OTC - ACTIVE INGREDIENT SECTION
ACTIVE INGREDIENTS:
AVOBENZONE (3%)
HOMOSALATE (5%)
OCTINOXATE (6%)
OCTISALATE (5%)
OCTOCRYLENE (10%)
ACTIVE INGREDIENTS:
AVOBENZONE (3%)
HOMOSALATE (5%)
OCTINOXATE (6%)
OCTISALATE (5%)
OCTOCRYLENE (10%)
PURPOSE:
SUNSCREEN
INDICATIONS:
HELPS PREVENT SUNBURN
DIRECTIONS:
APPLY LIBERALLY 15 MINUTES BEFORE SUN EXPOSURE.
REAPPLY: AFTER 40 MINUTES OF SWIMMING OR SWEATING; IMMEDIATELY AFTER TOWEL DRYING; AT LEAST EVERY 2 HOURS.
KEEP OUT OF REACH OF CHILDREN.
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. KEEP OUT OF REACH OF CHILDREN. IF PRODUCT IS SWALLOWED, GET MEDICAL HELP OR CONTACT A POISON CONTROL CENTER RIGHT AWAY.
Other Ingredients:
ACRYLATES/C10-30 ALKYL ACRYLATE CROSSPOLYMER, ALLANTOIN, ALOE BARBADENSIS LEAF JUICE, ALUMINUM STARCH OCTENYLSUCCINATE, BUTYLOCTYL SALICYLATE, C12-15 ALKYL BENZOATE, CAMELLIA SINENSIS LEAF EXTRACT, CARBOMER, IODOPROPYNYL BUTYLCARBAMATE, ISODECYL DEOPENTANOATE, METHYLISOTHIAZOLINONE, PHENOXYETHANOL, POLYETHYLENE, POLYSORBATE 20, PROPANEDIOL, SORBITOL, THEOBROMA CACAO (COCOA) SEED BUTTER, TOCOPHERYL ACETATE, TRIETHANOLAMINE, TRISODIUM ETHYLENEDIAMINE DISUCCINATE, WATER
| Ingredient | Type | UNII | SPL version | Uploaded |
|---|---|---|---|---|
| AVOBENZONE | ACTIVE INGREDIENT | G63QQF2NOX | 2 | |
| HOMOSALATE | ACTIVE INGREDIENT | V06SV4M95S | 2 | |
| OCTINOXATE | ACTIVE INGREDIENT | 4Y5P7MUD51 | 2 | |
| OCTISALATE | ACTIVE INGREDIENT | 4X49Y0596W | 2 | |
| OCTOCRYLENE | ACTIVE INGREDIENT | 5A68WGF6WM | 2 | |
| AVOBENZONE | ACTIVE MOIETY | G63QQF2NOX | 2 | |
| HOMOSALATE | ACTIVE MOIETY | V06SV4M95S | 2 | |
| OCTINOXATE | ACTIVE MOIETY | 4Y5P7MUD51 | 2 | |
| OCTISALATE | ACTIVE MOIETY | 4X49Y0596W | 2 | |
| OCTOCRYLENE | ACTIVE MOIETY | 5A68WGF6WM | 2 | |
| .ALPHA.-TOCOPHEROL ACETATE | INACTIVE INGREDIENT | 9E8X80D2L0 | 2 | |
| 3-BUTYLPHTHALIDE | INACTIVE INGREDIENT | 822Q956KGM | 2 | |
| ALLANTOIN | INACTIVE INGREDIENT | 344S277G0Z | 2 | |
| ALOE VERA LEAF | INACTIVE INGREDIENT | ZY81Z83H0X | 2 | |
| ALUMINUM STARCH OCTENYLSUCCINATE | INACTIVE INGREDIENT | I9PJ0O6294 | 2 | |
| C12-15 ALKYL BENZOATE | INACTIVE INGREDIENT | A9EJ3J61HQ | 2 | |
| CAMELLIA SINENSIS WHOLE | INACTIVE INGREDIENT | C5M4585ZBZ | 2 | |
| CARBOMER 940 | INACTIVE INGREDIENT | 4Q93RCW27E | 2 | |
| CARBOMER INTERPOLYMER TYPE A (55000 CPS) | INACTIVE INGREDIENT | 59TL3WG5CO | 2 | |
| COCOA BUTTER | INACTIVE INGREDIENT | 512OYT1CRR | 2 | |
| HIGH DENSITY POLYETHYLENE | INACTIVE INGREDIENT | UG00KM4WR7 | 2 | |
| ISODECYL NEOPENTANOATE | INACTIVE INGREDIENT | W60VYE24XC | 2 | |
| ISOPROPYLPHTHALIMIDE | INACTIVE INGREDIENT | 1J1MM83329 | 2 | |
| METHYLISOTHIAZOLINONE | INACTIVE INGREDIENT | 229D0E1QFA | 2 | |
| PHENOXYETHANOL | INACTIVE INGREDIENT | HIE492ZZ3T | 2 | |
| POLYETHYLENE GLYCOL 400 | INACTIVE INGREDIENT | B697894SGQ | 2 | |
| POLYSORBATE 20 | INACTIVE INGREDIENT | 7T1F30V5YH | 2 | |
| PROPANEDIOL | INACTIVE INGREDIENT | 5965N8W85T | 2 | |
| SORBITOL | INACTIVE INGREDIENT | 506T60A25R | 2 | |
| TRISODIUM ETHYLENEDIAMINE DISUCCINATE | INACTIVE INGREDIENT | YA22H34H9Q | 2 | |
| TROLAMINE | INACTIVE INGREDIENT | 9O3K93S3TK | 2 | |
| WATER | INACTIVE INGREDIENT | 059QF0KO0R | 2 |
Every source-derived product name is available through these pages.
| Product NDC | Package NDC |
|---|---|
| 61477-203 | 61477-203-16 |
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 |
|---|---|---|---|---|---|---|
| HIGH DENSITY POLYETHYLENE | HIGH DENSITY POLYETHYLENE | UG00KM4WR7 | SUPPOSITORY / VAGINAL | NA | ||
| HIGH DENSITY POLYETHYLENE | HIGH DENSITY POLYETHYLENE | UG00KM4WR7 | FILM, EXTENDED RELEASE / TRANSDERMAL | 85 mg | ||
| PHENOXYETHANOL | PHENOXYETHANOL | HIE492ZZ3T | LOTION / TOPICAL | 1 %w/w | ||
| TROLAMINE | TROLAMINE | 9O3K93S3TK | CREAM / VAGINAL | 56 mg | ||
| SORBITOL | SORBITOL | 506T60A25R | INJECTION / INTRALESIONAL | 45 %w/v | ||
| POLYETHYLENE GLYCOL 400 | POLYETHYLENE GLYCOL 400 | B697894SGQ | TABLET, FILM COATED, EXTENDED RELEASE / ORAL | 2 mg | ||
| SORBITOL | SORBITOL | 506T60A25R | SUSPENSION / RECTAL | 46.18 %w/v | ||
| POLYETHYLENE GLYCOL 400 | POLYETHYLENE GLYCOL 400 | B697894SGQ | OINTMENT / TOPICAL | 1950 mg | ||
| TROLAMINE | TROLAMINE | 9O3K93S3TK | INJECTION, POWDER, FOR SUSPENSION / INTRAVENOUS | 0.02 %w/v | ||
| SORBITOL | SORBITOL | 506T60A25R | ELIXIR / ORAL | 833.3 mg | ||
| PHENOXYETHANOL | PHENOXYETHANOL | HIE492ZZ3T | AEROSOL, FOAM / TOPICAL | 72 mg | ||
| SORBITOL | SORBITOL | 506T60A25R | CREAM, AUGMENTED / TOPICAL | 15 %w/w | ||
| ALLANTOIN | ALLANTOIN | 344S277G0Z | GEL / TOPICAL | 8 mg | ||
| POLYETHYLENE GLYCOL 400 | POLYETHYLENE GLYCOL 400 | B697894SGQ | CREAM / TOPICAL | 10 %w/w | ||
| SORBITOL | SORBITOL | 506T60A25R | SUSPENSION / ORAL | 45000 mg | ||
| PHENOXYETHANOL | PHENOXYETHANOL | HIE492ZZ3T | GEL / TOPICAL | 14 mg | ||
| SORBITOL | SORBITOL | 506T60A25R | TABLET / ORAL | 337.28 mg | ||
| POLYSORBATE 20 | POLYSORBATE 20 | 7T1F30V5YH | CREAM / TOPICAL | 108 mg | ||
| POLYETHYLENE GLYCOL 400 | POLYETHYLENE GLYCOL 400 | B697894SGQ | SUPPOSITORY / VAGINAL | 30 mg | ||
| POLYSORBATE 20 | POLYSORBATE 20 | 7T1F30V5YH | INJECTION, SUSPENSION, EXTENDED RELEASE / INTRAMUSCULAR | 60 mg | ||
| SORBITOL | SORBITOL | 506T60A25R | TABLET, DELAYED RELEASE / ORAL | 0.01 mg | ||
| POLYETHYLENE GLYCOL 400 | POLYETHYLENE GLYCOL 400 | B697894SGQ | LOTION / TOPICAL | 5 %w/w | ||
| POLYSORBATE 20 | POLYSORBATE 20 | 7T1F30V5YH | AEROSOL, FOAM / TOPICAL | 3.7 %w/w | ||
| POLYETHYLENE GLYCOL 400 | POLYETHYLENE GLYCOL 400 | B697894SGQ | SPRAY, METERED / NASAL | 320 mg | ||
| POLYSORBATE 20 | POLYSORBATE 20 | 7T1F30V5YH | INJECTION, POWDER, FOR SOLUTION / INTRAVENOUS | NA | ||
| POLYSORBATE 20 | POLYSORBATE 20 | 7T1F30V5YH | TAMPON / VAGINAL | 64.8 mg | ||
| POLYSORBATE 20 | POLYSORBATE 20 | 7T1F30V5YH | SHAMPOO / TOPICAL | 8 %w/w | ||
| SORBITOL | SORBITOL | 506T60A25R | SOLUTION/ DROPS / OPHTHALMIC | 0.25 %w/v | ||
| SORBITOL | SORBITOL | 506T60A25R | OINTMENT / TOPICAL | 10 %w/w | ||
| POLYETHYLENE GLYCOL 400 | POLYETHYLENE GLYCOL 400 | B697894SGQ | GEL / VAGINAL | 1250 mg | ||
| TROLAMINE | TROLAMINE | 9O3K93S3TK | GEL / TOPICAL | 6 mg | ||
| POLYETHYLENE GLYCOL 400 | POLYETHYLENE GLYCOL 400 | B697894SGQ | SOLUTION / TOPICAL | 11100 mg | ||
| HIGH DENSITY POLYETHYLENE | HIGH DENSITY POLYETHYLENE | UG00KM4WR7 | PASTE / DENTAL | 60 mg | ||
| CARBOMER 940 | CARBOMER HOMOPOLYMER TYPE C (ALLYL PENTAERYTHRITOL CROSSLINKED) | 4Q93RCW27E | OINTMENT, AUGMENTED / TOPICAL | 23 mg | ||
| TROLAMINE | TROLAMINE | 9O3K93S3TK | SPRAY / NASAL | NA | ||
| SORBITOL | SORBITOL | 506T60A25R | CAPSULE / ORAL | 1111 mg | ||
| TROLAMINE | TROLAMINE | 9O3K93S3TK | DROPS / NASAL | NA | ||
| TROLAMINE | TROLAMINE | 9O3K93S3TK | AEROSOL, METERED / RECTAL | ADJ PH | ||
| SORBITOL | SORBITOL | 506T60A25R | INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION / INTRAVENOUS | 1.04 %w/v | ||
| SORBITOL | SORBITOL | 506T60A25R | POWDER / ORAL | 36000 mg | ||
| POLYETHYLENE GLYCOL 400 | POLYETHYLENE GLYCOL 400 | B697894SGQ | LIQUID / TOPICAL | 1 %w/w | ||
| POLYSORBATE 20 | POLYSORBATE 20 | 7T1F30V5YH | TABLET / ORAL | 17 mg | ||
| POLYETHYLENE GLYCOL 400 | POLYETHYLENE GLYCOL 400 | B697894SGQ | INJECTION, SOLUTION / INTRAMUSCULAR | 20.3 %w/v | ||
| POLYSORBATE 20 | POLYSORBATE 20 | 7T1F30V5YH | CAPSULE / ORAL | 563 mg | ||
| HIGH DENSITY POLYETHYLENE | HIGH DENSITY POLYETHYLENE | UG00KM4WR7 | OINTMENT / OPHTHALMIC | NA | ||
| SORBITOL | SORBITOL | 506T60A25R | TABLET, COATED / ORAL | 12.96 mg | ||
| POLYETHYLENE GLYCOL 400 | POLYETHYLENE GLYCOL 400 | B697894SGQ | CONCENTRATE / ORAL | 3000 mg | ||
| POLYETHYLENE GLYCOL 400 | POLYETHYLENE GLYCOL 400 | B697894SGQ | CAPSULE, LIQUID FILLED / ORAL | 1122 mg | ||
| POLYETHYLENE GLYCOL 400 | POLYETHYLENE GLYCOL 400 | B697894SGQ | SYRUP / ORAL | 740 mg | ||
| SORBITOL | SORBITOL | 506T60A25R | SOLUTION / ORAL | 29268 mg | ||
| SORBITOL | SORBITOL | 506T60A25R | INJECTION / INTRAVENOUS | 1276 mg | ||
| POLYSORBATE 20 | POLYSORBATE 20 | 7T1F30V5YH | AEROSOL, FOAM / VAGINAL | 3 %w/w | ||
| TROLAMINE | TROLAMINE | 9O3K93S3TK | SOLUTION / NASAL | NA | ||
| TROLAMINE | TROLAMINE | 9O3K93S3TK | SOAP / TOPICAL | 0.08 %w/w | ||
| TROLAMINE | TROLAMINE | 9O3K93S3TK | POWDER / TOPICAL | 0.02 mg/mg | ||
| POLYETHYLENE GLYCOL 400 | POLYETHYLENE GLYCOL 400 | B697894SGQ | TABLET, DELAYED RELEASE / ORAL | 35 mg | ||
| CARBOMER 940 | CARBOMER HOMOPOLYMER TYPE C (ALLYL PENTAERYTHRITOL CROSSLINKED) | 4Q93RCW27E | CREAM / TOPICAL | 103 mg | ||
| TROLAMINE | TROLAMINE | 9O3K93S3TK | GEL, METERED / TRANSDERMAL | 14 mg | ||
| SORBITOL | SORBITOL | 506T60A25R | TABLET, EXTENDED RELEASE / ORAL | 428 mg | ||
| SORBITOL | SORBITOL | 506T60A25R | INJECTION / SUBCUTANEOUS | 4.7 %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 |
|---|---|---|---|---|---|---|
| 114a5cb2-4085-3c3d-e063-6294a90a777d | 625ba6d7-e8ba-44bf-89d5-4530a232fa54 | 2024-02-13 | Warnings | 625ba6d7-e8ba-44bf-89d5-4530a232fa54 |
Adverse event summaries are temporarily unavailable. Other product information remains available.