Indications and uses
Helps prevent sunburn.
Helps prevent sunburn.
Apply liberally and evenly 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
Protect the product in this container from excessive heat and direct sun.
Drug Facts
| Active Ingredients | Purpose |
|---|---|
| AVOBENZONE 3.0% | Sunscreen |
| OCTISALATE 5.0% | Sunscreen |
| OCTOCRYLENE 3.0% | Sunscreen |
| OXYBENZONE 5.0% | Sunscreen |
AQUA (WATER), C12-15 ALKYL BENZOATE, CYCLOHEXASILOXANE, GLYCERIN, POTASSIUM CETYL PHOSPHATE, ALBIZIA JULIBRISSIN BARK EXTRACT, DIMETHICONE, GLYCERYL STEARATE, PENTYLENE GLYCOL, METHYL METHACRYLATE CROSSPOLYMER, HYDROGENATED PALM GLYCERIDES, PHENOXYETHANOL, XANTHAN GUM, C20-22 ALKYL PHOSPHATE, ACRYLATES/VINYL ISODECANOATE CROSSPOLYMER, PARFUM (FRAGRANCE), C20-22 ALCOHOLS, CHLORPHENESIN, HYDROLYZED CERATONIA SILIQUA SEED EXTRACT, ACACIA SENEGAL GUM, SODIUM HYDROXIDE, DISODIUM EDTA, OLIVE OIL AMINOPROPANEDIOL ESTERS, RASPBERRY SEED OIL/TOCOPHERYL SUCCINATE AMINOPROPANEDIOL ESTERS, HYDROXYPROPYL CYCLODEXTRIN, PALMITOYL TRIPEPTIDE-38
Distributed by Ventura Corporation, Ltd. San Juan, Puerto Rico 00926.
| Ingredient | Type | UNII | SPL version | Uploaded |
|---|---|---|---|---|
| Avobenzone | ACTIVE INGREDIENT | G63QQF2NOX | 1 | |
| Octisalate | ACTIVE INGREDIENT | 4X49Y0596W | 1 | |
| Octocrylene | ACTIVE INGREDIENT | 5A68WGF6WM | 1 | |
| Oxybenzone | ACTIVE INGREDIENT | 95OOS7VE0Y | 1 | |
| Avobenzone | ACTIVE MOIETY | G63QQF2NOX | 1 | |
| Octisalate | ACTIVE MOIETY | 4X49Y0596W | 1 | |
| Octocrylene | ACTIVE MOIETY | 5A68WGF6WM | 1 | |
| Oxybenzone | ACTIVE MOIETY | 95OOS7VE0Y | 1 | |
| ACACIA | INACTIVE INGREDIENT | 5C5403N26O | 1 | |
| ALBIZIA JULIBRISSIN BARK | INACTIVE INGREDIENT | 0J9G6W44DV | 1 | |
| ALKYL (C12-15) BENZOATE | INACTIVE INGREDIENT | A9EJ3J61HQ | 1 | |
| C20-22 ALCOHOLS | INACTIVE INGREDIENT | O4M0347C6A | 1 | |
| C20-22 ALKYL PHOSPHATE | INACTIVE INGREDIENT | L4VKP0Y7RP | 1 | |
| CHLORPHENESIN | INACTIVE INGREDIENT | I670DAL4SZ | 1 | |
| CYCLOMETHICONE 6 | INACTIVE INGREDIENT | XHK3U310BA | 1 | |
| DIMETHICONE | INACTIVE INGREDIENT | 92RU3N3Y1O | 1 | |
| EDETATE DISODIUM | INACTIVE INGREDIENT | 7FLD91C86K | 1 | |
| GLYCERIN | INACTIVE INGREDIENT | PDC6A3C0OX | 1 | |
| GLYCERYL MONOSTEARATE | INACTIVE INGREDIENT | 230OU9XXE4 | 1 | |
| HYDROGENATED PALM GLYCERIDES | INACTIVE INGREDIENT | YCZ8EM144Q | 1 | |
| PENTYLENE GLYCOL | INACTIVE INGREDIENT | 50C1307PZG | 1 | |
| PHENOXYETHANOL | INACTIVE INGREDIENT | HIE492ZZ3T | 1 | |
| POTASSIUM CETYL PHOSPHATE | INACTIVE INGREDIENT | 03KCY6P7UT | 1 | |
| SODIUM HYDROXIDE | INACTIVE INGREDIENT | 55X04QC32I | 1 | |
| WATER | INACTIVE INGREDIENT | 059QF0KO0R | 1 | |
| XANTHAN GUM | INACTIVE INGREDIENT | TTV12P4NEE | 1 |
Every source-derived product name is available through these pages.
| Product NDC | Package NDC |
|---|---|
| 13537-446 | 13537-446-01, 13537-446-03, 13537-446-04, 13537-446-05, 13537-446-06 |
Every source-derived ingredient row is available through these pages.
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 |
|---|---|---|---|---|---|---|
| SODIUM HYDROXIDE | SODIUM HYDROXIDE | 55X04QC32I | SWAB / TOPICAL | 0.01 %w/w | ||
| GLYCERYL MONOSTEARATE | GLYCERYL MONOSTEARATE | 230OU9XXE4 | CREAM / VAGINAL | 140 mg | ||
| SODIUM HYDROXIDE | SODIUM HYDROXIDE | 55X04QC32I | CAPSULE / ORAL | 60 mg | ||
| ACACIA | ACACIA | 5C5403N26O | TABLET / SUBLINGUAL | 9.1 mg | ||
| SODIUM HYDROXIDE | SODIUM HYDROXIDE | 55X04QC32I | SOLUTION / INTRAVENOUS | 2.78 %w/v | ||
| SODIUM HYDROXIDE | SODIUM HYDROXIDE | 55X04QC32I | SOLUTION / IRRIGATION | ADJ PH | ||
| XANTHAN GUM | XANTHAN GUM | TTV12P4NEE | SUSPENSION/ DROPS / ORAL | 22 mg | ||
| SODIUM HYDROXIDE | SODIUM HYDROXIDE | 55X04QC32I | GEL / TOPICAL | 70 mg | ||
| EDETATE DISODIUM | EDETATE DISODIUM | 7FLD91C86K | SYRUP / ORAL | 40 mg | ||
| GLYCERIN | GLYCERIN | PDC6A3C0OX | TABLET / PERIODONTAL | 0.53 mg | ||
| XANTHAN GUM | XANTHAN GUM | TTV12P4NEE | SOLUTION, GEL FORMING, EXTENDED RELEASE / OPHTHALMIC | 0.6 %w/w | ||
| GLYCERIN | GLYCERIN | PDC6A3C0OX | INJECTION, SOLUTION / INTRAVENOUS | 15 %w/v | ||
| ACACIA | ACACIA | 5C5403N26O | TABLET / BUCCAL | 9.1 mg | ||
| SODIUM HYDROXIDE | SODIUM HYDROXIDE | 55X04QC32I | INJECTION, SOLUTION / INTRAVESICAL | ADJ PH | ||
| GLYCERIN | GLYCERIN | PDC6A3C0OX | CREAM, AUGMENTED / TOPICAL | 55 mg | ||
| GLYCERIN | GLYCERIN | PDC6A3C0OX | SYSTEM / IONTOPHORESIS | 168.1 mg | ||
| EDETATE DISODIUM | EDETATE DISODIUM | 7FLD91C86K | TABLET / ORAL | 100 mg | ||
| SODIUM HYDROXIDE | SODIUM HYDROXIDE | 55X04QC32I | CREAM / TOPICAL | 69 mg | ||
| SODIUM HYDROXIDE | SODIUM HYDROXIDE | 55X04QC32I | SOLUTION / DENTAL | ADJ PH | ||
| SODIUM HYDROXIDE | SODIUM HYDROXIDE | 55X04QC32I | SOLUTION / RESPIRATORY (INHALATION) | 8 %w/v | ||
| SODIUM HYDROXIDE | SODIUM HYDROXIDE | 55X04QC32I | INJECTION / INTRAVASCULAR | ADJ PH | ||
| ACACIA | ACACIA | 5C5403N26O | SUSPENSION / ORAL | 2 mg | ||
| SODIUM HYDROXIDE | SODIUM HYDROXIDE | 55X04QC32I | INJECTION / RETROBULBAR | ADJ PH | ||
| GLYCERIN | GLYCERIN | PDC6A3C0OX | INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION / INTRAVENOUS | 225 mg | ||
| SODIUM HYDROXIDE | SODIUM HYDROXIDE | 55X04QC32I | INJECTION / INFILTRATION | ADJ PH | ||
| ACACIA | ACACIA | 5C5403N26O | SYRUP / ORAL | NA | ||
| SODIUM HYDROXIDE | SODIUM HYDROXIDE | 55X04QC32I | SUSPENSION, EXTENDED RELEASE / INTRADERMAL | ADJ PH | ||
| SODIUM HYDROXIDE | SODIUM HYDROXIDE | 55X04QC32I | SOLUTION / INTRAOCULAR | ADJ PH | ||
| SODIUM HYDROXIDE | SODIUM HYDROXIDE | 55X04QC32I | SOLUTION / URETHRAL | ADJ PH | ||
| XANTHAN GUM | XANTHAN GUM | TTV12P4NEE | TABLET, EXTENDED RELEASE / ORAL | 528 mg | ||
| SODIUM HYDROXIDE | SODIUM HYDROXIDE | 55X04QC32I | ENEMA / RECTAL | 0.44 %v/v | ||
| SODIUM HYDROXIDE | SODIUM HYDROXIDE | 55X04QC32I | INJECTION / INTERSTITIAL | ADJ PH | ||
| SODIUM HYDROXIDE | SODIUM HYDROXIDE | 55X04QC32I | SOLUTION / TOPICAL | 39 mg | ||
| GLYCERIN | GLYCERIN | PDC6A3C0OX | SOLUTION/ DROPS / AURICULAR (OTIC) | 25 mg | ||
| GLYCERIN | GLYCERIN | PDC6A3C0OX | CAPSULE, LIQUID FILLED / ORAL | 185 mg | ||
| SODIUM HYDROXIDE | SODIUM HYDROXIDE | 55X04QC32I | OINTMENT, AUGMENTED / TOPICAL | 0.11 %w/w | ||
| EDETATE DISODIUM | EDETATE DISODIUM | 7FLD91C86K | CAPSULE / ORAL | 5 mg | ||
| ACACIA | ACACIA | 5C5403N26O | TABLET / ORAL | 70 mg | ||
| GLYCERYL MONOSTEARATE | GLYCERYL MONOSTEARATE | 230OU9XXE4 | EMULSION / ORAL | NA | ||
| GLYCERIN | GLYCERIN | PDC6A3C0OX | FILM, EXTENDED RELEASE / TRANSDERMAL | 306.2 mg | ||
| GLYCERIN | GLYCERIN | PDC6A3C0OX | JELLY / VAGINAL | NA | ||
| SODIUM HYDROXIDE | SODIUM HYDROXIDE | 55X04QC32I | INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION / INTRATHECAL | ADJ PH | ||
| EDETATE DISODIUM | EDETATE DISODIUM | 7FLD91C86K | SOLUTION / NASAL | 100 mg/100ml | ||
| SODIUM HYDROXIDE | SODIUM HYDROXIDE | 55X04QC32I | INJECTION / DENTAL | ADJ PH | ||
| EDETATE DISODIUM | EDETATE DISODIUM | 7FLD91C86K | DROPS / AURICULAR (OTIC) | 0.05 %w/w | ||
| EDETATE DISODIUM | EDETATE DISODIUM | 7FLD91C86K | LIQUID / ORAL | 0.5 mg/1ml | ||
| SODIUM HYDROXIDE | SODIUM HYDROXIDE | 55X04QC32I | OINTMENT / TOPICAL | ADJ PH | ||
| SODIUM HYDROXIDE | SODIUM HYDROXIDE | 55X04QC32I | SUSPENSION/ DROPS / TOPICAL | ADJ PH | ||
| GLYCERIN | GLYCERIN | PDC6A3C0OX | LIQUID / TOPICAL | 2.5 %w/w | ||
| SODIUM HYDROXIDE | SODIUM HYDROXIDE | 55X04QC32I | EMULSION / TOPICAL | 0.2 %w/w | ||
| SODIUM HYDROXIDE | SODIUM HYDROXIDE | 55X04QC32I | LOTION / TOPICAL | 21 mg | ||
| SODIUM HYDROXIDE | SODIUM HYDROXIDE | 55X04QC32I | SOLUTION / AURICULAR (OTIC) | 0.8 %w/w | ||
| GLYCERIN | GLYCERIN | PDC6A3C0OX | LOTION / TOPICAL | 3990 mg | ||
| GLYCERIN | GLYCERIN | PDC6A3C0OX | EMULSION / INTRAVENOUS | 2.2 %w/v | ||
| SODIUM HYDROXIDE | SODIUM HYDROXIDE | 55X04QC32I | FILM, SOLUBLE / ORAL | 11 mg | ||
| SODIUM HYDROXIDE | SODIUM HYDROXIDE | 55X04QC32I | INJECTION, POWDER, FOR SOLUTION / SUBCUTANEOUS | ADJ PH | ||
| SODIUM HYDROXIDE | SODIUM HYDROXIDE | 55X04QC32I | INJECTION / PERIDURAL | ADJ PH | ||
| PHENOXYETHANOL | PHENOXYETHANOL | HIE492ZZ3T | LOTION / TOPICAL | 1 %w/w | ||
| EDETATE DISODIUM | EDETATE DISODIUM | 7FLD91C86K | INJECTION / INFILTRATION | 6 mg | ||
| SODIUM HYDROXIDE | SODIUM HYDROXIDE | 55X04QC32I | INJECTION / PARENTERAL | ADJ PH |
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 |
|---|---|---|---|---|---|---|
| 33891f3f-3b0d-7b77-e063-6394a90a969a | fe29e622-d25f-4f5a-be59-7df5662f4cd3 | 2025-04-24 | Warnings | fe29e622-d25f-4f5a-be59-7df5662f4cd3 |
Adverse event summaries are temporarily unavailable. Other product information remains available.