Storage and handling
Other information: Store at 68-77F (20-25C)
Other information: Store at 68-77F (20-25C)
Active Ingredients: Octinoxate 7%, Oxybenzone 3%
Use: helps prevent sunburn
Warning: stop use if skin rash occurs
Directions: Apply and reapply at least every 2 hours for sunburn protection. children under 6 months of age: ask a doctor.
Other information: Store at 68-77F (20-25C)
Inactive Ingredients:
Mineral Oil, Polybutene, Ethylhexyl Palmitate, Parafin, Ceresin, Microcrystalline Wax, Petrolatum, Beeswax, Fragrance, Methylparaben, Propylparaben, BHT.
HC301LB Dist. by Beacon Promotions Inc.
New lm, MN 56073
(507) 233-3278
Made in China
| NDC | Effective | Action | Document | Indexing SPL | Related label |
|---|---|---|---|---|---|
| 75866-301-01 | 2019-10-29 | C162847 | 48780-1 | 960f7f55-c39b-8e05-e053-dbdaa90a074a | Bubble Gum Sunscreen Lip Moisturizer SPF 15 |
| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|---|---|---|---|---|---|
| 75866-301-01 | Bubble Gum Sunscreen Lip Moisturizer | 4.2 g in 1 CONTAINER | LIPSTICK | 4.2 | 1 |
| Ingredient | Type | UNII | SPL version | Uploaded |
|---|---|---|---|---|
| OCTINOXATE | ACTIVE INGREDIENT | 4Y5P7MUD51 | 1 | |
| OXYBENZONE | ACTIVE INGREDIENT | 95OOS7VE0Y | 1 | |
| OCTINOXATE | ACTIVE MOIETY | 4Y5P7MUD51 | 1 | |
| OXYBENZONE | ACTIVE MOIETY | 95OOS7VE0Y | 1 | |
| BUTYLATED HYDROXYTOLUENE | INACTIVE INGREDIENT | 1P9D0Z171K | 1 | |
| CERESIN | INACTIVE INGREDIENT | Q1LS2UJO3A | 1 | |
| ETHYLHEXYL PALMITATE | INACTIVE INGREDIENT | 2865993309 | 1 | |
| METHYLPARABEN | INACTIVE INGREDIENT | A2I8C7HI9T | 1 | |
| MICROCRYSTALLINE WAX | INACTIVE INGREDIENT | XOF597Q3KY | 1 | |
| MINERAL OIL | INACTIVE INGREDIENT | T5L8T28FGP | 1 | |
| PARAFFIN | INACTIVE INGREDIENT | I9O0E3H2ZE | 1 | |
| PETROLATUM | INACTIVE INGREDIENT | 4T6H12BN9U | 1 | |
| PROPYLPARABEN | INACTIVE INGREDIENT | Z8IX2SC1OH | 1 | |
| YELLOW WAX | INACTIVE INGREDIENT | 2ZA36H0S2V | 1 |
Every source-derived product name is available through these pages.
| Product NDC | Package NDC |
|---|---|
| 75866-301 | 75866-301-01 |
Every source-derived ingredient row is available through these pages.
| Name | UNII | Kind |
|---|---|---|
| OCTINOXATE | 4Y5P7MUD51 | ACTIB |
| OXYBENZONE | 95OOS7VE0Y | ACTIB |
| MINERAL OIL | T5L8T28FGP | IACT |
| ETHYLHEXYL PALMITATE | 2865993309 | IACT |
| PARAFFIN | I9O0E3H2ZE | IACT |
| CERESIN | Q1LS2UJO3A | IACT |
| MICROCRYSTALLINE WAX | XOF597Q3KY | IACT |
| PETROLATUM | 4T6H12BN9U | IACT |
| YELLOW WAX | 2ZA36H0S2V | IACT |
| METHYLPARABEN | A2I8C7HI9T | IACT |
| PROPYLPARABEN | Z8IX2SC1OH | IACT |
| BUTYLATED HYDROXYTOLUENE | 1P9D0Z171K | 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 | INJECTION / INTRAMUSCULAR | 95 mg | ||
| PROPYLPARABEN | PROPYLPARABEN | Z8IX2SC1OH | INJECTION, POWDER, FOR SOLUTION / INTRAVENOUS | 0.8 mg | ||
| METHYLPARABEN | METHYLPARABEN | A2I8C7HI9T | INJECTION / SOFT TISSUE | 0.15 %w/v | ||
| METHYLPARABEN | METHYLPARABEN | A2I8C7HI9T | CREAM, AUGMENTED / TOPICAL | 2 mg | ||
| MINERAL OIL | MINERAL OIL | T5L8T28FGP | CAPSULE, EXTENDED RELEASE / ORAL | 120 mg | ||
| METHYLPARABEN | METHYLPARABEN | A2I8C7HI9T | TABLET, COATED / ORAL | 0.8 mg | ||
| MINERAL OIL | MINERAL OIL | T5L8T28FGP | DROPS / ORAL | NA | ||
| PROPYLPARABEN | PROPYLPARABEN | Z8IX2SC1OH | INJECTION / INTRA-ARTICULAR | 0.03 %w/v | ||
| PETROLATUM | PETROLATUM | 4T6H12BN9U | CAPSULE, EXTENDED RELEASE / ORAL | 0.07 mg | ||
| METHYLPARABEN | METHYLPARABEN | A2I8C7HI9T | SOLUTION / INTRAMUSCULAR | 0.13 %w/v | ||
| MINERAL OIL | MINERAL OIL | T5L8T28FGP | PASTE / TOPICAL | 47.5 %w/w | ||
| BUTYLATED HYDROXYTOLUENE | BUTYLATED HYDROXYTOLUENE | 1P9D0Z171K | FILM, SOLUBLE / ORAL | 0.06 mg | ||
| PROPYLPARABEN | PROPYLPARABEN | Z8IX2SC1OH | GEL / TOPICAL | 4 mg | ||
| PROPYLPARABEN | PROPYLPARABEN | Z8IX2SC1OH | SOLUTION / RESPIRATORY (INHALATION) | 0.01 %w/w | ||
| METHYLPARABEN | METHYLPARABEN | A2I8C7HI9T | SOLUTION, CONCENTRATE / ORAL | 1 mg/1ml | ||
| METHYLPARABEN | METHYLPARABEN | A2I8C7HI9T | SYSTEM / TOPICAL | 42 mg | ||
| PROPYLPARABEN | PROPYLPARABEN | Z8IX2SC1OH | FILM / BUCCAL | 0.22 mg | ||
| METHYLPARABEN | METHYLPARABEN | A2I8C7HI9T | SHAMPOO, SUSPENSION / TOPICAL | 0.15 %w/w | ||
| METHYLPARABEN | METHYLPARABEN | A2I8C7HI9T | INJECTION / PERIDURAL | 1 mg | ||
| PROPYLPARABEN | PROPYLPARABEN | Z8IX2SC1OH | SUSPENSION / AURICULAR (OTIC) | NA | ||
| METHYLPARABEN | METHYLPARABEN | A2I8C7HI9T | FILM, SOLUBLE / BUCCAL | 3 mg | ||
| PROPYLPARABEN | PROPYLPARABEN | Z8IX2SC1OH | SUPPOSITORY / VAGINAL | NA | ||
| METHYLPARABEN | METHYLPARABEN | A2I8C7HI9T | INJECTION / PARENTERAL | 18 mg | ||
| METHYLPARABEN | METHYLPARABEN | A2I8C7HI9T | SUPPOSITORY / VAGINAL | NA | ||
| METHYLPARABEN | METHYLPARABEN | A2I8C7HI9T | OINTMENT / TOPICAL | 29 mg | ||
| MINERAL OIL | MINERAL OIL | T5L8T28FGP | TABLET, CHEWABLE / ORAL | 6 mg | ||
| BUTYLATED HYDROXYTOLUENE | BUTYLATED HYDROXYTOLUENE | 1P9D0Z171K | CAPSULE, LIQUID FILLED / ORAL | 0.1 mg | ||
| MINERAL OIL | MINERAL OIL | T5L8T28FGP | SOAP / TOPICAL | 0.82 %w/w | ||
| PROPYLPARABEN | PROPYLPARABEN | Z8IX2SC1OH | SUSPENSION / SUBCUTANEOUS | 0.02 %w/v | ||
| PROPYLPARABEN | PROPYLPARABEN | Z8IX2SC1OH | INJECTION, SOLUTION / INTRAVENOUS | 5 mg | ||
| PROPYLPARABEN | PROPYLPARABEN | Z8IX2SC1OH | ENEMA / RECTAL | 0.02 %w/w | ||
| PROPYLPARABEN | PROPYLPARABEN | Z8IX2SC1OH | CREAM / TOPICAL | 6 mg | ||
| BUTYLATED HYDROXYTOLUENE | BUTYLATED HYDROXYTOLUENE | 1P9D0Z171K | SHAMPOO / TOPICAL | 0.1 %w/w | ||
| BUTYLATED HYDROXYTOLUENE | BUTYLATED HYDROXYTOLUENE | 1P9D0Z171K | OINTMENT / TOPICAL | 57 mg | ||
| MICROCRYSTALLINE WAX | MICROCRYSTALLINE WAX | XOF597Q3KY | CREAM / VAGINAL | 23 mg | ||
| PETROLATUM | PETROLATUM | 4T6H12BN9U | AEROSOL, FOAM / TOPICAL | 7.9 %w/w | ||
| MINERAL OIL | MINERAL OIL | T5L8T28FGP | OINTMENT / AURICULAR (OTIC) | NA | ||
| METHYLPARABEN | METHYLPARABEN | A2I8C7HI9T | INJECTION, SOLUTION / EPIDURAL | 30 mg | ||
| BUTYLATED HYDROXYTOLUENE | BUTYLATED HYDROXYTOLUENE | 1P9D0Z171K | SOLUTION / TOPICAL | 3 mg | ||
| YELLOW WAX | YELLOW WAX | 2ZA36H0S2V | TABLET, COATED / ORAL | 213.7 mg | ||
| PROPYLPARABEN | PROPYLPARABEN | Z8IX2SC1OH | CONCENTRATE / ORAL | 2.5 mg/5ml | ||
| BUTYLATED HYDROXYTOLUENE | BUTYLATED HYDROXYTOLUENE | 1P9D0Z171K | CREAM / VAGINAL | 0.05 %w/w | ||
| METHYLPARABEN | METHYLPARABEN | A2I8C7HI9T | INJECTION / SUBCUTANEOUS | 22 mg | ||
| PROPYLPARABEN | PROPYLPARABEN | Z8IX2SC1OH | SOLUTION / INTRAVENOUS | 0.02 %w/v | ||
| PROPYLPARABEN | PROPYLPARABEN | Z8IX2SC1OH | SOLUTION, CONCENTRATE / ORAL | 0.2 mg/1ml | ||
| MINERAL OIL | MINERAL OIL | T5L8T28FGP | SUSPENSION / OPHTHALMIC | 0.1 %w/w | ||
| PARAFFIN | PARAFFIN | I9O0E3H2ZE | AEROSOL, FOAM / TOPICAL | 14235 mg | ||
| PROPYLPARABEN | PROPYLPARABEN | Z8IX2SC1OH | INJECTION / SOFT TISSUE | 0.02 %w/v | ||
| METHYLPARABEN | METHYLPARABEN | A2I8C7HI9T | TABLET, CHEWABLE / ORAL | 1.28 mg | ||
| BUTYLATED HYDROXYTOLUENE | BUTYLATED HYDROXYTOLUENE | 1P9D0Z171K | GUM, CHEWING / BUCCAL | 5 mg | ||
| PETROLATUM | PETROLATUM | 4T6H12BN9U | CAPSULE / VAGINAL | NA | ||
| METHYLPARABEN | METHYLPARABEN | A2I8C7HI9T | SUSPENSION / RECTAL | 1808 mg | ||
| PROPYLPARABEN | PROPYLPARABEN | Z8IX2SC1OH | INJECTION / PARENTERAL | 2 mg | ||
| MINERAL OIL | MINERAL OIL | T5L8T28FGP | SYSTEM / TRANSDERMAL | 6.09 mg | ||
| PROPYLPARABEN | PROPYLPARABEN | Z8IX2SC1OH | PASTE, DENTIFRICE / DENTAL | NA | ||
| METHYLPARABEN | METHYLPARABEN | A2I8C7HI9T | INJECTION / INTRALESIONAL | 0.15 %w/v | ||
| BUTYLATED HYDROXYTOLUENE | BUTYLATED HYDROXYTOLUENE | 1P9D0Z171K | GEL / TOPICAL | 8 mg | ||
| PARAFFIN | PARAFFIN | I9O0E3H2ZE | CAPSULE, EXTENDED RELEASE / ORAL | 100 mg | ||
| PROPYLPARABEN | PROPYLPARABEN | Z8IX2SC1OH | FILM, SOLUBLE / BUCCAL | 1 mg | ||
| METHYLPARABEN | METHYLPARABEN | A2I8C7HI9T | ENEMA / RECTAL | 0.18 %w/v |
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 |
|---|---|---|---|---|---|---|
| 1f7524e4-1a47-4f7b-87f2-697ffc1edf8a | b97725e1-29e9-428b-aaac-02fe3c8c173c | 2010-12-29 | Warnings | 1f7524e4-1a47-4f7b-87f2-697ffc1edf8a b97725e1-29e9-428b-aaac-02fe3c8c173c |
Adverse event summaries are temporarily unavailable. Other product information remains available.