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 ACRYLATES CROSSPOLYMER, ALLANTOIN, ALOE BARBADENSIS LEAF JUICE, ALUMINUM STARCH OCTENYLSUCCINATE, BUTYLOCTYL SALICYLATE, C12-15 ALKYL BENZOATE, CAMELLIA SINENSIS LEAF EXTRACT, CARBOMER, IODOPROPYNYL BUTYLCARBAMATE, ISODECYL NEOPENTANOATE, 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 | |
| ALLANTOIN | INACTIVE INGREDIENT | 344S277G0Z | 2 | |
| ALOE VERA LEAF | INACTIVE INGREDIENT | ZY81Z83H0X | 2 | |
| ALUMINUM STARCH OCTENYLSUCCINATE | INACTIVE INGREDIENT | I9PJ0O6294 | 2 | |
| BUTYLOCTYL SALICYLATE | INACTIVE INGREDIENT | 2EH13UN8D3 | 2 | |
| C12-15 ALKYL BENZOATE | INACTIVE INGREDIENT | A9EJ3J61HQ | 2 | |
| CAMELLIA SINENSIS WHOLE | INACTIVE INGREDIENT | C5M4585ZBZ | 2 | |
| CARBOMER 934 | INACTIVE INGREDIENT | Z135WT9208 | 2 | |
| CARBOMER COPOLYMER TYPE A | INACTIVE INGREDIENT | 71DD5V995L | 2 | |
| COCOA BUTTER | INACTIVE INGREDIENT | 512OYT1CRR | 2 | |
| HIGH DENSITY POLYETHYLENE | INACTIVE INGREDIENT | UG00KM4WR7 | 2 | |
| IODOPROPYNYL BUTYLCARBAMATE | INACTIVE INGREDIENT | 603P14DHEB | 2 | |
| ISODECYL NEOPENTANOATE | INACTIVE INGREDIENT | W60VYE24XC | 2 | |
| METHYLISOTHIAZOLINONE | INACTIVE INGREDIENT | 229D0E1QFA | 2 | |
| PHENOXYETHANOL | INACTIVE INGREDIENT | HIE492ZZ3T | 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 |
|---|---|
| 61477-205 | 61477-205-14 |
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 |
|---|---|---|---|---|---|---|
| SORBITOL | SORBITOL | 506T60A25R | CAPSULE / ORAL | 1111 mg | ||
| TROLAMINE | TROLAMINE | 9O3K93S3TK | LIQUID / TOPICAL | NA | ||
| POLYSORBATE 20 | POLYSORBATE 20 | 7T1F30V5YH | GEL / TOPICAL | 5 %w/w | ||
| HIGH DENSITY POLYETHYLENE | HIGH DENSITY POLYETHYLENE | UG00KM4WR7 | SUPPOSITORY / RECTAL | NA | ||
| HIGH DENSITY POLYETHYLENE | HIGH DENSITY POLYETHYLENE | UG00KM4WR7 | SYSTEM / TRANSDERMAL | NA | ||
| SORBITOL | SORBITOL | 506T60A25R | TABLET, COATED / ORAL | 12.96 mg | ||
| CARBOMER 934 | CARBOMER HOMOPOLYMER TYPE B (ALLYL SUCROSE CROSSLINKED) | Z135WT9208 | OINTMENT / TOPICAL | 0.5 %w/w | ||
| CARBOMER 934 | CARBOMER HOMOPOLYMER TYPE B (ALLYL SUCROSE CROSSLINKED) | Z135WT9208 | CREAM / TOPICAL | 600 mg | ||
| CARBOMER COPOLYMER TYPE A | CARBOMER COPOLYMER TYPE A (ALLYL PENTAERYTHRITOL CROSSLINKED) | 71DD5V995L | LOTION / TOPICAL | 21 mg | ||
| TROLAMINE | TROLAMINE | 9O3K93S3TK | SPRAY / NASAL | NA | ||
| HIGH DENSITY POLYETHYLENE | HIGH DENSITY POLYETHYLENE | UG00KM4WR7 | TABLET / ORAL | 50 mg | ||
| SORBITOL | SORBITOL | 506T60A25R | SOLUTION / NASAL | 25 mg/1ml | ||
| POLYSORBATE 20 | POLYSORBATE 20 | 7T1F30V5YH | INJECTION, SOLUTION / INTRAVENOUS | 30 mg | ||
| SORBITOL | SORBITOL | 506T60A25R | INJECTION / INTRALESIONAL | 45 %w/v | ||
| ALUMINUM STARCH OCTENYLSUCCINATE | ALUMINUM STARCH OCTENYLSUCCINATE | I9PJ0O6294 | CREAM / TOPICAL | 321 mg | ||
| POLYSORBATE 20 | POLYSORBATE 20 | 7T1F30V5YH | TABLET, FILM COATED / ORAL | 0.35 mg | ||
| POLYSORBATE 20 | POLYSORBATE 20 | 7T1F30V5YH | CLOTH / TOPICAL | NA | ||
| POLYSORBATE 20 | POLYSORBATE 20 | 7T1F30V5YH | EMULSION / TOPICAL | 2 %w/w | ||
| COCOA BUTTER | COCOA BUTTER | 512OYT1CRR | SUPPOSITORY / RECTAL | 2280 mg | ||
| POLYSORBATE 20 | POLYSORBATE 20 | 7T1F30V5YH | INJECTION, SOLUTION / SUBCUTANEOUS | NA | ||
| POLYSORBATE 20 | POLYSORBATE 20 | 7T1F30V5YH | SUSPENSION / ORAL | 80 mg | ||
| POLYSORBATE 20 | POLYSORBATE 20 | 7T1F30V5YH | TABLET / ORAL | 17 mg | ||
| SORBITOL | SORBITOL | 506T60A25R | OINTMENT / TOPICAL | 10 %w/w | ||
| SORBITOL | SORBITOL | 506T60A25R | SOLUTION / OPHTHALMIC | 6 mg | ||
| SORBITOL | SORBITOL | 506T60A25R | INJECTION / INTRAVENOUS | 1276 mg | ||
| POLYSORBATE 20 | POLYSORBATE 20 | 7T1F30V5YH | CAPSULE / ORAL | 563 mg | ||
| HIGH DENSITY POLYETHYLENE | HIGH DENSITY POLYETHYLENE | UG00KM4WR7 | PASTE / TOPICAL | 2.5 %w/w | ||
| TROLAMINE | TROLAMINE | 9O3K93S3TK | INJECTION, POWDER, FOR SUSPENSION / INTRAVENOUS | 0.02 %w/v | ||
| CARBOMER 934 | CARBOMER HOMOPOLYMER TYPE B (ALLYL SUCROSE CROSSLINKED) | Z135WT9208 | TABLET, EXTENDED RELEASE / ORAL | 90 mg | ||
| POLYSORBATE 20 | POLYSORBATE 20 | 7T1F30V5YH | INJECTION, SUSPENSION, EXTENDED RELEASE / INTRAMUSCULAR | 60 mg | ||
| HIGH DENSITY POLYETHYLENE | HIGH DENSITY POLYETHYLENE | UG00KM4WR7 | CREAM / TOPICAL | 54.5 %w/w | ||
| POLYSORBATE 20 | POLYSORBATE 20 | 7T1F30V5YH | SUPPOSITORY / VAGINAL | NA | ||
| SORBITOL | SORBITOL | 506T60A25R | SUSPENSION / ORAL | 45000 mg | ||
| PHENOXYETHANOL | PHENOXYETHANOL | HIE492ZZ3T | AEROSOL / TOPICAL | 1.05 %w/w | ||
| PHENOXYETHANOL | PHENOXYETHANOL | HIE492ZZ3T | CREAM / TOPICAL | 57 mg | ||
| CARBOMER COPOLYMER TYPE A | CARBOMER COPOLYMER TYPE A (ALLYL PENTAERYTHRITOL CROSSLINKED) | 71DD5V995L | EMULSION / OPHTHALMIC | 0.05 %w/v | ||
| SORBITOL | SORBITOL | 506T60A25R | LOTION / TOPICAL | 10.7 %w/w | ||
| SORBITOL | SORBITOL | 506T60A25R | SOLUTION/ DROPS / OPHTHALMIC | 0.25 %w/v | ||
| POLYSORBATE 20 | POLYSORBATE 20 | 7T1F30V5YH | INJECTION, POWDER, FOR SOLUTION / INTRAVENOUS | NA | ||
| HIGH DENSITY POLYETHYLENE | HIGH DENSITY POLYETHYLENE | UG00KM4WR7 | JELLY / VAGINAL | 42.6 %w/w | ||
| ALLANTOIN | ALLANTOIN | 344S277G0Z | GEL / TOPICAL | 8 mg | ||
| SORBITOL | SORBITOL | 506T60A25R | TABLET, CHEWABLE / ORAL | 3555 mg | ||
| SORBITOL | SORBITOL | 506T60A25R | SUSPENSION / RECTAL | 46.18 %w/v | ||
| TROLAMINE | TROLAMINE | 9O3K93S3TK | DROPS / NASAL | NA | ||
| POLYSORBATE 20 | POLYSORBATE 20 | 7T1F30V5YH | SOLUTION / TOPICAL | 15 %w/w | ||
| TROLAMINE | TROLAMINE | 9O3K93S3TK | GEL, METERED / TRANSDERMAL | 14 mg | ||
| SORBITOL | SORBITOL | 506T60A25R | SPRAY / NASAL | 49 mg | ||
| CARBOMER 934 | CARBOMER HOMOPOLYMER TYPE B (ALLYL SUCROSE CROSSLINKED) | Z135WT9208 | GEL / TOPICAL | 30 mg | ||
| POLYSORBATE 20 | POLYSORBATE 20 | 7T1F30V5YH | INJECTION / INTRAMUSCULAR | 1.62 %w/v | ||
| CARBOMER 934 | CARBOMER HOMOPOLYMER TYPE B (ALLYL SUCROSE CROSSLINKED) | Z135WT9208 | ENEMA / RECTAL | 0.24 %w/v | ||
| HIGH DENSITY POLYETHYLENE | HIGH DENSITY POLYETHYLENE | UG00KM4WR7 | TABLET, COATED / ORAL | 25 mg | ||
| HIGH DENSITY POLYETHYLENE | HIGH DENSITY POLYETHYLENE | UG00KM4WR7 | CAPSULE, EXTENDED RELEASE / ORAL | 4.53 mg | ||
| POLYSORBATE 20 | POLYSORBATE 20 | 7T1F30V5YH | AEROSOL, FOAM / TOPICAL | 3.7 %w/w | ||
| TROLAMINE | TROLAMINE | 9O3K93S3TK | SPONGE / TOPICAL | 11 %w/w | ||
| TROLAMINE | TROLAMINE | 9O3K93S3TK | GEL / TOPICAL | 6 mg | ||
| TROLAMINE | TROLAMINE | 9O3K93S3TK | LOTION / TOPICAL | 360 mg | ||
| POLYSORBATE 20 | POLYSORBATE 20 | 7T1F30V5YH | TAMPON / VAGINAL | 64.8 mg | ||
| SORBITOL | SORBITOL | 506T60A25R | INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION / INTRAVENOUS | 1.04 %w/v | ||
| SORBITOL | SORBITOL | 506T60A25R | CONCENTRATE / ORAL | 600 mg/1ml | ||
| PHENOXYETHANOL | PHENOXYETHANOL | HIE492ZZ3T | LOTION / TOPICAL | 1 %w/w |
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 |
|---|---|---|---|---|---|---|
| 114a0314-c427-016f-e063-6294a90acd57 | 3f4a674b-5f4f-4262-be81-7b8e477d4aa4 | 2024-02-13 | Warnings | 3f4a674b-5f4f-4262-be81-7b8e477d4aa4 |
Adverse event summaries are temporarily unavailable. Other product information remains available.