OTC - ACTIVE INGREDIENT SECTION
ACTIVE INGREDIENT: OCTINOXATE, 3.5%
ACTIVE INGREDIENT: OCTINOXATE, 3.5%
INACTIVE INGREDIENTS: WATER [] CYCLOPENTASILOXANE [] BUTYLENE GLYCOL [] STEARETH-21 [] GLYCERYL STEARATE [] DIMETHICONE [] ISOSTEARIC ACID [] TROMETHAMINE [] TOCOPHERYL ACETATE [] LECITHIN [] CHOLESTEROL [] ASCORBYL PALMITATE [] SODIUM HYALURONATE [] CAFFEINE [] ALOE BARBADENSIS LEAF WATER [] HYDROGENATED LECITHIN [] SUCROSE [] SORBITOL [] SILICA [] TREHALOSE [] MAGNESIUM ALUMINUM SILICATE [] CARBOMER [] STEARETH-2 [] CELLULOSE GUM [] PVP [] PALMITOYL OLIGOPEPTIDE [] GLYCERYL POLYMETHACRYLATE [] METHYLDIHYDROJASMONATE [] XANTHAN GUM [] CAPRYLYL GLYCOL [] STEARIC ACID [] SODIUM CITRATE [] PEG-8 [] GLYCERIN [] DISODIUM EDTA [] HEXYLENE GLYCOL [] BHT [] PHENOXYETHANOL [] CHLORPHENESIN [] CHLOROXYLENOL [] [+/- MICA [] TITANIUM DIOXIDE (CI 77891) [] IRON OXIDES (CI 77491, CI 77492, CI 77499)
DIRECTIONS: AFTER CLEANSING, APPLY TO CLEAN SKIN WITH FINGERTIPS, SPONGE OR BRUSH
WARNING: KEEP OUT OF EYES. STOP USE IF IRRITATION OCCURS. KEEP OUT OF REACH OF CHILDREN.
| NDC | Effective | Action | Document | Indexing SPL | Related label |
|---|---|---|---|---|---|
| 40046-0033-1 | 2019-10-29 | C162847 | 48780-1 | 960f7f55-cdaf-8e05-e053-dbdaa90a074a | 607ff715-c197-4384-a81e-c4c64ead2975 |
| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|---|---|---|---|---|---|
| 40046-0033-1 | STUDIO MOISTURE TINTSPF 15 | 1 in 1 CARTON | GEL | 1 | 1 | |
| 40046-0033-2 | STUDIO MOISTURE TINTSPF 15 | 40 mL in 1 TUBE | GEL | 40 | 1 |
| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|---|---|---|---|
| 40046-0033 | STUDIO MOISTURE TINT SPF 15 (OCTINOXATE) GEL [MAKE UP ART COSMETICS] | 1 | Legacy NDC, 2 package rows | 20110621_607ff715-c197-4384-a81e-c4c64ead2975.zip |
| Ingredient | Type | UNII | SPL version | Uploaded |
|---|---|---|---|---|
| OCTINOXATE | ACTIVE INGREDIENT | 4Y5P7MUD51 | 1 | |
| OCTINOXATE | ACTIVE MOIETY | 4Y5P7MUD51 | 1 | |
| .ALPHA.-TOCOPHEROL ACETATE, D- | INACTIVE INGREDIENT | A7E6112E4N | 1 | |
| ALOE VERA LEAF | INACTIVE INGREDIENT | ZY81Z83H0X | 1 | |
| ASCORBYL PALMITATE | INACTIVE INGREDIENT | QN83US2B0N | 1 | |
| BUTYLATED HYDROXYTOLUENE | INACTIVE INGREDIENT | 1P9D0Z171K | 1 | |
| BUTYLENE GLYCOL | INACTIVE INGREDIENT | 3XUS85K0RA | 1 | |
| CAFFEINE | INACTIVE INGREDIENT | 3G6A5W338E | 1 | |
| CAPRYLYL GLYCOL | INACTIVE INGREDIENT | 00YIU5438U | 1 | |
| CARBOMER HOMOPOLYMER TYPE C | INACTIVE INGREDIENT | 4Q93RCW27E | 1 | |
| CARBOXYMETHYLCELLULOSE SODIUM | INACTIVE INGREDIENT | K679OBS311 | 1 | |
| CHLOROXYLENOL | INACTIVE INGREDIENT | 0F32U78V2Q | 1 | |
| CHLORPHENESIN | INACTIVE INGREDIENT | I670DAL4SZ | 1 | |
| CHOLESTEROL | INACTIVE INGREDIENT | 97C5T2UQ7J | 1 | |
| CYCLOMETHICONE 5 | INACTIVE INGREDIENT | 0THT5PCI0R | 1 | |
| DIMETHICONE | INACTIVE INGREDIENT | 92RU3N3Y1O | 1 | |
| EDETATE DISODIUM | INACTIVE INGREDIENT | 7FLD91C86K | 1 | |
| FERRIC OXIDE RED | INACTIVE INGREDIENT | 1K09F3G675 | 1 | |
| FERRIC OXIDE YELLOW | INACTIVE INGREDIENT | EX438O2MRT | 1 | |
| FERROSOFERRIC OXIDE | INACTIVE INGREDIENT | XM0M87F357 | 1 | |
| GLYCERIN | INACTIVE INGREDIENT | PDC6A3C0OX | 1 | |
| GLYCERYL MONOSTEARATE | INACTIVE INGREDIENT | 230OU9XXE4 | 1 | |
| HEXYLENE GLYCOL | INACTIVE INGREDIENT | KEH0A3F75J | 1 | |
| HYALURONATE SODIUM | INACTIVE INGREDIENT | YSE9PPT4TH | 1 | |
| HYDROGENATED SOYBEAN LECITHIN | INACTIVE INGREDIENT | H1109Z9J4N | 1 | |
| ISOSTEARIC ACID | INACTIVE INGREDIENT | X33R8U0062 | 1 | |
| LECITHIN, SOYBEAN | INACTIVE INGREDIENT | 1DI56QDM62 | 1 | |
| MAGNESIUM ALUMINUM SILICATE | INACTIVE INGREDIENT | 6M3P64V0NC | 1 | |
| MICA | INACTIVE INGREDIENT | V8A1AW0880 | 1 | |
| PALMITOYL OLIGOPEPTIDE | INACTIVE INGREDIENT | HO4ZT5S86C | 1 | |
| PHENOXYETHANOL | INACTIVE INGREDIENT | HIE492ZZ3T | 1 | |
| SILICON DIOXIDE | INACTIVE INGREDIENT | ETJ7Z6XBU4 | 1 | |
| SODIUM CITRATE | INACTIVE INGREDIENT | 1Q73Q2JULR | 1 | |
| SORBITOL | INACTIVE INGREDIENT | 506T60A25R | 1 | |
| STEARETH-2 | INACTIVE INGREDIENT | V56DFE46J5 | 1 | |
| STEARETH-21 | INACTIVE INGREDIENT | 53J3F32P58 | 1 | |
| STEARIC ACID | INACTIVE INGREDIENT | 4ELV7Z65AP | 1 | |
| SUCROSE | INACTIVE INGREDIENT | C151H8M554 | 1 | |
| TITANIUM DIOXIDE | INACTIVE INGREDIENT | 15FIX9V2JP | 1 | |
| TREHALOSE | INACTIVE INGREDIENT | B8WCK70T7I | 1 | |
| TROMETHAMINE | INACTIVE INGREDIENT | 023C2WHX2V | 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 |
|---|---|
| 40046-0033 | 40046-0033-2, 40046-0033-1 |
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 |
|---|---|---|---|---|---|---|
| SILICON DIOXIDE | SILICON DIOXIDE | ETJ7Z6XBU4 | CAPSULE / RESPIRATORY (INHALATION) | NA | ||
| STEARIC ACID | STEARIC ACID | 4ELV7Z65AP | TABLET, FILM COATED, EXTENDED RELEASE / ORAL | 120 mg | ||
| TITANIUM DIOXIDE | TITANIUM DIOXIDE | 15FIX9V2JP | POWDER / RESPIRATORY (INHALATION) | 2 mg | ||
| CARBOXYMETHYLCELLULOSE SODIUM | CARBOXYMETHYLCELLULOSE SODIUM | K679OBS311 | GRANULE / ORAL | NA | ||
| STEARETH-2 | STEARETH-2 | V56DFE46J5 | AEROSOL, FOAM / TOPICAL | 1.09 %w/w | ||
| SORBITOL | SORBITOL | 506T60A25R | SYRUP / ORAL | 4370 mg/5ml | ||
| BUTYLATED HYDROXYTOLUENE | BUTYLATED HYDROXYTOLUENE | 1P9D0Z171K | FILM, SOLUBLE / ORAL | 0.06 mg | ||
| SORBITOL | SORBITOL | 506T60A25R | CONCENTRATE / ORAL | 600 mg/1ml | ||
| CARBOXYMETHYLCELLULOSE SODIUM | CARBOXYMETHYLCELLULOSE SODIUM | K679OBS311 | TABLET, CHEWABLE / ORAL | 24.75 mg | ||
| CARBOXYMETHYLCELLULOSE SODIUM | CARBOXYMETHYLCELLULOSE SODIUM | K679OBS311 | SUSPENSION / ENTERAL | 2920 mg | ||
| TITANIUM DIOXIDE | TITANIUM DIOXIDE | 15FIX9V2JP | TABLET, COATED / ORAL | 49 mg | ||
| MAGNESIUM ALUMINUM SILICATE | MAGNESIUM ALUMINUM SILICATE | 6M3P64V0NC | LOTION / TOPICAL | 1.5 %w/w | ||
| GLYCERIN | GLYCERIN | PDC6A3C0OX | SUPPOSITORY / VAGINAL | 227.9 mg | ||
| TITANIUM DIOXIDE | TITANIUM DIOXIDE | 15FIX9V2JP | POWDER / ORAL | 2 mg | ||
| SUCROSE | SUCROSE | C151H8M554 | INJECTABLE, LIPOSOMAL / INTRAVENOUS | 7560 mg | ||
| SUCROSE | SUCROSE | C151H8M554 | TABLET, CHEWABLE / ORAL | 7258 mg | ||
| EDETATE DISODIUM | EDETATE DISODIUM | 7FLD91C86K | SUSPENSION / ORAL | 30 mg | ||
| CARBOXYMETHYLCELLULOSE SODIUM | CARBOXYMETHYLCELLULOSE SODIUM | K679OBS311 | LOTION / TOPICAL | NA | ||
| TITANIUM DIOXIDE | TITANIUM DIOXIDE | 15FIX9V2JP | PASTE / DENTAL | 0.5 %w/w | ||
| GLYCERIN | GLYCERIN | PDC6A3C0OX | DROPS / NASAL | 10 mg/1ml | ||
| EDETATE DISODIUM | EDETATE DISODIUM | 7FLD91C86K | SOLUTION / ORAL | 432 mg | ||
| CARBOMER HOMOPOLYMER TYPE C | CARBOMER HOMOPOLYMER TYPE C (ALLYL PENTAERYTHRITOL CROSSLINKED) | 4Q93RCW27E | GEL / OPHTHALMIC | 4 %w/w | ||
| SUCROSE | SUCROSE | C151H8M554 | ELIXIR / ORAL | 18000 mg | ||
| GLYCERIN | GLYCERIN | PDC6A3C0OX | SOLUTION/ DROPS / AURICULAR (OTIC) | 25 mg | ||
| CARBOXYMETHYLCELLULOSE SODIUM | CARBOXYMETHYLCELLULOSE SODIUM | K679OBS311 | INJECTION, POWDER, FOR SUSPENSION / INTRA-ARTICULAR | 25 mg | ||
| MAGNESIUM ALUMINUM SILICATE | MAGNESIUM ALUMINUM SILICATE | 6M3P64V0NC | LIQUID / ORAL | 82 mg/5ml | ||
| SILICON DIOXIDE | SILICON DIOXIDE | ETJ7Z6XBU4 | TABLET / BUCCAL | 3 mg | ||
| XANTHAN GUM | XANTHAN GUM | TTV12P4NEE | SUSPENSION, EXTENDED RELEASE / ORAL | 186.8 mg | ||
| GLYCERYL MONOSTEARATE | GLYCERYL MONOSTEARATE | 230OU9XXE4 | CREAM / VAGINAL | 140 mg | ||
| STEARIC ACID | STEARIC ACID | 4ELV7Z65AP | AEROSOL, FOAM / VAGINAL | 4 %w/w | ||
| EDETATE DISODIUM | EDETATE DISODIUM | 7FLD91C86K | INJECTION / INFILTRATION | 6 mg | ||
| STEARIC ACID | STEARIC ACID | 4ELV7Z65AP | AEROSOL, FOAM / TOPICAL | 8 %w/w | ||
| MAGNESIUM ALUMINUM SILICATE | MAGNESIUM ALUMINUM SILICATE | 6M3P64V0NC | TABLET, EXTENDED RELEASE / ORAL | 70 mg | ||
| EDETATE DISODIUM | EDETATE DISODIUM | 7FLD91C86K | INJECTION / INTRACARDIAC | 2 mg | ||
| FERRIC OXIDE RED | FERRIC OXIDE RED | 1K09F3G675 | CREAM / TOPICAL | NA | ||
| BUTYLATED HYDROXYTOLUENE | BUTYLATED HYDROXYTOLUENE | 1P9D0Z171K | INJECTION, SOLUTION / INTRAVENOUS | NA | ||
| SILICON DIOXIDE | SILICON DIOXIDE | ETJ7Z6XBU4 | LOZENGE / ORAL | 120 mg | ||
| EDETATE DISODIUM | EDETATE DISODIUM | 7FLD91C86K | INJECTION / INTRALESIONAL | 0.05 %w/v | ||
| EDETATE DISODIUM | EDETATE DISODIUM | 7FLD91C86K | SUSPENSION/ DROPS / OPHTHALMIC | 1 mg | ||
| EDETATE DISODIUM | EDETATE DISODIUM | 7FLD91C86K | TABLET, EFFERVESCENT / ORAL | 32 mg | ||
| SUCROSE | SUCROSE | C151H8M554 | WAFER / ORAL | 155.2 mg | ||
| EDETATE DISODIUM | EDETATE DISODIUM | 7FLD91C86K | INJECTION, POWDER, FOR SUSPENSION / INTRAVENOUS | 0.4 mg | ||
| MAGNESIUM ALUMINUM SILICATE | MAGNESIUM ALUMINUM SILICATE | 6M3P64V0NC | CAPSULE / ORAL | 60 mg | ||
| STEARIC ACID | STEARIC ACID | 4ELV7Z65AP | CREAM / VAGINAL | 1088 mg | ||
| FERROSOFERRIC OXIDE | FERROSOFERRIC OXIDE | XM0M87F357 | CAPSULE, EXTENDED RELEASE / ORAL | 1.49 mg | ||
| EDETATE DISODIUM | EDETATE DISODIUM | 7FLD91C86K | CONCENTRATE / ORAL | 20 mg | ||
| SILICON DIOXIDE | SILICON DIOXIDE | ETJ7Z6XBU4 | TABLET, EXTENDED RELEASE / ORAL | 450 mg | ||
| PHENOXYETHANOL | PHENOXYETHANOL | HIE492ZZ3T | AEROSOL / TOPICAL | 1.05 %w/w | ||
| SUCROSE | SUCROSE | C151H8M554 | SUSPENSION, EXTENDED RELEASE / ORAL | 5400 mg | ||
| TROMETHAMINE | TROMETHAMINE | 023C2WHX2V | SOLUTION, GEL FORMING / DROPS / OPHTHALMIC | 1 mg | ||
| GLYCERYL MONOSTEARATE | GLYCERYL MONOSTEARATE | 230OU9XXE4 | TABLET / ORAL | 33.34 mg | ||
| SILICON DIOXIDE | SILICON DIOXIDE | ETJ7Z6XBU4 | DROPS / ORAL | NA | ||
| SUCROSE | SUCROSE | C151H8M554 | TROCHE / BUCCAL | NA | ||
| SUCROSE | SUCROSE | C151H8M554 | TABLET / SUBLINGUAL | 109 mg | ||
| GLYCERYL MONOSTEARATE | GLYCERYL MONOSTEARATE | 230OU9XXE4 | LOTION / TOPICAL | 177 mg | ||
| EDETATE DISODIUM | EDETATE DISODIUM | 7FLD91C86K | SUSPENSION/ DROPS / ORAL | 4 mg | ||
| SORBITOL | SORBITOL | 506T60A25R | EMULSION / TOPICAL | 7 %w/w | ||
| TITANIUM DIOXIDE | TITANIUM DIOXIDE | 15FIX9V2JP | CAPSULE, COATED, EXTENDED RELEASE / ORAL | NA | ||
| SILICON DIOXIDE | SILICON DIOXIDE | ETJ7Z6XBU4 | SUPPOSITORY / RECTAL | 14 mg | ||
| TROMETHAMINE | TROMETHAMINE | 023C2WHX2V | SOLUTION, GEL FORMING, EXTENDED RELEASE / OPHTHALMIC | 0.8 %w/w |
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 |
|---|---|---|---|---|---|---|
| b1fa5950-814e-4a88-9c8d-501afad0426e | 607ff715-c197-4384-a81e-c4c64ead2975 | 2011-06-20 | Warnings | b1fa5950-814e-4a88-9c8d-501afad0426e 607ff715-c197-4384-a81e-c4c64ead2975 |
Adverse event summaries are temporarily unavailable. Other product information remains available.