OTC - ACTIVE INGREDIENT SECTION
Active ingredients
<Avobenzone 2%, Homosalate 10%, Octisalate 5%, Octocrylene 5%>
Active ingredients
<Avobenzone 2%, Homosalate 10%, Octisalate 5%, Octocrylene 5%>
Uses
Helps prevent sunburn.
Warnings
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. Stop use and ask a doctor if rash occurs.
Directions
Apply liberally 15 minutes before sun exposure. Reapply: after 80 minutes of swimming or sweating, immediately after towel drying, at least every 2 hours.
Sun Protection Measures: spending time in the sun increases your risk of skin cancer and early skin again. To decrease this risk, regularly use a sunscreen with a broad spectrum SPF of 15 or higher and other sun protection measures including: limit time in the sun, specially from 10am - 2pm, wear long-sleeve shirts, pants, hats, and sunglasses.
Children under 6 months: ask a doctor.
Inactive ingredients
Acrylates/C10-30 Alykl Acrylate Crosspolymer, Aloe Barbadensis Leaf Juice, Benzyl Alcohol, Bis-Stearyl Ethylenediamine/Neopentyl Glycol/Stearyl Hydrogenated Dimer Dilinoleate Copolymer, Carbomer, Cetyl Phosphate, Chlorphenesin, Dimethicone, Disodium EDTA, Ethylhexyl Palmitate, Fragrance, Sorbitol, Tocopherol, Triethanolamine, Water.
Purpose
Sunscreen.
Keep out of reach of children.
If swallowed, get medical help or contact a Poison Control Center right away.
Preferred Plus Pharmacy
Broad Spectrum SPF 15
Water Resistant (80 Minutes)
| NDC | Effective | Action | Document | Indexing SPL | Related label |
|---|---|---|---|---|---|
| 61715-023-08 | 2025-05-28 | C162847 | 48780-1 | 9d75b9d0-2f5c-f424-e053-dadaa90a57ce | Drug Facts |
| 61715-023-08 | 2020-01-31 | C162847 | 48780-1 | 9d75b9d0-2f5c-f424-e053-dadaa90a57ce | Drug Facts |
| Ingredient | Type | UNII | SPL version | Uploaded |
|---|---|---|---|---|
| AVOBENZONE | ACTIVE INGREDIENT | G63QQF2NOX | 1 | |
| HOMOSALATE | ACTIVE INGREDIENT | V06SV4M95S | 1 | |
| OCTISALATE | ACTIVE INGREDIENT | 4X49Y0596W | 1 | |
| OCTOCRYLENE | ACTIVE INGREDIENT | 5A68WGF6WM | 1 | |
| AVOBENZONE | ACTIVE MOIETY | G63QQF2NOX | 1 | |
| HOMOSALATE | ACTIVE MOIETY | V06SV4M95S | 1 | |
| OCTISALATE | ACTIVE MOIETY | 4X49Y0596W | 1 | |
| OCTOCRYLENE | ACTIVE MOIETY | 5A68WGF6WM | 1 | |
| ALOE VERA LEAF | INACTIVE INGREDIENT | ZY81Z83H0X | 1 | |
| BENZYL ALCOHOL | INACTIVE INGREDIENT | LKG8494WBH | 1 | |
| CARBOMER 1342 | INACTIVE INGREDIENT | 809Y72KV36 | 1 | |
| CARBOMER 940 | INACTIVE INGREDIENT | 4Q93RCW27E | 1 | |
| CETYL PHOSPHATE | INACTIVE INGREDIENT | VT07D6X67O | 1 | |
| CHLORPHENESIN | INACTIVE INGREDIENT | I670DAL4SZ | 1 | |
| EDETATE DISODIUM | INACTIVE INGREDIENT | 7FLD91C86K | 1 | |
| ETHYLHEXYL PALMITATE | INACTIVE INGREDIENT | 2865993309 | 1 | |
| SORBITOL | INACTIVE INGREDIENT | 506T60A25R | 1 | |
| TOCOPHEROL | INACTIVE INGREDIENT | R0ZB2556P8 | 1 | |
| WATER | INACTIVE INGREDIENT | 059QF0KO0R | 1 |
Every source-derived product name is available through these pages.
| Product NDC | Package NDC |
|---|---|
| 61715-023 | 61715-023-08 |
Every source-derived ingredient row is available through these pages.
| Name | UNII | Kind |
|---|---|---|
| AVOBENZONE | G63QQF2NOX | ACTIB |
| HOMOSALATE | V06SV4M95S | ACTIB |
| OCTISALATE | 4X49Y0596W | ACTIB |
| OCTOCRYLENE | 5A68WGF6WM | ACTIB |
| CARBOMER 1342 | 809Y72KV36 | IACT |
| ALOE VERA LEAF | ZY81Z83H0X | IACT |
| BENZYL ALCOHOL | LKG8494WBH | IACT |
| CARBOMER 940 | 4Q93RCW27E | IACT |
| CETYL PHOSPHATE | VT07D6X67O | IACT |
| CHLORPHENESIN | I670DAL4SZ | IACT |
| EDETATE DISODIUM | 7FLD91C86K | IACT |
| ETHYLHEXYL PALMITATE | 2865993309 | IACT |
| SORBITOL | 506T60A25R | IACT |
| TOCOPHEROL | R0ZB2556P8 | IACT |
| WATER | 059QF0KO0R | 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 |
|---|---|---|---|---|---|---|
| BENZYL ALCOHOL | BENZYL ALCOHOL | LKG8494WBH | INJECTION, SOLUTION / INTRAVENOUS | 400 mg | ||
| EDETATE DISODIUM | EDETATE DISODIUM | 7FLD91C86K | SOLUTION / NASAL | 100 mg/100ml | ||
| EDETATE DISODIUM | EDETATE DISODIUM | 7FLD91C86K | CREAM / VAGINAL | 3 mg | ||
| EDETATE DISODIUM | EDETATE DISODIUM | 7FLD91C86K | SPRAY / RESPIRATORY (INHALATION) | 0.05 %w/w | ||
| EDETATE DISODIUM | EDETATE DISODIUM | 7FLD91C86K | INJECTION / INTRAVENOUS | 10 %w/v | ||
| EDETATE DISODIUM | EDETATE DISODIUM | 7FLD91C86K | SOLUTION/ DROPS / OPHTHALMIC | 0.13 %w/v | ||
| EDETATE DISODIUM | EDETATE DISODIUM | 7FLD91C86K | INJECTION / INTRABURSAL | 0.01 %w/v | ||
| EDETATE DISODIUM | EDETATE DISODIUM | 7FLD91C86K | SPRAY / NASAL | 1 mg | ||
| EDETATE DISODIUM | EDETATE DISODIUM | 7FLD91C86K | LOTION / TOPICAL | 22 mg | ||
| EDETATE DISODIUM | EDETATE DISODIUM | 7FLD91C86K | INJECTION / SUBCUTANEOUS | 6 mg | ||
| BENZYL ALCOHOL | BENZYL ALCOHOL | LKG8494WBH | SUSPENSION / TOPICAL | 1 %w/w | ||
| EDETATE DISODIUM | EDETATE DISODIUM | 7FLD91C86K | INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION / INTRAVENOUS | 19 mg | ||
| SORBITOL | SORBITOL | 506T60A25R | SUSPENSION / ORAL | 45000 mg | ||
| EDETATE DISODIUM | EDETATE DISODIUM | 7FLD91C86K | INJECTION / INTRALESIONAL | 0.05 %w/v | ||
| EDETATE DISODIUM | EDETATE DISODIUM | 7FLD91C86K | EMULSION / OPHTHALMIC | 0.3 %w/v | ||
| EDETATE DISODIUM | EDETATE DISODIUM | 7FLD91C86K | INJECTION, SUSPENSION / INTRAMUSCULAR | 1 mg | ||
| BENZYL ALCOHOL | BENZYL ALCOHOL | LKG8494WBH | CREAM / TOPICAL | 160 mg | ||
| BENZYL ALCOHOL | BENZYL ALCOHOL | LKG8494WBH | INJECTION, SOLUTION / INTRAMUSCULAR | 500 mg | ||
| SORBITOL | SORBITOL | 506T60A25R | INJECTION / INTRAVENOUS | 1276 mg | ||
| SORBITOL | SORBITOL | 506T60A25R | OINTMENT / TOPICAL | 10 %w/w | ||
| CARBOMER 1342 | CARBOMER COPOLYMER TYPE B (ALLYL PENTAERYTHRITOL CROSSLINKED) | 809Y72KV36 | EMULSION / OPHTHALMIC | 0.05 %w/w | ||
| EDETATE DISODIUM | EDETATE DISODIUM | 7FLD91C86K | DROPS / OPHTHALMIC | 0.05 %w/v | ||
| EDETATE DISODIUM | EDETATE DISODIUM | 7FLD91C86K | GEL / OPHTHALMIC | 396 mg | ||
| SORBITOL | SORBITOL | 506T60A25R | TABLET, DELAYED RELEASE / ORAL | 0.01 mg | ||
| CARBOMER 940 | CARBOMER HOMOPOLYMER TYPE C (ALLYL PENTAERYTHRITOL CROSSLINKED) | 4Q93RCW27E | CREAM / TOPICAL | 103 mg | ||
| BENZYL ALCOHOL | BENZYL ALCOHOL | LKG8494WBH | INJECTION, SOLUTION / SUBCUTANEOUS | 0.95 %w/v | ||
| EDETATE DISODIUM | EDETATE DISODIUM | 7FLD91C86K | TABLET, CHEWABLE / ORAL | 1 mg | ||
| SORBITOL | SORBITOL | 506T60A25R | SYSTEM / TOPICAL | 6300 mg | ||
| BENZYL ALCOHOL | BENZYL ALCOHOL | LKG8494WBH | SUPPOSITORY / RECTAL | 129 mg | ||
| EDETATE DISODIUM | EDETATE DISODIUM | 7FLD91C86K | SOLUTION / ORAL | 432 mg | ||
| SORBITOL | SORBITOL | 506T60A25R | INJECTION / INTRAMUSCULAR | NA | ||
| SORBITOL | SORBITOL | 506T60A25R | TABLET / SUBLINGUAL | 50.5 mg | ||
| SORBITOL | SORBITOL | 506T60A25R | SOLUTION / ORAL | 29268 mg | ||
| CARBOMER 1342 | CARBOMER COPOLYMER TYPE B (ALLYL PENTAERYTHRITOL CROSSLINKED) | 809Y72KV36 | LOTION / TOPICAL | 29 mg | ||
| BENZYL ALCOHOL | BENZYL ALCOHOL | LKG8494WBH | SPRAY, METERED / NASAL | 5 mg/1ml | ||
| EDETATE DISODIUM | EDETATE DISODIUM | 7FLD91C86K | TABLET, ORALLY DISINTEGRATING / ORAL | 3 mg | ||
| SORBITOL | SORBITOL | 506T60A25R | EMULSION / TOPICAL | 7 %w/w | ||
| EDETATE DISODIUM | EDETATE DISODIUM | 7FLD91C86K | GEL / VAGINAL | 5 mg | ||
| EDETATE DISODIUM | EDETATE DISODIUM | 7FLD91C86K | SUSPENSION/ DROPS / AURICULAR (OTIC) | 0.01 %w/v | ||
| BENZYL ALCOHOL | BENZYL ALCOHOL | LKG8494WBH | SOLUTION / TOPICAL | 2 %w/w | ||
| BENZYL ALCOHOL | BENZYL ALCOHOL | LKG8494WBH | INJECTION, SOLUTION / INTRA-ARTICULAR | 23 mg | ||
| BENZYL ALCOHOL | BENZYL ALCOHOL | LKG8494WBH | INJECTION, POWDER, FOR SOLUTION / INTRAVENOUS | 144 mg | ||
| BENZYL ALCOHOL | BENZYL ALCOHOL | LKG8494WBH | INJECTION, SUSPENSION / SOFT TISSUE | 40 mg | ||
| BENZYL ALCOHOL | BENZYL ALCOHOL | LKG8494WBH | CAPSULE, EXTENDED RELEASE / ORAL | 1.23 mg | ||
| CARBOMER 940 | CARBOMER HOMOPOLYMER TYPE C (ALLYL PENTAERYTHRITOL CROSSLINKED) | 4Q93RCW27E | EMULSION / TOPICAL | 6 mg | ||
| CARBOMER 1342 | CARBOMER COPOLYMER TYPE B (ALLYL PENTAERYTHRITOL CROSSLINKED) | 809Y72KV36 | CREAM / TOPICAL | 2 mg | ||
| TOCOPHEROL | TOCOPHEROL | R0ZB2556P8 | TABLET / ORAL | 0.08 mg | ||
| BENZYL ALCOHOL | BENZYL ALCOHOL | LKG8494WBH | INJECTION, SUSPENSION / INTRA-ARTICULAR | 40 mg | ||
| SORBITOL | SORBITOL | 506T60A25R | POWDER / ORAL | 36000 mg | ||
| BENZYL ALCOHOL | BENZYL ALCOHOL | LKG8494WBH | INJECTION / INTRACAVITARY | 0.01 ml | ||
| SORBITOL | SORBITOL | 506T60A25R | INJECTION, SOLUTION / SUBCUTANEOUS | 4.7 %w/v | ||
| BENZYL ALCOHOL | BENZYL ALCOHOL | LKG8494WBH | INJECTION, EMULSION / SUBCUTANEOUS | 225 mg | ||
| BENZYL ALCOHOL | BENZYL ALCOHOL | LKG8494WBH | INJECTION / ENDOTRACHEAL | 54 mg | ||
| SORBITOL | SORBITOL | 506T60A25R | TABLET, EXTENDED RELEASE / ORAL | 428 mg | ||
| SORBITOL | SORBITOL | 506T60A25R | CAPSULE / ORAL | 1111 mg | ||
| EDETATE DISODIUM | EDETATE DISODIUM | 7FLD91C86K | SHAMPOO, SUSPENSION / TOPICAL | 1 %w/w | ||
| BENZYL ALCOHOL | BENZYL ALCOHOL | LKG8494WBH | CREAM / VAGINAL | 1 %w/w | ||
| CARBOMER 1342 | CARBOMER COPOLYMER TYPE B (ALLYL PENTAERYTHRITOL CROSSLINKED) | 809Y72KV36 | GEL / TRANSDERMAL | 30 mg | ||
| EDETATE DISODIUM | EDETATE DISODIUM | 7FLD91C86K | LIQUID / NASAL | 2 mg/1ml | ||
| EDETATE DISODIUM | EDETATE DISODIUM | 7FLD91C86K | AEROSOL, FOAM / RECTAL | 2 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 |
|---|---|---|---|---|---|---|
| e76f216d-9fa8-48ce-8646-c2a076051ca1 | d6958759-73aa-4841-96f1-47943bb29c74 | 2025-05-27 | Warnings | d6958759-73aa-4841-96f1-47943bb29c74 |
Adverse event summaries are temporarily unavailable. Other product information remains available.