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 (3.00%) | Sunscreen |
| OCTINOXATE (3.00%) | Sunscreen |
| OCTISALATE (5.00%) | Sunscreen |
| OCTOCRYLENE (6.00%) | Sunscreen |
WATER, GLYCERIN, BUTYLENE GLYCOL, C12-15 ALKYL BENZOATE, GLYCERYL STEARATE, DIMETHICONE, CYCLOHEXASILOXANE, TAPIOCA STARCH, ISOPROPYL PALMITATE, TOCOPHERYL ACETATE, IMPERATA CYLINDRICA ROOT EXTRACT, PHENOXYETHANOL, ETHYLHEXYLGLYCERIN, CETYL ALCOHOL, ACRYLATES/C10-30 ALKYL ACRYLATE CROSSPOLYMER, XANTHAN GUM, PEG-75 STEARATE, CETEARYL ISONONANOATE, FRAGRANCE, DIMETHICONOL, METHYLPROPANEDIOL, CETEARETH-20, CETEARYL ALCOHOL, BHT, PEG- 8, TETRASODIUM EDTA, CETETH-20, SACCHAROMYCES LYSATE, STEARETH-20, SILANEDIOL SALICYLATE , SODIUM HYDROXIDE, TROMETHAMINE, METHYL PERFLUOROBUTYL ETHER, CARBOMER, ISODODECANE, CETEARETH-12, CETYL PALMITATE, DISODIUM SUCCINATE, GLUTAMIC ACID, GLYCINE, THREONINE, VALINE, POLYS ILICONE-11, DECYL GLUCOSIDE.
PUERTO RICO: Dist. by Ventura Corp, Ltd., San Juan,
Puerto Rico 00926.
| Ingredient | Type | UNII | SPL version | Uploaded |
|---|---|---|---|---|
| Avobenzone | ACTIVE INGREDIENT | G63QQF2NOX | 1 | |
| Octinoxate | ACTIVE INGREDIENT | 4Y5P7MUD51 | 1 | |
| Octisalate | ACTIVE INGREDIENT | 4X49Y0596W | 1 | |
| Octocrylene | ACTIVE INGREDIENT | 5A68WGF6WM | 1 | |
| Avobenzone | ACTIVE MOIETY | G63QQF2NOX | 1 | |
| Octinoxate | ACTIVE MOIETY | 4Y5P7MUD51 | 1 | |
| Octisalate | ACTIVE MOIETY | 4X49Y0596W | 1 | |
| Octocrylene | ACTIVE MOIETY | 5A68WGF6WM | 1 | |
| .ALPHA.-TOCOPHEROL ACETATE | INACTIVE INGREDIENT | 9E8X80D2L0 | 1 | |
| ALKYL (C12-15) BENZOATE | INACTIVE INGREDIENT | A9EJ3J61HQ | 1 | |
| BUTYLATED HYDROXYTOLUENE | INACTIVE INGREDIENT | 1P9D0Z171K | 1 | |
| BUTYLENE GLYCOL | INACTIVE INGREDIENT | 3XUS85K0RA | 1 | |
| CETEARETH-12 | INACTIVE INGREDIENT | 7V4MR24V5P | 1 | |
| CETEARYL ISONONANOATE | INACTIVE INGREDIENT | P5O01U99NI | 1 | |
| CETETH-20 | INACTIVE INGREDIENT | I835H2IHHX | 1 | |
| CETOSTEARYL ALCOHOL | INACTIVE INGREDIENT | 2DMT128M1S | 1 | |
| CETYL ALCOHOL | INACTIVE INGREDIENT | 936JST6JCN | 1 | |
| CETYL PALMITATE | INACTIVE INGREDIENT | 5ZA2S6B08X | 1 | |
| CYCLOMETHICONE 6 | INACTIVE INGREDIENT | XHK3U310BA | 1 | |
| DECYL GLUCOSIDE | INACTIVE INGREDIENT | Z17H97EA6Y | 1 | |
| DIMETHICONE | INACTIVE INGREDIENT | 92RU3N3Y1O | 1 | |
| EDETATE SODIUM | INACTIVE INGREDIENT | MP1J8420LU | 1 | |
| ETHYLHEXYLGLYCERIN | INACTIVE INGREDIENT | 147D247K3P | 1 | |
| GLUTAMIC ACID | INACTIVE INGREDIENT | 3KX376GY7L | 1 | |
| GLYCERIN | INACTIVE INGREDIENT | PDC6A3C0OX | 1 | |
| GLYCERYL MONOSTEARATE | INACTIVE INGREDIENT | 230OU9XXE4 | 1 | |
| GLYCINE | INACTIVE INGREDIENT | TE7660XO1C | 1 | |
| IMPERATA CYLINDRICA ROOT | INACTIVE INGREDIENT | VYT2JA85NH | 1 | |
| ISODODECANE | INACTIVE INGREDIENT | A8289P68Y2 | 1 | |
| ISOPROPYL PALMITATE | INACTIVE INGREDIENT | 8CRQ2TH63M | 1 | |
| METHYL PERFLUOROBUTYL ETHER | INACTIVE INGREDIENT | H637A50B7U | 1 | |
| METHYLPROPANEDIOL | INACTIVE INGREDIENT | N8F53B3R4R | 1 | |
| PEG-75 STEARATE | INACTIVE INGREDIENT | OT38R0N74H | 1 | |
| PHENOXYETHANOL | INACTIVE INGREDIENT | HIE492ZZ3T | 1 | |
| POLYETHYLENE GLYCOL 400 | INACTIVE INGREDIENT | B697894SGQ | 1 | |
| POLYOXYL 20 CETOSTEARYL ETHER | INACTIVE INGREDIENT | YRC528SWUY | 1 | |
| SACCHAROMYCES LYSATE | INACTIVE INGREDIENT | R85W246Z1C | 1 | |
| SILANEDIOL SALICYLATE | INACTIVE INGREDIENT | C054DF30K0 | 1 | |
| SODIUM HYDROXIDE | INACTIVE INGREDIENT | 55X04QC32I | 1 | |
| SODIUM SUCCINATE ANHYDROUS | INACTIVE INGREDIENT | V8ZGC8ISR3 | 1 | |
| STARCH, TAPIOCA | INACTIVE INGREDIENT | 24SC3U704I | 1 | |
| STEARETH-20 | INACTIVE INGREDIENT | L0Q8IK9E08 | 1 | |
| THREONINE | INACTIVE INGREDIENT | 2ZD004190S | 1 | |
| TROMETHAMINE | INACTIVE INGREDIENT | 023C2WHX2V | 1 | |
| VALINE | INACTIVE INGREDIENT | HG18B9YRS7 | 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 |
|---|---|
| 13537-641 | 13537-641-01, 13537-641-02, 13537-641-03, 13537-641-04, 13537-641-05, 13537-641-06, 13537-641-07, 13537-641-08 |
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 | INJECTION / INTRABURSAL | ADJ PH | ||
| EDETATE SODIUM | EDETATE SODIUM | MP1J8420LU | SOLUTION / OPHTHALMIC | 0.1 %w/v | ||
| SODIUM HYDROXIDE | SODIUM HYDROXIDE | 55X04QC32I | SHAMPOO / TOPICAL | 3 mg | ||
| SODIUM HYDROXIDE | SODIUM HYDROXIDE | 55X04QC32I | CREAM / VAGINAL | 0.19 %w/w | ||
| CETETH-20 | CETETH-20 | I835H2IHHX | CREAM / TOPICAL | 429 mg | ||
| SODIUM HYDROXIDE | SODIUM HYDROXIDE | 55X04QC32I | INJECTION / PERINEURAL | ADJ PH | ||
| GLYCERYL MONOSTEARATE | GLYCERYL MONOSTEARATE | 230OU9XXE4 | CAPSULE, DELAYED RELEASE / ORAL | 15 mg | ||
| SODIUM HYDROXIDE | SODIUM HYDROXIDE | 55X04QC32I | SOLUTION / ORAL | 9120 mg | ||
| SODIUM HYDROXIDE | SODIUM HYDROXIDE | 55X04QC32I | INJECTION, POWDER, FOR SOLUTION / RECTAL | ADJ PH | ||
| SODIUM HYDROXIDE | SODIUM HYDROXIDE | 55X04QC32I | ENEMA / RECTAL | 0.44 %v/v | ||
| VALINE | VALINE | HG18B9YRS7 | INJECTION, SOLUTION / INTRAVENOUS | 0.2 %w/v | ||
| TROMETHAMINE | TROMETHAMINE | 023C2WHX2V | SOLUTION / URETHRAL | 0.12 %w/v | ||
| SODIUM HYDROXIDE | SODIUM HYDROXIDE | 55X04QC32I | INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION / INTRAVENOUS | 78.36 mg | ||
| SODIUM HYDROXIDE | SODIUM HYDROXIDE | 55X04QC32I | INJECTION, SOLUTION / SUBCUTANEOUS | 1 %w/v | ||
| GLYCERIN | GLYCERIN | PDC6A3C0OX | FILM, EXTENDED RELEASE / BUCCAL | 34 mg | ||
| GLYCERIN | GLYCERIN | PDC6A3C0OX | CAPSULE / ORAL | 3487 mg | ||
| POLYETHYLENE GLYCOL 400 | POLYETHYLENE GLYCOL 400 | B697894SGQ | GEL / TOPICAL | 6300 mg | ||
| SODIUM HYDROXIDE | SODIUM HYDROXIDE | 55X04QC32I | SOLUTION / URETERAL | ADJ PH | ||
| POLYOXYL 20 CETOSTEARYL ETHER | POLYOXYL 20 CETOSTEARYL ETHER | YRC528SWUY | SUSPENSION / ORAL | 20 mg | ||
| SODIUM HYDROXIDE | SODIUM HYDROXIDE | 55X04QC32I | FILM, SOLUBLE / BUCCAL | 5 mg | ||
| ISOPROPYL PALMITATE | ISOPROPYL PALMITATE | 8CRQ2TH63M | LOTION / TOPICAL | 5 %w/w | ||
| GLYCERYL MONOSTEARATE | GLYCERYL MONOSTEARATE | 230OU9XXE4 | CAPSULE / ORAL | 13.75 mg | ||
| TROMETHAMINE | TROMETHAMINE | 023C2WHX2V | SOLUTION / ORAL | 1.21 mg/1ml | ||
| GLYCERIN | GLYCERIN | PDC6A3C0OX | INJECTION, SOLUTION / INTRAVENOUS | 15 %w/v | ||
| GLYCERIN | GLYCERIN | PDC6A3C0OX | CAPSULE, EXTENDED RELEASE / ORAL | 265 mg | ||
| SODIUM HYDROXIDE | SODIUM HYDROXIDE | 55X04QC32I | INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION / INTRATHECAL | ADJ PH | ||
| CETYL ALCOHOL | CETYL ALCOHOL | 936JST6JCN | CAPSULE, DELAYED RELEASE / ORAL | 59 mg | ||
| SODIUM HYDROXIDE | SODIUM HYDROXIDE | 55X04QC32I | SUSPENSION / SUBCUTANEOUS | ADJ PH | ||
| POLYETHYLENE GLYCOL 400 | POLYETHYLENE GLYCOL 400 | B697894SGQ | INJECTION, SOLUTION / INTRAMUSCULAR | 20.3 %w/v | ||
| XANTHAN GUM | XANTHAN GUM | TTV12P4NEE | CREAM / TOPICAL | 46 mg | ||
| SODIUM HYDROXIDE | SODIUM HYDROXIDE | 55X04QC32I | INJECTION / INTRACARDIAC | ADJ PH | ||
| SODIUM HYDROXIDE | SODIUM HYDROXIDE | 55X04QC32I | EMULSION / TOPICAL | 0.2 %w/w | ||
| SODIUM HYDROXIDE | SODIUM HYDROXIDE | 55X04QC32I | SOLUTION / TOPICAL | 39 mg | ||
| GLYCERIN | GLYCERIN | PDC6A3C0OX | OINTMENT / TOPICAL | NA | ||
| SODIUM HYDROXIDE | SODIUM HYDROXIDE | 55X04QC32I | INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION / INTRA-ARTERIAL | ADJ PH | ||
| CETOSTEARYL ALCOHOL | CETOSTEARYL ALCOHOL | 2DMT128M1S | CREAM / TOPICAL | 1428 mg | ||
| CETYL PALMITATE | CETYL PALMITATE | 5ZA2S6B08X | CREAM / TOPICAL | 0.32 %w/w | ||
| BUTYLATED HYDROXYTOLUENE | BUTYLATED HYDROXYTOLUENE | 1P9D0Z171K | TABLET, FOR SUSPENSION / ORAL | 0.1 mg | ||
| SODIUM HYDROXIDE | SODIUM HYDROXIDE | 55X04QC32I | INJECTION / INTRATUMOR | ADJ PH | ||
| CETOSTEARYL ALCOHOL | CETOSTEARYL ALCOHOL | 2DMT128M1S | SPRAY / TOPICAL | 1 %w/w | ||
| XANTHAN GUM | XANTHAN GUM | TTV12P4NEE | ENEMA / RECTAL | 150 mg | ||
| SODIUM HYDROXIDE | SODIUM HYDROXIDE | 55X04QC32I | INJECTION / INTRA-ARTICULAR | ADJ PH | ||
| CETYL ALCOHOL | CETYL ALCOHOL | 936JST6JCN | AEROSOL / TOPICAL | 1.16 %w/w | ||
| SODIUM HYDROXIDE | SODIUM HYDROXIDE | 55X04QC32I | INJECTION / INTRAPLEURAL | ADJ PH | ||
| XANTHAN GUM | XANTHAN GUM | TTV12P4NEE | SUSPENSION/ DROPS / ORAL | 22 mg | ||
| CETETH-20 | CETETH-20 | I835H2IHHX | LOTION / TOPICAL | 2 %w/w | ||
| EDETATE SODIUM | EDETATE SODIUM | MP1J8420LU | SOAP / TOPICAL | 0.12 %w/w | ||
| SODIUM HYDROXIDE | SODIUM HYDROXIDE | 55X04QC32I | INJECTION / INTERSTITIAL | ADJ PH | ||
| SODIUM HYDROXIDE | SODIUM HYDROXIDE | 55X04QC32I | POWDER / RESPIRATORY (INHALATION) | ADJ PH | ||
| CETYL ALCOHOL | CETYL ALCOHOL | 936JST6JCN | SOLUTION / TOPICAL | NA | ||
| POLYETHYLENE GLYCOL 400 | POLYETHYLENE GLYCOL 400 | B697894SGQ | CREAM / TOPICAL | 10 %w/w | ||
| TROMETHAMINE | TROMETHAMINE | 023C2WHX2V | INJECTION / INTRAVENOUS | 1134 mg | ||
| POLYETHYLENE GLYCOL 400 | POLYETHYLENE GLYCOL 400 | B697894SGQ | SOLUTION / ORAL | 70200 mg | ||
| ISOPROPYL PALMITATE | ISOPROPYL PALMITATE | 8CRQ2TH63M | FILM / TRANSDERMAL | 2 mg | ||
| SODIUM HYDROXIDE | SODIUM HYDROXIDE | 55X04QC32I | INJECTION / RETROBULBAR | ADJ PH | ||
| XANTHAN GUM | XANTHAN GUM | TTV12P4NEE | FILM, SOLUBLE / ORAL | 1 mg | ||
| GLYCERIN | GLYCERIN | PDC6A3C0OX | MOUTHWASH / BUCCAL | 100 mg/1ml | ||
| GLYCINE | GLYCINE | TE7660XO1C | TABLET, ORALLY DISINTEGRATING / ORAL | 60 mg | ||
| SODIUM HYDROXIDE | SODIUM HYDROXIDE | 55X04QC32I | INJECTION, SOLUTION / INTRAVESICAL | ADJ PH | ||
| XANTHAN GUM | XANTHAN GUM | TTV12P4NEE | TROCHE / ORAL | 948 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 |
|---|---|---|---|---|---|---|
| 303b9440-e4ab-9023-e063-6294a90a22d2 | b0906d23-8aa8-41bb-b133-320d5fa1e296 | 2025-03-13 | Warnings | b0906d23-8aa8-41bb-b133-320d5fa1e296 |
Adverse event summaries are temporarily unavailable. Other product information remains available.