Indications and uses
helps prevent sunburn higher SPF gives more sunburn protection retains SPF after 80 minutes of activity in the water
helps prevent sunburn higher SPF gives more sunburn protection retains SPF after 80 minutes of activity in the water
apply generously before sun exposure and as needed children under 6 months of age:ask a doctor reapply frequently and after towel drying, swimming or perspiring.
Octinoxate 7.5%
Oxybenzone 4.5%
Sunscreen
For external use only
If swallowed get medical help or contact a Poison Control Center right away.
exchange
select
X
SUNSCREEN
Lotion
SPF
15
UVA/UVB Protection
Very Water Resistant
4 FL. OZ. (118 mL)
| NDC | Effective | Action | Document | Indexing SPL | Related label |
|---|---|---|---|---|---|
| 55301-000-13 | 2020-01-31 | C162847 | 48780-1 | 9d75b9d0-bf29-f424-e053-dadaa90a57ce | Drug Facts |
| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|---|---|---|---|---|---|
| 55301-000-13 | Exchange Select SunscreenSPF 15 | 113 g in 1 BOTTLE, PLASTIC | LOTION | 113 | 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 | |
| ALOE VERA LEAF | INACTIVE INGREDIENT | ZY81Z83H0X | 1 | |
| BENZYL ALCOHOL | INACTIVE INGREDIENT | LKG8494WBH | 1 | |
| DIMETHICONE | INACTIVE INGREDIENT | 92RU3N3Y1O | 1 | |
| EDETATE DISODIUM | INACTIVE INGREDIENT | 7FLD91C86K | 1 | |
| GLYCERYL STEARATE SE | INACTIVE INGREDIENT | FCZ5MH785I | 1 | |
| HYDROGENATED SOYBEAN OIL | INACTIVE INGREDIENT | A2M91M918C | 1 | |
| IMIDUREA | INACTIVE INGREDIENT | M629807ATL | 1 | |
| ISOPROPYL MYRISTATE | INACTIVE INGREDIENT | 0RE8K4LNJS | 1 | |
| JOJOBA OIL | INACTIVE INGREDIENT | 724GKU717M | 1 | |
| METHYLPARABEN | INACTIVE INGREDIENT | A2I8C7HI9T | 1 | |
| PROPYLPARABEN | INACTIVE INGREDIENT | Z8IX2SC1OH | 1 | |
| SORBITAN MONOSTEARATE | INACTIVE INGREDIENT | NVZ4I0H58X | 1 | |
| SORBITOL | INACTIVE INGREDIENT | 506T60A25R | 1 | |
| STEARIC ACID | INACTIVE INGREDIENT | 4ELV7Z65AP | 1 | |
| TOCOPHEROL | INACTIVE INGREDIENT | R0ZB2556P8 | 1 | |
| TROLAMINE | INACTIVE INGREDIENT | 9O3K93S3TK | 1 | |
| WATER | INACTIVE INGREDIENT | 059QF0KO0R | 1 |
Every source-derived product name is available through these pages.
| Product NDC | Package NDC |
|---|---|
| 55301-000 | 55301-000-13 |
Every source-derived ingredient row is available through these pages.
| Name | UNII | Kind |
|---|---|---|
| OCTINOXATE | 4Y5P7MUD51 | ACTIB |
| OXYBENZONE | 95OOS7VE0Y | ACTIB |
| WATER | 059QF0KO0R | IACT |
| STEARIC ACID | 4ELV7Z65AP | IACT |
| SORBITAN MONOSTEARATE | NVZ4I0H58X | IACT |
| SORBITOL | 506T60A25R | IACT |
| GLYCERYL STEARATE SE | FCZ5MH785I | IACT |
| HYDROGENATED SOYBEAN OIL | A2M91M918C | IACT |
| ISOPROPYL MYRISTATE | 0RE8K4LNJS | IACT |
| TROLAMINE | 9O3K93S3TK | IACT |
| BENZYL ALCOHOL | LKG8494WBH | IACT |
| DIMETHICONE | 92RU3N3Y1O | IACT |
| JOJOBA OIL | 724GKU717M | IACT |
| TOCOPHEROL | R0ZB2556P8 | IACT |
| EDETATE DISODIUM | 7FLD91C86K | IACT |
| ALOE VERA LEAF | ZY81Z83H0X | IACT |
| IMIDUREA | M629807ATL | IACT |
| METHYLPARABEN | A2I8C7HI9T | IACT |
| PROPYLPARABEN | Z8IX2SC1OH | 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 |
|---|---|---|---|---|---|---|
| EDETATE DISODIUM | EDETATE DISODIUM | 7FLD91C86K | SUSPENSION / ORAL | 30 mg | ||
| EDETATE DISODIUM | EDETATE DISODIUM | 7FLD91C86K | SPRAY / RESPIRATORY (INHALATION) | 0.05 %w/w | ||
| BENZYL ALCOHOL | BENZYL ALCOHOL | LKG8494WBH | INJECTION / INTRA-ARTICULAR | 1 %w/v | ||
| ISOPROPYL MYRISTATE | ISOPROPYL MYRISTATE | 0RE8K4LNJS | AEROSOL / TOPICAL | 9.3 %w/w | ||
| GLYCERYL STEARATE SE | GLYCERYL STEARATE SE | FCZ5MH785I | LOTION / TOPICAL | 46 mg | ||
| METHYLPARABEN | METHYLPARABEN | A2I8C7HI9T | POWDER, FOR SUSPENSION / ORAL | 75 mg | ||
| EDETATE DISODIUM | EDETATE DISODIUM | 7FLD91C86K | SPRAY, METERED / NASAL | 4 mg | ||
| TROLAMINE | TROLAMINE | 9O3K93S3TK | POWDER / TOPICAL | 0.02 mg/mg | ||
| PROPYLPARABEN | PROPYLPARABEN | Z8IX2SC1OH | POWDER, FOR SUSPENSION / ORAL | 8 mg | ||
| STEARIC ACID | STEARIC ACID | 4ELV7Z65AP | AEROSOL, FOAM / VAGINAL | 4 %w/w | ||
| BENZYL ALCOHOL | BENZYL ALCOHOL | LKG8494WBH | SUSPENSION / AURICULAR (OTIC) | 0.9 %w/v | ||
| EDETATE DISODIUM | EDETATE DISODIUM | 7FLD91C86K | INJECTION / INTRAVENOUS | 10 %w/v | ||
| BENZYL ALCOHOL | BENZYL ALCOHOL | LKG8494WBH | CAPSULE / ORAL | 450 mg | ||
| ISOPROPYL MYRISTATE | ISOPROPYL MYRISTATE | 0RE8K4LNJS | SYSTEM / TOPICAL | 7 mg | ||
| PROPYLPARABEN | PROPYLPARABEN | Z8IX2SC1OH | OINTMENT / TOPICAL | 0.2 %w/w | ||
| PROPYLPARABEN | PROPYLPARABEN | Z8IX2SC1OH | LOTION / TOPICAL | 140 mg | ||
| BENZYL ALCOHOL | BENZYL ALCOHOL | LKG8494WBH | INJECTION, SUSPENSION / INTRASYNOVIAL | 18 mg | ||
| METHYLPARABEN | METHYLPARABEN | A2I8C7HI9T | SPRAY / TOPICAL | 0.2 %w/w | ||
| METHYLPARABEN | METHYLPARABEN | A2I8C7HI9T | INJECTION / PARENTERAL | 18 mg | ||
| HYDROGENATED SOYBEAN OIL | HYDROGENATED SOYBEAN OIL | A2M91M918C | CAPSULE / ORAL | 95 mg | ||
| TROLAMINE | TROLAMINE | 9O3K93S3TK | AEROSOL, FOAM / TOPICAL | 2.6 %w/w | ||
| METHYLPARABEN | METHYLPARABEN | A2I8C7HI9T | DROPS / AURICULAR (OTIC) | 0.01 %w/w | ||
| METHYLPARABEN | METHYLPARABEN | A2I8C7HI9T | GRANULE, FOR SUSPENSION / ORAL | 80 mg | ||
| EDETATE DISODIUM | EDETATE DISODIUM | 7FLD91C86K | TABLET, EFFERVESCENT / ORAL | 32 mg | ||
| SORBITAN MONOSTEARATE | SORBITAN MONOSTEARATE | NVZ4I0H58X | SOLUTION / TOPICAL | NA | ||
| SORBITOL | SORBITOL | 506T60A25R | GUM, CHEWING / ORAL | 6168 mg | ||
| TROLAMINE | TROLAMINE | 9O3K93S3TK | SPRAY / NASAL | NA | ||
| BENZYL ALCOHOL | BENZYL ALCOHOL | LKG8494WBH | SUPPOSITORY / VAGINAL | NA | ||
| TROLAMINE | TROLAMINE | 9O3K93S3TK | GEL / TRANSDERMAL | 6 mg | ||
| STEARIC ACID | STEARIC ACID | 4ELV7Z65AP | EMULSION / TOPICAL | NA | ||
| EDETATE DISODIUM | EDETATE DISODIUM | 7FLD91C86K | INJECTION / INTRAVASCULAR | 0.48 mg | ||
| HYDROGENATED SOYBEAN OIL | HYDROGENATED SOYBEAN OIL | A2M91M918C | TABLET / ORAL | 13.5 mg | ||
| BENZYL ALCOHOL | BENZYL ALCOHOL | LKG8494WBH | SOLUTION / INTRAMUSCULAR | 54 mg | ||
| METHYLPARABEN | METHYLPARABEN | A2I8C7HI9T | INJECTION / EPIDURAL | 1 mg | ||
| STEARIC ACID | STEARIC ACID | 4ELV7Z65AP | SOLUTION / TOPICAL | NA | ||
| SORBITOL | SORBITOL | 506T60A25R | INJECTION / INTRASYNOVIAL | 45 %w/v | ||
| TROLAMINE | TROLAMINE | 9O3K93S3TK | SHAMPOO / TOPICAL | 3.7 %w/w | ||
| EDETATE DISODIUM | EDETATE DISODIUM | 7FLD91C86K | TABLET, CHEWABLE / ORAL | 1 mg | ||
| EDETATE DISODIUM | EDETATE DISODIUM | 7FLD91C86K | SUSPENSION / AURICULAR (OTIC) | 0.01 %w/v | ||
| STEARIC ACID | STEARIC ACID | 4ELV7Z65AP | CREAM / TOPICAL | 190 mg | ||
| SORBITOL | SORBITOL | 506T60A25R | SYSTEM / TOPICAL | 6300 mg | ||
| SORBITOL | SORBITOL | 506T60A25R | SUSPENSION / ORAL | 45000 mg | ||
| METHYLPARABEN | METHYLPARABEN | A2I8C7HI9T | SUSPENSION / RECTAL | 1808 mg | ||
| SORBITOL | SORBITOL | 506T60A25R | CREAM, AUGMENTED / TOPICAL | 15 %w/w | ||
| SORBITOL | SORBITOL | 506T60A25R | PASTE / DENTAL | 14.6 %w/w | ||
| SORBITOL | SORBITOL | 506T60A25R | SPRAY / NASAL | 49 mg | ||
| EDETATE DISODIUM | EDETATE DISODIUM | 7FLD91C86K | ELIXIR / ORAL | 1.3 mg/5ml | ||
| METHYLPARABEN | METHYLPARABEN | A2I8C7HI9T | OINTMENT / TOPICAL | 29 mg | ||
| STEARIC ACID | STEARIC ACID | 4ELV7Z65AP | TABLET, FILM COATED, EXTENDED RELEASE / ORAL | 120 mg | ||
| STEARIC ACID | STEARIC ACID | 4ELV7Z65AP | CAPSULE / ORAL | 90 mg | ||
| SORBITOL | SORBITOL | 506T60A25R | TABLET, EXTENDED RELEASE / ORAL | 428 mg | ||
| METHYLPARABEN | METHYLPARABEN | A2I8C7HI9T | LOTION / TOPICAL | 351 mg | ||
| EDETATE DISODIUM | EDETATE DISODIUM | 7FLD91C86K | TABLET, COATED / ORAL | 0.21 mg | ||
| EDETATE DISODIUM | EDETATE DISODIUM | 7FLD91C86K | SYRUP / ORAL | 40 mg | ||
| SORBITOL | SORBITOL | 506T60A25R | TABLET, CHEWABLE / ORAL | 3555 mg | ||
| ISOPROPYL MYRISTATE | ISOPROPYL MYRISTATE | 0RE8K4LNJS | SPRAY / TOPICAL | 3665 mg | ||
| METHYLPARABEN | METHYLPARABEN | A2I8C7HI9T | PASTE, DENTIFRICE / DENTAL | 0.05 %w/w | ||
| STEARIC ACID | STEARIC ACID | 4ELV7Z65AP | AEROSOL, FOAM / TOPICAL | 8 %w/w | ||
| PROPYLPARABEN | PROPYLPARABEN | Z8IX2SC1OH | SUSPENSION / SUBCUTANEOUS | 0.02 %w/v | ||
| EDETATE DISODIUM | EDETATE DISODIUM | 7FLD91C86K | INJECTION, SUSPENSION / INTRAMUSCULAR | 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 |
|---|---|---|---|---|---|---|
| 9a44a271-73ba-497e-bbea-f7c57e84de6b | 90660f78-7f88-46b2-8cf9-0a339331e5b5 | 2012-11-15 | Warnings | 9a44a271-73ba-497e-bbea-f7c57e84de6b 90660f78-7f88-46b2-8cf9-0a339331e5b5 |
Adverse event summaries are temporarily unavailable. Other product information remains available.