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 15 minutes before sun exposure. Reapply as needed. Children under 6 months of age: Ask a doctor before use.
Padimate O, Petrolatum
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
Do not use on damaged or broken skin
Stop use and ask a doctor: If rash or irritation develops and lasts for more than 7 days.
When using this product keep out of eyes. Rinse with water to remove.
Keep out of reach of children: If swallowed get medical help or contact a Poison Control Center right away.
Apply liberally 15 minutes before sun exposure. Reapply as needed.
Children under 6 months of age: Ask a doctor before use.
Mineral Oil, Ozokerite, Flavor, Microcrystalline Wax, Isopropyl Myristate, Phenyl Trimethicone, Copernicia Cerifera (Carnauba) Wax, Lanolin, Euphorbia Cerifera (Candelilla) Wax, Cetyl Alcohol, Camphor, Red 6 Lake (CI 15850), Methylparaben
| NDC | Effective | Action | Document | Indexing SPL | Related label |
|---|---|---|---|---|---|
| 67091-252-30 | 2020-03-16 | C162847 | 48780-1 | 9d75b9d0-be45-f424-e053-dadaa90a57ce | Drug Facts |
| 67091-252-30 | 2020-01-31 | C162847 | 48780-1 | 9d75b9d0-be45-f424-e053-dadaa90a57ce | Drug Facts |
| Ingredient | Type | UNII | SPL version | Uploaded |
|---|---|---|---|---|
| PADIMATE O | ACTIVE INGREDIENT | Z11006CMUZ | 1 | |
| PETROLATUM | ACTIVE INGREDIENT | 4T6H12BN9U | 1 | |
| PADIMATE O | ACTIVE MOIETY | Z11006CMUZ | 1 | |
| PETROLATUM | ACTIVE MOIETY | 4T6H12BN9U | 1 | |
| CARNAUBA WAX | INACTIVE INGREDIENT | R12CBM0EIZ | 1 | |
| CERESIN | INACTIVE INGREDIENT | Q1LS2UJO3A | 1 | |
| ISOPROPYL MYRISTATE | INACTIVE INGREDIENT | 0RE8K4LNJS | 1 | |
| LANOLIN | INACTIVE INGREDIENT | 7EV65EAW6H | 1 | |
| LIGHT MINERAL OIL | INACTIVE INGREDIENT | N6K5787QVP | 1 | |
| MICROCRYSTALLINE WAX | INACTIVE INGREDIENT | XOF597Q3KY | 1 |
Every source-derived product name is available through these pages.
| Product NDC | Package NDC |
|---|---|
| 67091-252 | 67091-252-30 |
Every source-derived ingredient row is available through these pages.
| Name | UNII | Kind |
|---|---|---|
| PETROLATUM | 4T6H12BN9U | ACTIB |
| LIGHT MINERAL OIL | N6K5787QVP | IACT |
| MICROCRYSTALLINE WAX | XOF597Q3KY | IACT |
| LANOLIN | 7EV65EAW6H | IACT |
| PADIMATE O | Z11006CMUZ | ACTIB |
| CERESIN | Q1LS2UJO3A | IACT |
| CARNAUBA WAX | R12CBM0EIZ | IACT |
| ISOPROPYL MYRISTATE | 0RE8K4LNJS | 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 |
|---|---|---|---|---|---|---|
| ISOPROPYL MYRISTATE | ISOPROPYL MYRISTATE | 0RE8K4LNJS | OINTMENT / TOPICAL | 35 %w/w | ||
| LIGHT MINERAL OIL | LIGHT MINERAL OIL | N6K5787QVP | TABLET, COATED / ORAL | 4.8 mg | ||
| ISOPROPYL MYRISTATE | ISOPROPYL MYRISTATE | 0RE8K4LNJS | OIL / TOPICAL | 213 mg | ||
| CARNAUBA WAX | CARNAUBA WAX | R12CBM0EIZ | TABLET, FILM COATED, EXTENDED RELEASE / ORAL | 140 mg | ||
| CERESIN | CERESIN | Q1LS2UJO3A | CREAM / VAGINAL | 280 mg | ||
| LIGHT MINERAL OIL | LIGHT MINERAL OIL | N6K5787QVP | TABLET / ORAL | 7.5 mg | ||
| CARNAUBA WAX | CARNAUBA WAX | R12CBM0EIZ | TABLET, COATED / ORAL | 207.5 mg | ||
| LANOLIN | LANOLIN | 7EV65EAW6H | EMULSION / TOPICAL | 0.25 %w/w | ||
| ISOPROPYL MYRISTATE | ISOPROPYL MYRISTATE | 0RE8K4LNJS | FILM, EXTENDED RELEASE / TRANSDERMAL | 20.4 mg | ||
| LIGHT MINERAL OIL | LIGHT MINERAL OIL | N6K5787QVP | EMULSION / TOPICAL | 68100 mg | ||
| ISOPROPYL MYRISTATE | ISOPROPYL MYRISTATE | 0RE8K4LNJS | FILM / TRANSDERMAL | 58.08 mg | ||
| ISOPROPYL MYRISTATE | ISOPROPYL MYRISTATE | 0RE8K4LNJS | SPRAY / TOPICAL | 3665 mg | ||
| LIGHT MINERAL OIL | LIGHT MINERAL OIL | N6K5787QVP | OINTMENT / TOPICAL | 1335 mg | ||
| ISOPROPYL MYRISTATE | ISOPROPYL MYRISTATE | 0RE8K4LNJS | SYSTEM / TRANSDERMAL | 113 mg | ||
| LIGHT MINERAL OIL | LIGHT MINERAL OIL | N6K5787QVP | PASTILLE / ORAL | 3.6 mg | ||
| CERESIN | CERESIN | Q1LS2UJO3A | OINTMENT / TOPICAL | 1097 mg | ||
| LANOLIN | LANOLIN | 7EV65EAW6H | CREAM / VAGINAL | 2 %w/w | ||
| CARNAUBA WAX | CARNAUBA WAX | R12CBM0EIZ | TABLET, DELAYED RELEASE / ORAL | 230 mg | ||
| LANOLIN | LANOLIN | 7EV65EAW6H | CREAM / TOPICAL | 10 mg | ||
| ISOPROPYL MYRISTATE | ISOPROPYL MYRISTATE | 0RE8K4LNJS | AEROSOL, SPRAY / TOPICAL | 6.89 %w/w | ||
| ISOPROPYL MYRISTATE | ISOPROPYL MYRISTATE | 0RE8K4LNJS | GEL, METERED / TRANSDERMAL | 50 mg | ||
| ISOPROPYL MYRISTATE | ISOPROPYL MYRISTATE | 0RE8K4LNJS | GEL / TRANSDERMAL | 85 mg | ||
| LANOLIN | LANOLIN | 7EV65EAW6H | OINTMENT / OPHTHALMIC | 3 %w/w | ||
| LANOLIN | LANOLIN | 7EV65EAW6H | SHAMPOO / TOPICAL | 2 %w/w | ||
| LANOLIN | LANOLIN | 7EV65EAW6H | LOTION / TOPICAL | 1.5 %w/w | ||
| LIGHT MINERAL OIL | LIGHT MINERAL OIL | N6K5787QVP | OIL / AURICULAR (OTIC) | 419 mg | ||
| MICROCRYSTALLINE WAX | MICROCRYSTALLINE WAX | XOF597Q3KY | CAPSULE, EXTENDED RELEASE / ORAL | 6 mg | ||
| MICROCRYSTALLINE WAX | MICROCRYSTALLINE WAX | XOF597Q3KY | OINTMENT / TOPICAL | 3575 mg | ||
| LIGHT MINERAL OIL | LIGHT MINERAL OIL | N6K5787QVP | SYSTEM / TRANSDERMAL | 170 mg | ||
| ISOPROPYL MYRISTATE | ISOPROPYL MYRISTATE | 0RE8K4LNJS | LOTION / TOPICAL | 50 mg | ||
| LIGHT MINERAL OIL | LIGHT MINERAL OIL | N6K5787QVP | CREAM / TOPICAL | 456 mg | ||
| ISOPROPYL MYRISTATE | ISOPROPYL MYRISTATE | 0RE8K4LNJS | AEROSOL, FOAM / TOPICAL | 144 mg | ||
| CARNAUBA WAX | CARNAUBA WAX | R12CBM0EIZ | OINTMENT / TOPICAL | NA | ||
| ISOPROPYL MYRISTATE | ISOPROPYL MYRISTATE | 0RE8K4LNJS | GEL / TOPICAL | 29 mg | ||
| ISOPROPYL MYRISTATE | ISOPROPYL MYRISTATE | 0RE8K4LNJS | OIL / AURICULAR (OTIC) | 36 mg | ||
| ISOPROPYL MYRISTATE | ISOPROPYL MYRISTATE | 0RE8K4LNJS | SUSPENSION / AURICULAR (OTIC) | 0.02 %w/w | ||
| ISOPROPYL MYRISTATE | ISOPROPYL MYRISTATE | 0RE8K4LNJS | CREAM / VAGINAL | 50 mg | ||
| CARNAUBA WAX | CARNAUBA WAX | R12CBM0EIZ | TABLET, EXTENDED RELEASE / ORAL | 2150 mg | ||
| LIGHT MINERAL OIL | LIGHT MINERAL OIL | N6K5787QVP | TABLET, FILM COATED / ORAL | 2.49 mg | ||
| LIGHT MINERAL OIL | LIGHT MINERAL OIL | N6K5787QVP | LOTION / TOPICAL | 48000 mg | ||
| LIGHT MINERAL OIL | LIGHT MINERAL OIL | N6K5787QVP | CREAM, AUGMENTED / TOPICAL | 25 %w/w | ||
| CARNAUBA WAX | CARNAUBA WAX | R12CBM0EIZ | TABLET / ORAL | 167.8 mg | ||
| LIGHT MINERAL OIL | LIGHT MINERAL OIL | N6K5787QVP | AEROSOL, FOAM / TOPICAL | 240 mg | ||
| LIGHT MINERAL OIL | LIGHT MINERAL OIL | N6K5787QVP | GEL / TOPICAL | 20 mg | ||
| LIGHT MINERAL OIL | LIGHT MINERAL OIL | N6K5787QVP | TABLET, EXTENDED RELEASE / ORAL | 1 mg | ||
| LIGHT MINERAL OIL | LIGHT MINERAL OIL | N6K5787QVP | FILM, EXTENDED RELEASE / TRANSDERMAL | 162 mg | ||
| LANOLIN | LANOLIN | 7EV65EAW6H | OINTMENT / RECTAL | 105 mg | ||
| CARNAUBA WAX | CARNAUBA WAX | R12CBM0EIZ | CAPSULE / ORAL | NA | ||
| MICROCRYSTALLINE WAX | MICROCRYSTALLINE WAX | XOF597Q3KY | GEL / TOPICAL | NA | ||
| LIGHT MINERAL OIL | LIGHT MINERAL OIL | N6K5787QVP | CAPSULE / ORAL | 6 mg | ||
| LIGHT MINERAL OIL | LIGHT MINERAL OIL | N6K5787QVP | PASTE / DENTAL | 687 mg | ||
| LANOLIN | LANOLIN | 7EV65EAW6H | OINTMENT / TOPICAL | 10 %w/w | ||
| CARNAUBA WAX | CARNAUBA WAX | R12CBM0EIZ | CAPSULE, EXTENDED RELEASE / ORAL | 288 mg | ||
| CARNAUBA WAX | CARNAUBA WAX | R12CBM0EIZ | TABLET, FILM COATED / ORAL | 1 mg | ||
| LIGHT MINERAL OIL | LIGHT MINERAL OIL | N6K5787QVP | OIL / TOPICAL | 2509 mg | ||
| ISOPROPYL MYRISTATE | ISOPROPYL MYRISTATE | 0RE8K4LNJS | AEROSOL / TOPICAL | 9.3 %w/w | ||
| LANOLIN | LANOLIN | 7EV65EAW6H | SPRAY / NASAL | NA | ||
| MICROCRYSTALLINE WAX | MICROCRYSTALLINE WAX | XOF597Q3KY | CREAM / VAGINAL | 23 mg | ||
| ISOPROPYL MYRISTATE | ISOPROPYL MYRISTATE | 0RE8K4LNJS | CREAM / TOPICAL | 65000 mg | ||
| ISOPROPYL MYRISTATE | ISOPROPYL MYRISTATE | 0RE8K4LNJS | SYSTEM / TOPICAL | 7 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 |
|---|---|---|---|---|---|---|
| a7b39223-db18-44f8-a46f-cb14345d1db1 | e3937472-0d9d-4f3d-aa8a-72df67e38c6b | 2022-01-17 | Warnings | a7b39223-db18-44f8-a46f-cb14345d1db1 e3937472-0d9d-4f3d-aa8a-72df67e38c6b |
Adverse event summaries are temporarily unavailable. Other product information remains available.