Indications and uses
Helps prevent sunburn.
LBEL Couleur Luxe Rouge Amplifier XP amplifying SPF 15
- Manufacturer
- Ventura Corporation LTD | Bel Star S.A. (Colombia)
- Effective date
- 2014-01-30
- Label type
- HUMAN OTC DRUG LABEL
- Version
- 1
- Source
- legacy-cache
- Hydrated at
- 2026-08-02 01:37:07
Label at a glance#
ProductLBEL Couleur Luxe Rouge Amplifier XP amplifying SPF 15 (MARRON ILLIMITE) - BROWN
Active ingredientOctinoxate, Oxybenzone
Label structure38 sections
Dosage and administration
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.
Storage and handling
Protect the product in this container from excessive heat and direct sun.
Label contents#
Full prescribing information#
SPL UNCLASSIFIED SECTION
Drug Facts
OTC - ACTIVE INGREDIENT SECTION
OTC - PURPOSE SECTION
| Active Ingredients | Purpose |
|---|---|
| Octinoxate 4.7%, | Sunscreen |
| Oxybenzone 0.9 % | Sunscreen |
Uses
- Helps prevent sunburn.
Warnings
SPL UNCLASSIFIED SECTION
- Skin Cancer / Skin Aging Alert: Spending time in the sun increases your risk of skin cancer and early skin aging. This product has been shown only to help prevent sunburn, not skin cancer or early skin aging.
SPL UNCLASSIFIED SECTION
- For external use only.
OTC - DO NOT USE SECTION
- Do not use on damaged or broken skin.
OTC - WHEN USING SECTION
- When using this product keep out of eyes. Rinse with water to remove.
OTC - STOP USE SECTION
- Stop use and ask a doctor if rash occurs.
OTC - KEEP OUT OF REACH OF CHILDREN SECTION
- Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center right away.
Directions
- 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.
Other information
- Protect the product in this container from excessive heat and direct sun.
Inactive ingredients
Isostearyl neopentanoate, diisopropyl dimer dilinoleate, mica, methyl hydrogenated rosinate, polyethylene, castor isostearate beeswax succinate, hydrogenated polycyclopentadiene, ozokerite, silica, copernicia cerifera (carnauba) wax, euphorbia cerifera (candelilla) wax, ethylhexyl palmitate, isododecane, hydrogenated polyisobutene, paraffin, polyglyceryl-3 diisostearate, glyceryl isostearate, isostearyl alcohol, dipalmitoyl hydroxyproline, ceramide 3, butyrospermum parkii (shea) butter, beta-sitosterol, propylparaben, dimethicone, luffa cylindrica seed oil, silica silylate, methylparaben, disteardimonium hectorite, fragrance, peg-40 hydrogenated castor oil, polysorbate 80, ppg-26-buteth-26, bht, trimethylsiloxysilicate, hedera helix (ivy) leaf/stem extract, retinyl palmitate, tocopheryl acetate, bioflavonoids, allantoin, ascorbyl palmitate.
May contain: mica, bismuth oxychloride, red 7 lake, manganese violet, iron oxides, titanium dioxide, yellow 5 lake, red 21 lake, red 27 lake, red 6 lake, calcium sodium borosilicate, iron oxides, talc, blue 1 lake, carmine, c9-15 fluoroalcohol phosphate, lauroyl lysine.
SPL UNCLASSIFIED SECTION
PUERTO RICO: Distributed by Ventura Corporation, Ltd. San Juan, Puerto Rico 00926.
PRINCIPAL DISPLAY PANEL - 4 g Tube Box - (MARRON ILLIMITÉ) - BROWN
COULEUR LUXE ROUGE AMPLIFIER XP
amplifying lipstick
SPF 15
Net Weight 0.14 oz. (4 g)
L'BEL
PRINCIPAL DISPLAY PANEL - 4 g Tube Box - (CHOCOLAT MAJESTIC) - BROWN
COULEUR LUXE ROUGE AMPLIFIER XP
amplifying lipstick
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Net Weight 0.14 oz. (4 g)
L'BEL
PRINCIPAL DISPLAY PANEL - 4 g Tube Box - (CORAIL MAXIMUM) - ORANGE
COULEUR LUXE ROUGE AMPLIFIER XP
amplifying lipstick
SPF 15
Net Weight 0.14 oz. (4 g)
L'BEL
PRINCIPAL DISPLAY PANEL - 4 g Tube Box - (FUCSIA SPLENDIDE) - MAGENTA
COULEUR LUXE ROUGE AMPLIFIER XP
amplifying lipstick
SPF 15
Net Weight 0.14 oz. (4 g)
L'BEL
PRINCIPAL DISPLAY PANEL - 4 g Tube Box - (ROUGE PRODIGEUX) - RED
COULEUR LUXE ROUGE AMPLIFIER XP
amplifying lipstick
SPF 15
Net Weight 0.14 oz. (4 g)
L'BEL
PRINCIPAL DISPLAY PANEL - 4 g Tube Box - (ROUGE GRANDOISE) - RED
COULEUR LUXE ROUGE AMPLIFIER XP
amplifying lipstick
SPF 15
Net Weight 0.14 oz. (4 g)
L'BEL
PRINCIPAL DISPLAY PANEL - 4 g Tube Box - (ROSE CHAMPAGNE) - PINK
COULEUR LUXE ROUGE AMPLIFIER XP
amplifying lipstick
SPF 15
Net Weight 0.14 oz. (4 g)
L'BEL
PRINCIPAL DISPLAY PANEL - 4 g Tube Box - (ROSE D'AMOUR) - PINK
COULEUR LUXE ROUGE AMPLIFIER XP
amplifying lipstick
SPF 15
Net Weight 0.14 oz. (4 g)
L'BEL
PRINCIPAL DISPLAY PANEL - 4 g Tube Box - (ROUGE RUBI) - RED
COULEUR LUXE ROUGE AMPLIFIER XP
amplifying lipstick
SPF 15
Net Weight 0.14 oz. (4 g)
L'BEL
PRINCIPAL DISPLAY PANEL - 4 g Tube Box - (SAUMON ESSENTIEL) - PINK
COULEUR LUXE ROUGE AMPLIFIER XP
amplifying lipstick
SPF 15
Net Weight 0.14 oz. (4 g)
L'BEL
PRINCIPAL DISPLAY PANEL - 4 g Tube Box - (BOURGOGNE VIF) - BROWN
COULEUR LUXE ROUGE AMPLIFIER XP
amplifying lipstick
SPF 15
Net Weight 0.14 oz. (4 g)
L'BEL
PRINCIPAL DISPLAY PANEL - 4 g Tube Box - (VIOLET POURPRE) - PURPLE
COULEUR LUXE ROUGE AMPLIFIER XP
amplifying lipstick
SPF 15
Net Weight 0.14 oz. (4 g)
L'BEL
PRINCIPAL DISPLAY PANEL - 4 g Tube Box - (ORANGE DÉLIRANT) - ORANGE
COULEUR LUXE ROUGE AMPLIFIER XP
amplifying lipstick
SPF 15
Net Weight 0.14 oz. (4 g)
L'BEL
PRINCIPAL DISPLAY PANEL - 4 g Tube Box - (ROSE FEMME) - PINK
COULEUR LUXE ROUGE AMPLIFIER XP
amplifying lipstick
SPF 15
Net Weight 0.14 oz. (4 g)
L'BEL
PRINCIPAL DISPLAY PANEL - 4 g Tube Box - (ROUGE INTENSE) - RED
COULEUR LUXE ROUGE AMPLIFIER XP
amplifying lipstick
SPF 15
Net Weight 0.14 oz. (4 g)
L'BEL
PRINCIPAL DISPLAY PANEL - 4 g Tube Box - (DORÉ CHOCOLAT) - BROWN
COULEUR LUXE ROUGE AMPLIFIER XP
amplifying lipstick
SPF 15
Net Weight 0.14 oz. (4 g)
L'BEL
PRINCIPAL DISPLAY PANEL - 4 g Tube Box - (FUCSIA DÉSIR) - MAGENTA
COULEUR LUXE ROUGE AMPLIFIER XP
amplifying lipstick
SPF 15
Net Weight 0.14 oz. (4 g)
L'BEL
PRINCIPAL DISPLAY PANEL - 4 g Tube Box - (MER DE ROSES) - PINK
COULEUR LUXE ROUGE AMPLIFIER XP
amplifying lipstick
SPF 15
Net Weight 0.14 oz. (4 g)
L'BEL
PRINCIPAL DISPLAY PANEL - 4 g Tube Box - (ROUGE PROVOCATION) - RED
COULEUR LUXE ROUGE AMPLIFIER XP
amplifying lipstick
SPF 15
Net Weight 0.14 oz. (4 g)
L'BEL
PRINCIPAL DISPLAY PANEL - 4 g Tube Box - (ROSE TENTATION) - PINK
COULEUR LUXE ROUGE AMPLIFIER XP
amplifying lipstick
SPF 15
Net Weight 0.14 oz. (4 g)
L'BEL
PRINCIPAL DISPLAY PANEL - 4 g Tube Box - (ROSE DÉLICAT) - PINK
COULEUR LUXE ROUGE AMPLIFIER XP
amplifying lipstick
SPF 15
Net Weight 0.14 oz. (4 g)
L'BEL
PRINCIPAL DISPLAY PANEL - 4 g Tube Box - (CARMINE) - RED
COULEUR LUXE ROUGE AMPLIFIER XP
amplifying lipstick
SPF 15
Net Weight 0.14 oz. (4 g)
L'BEL
PRINCIPAL DISPLAY PANEL - 4 g Tube Box - (NOBLESSE) - RED
COULEUR LUXE ROUGE AMPLIFIER XP
amplifying lipstick
SPF 15
Net Weight 0.14 oz. (4 g)
L'BEL
PRINCIPAL DISPLAY PANEL - 4 g Tube Box - (MALBEC) - BROWN
COULEUR LUXE ROUGE AMPLIFIER XP
amplifying lipstick
SPF 15
Net Weight 0.14 oz. (4 g)
L'BEL
PRINCIPAL DISPLAY PANEL - 4 g Tube Box - (AMANDIER) - BROWN
COULEUR LUXE ROUGE AMPLIFIER XP
amplifying lipstick
SPF 15
Net Weight 0.14 oz. (4 g)
L'BEL
PRINCIPAL DISPLAY PANEL - 4 g Tube Box - (SOBRIETE) - BROWN
COULEUR LUXE ROUGE AMPLIFIER XP
amplifying lipstick
SPF 15
Net Weight 0.14 oz. (4 g)
L'BEL
PRINCIPAL DISPLAY PANEL - 4 g Tube Box - (FIANCEE) - PINK
COULEUR LUXE ROUGE AMPLIFIER XP
amplifying lipstick
SPF 15
Net Weight 0.14 oz. (4 g)
L'BEL
PRINCIPAL DISPLAY PANEL - 4 g Tube Box - (ROMANCE) - PINK
COULEUR LUXE ROUGE AMPLIFIER XP
amplifying lipstick
SPF 15
Net Weight 0.14 oz. (4 g)
L'BEL
PRINCIPAL DISPLAY PANEL - 4 g Tube Box - (ROSE FUCSIA) - MAGENTA
COULEUR LUXE ROUGE AMPLIFIER XP
amplifying lipstick
SPF 15
Net Weight 0.14 oz. (4 g)
L'BEL
PRINCIPAL DISPLAY PANEL - 4 g Tube Box - (MIEL ECHANTER) - ORANGE
COULEUR LUXE ROUGE AMPLIFIER XP
amplifying lipstick
SPF 15
Net Weight 0.14 oz. (4 g)
L'BEL
FDA-Initiated Inactive NDC Indexing#
DailyMed Socrata Ingredients#
| Ingredient | Type | UNII | SPL version | Uploaded |
|---|---|---|---|---|
| Octinoxate | ACTIVE INGREDIENT | 4Y5P7MUD51 | 1 | |
| Oxybenzone | ACTIVE INGREDIENT | 95OOS7VE0Y | 1 | |
| Octinoxate | ACTIVE MOIETY | 4Y5P7MUD51 | 1 | |
| Oxybenzone | ACTIVE MOIETY | 95OOS7VE0Y | 1 | |
| .ALPHA.-TOCOPHEROL ACETATE | INACTIVE INGREDIENT | 9E8X80D2L0 | 1 | |
| .BETA.-SITOSTEROL | INACTIVE INGREDIENT | S347WMO6M4 | 1 | |
| ALLANTOIN | INACTIVE INGREDIENT | 344S277G0Z | 1 | |
| ALUMINUM OXIDE | INACTIVE INGREDIENT | LMI26O6933 | 1 | |
| ASCORBYL PALMITATE | INACTIVE INGREDIENT | QN83US2B0N | 1 | |
| BISMUTH OXYCHLORIDE | INACTIVE INGREDIENT | 4ZR792I587 | 1 | |
| BUTYLATED HYDROXYTOLUENE | INACTIVE INGREDIENT | 1P9D0Z171K | 1 | |
| CANDELILLA WAX | INACTIVE INGREDIENT | WL0328HX19 | 1 | |
| CARNAUBA WAX | INACTIVE INGREDIENT | R12CBM0EIZ | 1 | |
| CERAMIDE 3 | INACTIVE INGREDIENT | 4370DF050B | 1 | |
| D&C RED NO. 21 | INACTIVE INGREDIENT | 08744Z6JNY | 1 | |
| D&C RED NO. 27 | INACTIVE INGREDIENT | 2LRS185U6K | 1 | |
| D&C RED NO. 6 | INACTIVE INGREDIENT | 481744AI4O | 1 | |
| D&C RED NO. 7 | INACTIVE INGREDIENT | ECW0LZ41X8 | 1 | |
| DIISOPROPYL DILINOLEATE | INACTIVE INGREDIENT | 5323S7S2LR | 1 | |
| DIMETHICONE | INACTIVE INGREDIENT | 92RU3N3Y1O | 1 | |
| DIPALMITOYL HYDROXYPROLINE | INACTIVE INGREDIENT | E6AHA53N1H | 1 | |
| DISTEARDIMONIUM HECTORITE | INACTIVE INGREDIENT | X687XDK09L | 1 | |
| ETHYLHEXYL PALMITATE | INACTIVE INGREDIENT | 2865993309 | 1 | |
| FD&C BLUE NO. 1 | INACTIVE INGREDIENT | H3R47K3TBD | 1 | |
| FD&C YELLOW NO. 5 | INACTIVE INGREDIENT | I753WB2F1M | 1 | |
| FERRIC OXIDE RED | INACTIVE INGREDIENT | 1K09F3G675 | 1 | |
| GLYCERYL ISOSTEARATE | INACTIVE INGREDIENT | HYE7O27HAO | 1 | |
| HEDERA HELIX LEAF | INACTIVE INGREDIENT | ZP9XFG71A7 | 1 | |
| HIGH DENSITY POLYETHYLENE | INACTIVE INGREDIENT | UG00KM4WR7 | 1 | |
| ISODODECANE | INACTIVE INGREDIENT | A8289P68Y2 | 1 | |
| ISOSTEARYL ALCOHOL | INACTIVE INGREDIENT | Q613OCQ44Y | 1 | |
| ISOSTEARYL NEOPENTANOATE | INACTIVE INGREDIENT | 411THY156Q | 1 | |
| LAUROYL LYSINE | INACTIVE INGREDIENT | 113171Q70B | 1 | |
| LUFFA AEGYPTIACA SEED OIL | INACTIVE INGREDIENT | 1A281RJ859 | 1 | |
| MANGANESE VIOLET | INACTIVE INGREDIENT | 72M48QQV8Q | 1 | |
| METHYL HYDROGENATED ROSINATE | INACTIVE INGREDIENT | 13DHA19W9N | 1 | |
| METHYLPARABEN | INACTIVE INGREDIENT | A2I8C7HI9T | 1 | |
| MICA | INACTIVE INGREDIENT | V8A1AW0880 | 1 | |
| PARAFFIN | INACTIVE INGREDIENT | I9O0E3H2ZE | 1 | |
| POLYGLYCERYL-3 DIISOSTEARATE | INACTIVE INGREDIENT | 46P231IQV8 | 1 | |
| POLYOXYL 40 HYDROGENATED CASTOR OIL | INACTIVE INGREDIENT | 7YC686GQ8F | 1 | |
| POLYSORBATE 80 | INACTIVE INGREDIENT | 6OZP39ZG8H | 1 | |
| PPG-26-BUTETH-26 | INACTIVE INGREDIENT | 2II1K6TZ4P | 1 | |
| PROPYLPARABEN | INACTIVE INGREDIENT | Z8IX2SC1OH | 1 | |
| SHEA BUTTER | INACTIVE INGREDIENT | K49155WL9Y | 1 | |
| SILICON DIOXIDE | INACTIVE INGREDIENT | ETJ7Z6XBU4 | 1 | |
| TALC | INACTIVE INGREDIENT | 7SEV7J4R1U | 1 | |
| TITANIUM DIOXIDE | INACTIVE INGREDIENT | 15FIX9V2JP | 1 | |
| VITAMIN A PALMITATE | INACTIVE INGREDIENT | 1D1K0N0VVC | 1 |
Products#
Every source-derived product name is available through these pages.
- LBEL Couleur Luxe Rouge Amplifier XP amplifying SPF 15 (MARRON ILLIMITE) - BROWN
- Octinoxate and Oxybenzone
- Octinoxate
- Oxybenzone
- ISOSTEARYL NEOPENTANOATE
- DIISOPROPYL DILINOLEATE
- MICA
- METHYL HYDROGENATED ROSINATE
- HIGH DENSITY POLYETHYLENE
- SILICON DIOXIDE
- CARNAUBA WAX
- CANDELILLA WAX
- ETHYLHEXYL PALMITATE
- ISODODECANE
- PARAFFIN
- POLYGLYCERYL-3 DIISOSTEARATE
- GLYCERYL ISOSTEARATE
- ISOSTEARYL ALCOHOL
- DIPALMITOYL HYDROXYPROLINE
- CERAMIDE 3
- SHEA BUTTER
- .BETA.-SITOSTEROL
- PROPYLPARABEN
- DIMETHICONE
- LUFFA AEGYPTIACA SEED OIL
- METHYLPARABEN
- DISTEARDIMONIUM HECTORITE
- POLYOXYL 40 HYDROGENATED CASTOR OIL
- POLYSORBATE 80
- PPG-26-BUTETH-26
- BUTYLATED HYDROXYTOLUENE
- HEDERA HELIX LEAF
- VITAMIN A PALMITATE
- .ALPHA.-TOCOPHEROL ACETATE
- ALLANTOIN
- ASCORBYL PALMITATE
- BISMUTH OXYCHLORIDE
- D&C RED NO. 7
- ALUMINUM OXIDE
- MANGANESE VIOLET
NDC Codes#
Ingredients#
Every source-derived ingredient row is available through these pages.
Source Document#
Inactive ingredient matches#
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 |
|---|---|---|---|---|---|---|
| PARAFFIN | PARAFFIN | I9O0E3H2ZE | CREAM / TOPICAL | 300 mg | ||
| HIGH DENSITY POLYETHYLENE | HIGH DENSITY POLYETHYLENE | UG00KM4WR7 | TABLET / ORAL | 50 mg | ||
| POLYSORBATE 80 | POLYSORBATE 80 | 6OZP39ZG8H | INJECTION / INTRALESIONAL | 4 mg | ||
| METHYLPARABEN | METHYLPARABEN | A2I8C7HI9T | INJECTION, SOLUTION / PARENTERAL | 30 mg | ||
| ASCORBYL PALMITATE | ASCORBYL PALMITATE | QN83US2B0N | SOLUTION / TOPICAL | NA | ||
| SILICON DIOXIDE | SILICON DIOXIDE | ETJ7Z6XBU4 | SUPPOSITORY / RECTAL | 14 mg | ||
| PROPYLPARABEN | PROPYLPARABEN | Z8IX2SC1OH | SOLUTION / TOPICAL | 24 mg | ||
| FERRIC OXIDE RED | FERRIC OXIDE RED | 1K09F3G675 | POWDER, FOR SUSPENSION / ORAL | 1 mg | ||
| SILICON DIOXIDE | SILICON DIOXIDE | ETJ7Z6XBU4 | TABLET, EXTENDED RELEASE / ORAL | 450 mg | ||
| HIGH DENSITY POLYETHYLENE | HIGH DENSITY POLYETHYLENE | UG00KM4WR7 | TABLET, COATED / ORAL | 25 mg | ||
| D&C RED NO. 7 | D&C RED NO. 7 | ECW0LZ41X8 | CAPSULE / ORAL | NA | ||
| PROPYLPARABEN | PROPYLPARABEN | Z8IX2SC1OH | INJECTION, SOLUTION / INTRAMUSCULAR | 5 mg | ||
| FD&C BLUE NO. 1 | FD&C BLUE NO. 1 | H3R47K3TBD | SOAP / TOPICAL | 0.01 %w/w | ||
| SILICON DIOXIDE | SILICON DIOXIDE | ETJ7Z6XBU4 | DROPS / ORAL | NA | ||
| PROPYLPARABEN | PROPYLPARABEN | Z8IX2SC1OH | POWDER, FOR SOLUTION / ORAL | 13 mg | ||
| POLYSORBATE 80 | POLYSORBATE 80 | 6OZP39ZG8H | TABLET, ORALLY DISINTEGRATING / ORAL | 1 mg | ||
| POLYSORBATE 80 | POLYSORBATE 80 | 6OZP39ZG8H | CREAM / VAGINAL | 0.4 %w/w | ||
| CARNAUBA WAX | CARNAUBA WAX | R12CBM0EIZ | TABLET / ORAL | 167.8 mg | ||
| BUTYLATED HYDROXYTOLUENE | BUTYLATED HYDROXYTOLUENE | 1P9D0Z171K | SHAMPOO / TOPICAL | 0.1 %w/w | ||
| TITANIUM DIOXIDE | TITANIUM DIOXIDE | 15FIX9V2JP | FILM, EXTENDED RELEASE / TRANSDERMAL | NA | ||
| METHYLPARABEN | METHYLPARABEN | A2I8C7HI9T | SUSPENSION, EXTENDED RELEASE / ORAL | 40 mg | ||
| ASCORBYL PALMITATE | ASCORBYL PALMITATE | QN83US2B0N | TABLET / ORAL | 7.14 mg | ||
| FD&C BLUE NO. 1 | FD&C BLUE NO. 1 | H3R47K3TBD | CAPSULE, COATED PELLETS / ORAL | NA | ||
| CARNAUBA WAX | CARNAUBA WAX | R12CBM0EIZ | OINTMENT / TOPICAL | NA | ||
| POLYSORBATE 80 | POLYSORBATE 80 | 6OZP39ZG8H | CAPSULE, LIQUID FILLED / ORAL | 24 mg | ||
| SILICON DIOXIDE | SILICON DIOXIDE | ETJ7Z6XBU4 | TABLET / SUBLINGUAL | 10 mg | ||
| METHYLPARABEN | METHYLPARABEN | A2I8C7HI9T | TABLET / ORAL | 1.8 mg | ||
| PROPYLPARABEN | PROPYLPARABEN | Z8IX2SC1OH | TABLET, EXTENDED RELEASE / ORAL | 0.12 mg | ||
| PROPYLPARABEN | PROPYLPARABEN | Z8IX2SC1OH | JELLY / TOPICAL | 180 mg | ||
| FD&C BLUE NO. 1 | FD&C BLUE NO. 1 | H3R47K3TBD | TABLET, EXTENDED RELEASE / ORAL | 4 mg | ||
| METHYLPARABEN | METHYLPARABEN | A2I8C7HI9T | GEL / VAGINAL | 8 mg | ||
| POLYSORBATE 80 | POLYSORBATE 80 | 6OZP39ZG8H | POWDER / ORAL | 66 mg | ||
| PROPYLPARABEN | PROPYLPARABEN | Z8IX2SC1OH | SPRAY / TOPICAL | 0.8 %w/w | ||
| FERRIC OXIDE RED | FERRIC OXIDE RED | 1K09F3G675 | TABLET, ORALLY DISINTEGRATING, DELAYED RELEASE / ORAL | 0.15 mg | ||
| TALC | TALC | 7SEV7J4R1U | TABLET, SUGAR COATED / ORAL | NA | ||
| METHYLPARABEN | METHYLPARABEN | A2I8C7HI9T | SUSPENSION/ DROPS / OPHTHALMIC | 0.05 %w/w | ||
| CARNAUBA WAX | CARNAUBA WAX | R12CBM0EIZ | CAPSULE / ORAL | NA | ||
| FD&C YELLOW NO. 5 | FD&C YELLOW NO. 5 | I753WB2F1M | CONCENTRATE / BUCCAL | NA | ||
| POLYSORBATE 80 | POLYSORBATE 80 | 6OZP39ZG8H | SOLUTION / RECTAL | 315 mg | ||
| METHYLPARABEN | METHYLPARABEN | A2I8C7HI9T | SOLUTION / RECTAL | 0.13 %w/v | ||
| PROPYLPARABEN | PROPYLPARABEN | Z8IX2SC1OH | POWDER / ORAL | NA | ||
| SILICON DIOXIDE | SILICON DIOXIDE | ETJ7Z6XBU4 | CAPSULE, LIQUID FILLED / ORAL | 106 mg | ||
| FD&C BLUE NO. 1 | FD&C BLUE NO. 1 | H3R47K3TBD | CAPSULE, EXTENDED RELEASE / ORAL | 1 mg | ||
| METHYLPARABEN | METHYLPARABEN | A2I8C7HI9T | DROPS / ORAL | 1 mg/1ml | ||
| TALC | TALC | 7SEV7J4R1U | TABLET, COATED / ORAL | 320.75 mg | ||
| ALLANTOIN | ALLANTOIN | 344S277G0Z | GEL / TOPICAL | 8 mg | ||
| PROPYLPARABEN | PROPYLPARABEN | Z8IX2SC1OH | LIQUID / ORAL | 2 mg | ||
| SILICON DIOXIDE | SILICON DIOXIDE | ETJ7Z6XBU4 | CAPSULE, DELAYED RELEASE / ORAL | 40 mg | ||
| ASCORBYL PALMITATE | ASCORBYL PALMITATE | QN83US2B0N | CAPSULE / ORAL | 12 mg | ||
| METHYLPARABEN | METHYLPARABEN | A2I8C7HI9T | JELLY / NASAL | 250 mg | ||
| METHYLPARABEN | METHYLPARABEN | A2I8C7HI9T | GEL / TOPICAL | 24 mg | ||
| METHYLPARABEN | METHYLPARABEN | A2I8C7HI9T | INJECTION / PERINEURAL | 80 mg | ||
| METHYLPARABEN | METHYLPARABEN | A2I8C7HI9T | SOLUTION/ DROPS / OPHTHALMIC | 0.05 %w/v | ||
| HIGH DENSITY POLYETHYLENE | HIGH DENSITY POLYETHYLENE | UG00KM4WR7 | TABLET, DELAYED RELEASE / ORAL | NA | ||
| TALC | TALC | 7SEV7J4R1U | TABLET, ORALLY DISINTEGRATING, DELAYED RELEASE / ORAL | 357 mg | ||
| TALC | TALC | 7SEV7J4R1U | TABLET / SUBLINGUAL | 32.4 mg | ||
| PARAFFIN | PARAFFIN | I9O0E3H2ZE | OINTMENT / RECTAL | 38 mg | ||
| BUTYLATED HYDROXYTOLUENE | BUTYLATED HYDROXYTOLUENE | 1P9D0Z171K | SOLUTION / ORAL | 14 mg | ||
| PROPYLPARABEN | PROPYLPARABEN | Z8IX2SC1OH | SOLUTION / RECTAL | 0.02 %w/v | ||
| METHYLPARABEN | METHYLPARABEN | A2I8C7HI9T | AEROSOL, FOAM / TOPICAL | 0.16 %w/w |
openFDA label cross-check#
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 |
|---|---|---|---|---|---|---|
| 2fb28538-9e84-2ad0-e063-6394a90a9f7e | 1e56c9b8-d249-48a0-a700-fdb0244c48e8 | 2025-03-06 | Warnings | 1e56c9b8-d249-48a0-a700-fdb0244c48e8 |
Reported adverse events (FAERS/openFDA)#
Adverse event summaries are temporarily unavailable. Other product information remains available.