OTC - ACTIVE INGREDIENT SECTION
ACTIVE INGREDIENTS: OCTINOXATE 7.50% [] OCTISALATE 5.00%
ACTIVE INGREDIENTS: OCTINOXATE 7.50% [] OCTISALATE 5.00%
INACTIVE INGREDIENTS: PETROLATUM [] RICINUS COMMUNIS (CASTOR) SEED OIL [] POLYBUTENE [] MICROCRYSTALLINE WAX\CERA MICROCRISTALLINA\CIRE MICROCRISTALLINE [] ETHYLENE/PROPYLENE/STYRENE COPOLYMER [] HYDROGENATED POLYISOBUTENE [] TOCOPHERYL ACETATE [] LECITHIN [] SQUALANE [] PRUNUS AMYGDALUS DULCIS (SWEET ALMOND) OIL [] BUTYROSPERMUM PARKII (SHEA BUTTER) [] PERSEA GRATISSIMA (AVOCADO) OIL UNSAPONIFIABLES [] LAVANDULA ANGUSTIFOLIA (LAVENDER) FLOWER WAX [] ASTROCARYUM MURUMURU SEED BUTTER [] TRITICUM VULGARE (WHEAT) GERM OIL [] POLYDECENE [] CHOLESTEROL [] SILICA [] POLYETHYLENE [] BUTYLENE/ETHYLENE/STYRENE COPOLYMER [] TRIETHOXYCAPRYLYLSILANE [] SACCHARIN [] LINALOOL [] GERANIOL [] FLAVOUR (AROMA) [] BHT [] TETRAHEXYLDECYL ASCORBATE [] TITANIUM DIOXIDE (CI 77891)
WARNING: STOP USE IF IRRITATION OCCURS.
| NDC | Effective | Action | Document | Indexing SPL | Related label |
|---|---|---|---|---|---|
| 40046-0040-1 | 2019-10-29 | C162847 | 48780-1 | 960f7f55-d90a-8e05-e053-dbdaa90a074a | b526a373-7f2f-4696-b6b6-74b6dcde62b7 |
| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|---|---|---|---|---|---|
| 40046-0040-1 | LIP CONDITIONERSPF 15 PLUS LAVENDER | 1 in 1 CARTON | GEL | 1 | 1 | |
| 40046-0040-2 | LIP CONDITIONERSPF 15 PLUS LAVENDER | 15 mL in 1 JAR | GEL | 15 | 1 |
| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|---|---|---|---|
| 40046-0040 | LIP CONDITIONER SPF 15 PLUS LAVENDER (OCTINOXATE, OCTISALATE) GEL [MAKEUP ART COSMETICS] | 1 | Legacy NDC, 2 package rows | 20101201_b526a373-7f2f-4696-b6b6-74b6dcde62b7.zip |
| Ingredient | Type | UNII | SPL version | Uploaded |
|---|---|---|---|---|
| OCTINOXATE | ACTIVE INGREDIENT | 4Y5P7MUD51 | 1 | |
| OCTISALATE | ACTIVE INGREDIENT | 4X49Y0596W | 1 | |
| OCTINOXATE | ACTIVE MOIETY | 4Y5P7MUD51 | 1 | |
| OCTISALATE | ACTIVE MOIETY | 4X49Y0596W | 1 | |
| CASTOR OIL | INACTIVE INGREDIENT | D5340Y2I9G | 1 | |
| MICROCRYSTALLINE WAX | INACTIVE INGREDIENT | XOF597Q3KY | 1 | |
| PETROLATUM | INACTIVE INGREDIENT | 4T6H12BN9U | 1 |
Every source-derived product name is available through these pages.
| Product NDC | Package NDC |
|---|---|
| 40046-0040 | 40046-0040-2, 40046-0040-1 |
Every source-derived ingredient row is available through these pages.
| Name | UNII | Kind |
|---|---|---|
| OCTINOXATE | 4Y5P7MUD51 | ACTIB |
| OCTISALATE | 4X49Y0596W | ACTIB |
| PETROLATUM | 4T6H12BN9U | IACT |
| CASTOR OIL | D5340Y2I9G | IACT |
| MICROCRYSTALLINE WAX | XOF597Q3KY | 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 |
|---|---|---|---|---|---|---|
| CASTOR OIL | CASTOR OIL | D5340Y2I9G | CAPSULE / ORAL | 1.04 mg | ||
| CASTOR OIL | CASTOR OIL | D5340Y2I9G | CAPSULE, EXTENDED RELEASE / ORAL | 47 mg | ||
| CASTOR OIL | CASTOR OIL | D5340Y2I9G | TABLET, FILM COATED / ORAL | 15.29 mg | ||
| PETROLATUM | PETROLATUM | 4T6H12BN9U | SPONGE / TOPICAL | NA | ||
| MICROCRYSTALLINE WAX | MICROCRYSTALLINE WAX | XOF597Q3KY | CAPSULE, EXTENDED RELEASE / ORAL | 6 mg | ||
| CASTOR OIL | CASTOR OIL | D5340Y2I9G | TABLET / SUBLINGUAL | 1.6 mg | ||
| CASTOR OIL | CASTOR OIL | D5340Y2I9G | GRANULE, FOR SUSPENSION / ORAL | 128 mg | ||
| PETROLATUM | PETROLATUM | 4T6H12BN9U | TABLET, EXTENDED RELEASE / ORAL | 0.18 mg | ||
| PETROLATUM | PETROLATUM | 4T6H12BN9U | CREAM, AUGMENTED / TOPICAL | 26 %w/w | ||
| PETROLATUM | PETROLATUM | 4T6H12BN9U | CAPSULE, EXTENDED RELEASE / ORAL | 0.07 mg | ||
| PETROLATUM | PETROLATUM | 4T6H12BN9U | OINTMENT, AUGMENTED / TOPICAL | 81.94 %w/w | ||
| PETROLATUM | PETROLATUM | 4T6H12BN9U | OINTMENT / TOPICAL | 7275 mg | ||
| CASTOR OIL | CASTOR OIL | D5340Y2I9G | TABLET, COATED / ORAL | 0.9 mg | ||
| PETROLATUM | PETROLATUM | 4T6H12BN9U | LIQUID / RESPIRATORY (INHALATION) | NA | ||
| CASTOR OIL | CASTOR OIL | D5340Y2I9G | TABLET, DELAYED RELEASE / ORAL | 0.01 mg | ||
| PETROLATUM | PETROLATUM | 4T6H12BN9U | AEROSOL, FOAM / TOPICAL | 7.9 %w/w | ||
| MICROCRYSTALLINE WAX | MICROCRYSTALLINE WAX | XOF597Q3KY | OINTMENT / TOPICAL | 3575 mg | ||
| PETROLATUM | PETROLATUM | 4T6H12BN9U | TABLET / ORAL | 3.5 mg | ||
| PETROLATUM | PETROLATUM | 4T6H12BN9U | CAPSULE / VAGINAL | NA | ||
| CASTOR OIL | CASTOR OIL | D5340Y2I9G | GEL / NASAL | 429 mg | ||
| PETROLATUM | PETROLATUM | 4T6H12BN9U | SUPPOSITORY / VAGINAL | 27 mg | ||
| CASTOR OIL | CASTOR OIL | D5340Y2I9G | OINTMENT / TOPICAL | 14.9 %w/w | ||
| PETROLATUM | PETROLATUM | 4T6H12BN9U | LOTION / TOPICAL | 25 %w/w | ||
| CASTOR OIL | CASTOR OIL | D5340Y2I9G | SPRAY / NASAL | NA | ||
| CASTOR OIL | CASTOR OIL | D5340Y2I9G | EMULSION / OPHTHALMIC | 32 mg | ||
| CASTOR OIL | CASTOR OIL | D5340Y2I9G | TABLET / ORAL | 17 mg | ||
| PETROLATUM | PETROLATUM | 4T6H12BN9U | CREAM / TOPICAL | 4213 mg | ||
| PETROLATUM | PETROLATUM | 4T6H12BN9U | OINTMENT / VAGINAL | 4084 mg | ||
| MICROCRYSTALLINE WAX | MICROCRYSTALLINE WAX | XOF597Q3KY | CREAM / VAGINAL | 23 mg | ||
| CASTOR OIL | CASTOR OIL | D5340Y2I9G | SOLUTION / TOPICAL | 1.38 %w/w | ||
| CASTOR OIL | CASTOR OIL | D5340Y2I9G | INJECTION / INTRAMUSCULAR | 885 mg | ||
| PETROLATUM | PETROLATUM | 4T6H12BN9U | OINTMENT / OPHTHALMIC | 88.4 %w/w | ||
| CASTOR OIL | CASTOR OIL | D5340Y2I9G | INJECTION, SOLUTION / INTRAMUSCULAR | 525 mg | ||
| PETROLATUM | PETROLATUM | 4T6H12BN9U | EMULSION / TOPICAL | 7.8 %w/w | ||
| CASTOR OIL | CASTOR OIL | D5340Y2I9G | TABLET, EXTENDED RELEASE / ORAL | 23.27 mg | ||
| PETROLATUM | PETROLATUM | 4T6H12BN9U | OINTMENT / AURICULAR (OTIC) | NA | ||
| MICROCRYSTALLINE WAX | MICROCRYSTALLINE WAX | XOF597Q3KY | GEL / TOPICAL | NA | ||
| PETROLATUM | PETROLATUM | 4T6H12BN9U | SOAP / TOPICAL | 0.85 %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 |
|---|---|---|---|---|---|---|
| 03403b18-7531-4a12-861c-95e588209f38 | b526a373-7f2f-4696-b6b6-74b6dcde62b7 | 2010-11-30 | Warnings | 03403b18-7531-4a12-861c-95e588209f38 b526a373-7f2f-4696-b6b6-74b6dcde62b7 |
Adverse event summaries are temporarily unavailable. Other product information remains available.