OTC - ACTIVE INGREDIENT SECTION
active ingredient: titanium dioxide 1.80%
active ingredient: titanium dioxide 1.80%
inactive ingredients: canola oil [] beeswax (cera alba) [] lecithin [] mentha piperita (peppermint) essential oil (olea) [] cocos nucifera (coconut) oil [] vanilla planifolia [] aloe barbadensis (aloe) leaf juice [] lauroyl lysine [] tocopherol (vitamin e) [] aluminum stearate [] stearic acid
warning: stop use if signs of irritation appear and check with doctor.
| NDC | Effective | Action | Document | Indexing SPL | Related label |
|---|---|---|---|---|---|
| 59427-575-01 | 2019-10-29 | C162847 | 48780-1 | 960f7f55-d7f3-8e05-e053-dbdaa90a074a | a500c915-7dc5-4d34-9fa3-a68abf834bb9 |
| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|---|---|---|---|---|---|
| 59427-575-01 | COVER YOUR MOUTHSPF 8 LIP PROTECTOR | 4.5 g in 1 CASE | LIPSTICK | 4.5 | 1 |
| Ingredient | Type | UNII | SPL version | Uploaded |
|---|---|---|---|---|
| TITANIUM DIOXIDE | ACTIVE INGREDIENT | 15FIX9V2JP | 1 | |
| TITANIUM DIOXIDE | ACTIVE MOIETY | 15FIX9V2JP | 1 | |
| ALPHA-TOCOPHEROL | INACTIVE INGREDIENT | H4N855PNZ1 | 1 | |
| ALUMINUM STEARATE | INACTIVE INGREDIENT | U6XF9NP8HM | 1 | |
| CANOLA OIL | INACTIVE INGREDIENT | 331KBJ17RK | 1 | |
| COCONUT OIL | INACTIVE INGREDIENT | Q9L0O73W7L | 1 | |
| LAUROYL LYSINE | INACTIVE INGREDIENT | 113171Q70B | 1 | |
| LECITHIN, SOYBEAN | INACTIVE INGREDIENT | 1DI56QDM62 | 1 | |
| PEPPERMINT OIL | INACTIVE INGREDIENT | AV092KU4JH | 1 | |
| STEARIC ACID | INACTIVE INGREDIENT | 4ELV7Z65AP | 1 | |
| VANILLA | INACTIVE INGREDIENT | Q74T35078H | 1 | |
| WHITE WAX | INACTIVE INGREDIENT | 7G1J5DA97F | 1 |
Every source-derived product name is available through these pages.
| Product NDC | Package NDC |
|---|---|
| 59427-575 | 59427-575-01 |
Every source-derived ingredient row is available through these pages.
| Name | UNII | Kind |
|---|---|---|
| TITANIUM DIOXIDE | 15FIX9V2JP | ACTIB |
| CANOLA OIL | 331KBJ17RK | IACT |
| WHITE WAX | 7G1J5DA97F | IACT |
| LECITHIN, SOYBEAN | 1DI56QDM62 | IACT |
| PEPPERMINT OIL | AV092KU4JH | IACT |
| COCONUT OIL | Q9L0O73W7L | IACT |
| VANILLA | Q74T35078H | IACT |
| LAUROYL LYSINE | 113171Q70B | IACT |
| ALPHA-TOCOPHEROL | H4N855PNZ1 | IACT |
| ALUMINUM STEARATE | U6XF9NP8HM | IACT |
| STEARIC ACID | 4ELV7Z65AP | 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 |
|---|---|---|---|---|---|---|
| WHITE WAX | WHITE WAX | 7G1J5DA97F | TABLET, EXTENDED RELEASE / ORAL | 14 mg | ||
| STEARIC ACID | STEARIC ACID | 4ELV7Z65AP | EMULSION / ORAL | NA | ||
| STEARIC ACID | STEARIC ACID | 4ELV7Z65AP | TABLET, ORALLY DISINTEGRATING / ORAL | 10 mg | ||
| STEARIC ACID | STEARIC ACID | 4ELV7Z65AP | TABLET / SUBLINGUAL | 9 mg | ||
| PEPPERMINT OIL | PEPPERMINT OIL | AV092KU4JH | SOLUTION / ORAL | 53 mg | ||
| PEPPERMINT OIL | PEPPERMINT OIL | AV092KU4JH | SHAMPOO / TOPICAL | 0.2 %w/w | ||
| COCONUT OIL | COCONUT OIL | Q9L0O73W7L | SOLUTION / TOPICAL | 15.5 %w/w | ||
| STEARIC ACID | STEARIC ACID | 4ELV7Z65AP | CAPSULE / ORAL | 90 mg | ||
| PEPPERMINT OIL | PEPPERMINT OIL | AV092KU4JH | SYRUP / ORAL | 120 mg | ||
| PEPPERMINT OIL | PEPPERMINT OIL | AV092KU4JH | GUM, CHEWING / BUCCAL | 526 mg | ||
| WHITE WAX | WHITE WAX | 7G1J5DA97F | CREAM / VAGINAL | 40 mg | ||
| WHITE WAX | WHITE WAX | 7G1J5DA97F | SUPPOSITORY / RECTAL | 265 mg | ||
| ALPHA-TOCOPHEROL | .ALPHA.-TOCOPHEROL | H4N855PNZ1 | OINTMENT / TOPICAL | NA | ||
| STEARIC ACID | STEARIC ACID | 4ELV7Z65AP | TABLET, COATED / ORAL | 42.4 mg | ||
| ALPHA-TOCOPHEROL | .ALPHA.-TOCOPHEROL | H4N855PNZ1 | TABLET, CHEWABLE / ORAL | 0.1 mg | ||
| WHITE WAX | WHITE WAX | 7G1J5DA97F | LOTION / TOPICAL | 1 %w/w | ||
| STEARIC ACID | STEARIC ACID | 4ELV7Z65AP | SOAP / TOPICAL | 6 %w/w | ||
| PEPPERMINT OIL | PEPPERMINT OIL | AV092KU4JH | FILM, SOLUBLE / BUCCAL | 3 mg | ||
| LECITHIN, SOYBEAN | SOYBEAN LECITHIN | 1DI56QDM62 | AEROSOL, METERED / RESPIRATORY (INHALATION) | 0.1 %w/w | ||
| PEPPERMINT OIL | PEPPERMINT OIL | AV092KU4JH | SPRAY, METERED / SUBLINGUAL | 1 mg | ||
| STEARIC ACID | STEARIC ACID | 4ELV7Z65AP | TABLET, FILM COATED, EXTENDED RELEASE / ORAL | 120 mg | ||
| WHITE WAX | WHITE WAX | 7G1J5DA97F | CAPSULE / ORAL | 79 mg | ||
| ALPHA-TOCOPHEROL | .ALPHA.-TOCOPHEROL | H4N855PNZ1 | SOLUTION / ORAL | 1.05 mg/1ml | ||
| STEARIC ACID | STEARIC ACID | 4ELV7Z65AP | AEROSOL, FOAM / TOPICAL | 8 %w/w | ||
| STEARIC ACID | STEARIC ACID | 4ELV7Z65AP | SOLUTION / TOPICAL | NA | ||
| LECITHIN, SOYBEAN | SOYBEAN LECITHIN | 1DI56QDM62 | TABLET / ORAL | 8 mg | ||
| WHITE WAX | WHITE WAX | 7G1J5DA97F | OINTMENT, AUGMENTED / TOPICAL | 429 mg | ||
| STEARIC ACID | STEARIC ACID | 4ELV7Z65AP | CREAM / TOPICAL | 190 mg | ||
| PEPPERMINT OIL | PEPPERMINT OIL | AV092KU4JH | SUSPENSION / ORAL | 100 mg/1ml | ||
| STEARIC ACID | STEARIC ACID | 4ELV7Z65AP | OINTMENT / TOPICAL | 15 %w/w | ||
| ALPHA-TOCOPHEROL | .ALPHA.-TOCOPHEROL | H4N855PNZ1 | TABLET, EXTENDED RELEASE / ORAL | 4 mg | ||
| STEARIC ACID | STEARIC ACID | 4ELV7Z65AP | PELLET / SUBCUTANEOUS | 0.97 mg | ||
| PEPPERMINT OIL | PEPPERMINT OIL | AV092KU4JH | ELIXIR / ORAL | 0.04 mg/1ml | ||
| ALPHA-TOCOPHEROL | .ALPHA.-TOCOPHEROL | H4N855PNZ1 | INJECTION, POWDER, FOR SUSPENSION / INTRAVENOUS | 0.64 mg | ||
| PEPPERMINT OIL | PEPPERMINT OIL | AV092KU4JH | TABLET, ORALLY DISINTEGRATING / ORAL | 3 mg | ||
| LECITHIN, SOYBEAN | SOYBEAN LECITHIN | 1DI56QDM62 | TABLET, EXTENDED RELEASE / ORAL | 20 mg | ||
| STEARIC ACID | STEARIC ACID | 4ELV7Z65AP | TABLET, DELAYED RELEASE / ORAL | 80 mg | ||
| PEPPERMINT OIL | PEPPERMINT OIL | AV092KU4JH | CAPSULE / ORAL | 60 mg | ||
| WHITE WAX | WHITE WAX | 7G1J5DA97F | TABLET, COATED / ORAL | 3 mg | ||
| ALPHA-TOCOPHEROL | .ALPHA.-TOCOPHEROL | H4N855PNZ1 | TABLET / ORAL | 2 mg | ||
| STEARIC ACID | STEARIC ACID | 4ELV7Z65AP | TABLET, EXTENDED RELEASE / ORAL | 200 mg | ||
| WHITE WAX | WHITE WAX | 7G1J5DA97F | TABLET / ORAL | 5 mg | ||
| WHITE WAX | WHITE WAX | 7G1J5DA97F | CAPSULE, EXTENDED RELEASE / ORAL | 71 mg | ||
| PEPPERMINT OIL | PEPPERMINT OIL | AV092KU4JH | PASTE, DENTIFRICE / DENTAL | 49.3 %w/w | ||
| PEPPERMINT OIL | PEPPERMINT OIL | AV092KU4JH | TABLET / SUBLINGUAL | 0.15 mg | ||
| WHITE WAX | WHITE WAX | 7G1J5DA97F | CREAM / TOPICAL | 500 mg | ||
| COCONUT OIL | COCONUT OIL | Q9L0O73W7L | OINTMENT / TOPICAL | 14.75 %w/w | ||
| LECITHIN, SOYBEAN | SOYBEAN LECITHIN | 1DI56QDM62 | CAPSULE / ORAL | 20 mg | ||
| STEARIC ACID | STEARIC ACID | 4ELV7Z65AP | TABLET / BUCCAL | 6 mg | ||
| LECITHIN, SOYBEAN | SOYBEAN LECITHIN | 1DI56QDM62 | TABLET, FILM COATED / ORAL | 0.33 mg | ||
| ALUMINUM STEARATE | ALUMINUM STEARATE | U6XF9NP8HM | CAPSULE, EXTENDED RELEASE / ORAL | 1 mg | ||
| ALUMINUM STEARATE | ALUMINUM STEARATE | U6XF9NP8HM | OINTMENT / TOPICAL | 0.01 %w/w | ||
| ALPHA-TOCOPHEROL | .ALPHA.-TOCOPHEROL | H4N855PNZ1 | SYSTEM / TOPICAL | 0.1 mg | ||
| ALUMINUM STEARATE | ALUMINUM STEARATE | U6XF9NP8HM | CREAM / TOPICAL | 0.01 %w/w | ||
| STEARIC ACID | STEARIC ACID | 4ELV7Z65AP | TABLET / ORAL | 336 mg | ||
| COCONUT OIL | COCONUT OIL | Q9L0O73W7L | AEROSOL, FOAM / TOPICAL | 23.6 %w/w | ||
| WHITE WAX | WHITE WAX | 7G1J5DA97F | TABLET, DELAYED RELEASE / ORAL | 0.08 mg | ||
| STEARIC ACID | STEARIC ACID | 4ELV7Z65AP | LOTION / TOPICAL | 80 mg | ||
| STEARIC ACID | STEARIC ACID | 4ELV7Z65AP | EMULSION / TOPICAL | NA | ||
| PEPPERMINT OIL | PEPPERMINT OIL | AV092KU4JH | CONCENTRATE / ORAL | 0.05 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 |
|---|---|---|---|---|---|---|
| ff21882b-d525-4eeb-a88c-4c8c4d77fde2 | a500c915-7dc5-4d34-9fa3-a68abf834bb9 | 2011-07-27 | Warnings | ff21882b-d525-4eeb-a88c-4c8c4d77fde2 a500c915-7dc5-4d34-9fa3-a68abf834bb9 |
Adverse event summaries are temporarily unavailable. Other product information remains available.