Indications and uses
Helps prevent sunburn
Helps prevent sunburn
apply liberally 15 minutes before sun exposure reapply at least every 2 hours use a water-resistant sunscreen if swimming or sweating children under 6 months of age: Ask a doctor
Padimate O, 1.5%
Sunscreen
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 help prevent sunburn, not skin cancer or early skin aging.
For external use only
Do not use on damaged or broken skin
When using this product, keep out of eyes. Rinse with water to remove.
Petrolatum, paraffinum liquidum (mineral oil), ozokerite, octyldodecanol, phenyl methicone, flavor, arachidyl propionate, cera alba (beeswax), camphor, copernicia cerifera (carnauba) wax, isopropyl lanolate, isopropyl myristate, lanolin, paraffin, cetyl alcohol, saccharin, methylparaben, propylparaben, D&C red #6 (CI 15850), FD&C yellow #5 (CI 19140)
| NDC | Effective | Action | Document | Indexing SPL | Related label |
|---|---|---|---|---|---|
| 0363-6050-02 | 2019-11-27 | C162847 | 48780-1 | 9855e2a2-50f4-60a7-e053-dbdaa90a05bd | Drug Facts |
| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|---|---|---|---|---|---|
| 0363-6050-01 | Lip Balm Sunscreen SPF 4Original | 4 g in 1 CONTAINER | STICK | 4 | 2 | |
| 0363-6050-02 | Lip Balm Sunscreen SPF 4Original | 2 in 1 BLISTER PACK | STICK | 2 | 2 |
| Ingredient | Type | UNII | SPL version | Uploaded |
|---|---|---|---|---|
| PADIMATE O | ACTIVE INGREDIENT | Z11006CMUZ | 2 | |
| PADIMATE O | ACTIVE MOIETY | Z11006CMUZ | 2 | |
| ARACHIDYL PROPIONATE | INACTIVE INGREDIENT | QV5DAH3MSB | 2 | |
| CAMPHOR (NATURAL) | INACTIVE INGREDIENT | N20HL7Q941 | 2 | |
| CARNAUBA WAX | INACTIVE INGREDIENT | R12CBM0EIZ | 2 | |
| CETYL ALCOHOL | INACTIVE INGREDIENT | 936JST6JCN | 2 | |
| D&C RED NO. 6 | INACTIVE INGREDIENT | 481744AI4O | 2 | |
| FD&C YELLOW NO. 5 | INACTIVE INGREDIENT | I753WB2F1M | 2 | |
| ISOPROPYL MYRISTATE | INACTIVE INGREDIENT | 0RE8K4LNJS | 2 | |
| LANOLIN | INACTIVE INGREDIENT | 7EV65EAW6H | 2 | |
| LIGHT MINERAL OIL | INACTIVE INGREDIENT | N6K5787QVP | 2 | |
| METHYLPARABEN | INACTIVE INGREDIENT | A2I8C7HI9T | 2 | |
| OCTYLDODECANOL | INACTIVE INGREDIENT | 461N1O614Y | 2 | |
| PARAFFIN | INACTIVE INGREDIENT | I9O0E3H2ZE | 2 | |
| PETROLATUM | INACTIVE INGREDIENT | 4T6H12BN9U | 2 | |
| PHENYL TRIMETHICONE | INACTIVE INGREDIENT | DR0K5NOJ4R | 2 | |
| PROPYLPARABEN | INACTIVE INGREDIENT | Z8IX2SC1OH | 2 | |
| SACCHARIN | INACTIVE INGREDIENT | FST467XS7D | 2 | |
| WHITE WAX | INACTIVE INGREDIENT | 7G1J5DA97F | 2 |
Every source-derived product name is available through these pages.
| Product NDC | Package NDC |
|---|---|
| 0363-6050 | 0363-6050-01, 0363-6050-02 |
Every source-derived ingredient row is available through these pages.
| Name | UNII | Kind |
|---|---|---|
| PADIMATE O | Z11006CMUZ | ACTIB |
| PETROLATUM | 4T6H12BN9U | IACT |
| ARACHIDYL PROPIONATE | QV5DAH3MSB | IACT |
| WHITE WAX | 7G1J5DA97F | IACT |
| CAMPHOR (NATURAL) | N20HL7Q941 | IACT |
| CARNAUBA WAX | R12CBM0EIZ | IACT |
| CETYL ALCOHOL | 936JST6JCN | IACT |
| D&C RED NO. 6 | 481744AI4O | IACT |
| FD&C YELLOW NO. 5 | I753WB2F1M | IACT |
| ISOPROPYL MYRISTATE | 0RE8K4LNJS | IACT |
| LIGHT MINERAL OIL | N6K5787QVP | IACT |
| METHYLPARABEN | A2I8C7HI9T | IACT |
| OCTYLDODECANOL | 461N1O614Y | IACT |
| PARAFFIN | I9O0E3H2ZE | IACT |
| PROPYLPARABEN | Z8IX2SC1OH | IACT |
| SACCHARIN | FST467XS7D | IACT |
| LANOLIN | 7EV65EAW6H | IACT |
| PHENYL TRIMETHICONE | DR0K5NOJ4R | 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 |
|---|---|---|---|---|---|---|
| METHYLPARABEN | METHYLPARABEN | A2I8C7HI9T | POWDER, FOR SUSPENSION / ORAL | 75 mg | ||
| WHITE WAX | WHITE WAX | 7G1J5DA97F | TABLET, EXTENDED RELEASE / ORAL | 14 mg | ||
| METHYLPARABEN | METHYLPARABEN | A2I8C7HI9T | SOLUTION / ORAL | 346 mg | ||
| CARNAUBA WAX | CARNAUBA WAX | R12CBM0EIZ | CAPSULE, EXTENDED RELEASE / ORAL | 288 mg | ||
| PROPYLPARABEN | PROPYLPARABEN | Z8IX2SC1OH | ELIXIR / ORAL | 200 mg | ||
| PROPYLPARABEN | PROPYLPARABEN | Z8IX2SC1OH | INJECTION / INTRA-ARTICULAR | 0.03 %w/v | ||
| PETROLATUM | PETROLATUM | 4T6H12BN9U | OINTMENT / OPHTHALMIC | 88.4 %w/w | ||
| METHYLPARABEN | METHYLPARABEN | A2I8C7HI9T | SUSPENSION / AURICULAR (OTIC) | NA | ||
| PROPYLPARABEN | PROPYLPARABEN | Z8IX2SC1OH | TABLET / ORAL | 0.2 mg | ||
| PETROLATUM | PETROLATUM | 4T6H12BN9U | EMULSION / TOPICAL | 7.8 %w/w | ||
| METHYLPARABEN | METHYLPARABEN | A2I8C7HI9T | DROPS / OPHTHALMIC | 0.01 %w/w | ||
| LANOLIN | LANOLIN | 7EV65EAW6H | OINTMENT / RECTAL | 105 mg | ||
| FD&C YELLOW NO. 5 | FD&C YELLOW NO. 5 | I753WB2F1M | POWDER / TOPICAL | NA | ||
| PROPYLPARABEN | PROPYLPARABEN | Z8IX2SC1OH | ENEMA / RECTAL | 0.02 %w/w | ||
| OCTYLDODECANOL | OCTYLDODECANOL | 461N1O614Y | SYSTEM / TRANSDERMAL | 4.05 mg | ||
| PROPYLPARABEN | PROPYLPARABEN | Z8IX2SC1OH | INJECTION / PARENTERAL | 2 mg | ||
| SACCHARIN | SACCHARIN | FST467XS7D | TABLET / ORAL | 1.6 mg | ||
| LANOLIN | LANOLIN | 7EV65EAW6H | SPRAY / NASAL | NA | ||
| METHYLPARABEN | METHYLPARABEN | A2I8C7HI9T | SUSPENSION/ DROPS / OPHTHALMIC | 0.05 %w/w | ||
| PROPYLPARABEN | PROPYLPARABEN | Z8IX2SC1OH | INJECTION, SUSPENSION / SUBCUTANEOUS | 0.02 %w/v | ||
| PROPYLPARABEN | PROPYLPARABEN | Z8IX2SC1OH | CONCENTRATE / ORAL | 2.5 mg/5ml | ||
| SACCHARIN | SACCHARIN | FST467XS7D | PASTE, DENTIFRICE / DENTAL | 0.23 %w/w | ||
| WHITE WAX | WHITE WAX | 7G1J5DA97F | TABLET, DELAYED RELEASE / ORAL | 0.08 mg | ||
| PROPYLPARABEN | PROPYLPARABEN | Z8IX2SC1OH | JELLY / TOPICAL | 180 mg | ||
| PARAFFIN | PARAFFIN | I9O0E3H2ZE | TABLET, EXTENDED RELEASE / ORAL | 321 mg | ||
| WHITE WAX | WHITE WAX | 7G1J5DA97F | AEROSOL, FOAM / TOPICAL | 2 %w/w | ||
| CETYL ALCOHOL | CETYL ALCOHOL | 936JST6JCN | AEROSOL, FOAM / TOPICAL | 82 mg | ||
| LIGHT MINERAL OIL | LIGHT MINERAL OIL | N6K5787QVP | CREAM, AUGMENTED / TOPICAL | 25 %w/w | ||
| METHYLPARABEN | METHYLPARABEN | A2I8C7HI9T | SOLUTION / INTRAMUSCULAR | 0.13 %w/v | ||
| WHITE WAX | WHITE WAX | 7G1J5DA97F | LOTION / TOPICAL | 1 %w/w | ||
| LIGHT MINERAL OIL | LIGHT MINERAL OIL | N6K5787QVP | TABLET / ORAL | 7.5 mg | ||
| METHYLPARABEN | METHYLPARABEN | A2I8C7HI9T | INJECTION, POWDER, FOR SOLUTION / INTRAMUSCULAR | 3.6 mg | ||
| METHYLPARABEN | METHYLPARABEN | A2I8C7HI9T | OINTMENT / TOPICAL | 29 mg | ||
| METHYLPARABEN | METHYLPARABEN | A2I8C7HI9T | CREAM, AUGMENTED / TOPICAL | 2 mg | ||
| OCTYLDODECANOL | OCTYLDODECANOL | 461N1O614Y | FILM / TRANSDERMAL | 32.44 mg | ||
| METHYLPARABEN | METHYLPARABEN | A2I8C7HI9T | TABLET, EXTENDED RELEASE / ORAL | 0.17 mg | ||
| FD&C YELLOW NO. 5 | FD&C YELLOW NO. 5 | I753WB2F1M | SYRUP / ORAL | 0.1 mg | ||
| LIGHT MINERAL OIL | LIGHT MINERAL OIL | N6K5787QVP | EMULSION / TOPICAL | 68100 mg | ||
| METHYLPARABEN | METHYLPARABEN | A2I8C7HI9T | SUSPENSION / TOPICAL | 0.24 %w/v | ||
| WHITE WAX | WHITE WAX | 7G1J5DA97F | CREAM / TOPICAL | 500 mg | ||
| PROPYLPARABEN | PROPYLPARABEN | Z8IX2SC1OH | SOLUTION / NASAL | 140 mg | ||
| PROPYLPARABEN | PROPYLPARABEN | Z8IX2SC1OH | POWDER / ORAL | NA | ||
| METHYLPARABEN | METHYLPARABEN | A2I8C7HI9T | INJECTION / INTRADERMAL | 1 mg | ||
| PROPYLPARABEN | PROPYLPARABEN | Z8IX2SC1OH | CAPSULE, EXTENDED RELEASE / ORAL | 0.22 mg | ||
| ISOPROPYL MYRISTATE | ISOPROPYL MYRISTATE | 0RE8K4LNJS | SYSTEM / TOPICAL | 7 mg | ||
| PROPYLPARABEN | PROPYLPARABEN | Z8IX2SC1OH | GEL / VAGINAL | 2 mg | ||
| METHYLPARABEN | METHYLPARABEN | A2I8C7HI9T | SOLUTION / INTRAVENOUS | 0.13 %w/v | ||
| PARAFFIN | PARAFFIN | I9O0E3H2ZE | CAPSULE, EXTENDED RELEASE / ORAL | 100 mg | ||
| LIGHT MINERAL OIL | LIGHT MINERAL OIL | N6K5787QVP | CAPSULE / ORAL | 6 mg | ||
| METHYLPARABEN | METHYLPARABEN | A2I8C7HI9T | JELLY / TOPICAL | 420 mg | ||
| PROPYLPARABEN | PROPYLPARABEN | Z8IX2SC1OH | AEROSOL, FOAM / TOPICAL | 0.04 %w/w | ||
| METHYLPARABEN | METHYLPARABEN | A2I8C7HI9T | INJECTION / PERINEURAL | 80 mg | ||
| CETYL ALCOHOL | CETYL ALCOHOL | 936JST6JCN | SUSPENSION / TOPICAL | 2.01 %w/w | ||
| METHYLPARABEN | METHYLPARABEN | A2I8C7HI9T | INJECTION / INTRALESIONAL | 0.15 %w/v | ||
| METHYLPARABEN | METHYLPARABEN | A2I8C7HI9T | SUSPENSION / ORAL | 388 mg | ||
| METHYLPARABEN | METHYLPARABEN | A2I8C7HI9T | TABLET, CHEWABLE / ORAL | 1.28 mg | ||
| METHYLPARABEN | METHYLPARABEN | A2I8C7HI9T | INJECTION / SUBCUTANEOUS | 22 mg | ||
| LANOLIN | LANOLIN | 7EV65EAW6H | CREAM / TOPICAL | 10 mg | ||
| METHYLPARABEN | METHYLPARABEN | A2I8C7HI9T | SYSTEM / TOPICAL | 42 mg | ||
| FD&C YELLOW NO. 5 | FD&C YELLOW NO. 5 | I753WB2F1M | CAPSULE, EXTENDED RELEASE / ORAL | 0.26 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 |
|---|---|---|---|---|---|---|
| 04cd52a1-fc2c-4f46-918c-2e907b099316 | 884537bf-d003-4f3f-9d36-f75721b03805 | 2013-11-15 | Warnings | 04cd52a1-fc2c-4f46-918c-2e907b099316 884537bf-d003-4f3f-9d36-f75721b03805 |
Adverse event summaries are temporarily unavailable. Other product information remains available.