WARNINGS SECTION
WARNINGS: For External Use only. Avoid Eyes. Keep out of reach of children. Discontinue use if signs of irritation appear. Do not use on infants less than six months of age.
WARNINGS: For External Use only. Avoid Eyes. Keep out of reach of children. Discontinue use if signs of irritation appear. Do not use on infants less than six months of age.
ACTIVE INGREDIENTS: Zinc Oxide 25.0%
Package Label
| Product concept | Relation | Version | Effective |
|---|---|---|---|
| baf7f49c-75b6-496b-a00e-8e766a8e4f03 | Product name | 1 | 20210127 |
| ebc62596-fc97-4d03-9483-7ba095d25db7 | Product name | 1 | 20151210 |
| 0ca1d589-929b-4b33-bc5b-1d84abdafa6a | Product name | 1 | 20150324 |
| fc363c46-397b-4476-ac0f-70e43e8e4592 | Product name | 1 | 20150324 |
| NDC | Effective | Action | Document | Indexing SPL | Related label |
|---|---|---|---|---|---|
| 61481-0037-3 | 2019-10-29 | C162847 | 48780-1 | 960f7f55-bf90-8e05-e053-dbdaa90a074a | 9b41d15a-b0c3-4e97-9c43-6a445b88fe94 |
| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|---|---|---|---|---|---|
| 61481-0037-3 | KINeSYS EarthKind SPF 30 Sunscreen | 90 g in 1 JAR | OINTMENT | 90 | 8 |
| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|---|---|---|---|
| 61481-0037 | KINESYS EARTHKIND SPF 30 SUNSCREEN (ZINC OXIDE) OINTMENT [KINESYS PHARMACEUTICAL INC.] | 8 | Legacy NDC, 1 package rows | 20110228_9b41d15a-b0c3-4e97-9c43-6a445b88fe94.zip |
| Ingredient | Type | UNII | SPL version | Uploaded |
|---|---|---|---|---|
| ZINC OXIDE | ACTIVE INGREDIENT | SOI2LOH54Z | 8 | |
| ZINC OXIDE | ACTIVE MOIETY | SOI2LOH54Z | 8 | |
| ALOE VERA LEAF | INACTIVE INGREDIENT | ZY81Z83H0X | 8 | |
| ALPHA-TOCOPHEROL | INACTIVE INGREDIENT | H4N855PNZ1 | 8 | |
| COCONUT OIL | INACTIVE INGREDIENT | Q9L0O73W7L | 8 | |
| GLYCERYL ISOSTEARATE | INACTIVE INGREDIENT | HYE7O27HAO | 8 | |
| LEVOMENOL | INACTIVE INGREDIENT | 24WE03BX2T | 8 | |
| PEPPERMINT OIL | INACTIVE INGREDIENT | AV092KU4JH | 8 | |
| POLYHYDROXYSTEARIC ACID (2300 MW) | INACTIVE INGREDIENT | YXH47AOU0F | 8 | |
| ROSEMARY OIL | INACTIVE INGREDIENT | 8LGU7VM393 | 8 | |
| SOYBEAN OIL | INACTIVE INGREDIENT | 241ATL177A | 8 | |
| SUNFLOWER OIL | INACTIVE INGREDIENT | 3W1JG795YI | 8 | |
| TRICAPRIN | INACTIVE INGREDIENT | O1PB8EU98M | 8 | |
| YELLOW WAX | INACTIVE INGREDIENT | 2ZA36H0S2V | 8 |
Every source-derived product name is available through these pages.
| Product NDC | Package NDC |
|---|---|
| 61481-0037 | 61481-0037-3 |
Every source-derived ingredient row is available through these pages.
| Name | UNII | Kind |
|---|---|---|
| ZINC OXIDE | SOI2LOH54Z | ACTIB |
| COCONUT OIL | Q9L0O73W7L | IACT |
| SUNFLOWER OIL | 3W1JG795YI | IACT |
| YELLOW WAX | 2ZA36H0S2V | IACT |
| TRICAPRIN | O1PB8EU98M | IACT |
| SOYBEAN OIL | 241ATL177A | IACT |
| ALPHA-TOCOPHEROL | H4N855PNZ1 | IACT |
| POLYHYDROXYSTEARIC ACID (2300 MW) | YXH47AOU0F | IACT |
| GLYCERYL ISOSTEARATE | HYE7O27HAO | IACT |
| ALOE VERA LEAF | ZY81Z83H0X | IACT |
| PEPPERMINT OIL | AV092KU4JH | IACT |
| ROSEMARY OIL | 8LGU7VM393 | IACT |
| LEVOMENOL | 24WE03BX2T | 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 |
|---|---|---|---|---|---|---|
| PEPPERMINT OIL | PEPPERMINT OIL | AV092KU4JH | SOLUTION / DENTAL | 0.04 %v/v | ||
| PEPPERMINT OIL | PEPPERMINT OIL | AV092KU4JH | SPRAY, METERED / SUBLINGUAL | 1 mg | ||
| SOYBEAN OIL | SOYBEAN OIL | 241ATL177A | SOLUTION / TOPICAL | 5.82 %w/w | ||
| SOYBEAN OIL | SOYBEAN OIL | 241ATL177A | INJECTION, SOLUTION, CONCENTRATE / INTRAVENOUS | 223 mg | ||
| PEPPERMINT OIL | PEPPERMINT OIL | AV092KU4JH | TABLET / SUBLINGUAL | 0.15 mg | ||
| PEPPERMINT OIL | PEPPERMINT OIL | AV092KU4JH | GUM, CHEWING / ORAL | 526 mg | ||
| PEPPERMINT OIL | PEPPERMINT OIL | AV092KU4JH | TABLET, ORALLY DISINTEGRATING / ORAL | 3 mg | ||
| ALPHA-TOCOPHEROL | .ALPHA.-TOCOPHEROL | H4N855PNZ1 | SYSTEM / TOPICAL | 0.1 mg | ||
| COCONUT OIL | COCONUT OIL | Q9L0O73W7L | SOLUTION / TOPICAL | 15.5 %w/w | ||
| ALPHA-TOCOPHEROL | .ALPHA.-TOCOPHEROL | H4N855PNZ1 | TABLET, EXTENDED RELEASE / ORAL | 4 mg | ||
| PEPPERMINT OIL | PEPPERMINT OIL | AV092KU4JH | SHAMPOO / TOPICAL | 0.2 %w/w | ||
| COCONUT OIL | COCONUT OIL | Q9L0O73W7L | SOAP / TOPICAL | 4.6 %w/w | ||
| SOYBEAN OIL | SOYBEAN OIL | 241ATL177A | INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION / INTRAVENOUS | 10 %w/v | ||
| PEPPERMINT OIL | PEPPERMINT OIL | AV092KU4JH | FILM / BUCCAL | 12 mg | ||
| PEPPERMINT OIL | PEPPERMINT OIL | AV092KU4JH | SUSPENSION / ORAL | 100 mg/1ml | ||
| ALPHA-TOCOPHEROL | .ALPHA.-TOCOPHEROL | H4N855PNZ1 | TABLET, FILM COATED / ORAL | 246 mg | ||
| ALPHA-TOCOPHEROL | .ALPHA.-TOCOPHEROL | H4N855PNZ1 | OINTMENT / TOPICAL | NA | ||
| PEPPERMINT OIL | PEPPERMINT OIL | AV092KU4JH | PASTE, DENTIFRICE / DENTAL | 49.3 %w/w | ||
| PEPPERMINT OIL | PEPPERMINT OIL | AV092KU4JH | ELIXIR / ORAL | 0.04 mg/1ml | ||
| COCONUT OIL | COCONUT OIL | Q9L0O73W7L | OINTMENT / TOPICAL | 14.75 %w/w | ||
| SOYBEAN OIL | SOYBEAN OIL | 241ATL177A | INJECTION, EMULSION / INTRAVENOUS | 107100 mg | ||
| YELLOW WAX | YELLOW WAX | 2ZA36H0S2V | OINTMENT / TOPICAL | 20 %w/w | ||
| PEPPERMINT OIL | PEPPERMINT OIL | AV092KU4JH | FILM, SOLUBLE / BUCCAL | 3 mg | ||
| PEPPERMINT OIL | PEPPERMINT OIL | AV092KU4JH | POWDER, DENTIFRICE / DENTAL | NA | ||
| YELLOW WAX | YELLOW WAX | 2ZA36H0S2V | CREAM / TOPICAL | 5 %w/w | ||
| YELLOW WAX | YELLOW WAX | 2ZA36H0S2V | CAPSULE, EXTENDED RELEASE / ORAL | 80.67 mg | ||
| ALPHA-TOCOPHEROL | .ALPHA.-TOCOPHEROL | H4N855PNZ1 | TABLET / ORAL | 2 mg | ||
| YELLOW WAX | YELLOW WAX | 2ZA36H0S2V | TABLET, EXTENDED RELEASE / ORAL | 0.01 mg | ||
| YELLOW WAX | YELLOW WAX | 2ZA36H0S2V | TABLET, COATED / ORAL | 213.7 mg | ||
| PEPPERMINT OIL | PEPPERMINT OIL | AV092KU4JH | CONCENTRATE / ORAL | 0.05 mg | ||
| PEPPERMINT OIL | PEPPERMINT OIL | AV092KU4JH | CAPSULE / ORAL | 60 mg | ||
| YELLOW WAX | YELLOW WAX | 2ZA36H0S2V | CAPSULE / ORAL | 44 mg | ||
| PEPPERMINT OIL | PEPPERMINT OIL | AV092KU4JH | LOZENGE / ORAL | 12 mg | ||
| PEPPERMINT OIL | PEPPERMINT OIL | AV092KU4JH | SOLUTION / ORAL | 53 mg | ||
| GLYCERYL ISOSTEARATE | GLYCERYL ISOSTEARATE | HYE7O27HAO | CREAM / VAGINAL | 135 mg | ||
| ALPHA-TOCOPHEROL | .ALPHA.-TOCOPHEROL | H4N855PNZ1 | FILM, SOLUBLE / BUCCAL | 0.07 mg | ||
| SOYBEAN OIL | SOYBEAN OIL | 241ATL177A | INJECTION / INTRAVENOUS | 10 %w/v | ||
| ALPHA-TOCOPHEROL | .ALPHA.-TOCOPHEROL | H4N855PNZ1 | SOLUTION / ORAL | 1.05 mg/1ml | ||
| COCONUT OIL | COCONUT OIL | Q9L0O73W7L | CAPSULE, LIQUID FILLED / ORAL | NA | ||
| PEPPERMINT OIL | PEPPERMINT OIL | AV092KU4JH | SYRUP / ORAL | 120 mg | ||
| COCONUT OIL | COCONUT OIL | Q9L0O73W7L | TABLET / ORAL | NA | ||
| ALPHA-TOCOPHEROL | .ALPHA.-TOCOPHEROL | H4N855PNZ1 | INJECTION, POWDER, FOR SUSPENSION / INTRAVENOUS | 0.64 mg | ||
| YELLOW WAX | YELLOW WAX | 2ZA36H0S2V | TABLET, SUGAR COATED / ORAL | NA | ||
| SOYBEAN OIL | SOYBEAN OIL | 241ATL177A | CAPSULE / ORAL | 1318 mg | ||
| SOYBEAN OIL | SOYBEAN OIL | 241ATL177A | AEROSOL, FOAM / TOPICAL | 50 %w/w | ||
| YELLOW WAX | YELLOW WAX | 2ZA36H0S2V | TABLET / ORAL | 3.22 mg | ||
| YELLOW WAX | YELLOW WAX | 2ZA36H0S2V | TABLET, DELAYED RELEASE / ORAL | 0.1 mg | ||
| PEPPERMINT OIL | PEPPERMINT OIL | AV092KU4JH | GUM, CHEWING / BUCCAL | 526 mg | ||
| COCONUT OIL | COCONUT OIL | Q9L0O73W7L | AEROSOL, FOAM / TOPICAL | 23.6 %w/w | ||
| PEPPERMINT OIL | PEPPERMINT OIL | AV092KU4JH | POWDER / SUBLINGUAL | 1 mg | ||
| GLYCERYL ISOSTEARATE | GLYCERYL ISOSTEARATE | HYE7O27HAO | CREAM / TOPICAL | 2 %w/w | ||
| PEPPERMINT OIL | PEPPERMINT OIL | AV092KU4JH | OINTMENT / TOPICAL | 0.2 %w/w | ||
| ALPHA-TOCOPHEROL | .ALPHA.-TOCOPHEROL | H4N855PNZ1 | CAPSULE / ORAL | 16 mg | ||
| PEPPERMINT OIL | PEPPERMINT OIL | AV092KU4JH | TABLET / ORAL | 28 mg | ||
| ALPHA-TOCOPHEROL | .ALPHA.-TOCOPHEROL | H4N855PNZ1 | TABLET, CHEWABLE / ORAL | 0.1 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 |
|---|---|---|---|---|---|---|
| 0285d3fa-c9c9-4bc8-9883-b6331066dec3 | 9b41d15a-b0c3-4e97-9c43-6a445b88fe94 | 2011-02-15 | Warnings | 0285d3fa-c9c9-4bc8-9883-b6331066dec3 9b41d15a-b0c3-4e97-9c43-6a445b88fe94 |
Adverse event summaries are temporarily unavailable. Other product information remains available.