET / BUCCAL | 3 mg | ||
| FERRIC OXIDE RED | FERRIC OXIDE RED | 1K09F3G675 | CAPSULE / ORAL | 5 mg | ||
| BUTYLENE GLYCOL | BUTYLENE GLYCOL | 3XUS85K0RA | SYSTEM / TRANSDERMAL | 8.12 mg | ||
| CYCLOMETHICONE 5 | CYCLOMETHICONE 5 | 0THT5PCI0R | CREAM, AUGMENTED / TOPICAL | 260 mg | ||
| SILICON DIOXIDE | SILICON DIOXIDE | ETJ7Z6XBU4 | POWDER, FOR SUSPENSION / ORAL | 2553 mg | ||
| LECITHIN, SOYBEAN | SOYBEAN LECITHIN | 1DI56QDM62 | TABLET, EXTENDED RELEASE / ORAL | 20 mg | ||
| PHENOXYETHANOL | PHENOXYETHANOL | HIE492ZZ3T | AEROSOL / TOPICAL | 1.05 %w/w | ||
| ALPHA-TOCOPHEROL ACETATE | .ALPHA.-TOCOPHEROL ACETATE | 9E8X80D2L0 | TABLET / ORAL | 0.5 mg | ||
| SILICON DIOXIDE | SILICON DIOXIDE | ETJ7Z6XBU4 | CAPSULE, DELAYED RELEASE / ORAL | 40 mg | ||
| LECITHIN, SOYBEAN | SOYBEAN LECITHIN | 1DI56QDM62 | CREAM / VAGINAL | 1 %w/w | ||
| SILICON DIOXIDE | SILICON DIOXIDE | ETJ7Z6XBU4 | TABLET, DELAYED RELEASE PARTICLES / ORAL | 170 mg | ||
| SORBIC ACID | SORBIC ACID | X045WJ989B | SOLUTION / ORAL | 80 mg | ||
| SILICON DIOXIDE | SILICON DIOXIDE | ETJ7Z6XBU4 | GRANULE, FOR SOLUTION / ORAL | 1.8 mg/120ml | ||
| XANTHAN GUM | XANTHAN GUM | TTV12P4NEE | FILM, SOLUBLE / ORAL | 1 mg | ||
| SILICON DIOXIDE | SILICON DIOXIDE | ETJ7Z6XBU4 | POWDER, FOR SOLUTION / ORAL | 280 mg | ||
| FERRIC OXIDE RED | FERRIC OXIDE RED | 1K09F3G675 | TABLET, DELAYED RELEASE / ORAL | 37 mg | ||
| SILICON DIOXIDE | SILICON DIOXIDE | ETJ7Z6XBU4 | GEL / TOPICAL | 6 mg | ||
| CHLOROXYLENOL | CHLOROXYLENOL | 0F32U78V2Q | CREAM / TOPICAL | 0.15 %w/w | ||
| XANTHAN GUM | XANTHAN GUM | TTV12P4NEE | AEROSOL, FOAM / TOPICAL | 0.27 %w/w | ||
| XANTHAN GUM | XANTHAN GUM | TTV12P4NEE | SUSPENSION / RECTAL | 452 mg | ||
| SORBIC ACID | SORBIC ACID | X045WJ989B | SOLUTION/ DROPS / OPHTHALMIC | 0.2 %w/v | ||
| SILICON DIOXIDE | SILICON DIOXIDE | ETJ7Z6XBU4 | CREAM / VAGINAL | 51 mg | ||
| FERRIC OXIDE RED | FERRIC OXIDE RED | 1K09F3G675 | CAPSULE, COATED / ORAL | 0.12 mg | ||
| SILICON DIOXIDE | SILICON DIOXIDE | ETJ7Z6XBU4 | TABLET, ORALLY DISINTEGRATING, DELAYED RELEASE / ORAL | 69 mg | ||
| SILICON DIOXIDE | SILICON DIOXIDE | ETJ7Z6XBU4 | GRANULE, DELAYED RELEASE / ORAL | 3.2 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 |
|---|---|---|---|---|---|---|
| 9c8e9fd8-4461-4da6-9b00-5090973c5df9 | 9f5c0b30-ab8a-4217-b2cc-68352d129d66 | 2011-08-26 | Warnings | 9c8e9fd8-4461-4da6-9b00-5090973c5df9 9f5c0b30-ab8a-4217-b2cc-68352d129d66 |
Adverse event summaries are temporarily unavailable. Other product information remains available.