Indications and uses
Helps prevent sunburn. Helps prevent and temporarily protects dry, chapped or windburned lips.
Helps prevent sunburn. Helps prevent and temporarily protects dry, chapped or windburned lips.
Apply liberally before sun exposure and as needed. Children under 6 months of age: Ask a doctor before use.
Octinoxate (7.5%), Oxybenzone (3.5%)
Petrolatum (42%)
Sunscreen, Sunscreen, Skin Protectant
If swallowed get medical help or contact a Poison Control Center right away.
Helps prevent sunburn. Helps prevent and temporarily protects dry, chapped or windburned lips.
Skin Cancer/Skin Aging Alert: Spending time in the sun increases your risk of skin cancer and early skin aging. This product has been shown only to prevent sunburn, not skin cancer or early aging.
For external use only: Stop use and ask a doctor: if rash or irritation develops and lasts.
Apply liberally before sun exposure and as needed. Children under 6 months of age: Ask a doctor before use.
Ozokerite, Mineral Oil, PEG-8, Lanolin, Microcrystalline Wax, Flavor, Paraffin Wax, Copernicia Cerifera (Carnauba) Wax, Sucralose, Aloe Barbadenis Leaf Extract, Tocopherol, Methylparaben, Propylparaben.
| NDC | Effective | Action | Document | Indexing SPL | Related label |
|---|---|---|---|---|---|
| 52993-111-02 | 2020-01-31 | C162847 | 48780-1 | 9d75b9cf-f803-f424-e053-dadaa90a57ce | Drug Facts |
| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|---|---|---|---|---|---|
| 52993-111-02 | Zinka Passion Fruit SPF 15 Lip Balm | 1 g in 1 CONTAINER | STICK | 1 | 1 |
| Ingredient | Type | UNII | SPL version | Uploaded |
|---|---|---|---|---|
| OCTINOXATE | ACTIVE INGREDIENT | 4Y5P7MUD51 | 1 | |
| OXYBENZONE | ACTIVE INGREDIENT | 95OOS7VE0Y | 1 | |
| PETROLATUM | ACTIVE INGREDIENT | 4T6H12BN9U | 1 | |
| OCTINOXATE | ACTIVE MOIETY | 4Y5P7MUD51 | 1 | |
| OXYBENZONE | ACTIVE MOIETY | 95OOS7VE0Y | 1 | |
| PETROLATUM | ACTIVE MOIETY | 4T6H12BN9U | 1 | |
| CERESIN | INACTIVE INGREDIENT | Q1LS2UJO3A | 1 | |
| LANOLIN | INACTIVE INGREDIENT | 7EV65EAW6H | 1 | |
| LIGHT MINERAL OIL | INACTIVE INGREDIENT | N6K5787QVP | 1 | |
| MICROCRYSTALLINE WAX | INACTIVE INGREDIENT | XOF597Q3KY | 1 | |
| PEG-8 STEARATE | INACTIVE INGREDIENT | 2P9L47VI5E | 1 |
Every source-derived product name is available through these pages.
| Product NDC | Package NDC |
|---|---|
| 52993-111 | 52993-111-02 |
Every source-derived ingredient row is available through these pages.
| Name | UNII | Kind |
|---|---|---|
| OCTINOXATE | 4Y5P7MUD51 | ACTIB |
| OXYBENZONE | 95OOS7VE0Y | ACTIB |
| PETROLATUM | 4T6H12BN9U | ACTIB |
| LIGHT MINERAL OIL | N6K5787QVP | IACT |
| MICROCRYSTALLINE WAX | XOF597Q3KY | IACT |
| LANOLIN | 7EV65EAW6H | IACT |
| CERESIN | Q1LS2UJO3A | IACT |
| PEG-8 STEARATE | 2P9L47VI5E | 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 |
|---|---|---|---|---|---|---|
| LIGHT MINERAL OIL | LIGHT MINERAL OIL | N6K5787QVP | OINTMENT / TOPICAL | 1335 mg | ||
| LANOLIN | LANOLIN | 7EV65EAW6H | OINTMENT / RECTAL | 105 mg | ||
| LIGHT MINERAL OIL | LIGHT MINERAL OIL | N6K5787QVP | LOTION / TOPICAL | 48000 mg | ||
| MICROCRYSTALLINE WAX | MICROCRYSTALLINE WAX | XOF597Q3KY | OINTMENT / TOPICAL | 3575 mg | ||
| LIGHT MINERAL OIL | LIGHT MINERAL OIL | N6K5787QVP | FILM, EXTENDED RELEASE / TRANSDERMAL | 162 mg | ||
| LIGHT MINERAL OIL | LIGHT MINERAL OIL | N6K5787QVP | CREAM / TOPICAL | 456 mg | ||
| LANOLIN | LANOLIN | 7EV65EAW6H | LOTION / TOPICAL | 1.5 %w/w | ||
| LIGHT MINERAL OIL | LIGHT MINERAL OIL | N6K5787QVP | SUPPOSITORY / VAGINAL | 1464.9 mg | ||
| LIGHT MINERAL OIL | LIGHT MINERAL OIL | N6K5787QVP | TABLET, FILM COATED / ORAL | 2.49 mg | ||
| LANOLIN | LANOLIN | 7EV65EAW6H | OINTMENT / TOPICAL | 10 %w/w | ||
| PEG-8 STEARATE | PEG-8 MONOSTEARATE | 2P9L47VI5E | CONCENTRATE / ORAL | 25 mg/5ml | ||
| PEG-8 STEARATE | PEG-8 MONOSTEARATE | 2P9L47VI5E | CREAM / TOPICAL | 229 mg | ||
| LIGHT MINERAL OIL | LIGHT MINERAL OIL | N6K5787QVP | GEL / TOPICAL | 20 mg | ||
| CERESIN | CERESIN | Q1LS2UJO3A | CREAM / VAGINAL | 280 mg | ||
| LIGHT MINERAL OIL | LIGHT MINERAL OIL | N6K5787QVP | CREAM, AUGMENTED / TOPICAL | 25 %w/w | ||
| LIGHT MINERAL OIL | LIGHT MINERAL OIL | N6K5787QVP | SYSTEM / TRANSDERMAL | 170 mg | ||
| LANOLIN | LANOLIN | 7EV65EAW6H | SPRAY / NASAL | NA | ||
| MICROCRYSTALLINE WAX | MICROCRYSTALLINE WAX | XOF597Q3KY | GEL / TOPICAL | NA | ||
| LANOLIN | LANOLIN | 7EV65EAW6H | SHAMPOO / TOPICAL | 2 %w/w | ||
| MICROCRYSTALLINE WAX | MICROCRYSTALLINE WAX | XOF597Q3KY | CREAM / VAGINAL | 23 mg | ||
| PEG-8 STEARATE | PEG-8 MONOSTEARATE | 2P9L47VI5E | SPONGE / TOPICAL | NA | ||
| LIGHT MINERAL OIL | LIGHT MINERAL OIL | N6K5787QVP | AEROSOL, FOAM / TOPICAL | 240 mg | ||
| LIGHT MINERAL OIL | LIGHT MINERAL OIL | N6K5787QVP | OIL / AURICULAR (OTIC) | 419 mg | ||
| CERESIN | CERESIN | Q1LS2UJO3A | OINTMENT / TOPICAL | 1097 mg | ||
| LIGHT MINERAL OIL | LIGHT MINERAL OIL | N6K5787QVP | EMULSION / TOPICAL | 68100 mg | ||
| PEG-8 STEARATE | PEG-8 MONOSTEARATE | 2P9L47VI5E | SUSPENSION / ORAL | 60 mg | ||
| LIGHT MINERAL OIL | LIGHT MINERAL OIL | N6K5787QVP | PASTE / DENTAL | 687 mg | ||
| LIGHT MINERAL OIL | LIGHT MINERAL OIL | N6K5787QVP | CAPSULE / ORAL | 6 mg | ||
| LIGHT MINERAL OIL | LIGHT MINERAL OIL | N6K5787QVP | TABLET, COATED / ORAL | 4.8 mg | ||
| LANOLIN | LANOLIN | 7EV65EAW6H | CREAM / VAGINAL | 2 %w/w | ||
| LIGHT MINERAL OIL | LIGHT MINERAL OIL | N6K5787QVP | TABLET, EXTENDED RELEASE / ORAL | 1 mg | ||
| MICROCRYSTALLINE WAX | MICROCRYSTALLINE WAX | XOF597Q3KY | CAPSULE, EXTENDED RELEASE / ORAL | 6 mg | ||
| LIGHT MINERAL OIL | LIGHT MINERAL OIL | N6K5787QVP | OIL / TOPICAL | 2509 mg | ||
| LANOLIN | LANOLIN | 7EV65EAW6H | EMULSION / TOPICAL | 0.25 %w/w | ||
| LANOLIN | LANOLIN | 7EV65EAW6H | OINTMENT / OPHTHALMIC | 3 %w/w | ||
| LIGHT MINERAL OIL | LIGHT MINERAL OIL | N6K5787QVP | PASTILLE / ORAL | 3.6 mg | ||
| LIGHT MINERAL OIL | LIGHT MINERAL OIL | N6K5787QVP | TABLET / ORAL | 7.5 mg | ||
| LANOLIN | LANOLIN | 7EV65EAW6H | CREAM / TOPICAL | 10 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 |
|---|---|---|---|---|---|---|
| 662cac4f-c42b-4ec5-b8da-7a0819e481db | 662cac4f-c42b-4ec5-b8da-7a0819e481db | 2014-05-09 | Warnings | 662cac4f-c42b-4ec5-b8da-7a0819e481db 662cac4f-c42b-4ec5-b8da-7a0819e481db |
Adverse event summaries are temporarily unavailable. Other product information remains available.