Indications and uses
Helps prevent sunburn
LBEL COULEUR LUXE AMPLIFIER XP
- Manufacturer
- Ventura Corporation LTD. | Bel Star S.A. (Colombia)
- Effective date
- 2013-06-06
- Label type
- HUMAN OTC DRUG LABEL
- Version
- 1
- Source
- legacy-cache
- Hydrated at
- 2026-08-02 01:40:35
Label at a glance#
ProductLBEL COULEUR LUXE AMPLIFIER XP amplifying SPF 15 - ROSE CHAMPAGNE
Active ingredientOctinoxate, Oxybenzone
Label structure42 sections
Dosage and administration
Apply liberally and evenly 15 minutes before sun exposure. Children under 6 months of age: Ask a doctor. Reapply at least every 2 hours. Use a water resistant sunscreen if swimming or sweating. Apply lipstick following the curves of natural lip line. For added definition, use with a lip pencil.
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
Active Ingredients
Octinoxate 4.7 %, Oxybenzone 0.9%
Purpose
Sunscreen
Uses
- Helps prevent sunburn
Warnings
- 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.
- For external use only.
OTC - DO NOT USE SECTION
- Do not use on damage 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.
- Children under 6 months of age: Ask a doctor.
- Reapply at least every 2 hours.
- Use a water resistant sunscreen if swimming or sweating.
- Apply lipstick following the curves of natural lip line. For added definition, use with a lip pencil.
Other information
- Protect the product in this container from excessive heat and direct sun.
Inactive ingredients
ISOSTEARYL NEOPENTANOATE, DIISOPROPYL DIMER DILINOLEATE, METHYL HYDROGENATED ROSINATE, POLYETHYLENE, MICA, CASTOR ISOSTEARATE BEESWAX SUCCINATE, HYDROGENATED POLYCYCLOPENTADIENE, SILICA, COPERNICIA CERIFERA CERA (COPERNICIA CERIFERA (CARNAUBA ) WAX), CANDELILLA CERA (EUPHORBIA CERIFERA (CANDELILLA) WAX), OZOKERITE, ETHYLHEXYL PALMITATE, ISODODECANE, HYDROGENATED POLYISOBUTENE, PARAFFIN, POLYGLYCERYL-3 DIISOSTEARATE, GLYCERYL ISOSTEARATE, ISOSTEARYL ALCOHOL, DIPALMITOYL HYDROXYPROLINE, CERAMIDE 3, BUTYROSPERMUM PARKII BUTTER (BUTYROSPERMUM PARKII (SHEA) BUTTER), BETA-SITOSTEROL, DIMETHICONE, PROPYLPARABEN, LUFFA CYLINDRICA SEED OIL, SILICA SILYLATE, METHYLPARABEN, DISTEARDIMONIUM HECTORITE, PARFUM (FRAGRANCE), PEG-40 HYDROGENATED CASTOR OIL, POLYSORBATE 80, PPG-26-BUTETH-26, BHT, TRIMETHYLSILOXYSILICATE, HEDERA HELIX LEAF/STEM EXTRACT (HEDERA HELIX (IVY) LEAF/STEM EXTRACT), RETINYL PALMITATE, TOCOPHERYL ACETATE, BIOFLAVONOIDS, ALLANTOIN, ASCORBYL PALMITATE. MAY CONTAIN: CI 77019 (MICA), CI 77163 (BISMUTH OXYCHLORIDE), CI 15850 (RED 7 LAKE), CI 77742 (MANGANESE VIOLET), CI 77491 (IRON OXIDES), CI 77891 (TITANIUM DIOXIDE ), CI 19140 (YELLOW 5 LAKE), CI 45380 (RED 21 LAKE), CI 15850 (RED 6 LAKE), CI 45410 (RED 27 LAKE), CI 77499 (IRON OXIDES), CALCIUM SODIUM BOROSILICATE, CI 77492 (IRON OXIDES), TALC, CI 42090 (BLUE 1 LAKE), CI 75470 (CARMINE), C9-15 FLUOROALCOHOL PHOSPHATE, LAUROYL LYSINE.
SPL UNCLASSIFIED SECTION
Distributed by Ventura Corporation, Ltd, San Juan, Puerto Rico 00926
PRINCIPAL DISPLAY PANEL - 4 g Tube Box - ROSE CHAMPAGNE
COULEUR LUXE AMPLIFIER XP
amplifying lipstick
SPF 15
4 g e (.14 oz.)
L'BEL
PRINCIPAL DISPLAY PANEL - 4 g Tube Box - FUCSIA SPLENDIDE
COULEUR LUXE AMPLIFIER XP
amplifying lipstick
SPF 15
4 g e (.14 oz.)
L'BEL
PRINCIPAL DISPLAY PANEL - 4 g Tube Box - ROSE D'AMOUR
COULEUR LUXE AMPLIFIER XP
amplifying lipstick
SPF 15
4 g e (.14 oz.)
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PRINCIPAL DISPLAY PANEL - 4 g Tube Box - ROSE FORMIDABLE
COULEUR LUXE AMPLIFIER XP
amplifying lipstick
SPF 15
4 g e (.14 oz.)
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PRINCIPAL DISPLAY PANEL - 4 g Tube Box - NATUREL PERSISTANT
COULEUR LUXE AMPLIFIER XP
amplifying lipstick
SPF 15
4 g e (.14 oz.)
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PRINCIPAL DISPLAY PANEL - 4 g Tube Box - MIEL ECHANTER
COULEUR LUXE AMPLIFIER XP
amplifying lipstick
SPF 15
4 g e (.14 oz.)
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PRINCIPAL DISPLAY PANEL - 4 g Tube Box - ROUGE PRODIGEUX
COULEUR LUXE AMPLIFIER XP
amplifying lipstick
SPF 15
4 g e (.14 oz.)
L'BEL
PRINCIPAL DISPLAY PANEL - 4 g Tube Box - MARRON ILLIMITÉ
COULEUR LUXE AMPLIFIER XP
amplifying lipstick
SPF 15
4 g e (.14 oz.)
L'BEL
PRINCIPAL DISPLAY PANEL - 4 g Tube Box - CHOCOLAT MAJESTIC
COULEUR LUXE AMPLIFIER XP
amplifying lipstick
SPF 15
4 g e (.14 oz.)
L'BEL
PRINCIPAL DISPLAY PANEL - 4 g Tube Box - CAFÉ SUCCÈS
COULEUR LUXE AMPLIFIER XP
amplifying lipstick
SPF 15
4 g e (.14 oz.)
L'BEL
PRINCIPAL DISPLAY PANEL - 4 g Tube Box - ROUGE GRANDOISE
COULEUR LUXE AMPLIFIER XP
amplifying lipstick
SPF 15
4 g e (.14 oz.)
L'BEL
PRINCIPAL DISPLAY PANEL - 4 g Tube Box - ROUGE RUBI
COULEUR LUXE AMPLIFIER XP
amplifying lipstick
SPF 15
4 g e (.14 oz.)
L'BEL
PRINCIPAL DISPLAY PANEL - 4 g Tube Box - SAUMON ESSENTIEL
COULEUR LUXE AMPLIFIER XP
amplifying lipstick
SPF 15
4 g e (.14 oz.)
L'BEL
PRINCIPAL DISPLAY PANEL - 4 g Tube Box - BOURGOGNE VIF
COULEUR LUXE AMPLIFIER XP
amplifying lipstick
SPF 15
4 g e (.14 oz.)
L'BEL
PRINCIPAL DISPLAY PANEL - 4 g Tube Box - VIOLET POURPRE
COULEUR LUXE AMPLIFIER XP
amplifying lipstick
SPF 15
4 g e (.14 oz.)
L'BEL
PRINCIPAL DISPLAY PANEL - 4 g Tube Box - CORAIL MAXIMUM
COULEUR LUXE AMPLIFIER XP
amplifying lipstick
SPF 15
4 g e (.14 oz.)
L'BEL
PRINCIPAL DISPLAY PANEL - 4 g Tube Box - ORANGE DÉLIRANT
COULEUR LUXE AMPLIFIER XP
amplifying lipstick
SPF 15
4 g e (.14 oz.)
L'BEL
PRINCIPAL DISPLAY PANEL - 4 g Tube Box - ROUGE INTENSE
COULEUR LUXE AMPLIFIER XP
amplifying lipstick
SPF 15
4 g e (.14 oz.)
L'BEL
PRINCIPAL DISPLAY PANEL - 4 g Tube Box - ROSE FEMME
COULEUR LUXE AMPLIFIER XP
amplifying lipstick
SPF 15
4 g e (.14 oz.)
L'BEL
PRINCIPAL DISPLAY PANEL - 4 g Tube Box - DORÉ CHOCOLAT
COULEUR LUXE AMPLIFIER XP
amplifying lipstick
SPF 15
4 g e (.14 oz.)
L'BEL
PRINCIPAL DISPLAY PANEL - 4 g Tube Box - MER DE ROSES
COULEUR LUXE AMPLIFIER XP
amplifying lipstick
SPF 15
4 g e (.14 oz.)
L'BEL
PRINCIPAL DISPLAY PANEL - 4 g Tube Box - ROSE TENTATION
COULEUR LUXE AMPLIFIER XP
amplifying lipstick
SPF 15
4 g e (.14 oz.)
L'BEL
PRINCIPAL DISPLAY PANEL - 4 g Tube Box - ROSE DÉLICAT
COULEUR LUXE AMPLIFIER XP
amplifying lipstick
SPF 15
4 g e (.14 oz.)
L'BEL
PRINCIPAL DISPLAY PANEL - 4 g Tube Box - FUCSIA DÉSIR
COULEUR LUXE AMPLIFIER XP
amplifying lipstick
SPF 15
4 g e (.14 oz.)
L'BEL
PRINCIPAL DISPLAY PANEL - 4 g Tube Box - ROUGE PROVOCATION
COULEUR LUXE AMPLIFIER XP
amplifying lipstick
SPF 15
4 g e (.14 oz.)
L'BEL
PRINCIPAL DISPLAY PANEL - 4 g Tube Box - AMPLIFFIER AMANDIER
COULEUR LUXE AMPLIFIER XP
amplifying lipstick
SPF 15
4 g e (.14 oz.)
L'BEL
PRINCIPAL DISPLAY PANEL - 4 g Tube Box - SOBRIETE
COULEUR LUXE AMPLIFIER XP
amplifying lipstick
SPF 15
4 g e (.14 oz.)
L'BEL
PRINCIPAL DISPLAY PANEL - 4 g Tube Box - FIANCEE
COULEUR LUXE AMPLIFIER XP
amplifying lipstick
SPF 15
4 g e (.14 oz.)
L'BEL
PRINCIPAL DISPLAY PANEL - 4 g Tube Box - ROMANCE
COULEUR LUXE AMPLIFIER XP
amplifying lipstick
SPF 15
4 g e (.14 oz.)
L'BEL
PRINCIPAL DISPLAY PANEL - 4 g Tube Box - CARMINE
COULEUR LUXE AMPLIFIER XP
amplifying lipstick
SPF 15
4 g e (.14 oz.)
L'BEL
PRINCIPAL DISPLAY PANEL - 4 g Tube Box - NOBLESSE
COULEUR LUXE AMPLIFIER XP
amplifying lipstick
SPF 15
4 g e (.14 oz.)
L'BEL
PRINCIPAL DISPLAY PANEL - 4 g Tube Box - MALBEC
COULEUR LUXE AMPLIFIER XP
amplifying lipstick
SPF 15
4 g e (.14 oz.)
L'BEL
PRINCIPAL DISPLAY PANEL - 4 g Tube Box - ROSÉ FUCSIA
COULEUR LUXE AMPLIFIER XP
amplifying lipstick
SPF 15
4 g e (.14 oz.)
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 | |
| CARMINIC ACID | INACTIVE INGREDIENT | CID8Z8N95N | 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. 6 | INACTIVE INGREDIENT | 481744AI4O | 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 | |
| FERRIC OXIDE YELLOW | INACTIVE INGREDIENT | EX438O2MRT | 1 | |
| FERROSOFERRIC OXIDE | INACTIVE INGREDIENT | XM0M87F357 | 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 | |
| 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 AMPLIFIER XP amplifying SPF 15 - ROSE CHAMPAGNE
- Octinoxate and Oxybenzone
- Octinoxate
- Oxybenzone
- ISOSTEARYL NEOPENTANOATE
- DIISOPROPYL DILINOLEATE
- HIGH DENSITY POLYETHYLENE
- MICA
- 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
- DIMETHICONE
- PROPYLPARABEN
- 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
- MANGANESE VIOLET
- FERRIC OXIDE RED
- TITANIUM DIOXIDE
- FD&C YELLOW NO. 5
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 |
|---|---|---|---|---|---|---|
| CARNAUBA WAX | CARNAUBA WAX | R12CBM0EIZ | TABLET, DELAYED RELEASE / ORAL | 230 mg | ||
| METHYLPARABEN | METHYLPARABEN | A2I8C7HI9T | DROPS / OPHTHALMIC | 0.01 %w/w | ||
| TITANIUM DIOXIDE | TITANIUM DIOXIDE | 15FIX9V2JP | GRANULE, FOR SUSPENSION / ORAL | 143 mg | ||
| FERRIC OXIDE YELLOW | FERRIC OXIDE YELLOW | EX438O2MRT | FILM / BUCCAL | 0.27 mg | ||
| FERROSOFERRIC OXIDE | FERROSOFERRIC OXIDE | XM0M87F357 | TABLET, COATED / ORAL | NA | ||
| ASCORBYL PALMITATE | ASCORBYL PALMITATE | QN83US2B0N | CAPSULE / ORAL | 12 mg | ||
| POLYSORBATE 80 | POLYSORBATE 80 | 6OZP39ZG8H | INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION / INTRAMUSCULAR | 1 mg | ||
| TITANIUM DIOXIDE | TITANIUM DIOXIDE | 15FIX9V2JP | CAPSULE, COATED / ORAL | 17 mg | ||
| METHYLPARABEN | METHYLPARABEN | A2I8C7HI9T | TABLET, CHEWABLE / ORAL | 1.28 mg | ||
| POLYOXYL 40 HYDROGENATED CASTOR OIL | POLYOXYL 40 HYDROGENATED CASTOR OIL | 7YC686GQ8F | CAPSULE, COATED / ORAL | 101.25 mg | ||
| SILICON DIOXIDE | SILICON DIOXIDE | ETJ7Z6XBU4 | TABLET / ORAL | 750 mg | ||
| FD&C YELLOW NO. 5 | FD&C YELLOW NO. 5 | I753WB2F1M | TABLET, DELAYED RELEASE / ORAL | 3 mg | ||
| POLYSORBATE 80 | POLYSORBATE 80 | 6OZP39ZG8H | INJECTION, SUSPENSION / INTRA-ARTICULAR | 4 mg | ||
| SILICON DIOXIDE | SILICON DIOXIDE | ETJ7Z6XBU4 | TAMPON / VAGINAL | NA | ||
| ASCORBYL PALMITATE | ASCORBYL PALMITATE | QN83US2B0N | SYSTEM / TOPICAL | 0.04 mg | ||
| FERRIC OXIDE YELLOW | FERRIC OXIDE YELLOW | EX438O2MRT | CAPSULE / ORAL | 14 mg | ||
| METHYLPARABEN | METHYLPARABEN | A2I8C7HI9T | FILM, SOLUBLE / BUCCAL | 3 mg | ||
| FERROSOFERRIC OXIDE | FERROSOFERRIC OXIDE | XM0M87F357 | TABLET / ORAL | 2 mg | ||
| SILICON DIOXIDE | SILICON DIOXIDE | ETJ7Z6XBU4 | POWDER / RESPIRATORY (INHALATION) | NA | ||
| SILICON DIOXIDE | SILICON DIOXIDE | ETJ7Z6XBU4 | POWDER, FOR SOLUTION / ORAL | 280 mg | ||
| PROPYLPARABEN | PROPYLPARABEN | Z8IX2SC1OH | CREAM, AUGMENTED / TOPICAL | 2 mg | ||
| PROPYLPARABEN | PROPYLPARABEN | Z8IX2SC1OH | SOLUTION / RESPIRATORY (INHALATION) | 0.01 %w/w | ||
| POLYSORBATE 80 | POLYSORBATE 80 | 6OZP39ZG8H | ELIXIR / ORAL | 2.5 mg/15ml | ||
| PARAFFIN | PARAFFIN | I9O0E3H2ZE | OINTMENT / RECTAL | 38 mg | ||
| METHYLPARABEN | METHYLPARABEN | A2I8C7HI9T | TABLET / ORAL | 1.8 mg | ||
| ISOSTEARYL ALCOHOL | ISOSTEARYL ALCOHOL | Q613OCQ44Y | CREAM / TOPICAL | 3 %w/w | ||
| TALC | TALC | 7SEV7J4R1U | GRANULE, FOR SUSPENSION / ORAL | 296 mg | ||
| PROPYLPARABEN | PROPYLPARABEN | Z8IX2SC1OH | SUSPENSION, EXTENDED RELEASE / ORAL | 4 mg | ||
| TALC | TALC | 7SEV7J4R1U | SUSPENSION / ORAL | 234 mg | ||
| FD&C YELLOW NO. 5 | FD&C YELLOW NO. 5 | I753WB2F1M | CONCENTRATE / BUCCAL | NA | ||
| FERRIC OXIDE YELLOW | FERRIC OXIDE YELLOW | EX438O2MRT | GRANULE, FOR SUSPENSION / ORAL | 11 mg | ||
| SHEA BUTTER | SHEA BUTTER | K49155WL9Y | LOTION / TOPICAL | 2340 mg | ||
| POLYSORBATE 80 | POLYSORBATE 80 | 6OZP39ZG8H | TABLET, FILM COATED / ORAL | 24 mg | ||
| PARAFFIN | PARAFFIN | I9O0E3H2ZE | OINTMENT / TOPICAL | 2860 mg | ||
| SILICON DIOXIDE | SILICON DIOXIDE | ETJ7Z6XBU4 | CREAM / VAGINAL | 51 mg | ||
| CARNAUBA WAX | CARNAUBA WAX | R12CBM0EIZ | CAPSULE, EXTENDED RELEASE / ORAL | 288 mg | ||
| TALC | TALC | 7SEV7J4R1U | TABLET / SUBLINGUAL | 32.4 mg | ||
| FERRIC OXIDE RED | FERRIC OXIDE RED | 1K09F3G675 | SUSPENSION, EXTENDED RELEASE / ORAL | 2.7 mg | ||
| METHYLPARABEN | METHYLPARABEN | A2I8C7HI9T | OINTMENT / OPHTHALMIC | 0.05 %w/w | ||
| PROPYLPARABEN | PROPYLPARABEN | Z8IX2SC1OH | LIQUID / TOPICAL | 0.1 %w/w | ||
| FERROSOFERRIC OXIDE | FERROSOFERRIC OXIDE | XM0M87F357 | CAPSULE, DELAYED RELEASE / ORAL | 6 mg | ||
| FD&C BLUE NO. 1 | FD&C BLUE NO. 1 | H3R47K3TBD | MOUTHWASH / BUCCAL | NA | ||
| PROPYLPARABEN | PROPYLPARABEN | Z8IX2SC1OH | CAPSULE / ORAL | 1 mg | ||
| FERRIC OXIDE RED | FERRIC OXIDE RED | 1K09F3G675 | TABLET, EXTENDED RELEASE / ORAL | 7 mg | ||
| POLYSORBATE 80 | POLYSORBATE 80 | 6OZP39ZG8H | LOTION / TOPICAL | 15 %w/w | ||
| PROPYLPARABEN | PROPYLPARABEN | Z8IX2SC1OH | CONCENTRATE / ORAL | 2.5 mg/5ml | ||
| POLYSORBATE 80 | POLYSORBATE 80 | 6OZP39ZG8H | TABLET, CHEWABLE / ORAL | 84 mg | ||
| HIGH DENSITY POLYETHYLENE | HIGH DENSITY POLYETHYLENE | UG00KM4WR7 | PASTE / TOPICAL | 2.5 %w/w | ||
| METHYLPARABEN | METHYLPARABEN | A2I8C7HI9T | INJECTION / INTRALESIONAL | 0.15 %w/v | ||
| PROPYLPARABEN | PROPYLPARABEN | Z8IX2SC1OH | SUSPENSION / AURICULAR (OTIC) | NA | ||
| SILICON DIOXIDE | SILICON DIOXIDE | ETJ7Z6XBU4 | TABLET, COATED / ORAL | 176 mg | ||
| FD&C YELLOW NO. 5 | FD&C YELLOW NO. 5 | I753WB2F1M | LOZENGE / BUCCAL | NA | ||
| FD&C BLUE NO. 1 | FD&C BLUE NO. 1 | H3R47K3TBD | FILM, SOLUBLE / ORAL | 0.04 mg | ||
| HIGH DENSITY POLYETHYLENE | HIGH DENSITY POLYETHYLENE | UG00KM4WR7 | JELLY / VAGINAL | 42.6 %w/w | ||
| POLYSORBATE 80 | POLYSORBATE 80 | 6OZP39ZG8H | INJECTION, POWDER, FOR SUSPENSION / INTRAMUSCULAR | 4 mg | ||
| FERRIC OXIDE RED | FERRIC OXIDE RED | 1K09F3G675 | CAPSULE, EXTENDED RELEASE / ORAL | 5 mg | ||
| SILICON DIOXIDE | SILICON DIOXIDE | ETJ7Z6XBU4 | TABLET, EXTENDED RELEASE / ORAL | 450 mg | ||
| POLYSORBATE 80 | POLYSORBATE 80 | 6OZP39ZG8H | CAPSULE, LIQUID FILLED / ORAL | 24 mg | ||
| POLYSORBATE 80 | POLYSORBATE 80 | 6OZP39ZG8H | INJECTION / INTRAMUSCULAR | 4 %w/v | ||
| TITANIUM DIOXIDE | TITANIUM DIOXIDE | 15FIX9V2JP | CREAM / TOPICAL | 80 mg |
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 |
|---|---|---|---|---|---|---|
| 2f123a2c-3f93-ca2d-e063-6394a90aff68 | 50ed6c76-cb88-4250-b24b-2f528274294d | 2025-02-26 | Warnings | 50ed6c76-cb88-4250-b24b-2f528274294d |
Reported adverse events (FAERS/openFDA)#
Adverse event summaries are temporarily unavailable. Other product information remains available.