Indications and uses
Helps prevent sunburn
EFFET PARFAIT ROUGE AMPLIFIER
- Manufacturer
- Ventura International LTD | Bel Star S.A. (Colombia)
- Effective date
- 2015-06-19
- Label type
- HUMAN OTC DRUG LABEL
- Version
- 2
- Source
- legacy-cache
- Hydrated at
- 2026-08-02 01:31:31
Label at a glance#
ProductEFFET PARFAIT ROUGE AMPLIFIER AMPLIFYING SPF 15 (ROUGE GRANDIOSE) - RED
Active ingredientOCTINOXATE
Label structure31 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 7.270 %
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
DIISOPROPYL DIMER DILINOLEATE, METHYL HYDROGENATED ROSINATE, POLYETHYLENE, MICA, CASTOR ISOSTEARATE BEESWAX SUCCINATE, COPERNICIA CERIFERA (CARNAUBA) WAX, HYDROGENATED POLYCYCLOPENTADIENE, SILICA, EUPHORBIA CERIFERA (CANDELILLA) WAX, OZOKERITE, ETHYLHEXYL PALMITATE, ISODODECANE, HYDROGENATED POLYISOBUTENE, POLYGLYCERYL-3 DIISOSTEARATE, GLYCERYL ISOSTEARATE, ISOSTEARYL ALCOHOL, DIPALMITOYL HYDROXYPROLINE, BUTYROSPERMUM PARKII (SHEA) BUTTER, BETA-SITOSTEROL, DIETHYLHEXYL SYRINGYLIDENEMALONATE, DIMETHICONE, SILICA SILYLATE, PHENOXYETHANOL, LUFFA CYLINDRICA SEED OIL, FRAGRANCE, CAPRYLYL GLYCOL, TRIMETHYLSILOXYSILICATE, CHLORPHENESIN, CERAMIDE 3, TOCOPHERYL ACETATE, CAPRYLIC/CAPRIC TRIGLYCERIDE, ALLANTOIN.
MAY CONTAIN:
MANGANESE VIOLET, BISMUTH OXYCHLORIDE, MICA, TITANIUM DIOXIDE, IRON OXIDES, RED 27 LAKE, CALCIUM ALUMINUM BOROSILICATE, YELLOW 5 LAKE, RED 7 LAKE, SYNTHETIC FLUORPHLOGOPITE, RED 21 LAKE, TALC, BLUE 1 LAKE, CARMINE, PEG-8 METHYL ETHER TRIETHOXYSILANE, TIN OXIDE.
SPL UNCLASSIFIED SECTION
US: Dist by Ventura Int Ltd.
DBA Belcorp USA, San
Francisco, CA 94111.
PRINCIPAL DISPLAY PANEL - 4 g Tube Box - (ROUGE GRANDIOSE) - RED
L'BEL
EFFET
PARFAIT
ROUGE
AMPLIFIER
amplifying
lipstick SPF 15
Net Weight 0.14 oz (4g)
PRINCIPAL DISPLAY PANEL - 4 g Tube Box - (ROUGE RUBI) - RED
L'BEL
EFFET
PARFAIT
ROUGE
AMPLIFIER
amplifying
lipstick SPF 15
Net Weight 0.14 oz (4g)
PRINCIPAL DISPLAY PANEL - 4 g Tube Box - (SOBRIETE) - BROWN
L'BEL
EFFET
PARFAIT
ROUGE
AMPLIFIER
amplifying
lipstick SPF 15
Net Weight 0.14 oz (4g)
PRINCIPAL DISPLAY PANEL - 4 g Tube Box - (MARRON ILIMITEE) - BROWN
L'BEL
EFFET
PARFAIT
ROUGE
AMPLIFIER
amplifying
lipstick SPF 15
Net Weight 0.14 oz (4g)
PRINCIPAL DISPLAY PANEL - 4 g Tube Box - (CORAL MAXIMUM) - ORANGE
L'BEL
EFFET
PARFAIT
ROUGE
AMPLIFIER
amplifying
lipstick SPF 15
Net Weight 0.14 oz (4g)
PRINCIPAL DISPLAY PANEL - 4 g Tube Box - (ROSE TENTATION) - PINK
L'BEL
EFFET
PARFAIT
ROUGE
AMPLIFIER
amplifying
lipstick SPF 15
Net Weight 0.14 oz (4g)
PRINCIPAL DISPLAY PANEL - 4 g Tube Box - (ROSE CHAMPAGNE) - PINK
L'BEL
EFFET
PARFAIT
ROUGE
AMPLIFIER
amplifying
lipstick SPF 15
Net Weight 0.14 oz (4g)
PRINCIPAL DISPLAY PANEL - 4 g Tube Box - (ROSE D'AMOUR) - PINK
L'BEL
EFFET
PARFAIT
ROUGE
AMPLIFIER
amplifying
lipstick SPF 15
Net Weight 0.14 oz (4g)
PRINCIPAL DISPLAY PANEL - 4 g Tube Box - (ROMANCE) - PINK
L'BEL
EFFET
PARFAIT
ROUGE
AMPLIFIER
amplifying
lipstick SPF 15
Net Weight 0.14 oz (4g)
PRINCIPAL DISPLAY PANEL - 4 g Tube Box - (FUCSIA SPLENDIDE) - PINK
L'BEL
EFFET
PARFAIT
ROUGE
AMPLIFIER
amplifying
lipstick SPF 15
Net Weight 0.14 oz (4g)
PRINCIPAL DISPLAY PANEL - 4 g Tube Box - (FUCSIA DESIR) - BROWN
L'BEL
EFFET
PARFAIT
ROUGE
AMPLIFIER
amplifying
lipstick SPF 15
Net Weight 0.14 oz (4g)
PRINCIPAL DISPLAY PANEL - 4 g Tube Box - (ROUGE PROVOCATION) - RED
L'BEL
EFFET
PARFAIT
ROUGE
AMPLIFIER
amplifying
lipstick SPF 15
Net Weight 0.14 oz (4g)
PRINCIPAL DISPLAY PANEL - 4 g Tube Box - (CARMINE) - RED
L'BEL
EFFET
PARFAIT
ROUGE
AMPLIFIER
amplifying
lipstick SPF 15
Net Weight 0.14 oz (4g)
PRINCIPAL DISPLAY PANEL - 4 g Tube Box - (MALBEC) - BROWN
L'BEL
EFFET
PARFAIT
ROUGE
AMPLIFIER
amplifying
lipstick SPF 15
Net Weight 0.14 oz (4g)
PRINCIPAL DISPLAY PANEL - 4 g Tube Box - (SALMON ESSENTIAL) - ORANGE
L'BEL
EFFET
PARFAIT
ROUGE
AMPLIFIER
amplifying
lipstick SPF 15
Net Weight 0.14 oz (4g)
PRINCIPAL DISPLAY PANEL - 4 g Tube Box - (BOURGOGNE VIF) - PINK
L'BEL
EFFET
PARFAIT
ROUGE
AMPLIFIER
amplifying
lipstick SPF 15
Net Weight 0.14 oz (4g)
PRINCIPAL DISPLAY PANEL - 4 g Tube Box - (GENUINE ROUGE) - RED
L'BEL
EFFET
PARFAIT
ROUGE
AMPLIFIER
amplifying
lipstick SPF 15
Net Weight 0.14 oz (4g)
PRINCIPAL DISPLAY PANEL - 4 g Tube Box - (VIOLET VELVET) - PURPLE
L'BEL
EFFET
PARFAIT
ROUGE
AMPLIFIER
amplifying
lipstick SPF 15
Net Weight 0.14 oz (4g)
PRINCIPAL DISPLAY PANEL - 4 g Tube Box - (MYSTIC ROSE) - PINK
L'BEL
EFFET
PARFAIT
ROUGE
AMPLIFIER
amplifying
lipstick SPF 15
Net Weight 0.14 oz (4g)
PRINCIPAL DISPLAY PANEL - 4 g Tube Box - (BELLE NUDE) - BEIGE
L'BEL
EFFET
PARFAIT
ROUGE
AMPLIFIER
amplifying
lipstick SPF 15
Net Weight 0.14 oz (4g)
PRINCIPAL DISPLAY PANEL - 4 g Tube Box - (FUCSIA PASSION) - PURPLE
L'BEL
EFFET
PARFAIT
ROUGE
AMPLIFIER
amplifying
lipstick SPF 15
Net Weight 0.14 oz (4g)
PRINCIPAL DISPLAY PANEL - 4 g Tube Box - (VIN CHIC) - BROWN
L'BEL
EFFET
PARFAIT
ROUGE
AMPLIFIER
amplifying
lipstick SPF 15
Net Weight 0.14 oz (4g)
FDA-Initiated Inactive NDC Indexing#
DailyMed Socrata Ingredients#
| Ingredient | Type | UNII | SPL version | Uploaded |
|---|---|---|---|---|
| OCTINOXATE | ACTIVE INGREDIENT | 4Y5P7MUD51 | 2 | |
| OCTINOXATE | ACTIVE MOIETY | 4Y5P7MUD51 | 2 | |
| .ALPHA.-TOCOPHEROL ACETATE | INACTIVE INGREDIENT | 9E8X80D2L0 | 2 | |
| .BETA.-SITOSTEROL | INACTIVE INGREDIENT | S347WMO6M4 | 2 | |
| ALLANTOIN | INACTIVE INGREDIENT | 344S277G0Z | 2 | |
| ALUMINUM OXIDE | INACTIVE INGREDIENT | LMI26O6933 | 2 | |
| BISMUTH OXYCHLORIDE | INACTIVE INGREDIENT | 4ZR792I587 | 2 | |
| CALCIUM ALUMINUM BOROSILICATE | INACTIVE INGREDIENT | 3JRB8A35M0 | 2 | |
| CANDELILLA WAX | INACTIVE INGREDIENT | WL0328HX19 | 2 | |
| CAPRYLYL GLYCOL | INACTIVE INGREDIENT | 00YIU5438U | 2 | |
| CARNAUBA WAX | INACTIVE INGREDIENT | R12CBM0EIZ | 2 | |
| CERAMIDE 3 | INACTIVE INGREDIENT | 4370DF050B | 2 | |
| CHLORPHENESIN | INACTIVE INGREDIENT | I670DAL4SZ | 2 | |
| D&C RED NO. 21 | INACTIVE INGREDIENT | 08744Z6JNY | 2 | |
| D&C RED NO. 27 | INACTIVE INGREDIENT | 2LRS185U6K | 2 | |
| D&C RED NO. 7 | INACTIVE INGREDIENT | ECW0LZ41X8 | 2 | |
| DIETHYLHEXYL SYRINGYLIDENEMALONATE | INACTIVE INGREDIENT | 3V5U97P248 | 2 | |
| DIISOPROPYL DILINOLEATE | INACTIVE INGREDIENT | 5323S7S2LR | 2 | |
| DIMETHICONE | INACTIVE INGREDIENT | 92RU3N3Y1O | 2 | |
| DIPALMITOYL HYDROXYPROLINE | INACTIVE INGREDIENT | E6AHA53N1H | 2 | |
| ETHYLHEXYL PALMITATE | INACTIVE INGREDIENT | 2865993309 | 2 | |
| FD&C BLUE NO. 1 | INACTIVE INGREDIENT | H3R47K3TBD | 2 | |
| FD&C YELLOW NO. 5 | INACTIVE INGREDIENT | I753WB2F1M | 2 | |
| FERRIC OXIDE RED | INACTIVE INGREDIENT | 1K09F3G675 | 2 | |
| GLYCERYL ISOSTEARATE | INACTIVE INGREDIENT | HYE7O27HAO | 2 | |
| HIGH DENSITY POLYETHYLENE | INACTIVE INGREDIENT | UG00KM4WR7 | 2 | |
| ISODODECANE | INACTIVE INGREDIENT | A8289P68Y2 | 2 | |
| ISOSTEARYL ALCOHOL | INACTIVE INGREDIENT | Q613OCQ44Y | 2 | |
| LUFFA AEGYPTIACA SEED OIL | INACTIVE INGREDIENT | 1A281RJ859 | 2 | |
| MANGANESE VIOLET | INACTIVE INGREDIENT | 72M48QQV8Q | 2 | |
| MEDIUM-CHAIN TRIGLYCERIDES | INACTIVE INGREDIENT | C9H2L21V7U | 2 | |
| METHYL HYDROGENATED ROSINATE | INACTIVE INGREDIENT | 13DHA19W9N | 2 | |
| MICA | INACTIVE INGREDIENT | V8A1AW0880 | 2 | |
| PHENOXYETHANOL | INACTIVE INGREDIENT | HIE492ZZ3T | 2 | |
| POLYGLYCERYL-3 DIISOSTEARATE | INACTIVE INGREDIENT | 46P231IQV8 | 2 | |
| SHEA BUTTER | INACTIVE INGREDIENT | K49155WL9Y | 2 | |
| SILICON DIOXIDE | INACTIVE INGREDIENT | ETJ7Z6XBU4 | 2 | |
| STANNIC OXIDE | INACTIVE INGREDIENT | KM7N50LOS6 | 2 | |
| TALC | INACTIVE INGREDIENT | 7SEV7J4R1U | 2 | |
| TITANIUM DIOXIDE | INACTIVE INGREDIENT | 15FIX9V2JP | 2 |
Products#
Every source-derived product name is available through these pages.
- EFFET PARFAIT ROUGE AMPLIFIER AMPLIFYING SPF 15 (ROUGE GRANDIOSE) - RED
- OCTINOXATE
- DIISOPROPYL DILINOLEATE
- METHYL HYDROGENATED ROSINATE
- HIGH DENSITY POLYETHYLENE
- MICA
- CARNAUBA WAX
- SILICON DIOXIDE
- CANDELILLA WAX
- ETHYLHEXYL PALMITATE
- ISODODECANE
- POLYGLYCERYL-3 DIISOSTEARATE
- GLYCERYL ISOSTEARATE
- ISOSTEARYL ALCOHOL
- DIPALMITOYL HYDROXYPROLINE
- SHEA BUTTER
- .BETA.-SITOSTEROL
- DIETHYLHEXYL SYRINGYLIDENEMALONATE
- DIMETHICONE
- PHENOXYETHANOL
- LUFFA AEGYPTIACA SEED OIL
- CAPRYLYL GLYCOL
- CHLORPHENESIN
- CERAMIDE 3
- .ALPHA.-TOCOPHEROL ACETATE
- MEDIUM-CHAIN TRIGLYCERIDES
- ALLANTOIN
- MANGANESE VIOLET
- BISMUTH OXYCHLORIDE
- TITANIUM DIOXIDE
- FERRIC OXIDE RED
- D&C RED NO. 27
- ALUMINUM OXIDE
- CALCIUM ALUMINUM BOROSILICATE
- FD&C YELLOW NO. 5
- D&C RED NO. 7
- D&C RED NO. 21
- TALC
- FD&C BLUE NO. 1
- STANNIC OXIDE
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 |
|---|---|---|---|---|---|---|
| FD&C BLUE NO. 1 | FD&C BLUE NO. 1 | H3R47K3TBD | SYRUP / ORAL | 0.05 mg/5ml | ||
| TITANIUM DIOXIDE | TITANIUM DIOXIDE | 15FIX9V2JP | SUSPENSION / ORAL | 113 mg | ||
| TALC | TALC | 7SEV7J4R1U | DROPS / ORAL | NA | ||
| TITANIUM DIOXIDE | TITANIUM DIOXIDE | 15FIX9V2JP | CAPSULE, EXTENDED RELEASE / ORAL | 67 mg | ||
| TITANIUM DIOXIDE | TITANIUM DIOXIDE | 15FIX9V2JP | TABLET, FILM COATED, EXTENDED RELEASE / ORAL | 11 mg | ||
| D&C RED NO. 27 | D&C RED NO. 27 | 2LRS185U6K | TABLET, EXTENDED RELEASE / ORAL | 1.43 mg | ||
| FD&C YELLOW NO. 5 | FD&C YELLOW NO. 5 | I753WB2F1M | CAPSULE / ORAL | 652 mg | ||
| TALC | TALC | 7SEV7J4R1U | TABLET / BUCCAL | 15 mg | ||
| FD&C BLUE NO. 1 | FD&C BLUE NO. 1 | H3R47K3TBD | SOLUTION / ORAL | 1.13 mg/15ml | ||
| TALC | TALC | 7SEV7J4R1U | TABLET, DELAYED RELEASE PARTICLES / ORAL | 56 mg | ||
| TALC | TALC | 7SEV7J4R1U | CAPSULE, EXTENDED RELEASE / ORAL | 5119 mg | ||
| FD&C YELLOW NO. 5 | FD&C YELLOW NO. 5 | I753WB2F1M | TABLET, SUGAR COATED / ORAL | NA | ||
| FD&C BLUE NO. 1 | FD&C BLUE NO. 1 | H3R47K3TBD | TABLET, FILM COATED / ORAL | 0.16 mg | ||
| FERRIC OXIDE RED | FERRIC OXIDE RED | 1K09F3G675 | TABLET, ORALLY DISINTEGRATING / ORAL | 2 mg | ||
| HIGH DENSITY POLYETHYLENE | HIGH DENSITY POLYETHYLENE | UG00KM4WR7 | PASTE / DENTAL | 60 mg | ||
| SILICON DIOXIDE | SILICON DIOXIDE | ETJ7Z6XBU4 | TABLET, DELAYED RELEASE / ORAL | 1190 mg | ||
| SILICON DIOXIDE | SILICON DIOXIDE | ETJ7Z6XBU4 | GEL / NASAL | 20 mg | ||
| SILICON DIOXIDE | SILICON DIOXIDE | ETJ7Z6XBU4 | PASTE / DENTAL | 34 %w/w | ||
| FERRIC OXIDE RED | FERRIC OXIDE RED | 1K09F3G675 | DROPS / ORAL | NA | ||
| FD&C BLUE NO. 1 | FD&C BLUE NO. 1 | H3R47K3TBD | ELIXIR / ORAL | NA | ||
| MEDIUM-CHAIN TRIGLYCERIDES | MEDIUM-CHAIN TRIGLYCERIDES | C9H2L21V7U | LOTION / TOPICAL | 7 %w/w | ||
| FERRIC OXIDE RED | FERRIC OXIDE RED | 1K09F3G675 | CREAM / TOPICAL | NA | ||
| TALC | TALC | 7SEV7J4R1U | SUSPENSION / ORAL | 234 mg | ||
| FD&C YELLOW NO. 5 | FD&C YELLOW NO. 5 | I753WB2F1M | ELIXIR / ORAL | 0.15 mg | ||
| SILICON DIOXIDE | SILICON DIOXIDE | ETJ7Z6XBU4 | GEL / VAGINAL | 8 %w/w | ||
| TITANIUM DIOXIDE | TITANIUM DIOXIDE | 15FIX9V2JP | DROPS / ORAL | NA | ||
| TALC | TALC | 7SEV7J4R1U | TABLET, ORALLY DISINTEGRATING, DELAYED RELEASE / ORAL | 357 mg | ||
| TITANIUM DIOXIDE | TITANIUM DIOXIDE | 15FIX9V2JP | INSERT, EXTENDED RELEASE / OPHTHALMIC | 0.4 mg | ||
| CARNAUBA WAX | CARNAUBA WAX | R12CBM0EIZ | GUM, CHEWING / BUCCAL | 10 mg | ||
| TITANIUM DIOXIDE | TITANIUM DIOXIDE | 15FIX9V2JP | GRANULE, FOR SUSPENSION / ORAL | 143 mg | ||
| SILICON DIOXIDE | SILICON DIOXIDE | ETJ7Z6XBU4 | POWDER / RESPIRATORY (INHALATION) | NA | ||
| FD&C BLUE NO. 1 | FD&C BLUE NO. 1 | H3R47K3TBD | LIQUID / ORAL | NA | ||
| FERRIC OXIDE RED | FERRIC OXIDE RED | 1K09F3G675 | TABLET, COATED / ORAL | 1 mg | ||
| FD&C BLUE NO. 1 | FD&C BLUE NO. 1 | H3R47K3TBD | POWDER, FOR SUSPENSION / ORAL | 1 mg/5ml | ||
| MEDIUM-CHAIN TRIGLYCERIDES | MEDIUM-CHAIN TRIGLYCERIDES | C9H2L21V7U | SOLUTION / ORAL | 5566 mg | ||
| CANDELILLA WAX | CANDELILLA WAX | WL0328HX19 | TABLET, EXTENDED RELEASE / ORAL | 3 mg | ||
| D&C RED NO. 27 | D&C RED NO. 27 | 2LRS185U6K | POWDER, FOR SUSPENSION / ORAL | 1.67 mg/5ml | ||
| FERRIC OXIDE RED | FERRIC OXIDE RED | 1K09F3G675 | CAPSULE / ORAL | 5 mg | ||
| SILICON DIOXIDE | SILICON DIOXIDE | ETJ7Z6XBU4 | GRANULE, FOR SOLUTION / ORAL | 1.8 mg/120ml | ||
| TITANIUM DIOXIDE | TITANIUM DIOXIDE | 15FIX9V2JP | CAPSULE, DELAYED RELEASE / ORAL | 55 mg | ||
| SHEA BUTTER | SHEA BUTTER | K49155WL9Y | LOTION / TOPICAL | 2340 mg | ||
| CANDELILLA WAX | CANDELILLA WAX | WL0328HX19 | TABLET, DELAYED RELEASE / ORAL | 1 mg | ||
| .ALPHA.-TOCOPHEROL ACETATE | .ALPHA.-TOCOPHEROL ACETATE | 9E8X80D2L0 | CAPSULE / ORAL | 2 mg | ||
| CARNAUBA WAX | CARNAUBA WAX | R12CBM0EIZ | CAPSULE / ORAL | NA | ||
| HIGH DENSITY POLYETHYLENE | HIGH DENSITY POLYETHYLENE | UG00KM4WR7 | FILM, EXTENDED RELEASE / TRANSDERMAL | 85 mg | ||
| D&C RED NO. 7 | D&C RED NO. 7 | ECW0LZ41X8 | TABLET, EXTENDED RELEASE / ORAL | NA | ||
| FD&C YELLOW NO. 5 | FD&C YELLOW NO. 5 | I753WB2F1M | OINTMENT / TOPICAL | 0.01 %w/w | ||
| SILICON DIOXIDE | SILICON DIOXIDE | ETJ7Z6XBU4 | CAPSULE, DELAYED RELEASE / ORAL | 40 mg | ||
| FD&C BLUE NO. 1 | FD&C BLUE NO. 1 | H3R47K3TBD | SOLUTION / DENTAL | NA | ||
| HIGH DENSITY POLYETHYLENE | HIGH DENSITY POLYETHYLENE | UG00KM4WR7 | TAPE / TOPICAL | NA | ||
| FERRIC OXIDE RED | FERRIC OXIDE RED | 1K09F3G675 | SUSPENSION, EXTENDED RELEASE / ORAL | 2.7 mg | ||
| HIGH DENSITY POLYETHYLENE | HIGH DENSITY POLYETHYLENE | UG00KM4WR7 | CAPSULE, EXTENDED RELEASE / ORAL | 4.53 mg | ||
| TALC | TALC | 7SEV7J4R1U | TABLET / SUBLINGUAL | 32.4 mg | ||
| TITANIUM DIOXIDE | TITANIUM DIOXIDE | 15FIX9V2JP | TABLET, ORALLY DISINTEGRATING, DELAYED RELEASE / ORAL | 42 mg | ||
| FD&C BLUE NO. 1 | FD&C BLUE NO. 1 | H3R47K3TBD | TABLET / ORAL | 27.53 mg | ||
| SILICON DIOXIDE | SILICON DIOXIDE | ETJ7Z6XBU4 | TABLET, ORALLY DISINTEGRATING / ORAL | 68 mg | ||
| MEDIUM-CHAIN TRIGLYCERIDES | MEDIUM-CHAIN TRIGLYCERIDES | C9H2L21V7U | TABLET, ORALLY DISINTEGRATING / ORAL | 1 mg | ||
| TALC | TALC | 7SEV7J4R1U | TABLET, COATED / ORAL | 320.75 mg | ||
| FD&C BLUE NO. 1 | FD&C BLUE NO. 1 | H3R47K3TBD | CAPSULE, EXTENDED RELEASE / ORAL | 1 mg | ||
| FD&C YELLOW NO. 5 | FD&C YELLOW NO. 5 | I753WB2F1M | SUSPENSION / ORAL | NA |
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 |
|---|---|---|---|---|---|---|
| 301767d0-83f1-daef-e063-6394a90aeffc | 381aa212-713a-4df1-9a0c-1c2d3af86e8d | 2025-03-11 | Warnings | 381aa212-713a-4df1-9a0c-1c2d3af86e8d |
Reported adverse events (FAERS/openFDA)#
Adverse event summaries are temporarily unavailable. Other product information remains available.