Indications and uses
Helps prevent sunburn.
L'BEL REGRESSION JOUR Protective Complex With SPF 15 Facial Day Lotion Normal to Combination Skin
- Manufacturer
- Ventura International, LTD | MF Productions
- Effective date
- 2012-03-28
- Label type
- HUMAN OTC DRUG LABEL
- Version
- 1
- Source
- full-release
- Hydrated at
- 2026-05-31 22:31:20
Label at a glance#
ProductLBEL REGRESSION JOUR Protective Complex With SPF 15 Facial Day Normal to Combination Skin
Active ingredientOCTINOXATE, OCTISALATE, OXYBENZONE
Label structure11 sections
Dosage and administration
Apply liberally and evenly 15 minutes before sun exposure. Apply after cleansing and toning on face and neck Reapply at least every 2 hours. Use a water resistant sunscreen if swimming or sweating. Children under 6 months of age: Ask a doctor.
Label contents#
Full prescribing information#
Active Ingredients
Octinoxate (7.5%)
Octisalate (4%)
Oxybenzone (4%)
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.
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 swallowed, get medical help or contact a Poison Control Center right away.
Directions
- Apply liberally and evenly 15 minutes before sun exposure.
- Apply after cleansing and toning on face and neck
- 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.
- Apply in the morning at the end of your skin care routine.
- Apply with the fingertips, spreading softly throughout the face until completely absorbed
Inactive Ingredients
AQUA (WATER), GLYCINE SOJA PROTEIN (GLYCINE SOJA (SOYBEAN) PROTEIN), C12-15 ALKYL BENZOATE, PISUM SATIVUM EXTRACT (PISUM SATIVUM (PEA) EXTRACT), CYCLOHEXASILOXANE, DIMETHICONE, MANNITOL, CETEARYL ALCOHOL, HDI/TRIMETHYLOL HEXYLLACTONE CROSSPOLYMER, PHENOXYETHANOL, SODIUM ACRYLATE/ACRYLOYLDIMETHYLTAURATE/DIMETHYLACRYLAMIDE CROSSPOLYMER, C20-22 ALKYL PHOSPHATE, GLYCERYL STEARATE, HYDROXYETHYL ACRYLATE/SODIUM ACRYLOYLDYMETHYL TAURATE COPOLYMER, C20-22 ALCOHOLS, TRIETHANOLAMINE, ISOHEXADECANE, METHYLPARABEN, C14-22 ALCOHOLS,CETEARYL GLUCOSIDE, HYDROLYZED ADANSONIA DIGITATA EXTRACT, BUTYLPARABEN, CYCLOPENTASILOXANE, CHLORPHENESIN, XANTHAN GUM, PROPYLPARABEN, ACRYLATES/C10-30 ALKYL ACRYLATE CROSSPOLYMER, DISODIUM EDTA, PARFUM (FRAGRANCE), SORBIC ACID, POLYSORBATE 60, CYCLODEXTRIN, C12-20 ALKYL GLUCOSIDE, FAEX EXTRACT (YEAST EXTRACT), HYDROLYZED ALGIN, ETHYLPARABEN, CHLORELLA VULGARIS EXTRACT, MARIS AQUA (SEA WATER), ISOBUTYLPARABEN, SILICA, DISODIUM SUCCINATE, CI 42090 (BLUE 1)
Purpose
Sunscreen
Call us toll-free: In the United States at 1-800-992-LBEL (5235), in Puerto Rico, 1-866-366-3235 (Metro area). US: Dis. by Ventura International Ltd.
US: Dis. by Ventura International Ltd. DBA Belcorp USA, San Francisco, CA 94111 P.R.: Dist. by Ventura Corporation Ltd., San Juan, Puerto Rico 00926. MADE IN FRANCE
EXPERT ROUTINE L'BEL
L'Bel presents Expert Routine, a skin care program with two steps that work together for enhanced results:
- Cleanse the skin according to its needs
- Noursih according to age
Protective complex with SPF 15
The skin is an organ that acts as the body's first line of defense against environmental aggressions. However, after the age of 30, the skin's natural self-defense properties diminish, making it more vulnerable to ultraviolet (UVA and UVB) rays, as well as to pollution, which can accelerate the aging process.
The skin does not recover as quickly as it once did. For that reason, it is essential to give your skin the protection it needs.
Regression Jour with Sun Protection Factor (SPF) 15, in addition to moisturizing the skin, acts as a shield to protect its youthful appearance.
Discover the effectiveness of its action
- Protective Shield Complex: Effective plant-derived complex that helps maintain the skin's natural defenses.
- Hydra-Film Technology: Seaweed extract that helps recover the skin's hydrolipid layer - responsible for hydration, absorption and water retention - to transport moisture to the skin cells that need it most.
- Regression Jour protective complex with SPF 15 facial day cream normal to dry skin.
- Regression Jour protective complex with SPF 15 facial day cream normal to combination skin.
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. 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 swallowed, get medical help or contact a Poison Control Center right away.
DIRECTIONS:
- Apply liberally and evenly 15 minutes before sun exposure.
- Apply after cleansing and toning on face and neck
- Reapply at least every 2 hours
- Use a water resistant sunscreen if swimming or sweating.
- Children under 6 months of age: Ask a doctor
- Protect the product in this container from excessive heat and direct sun.
- Apply in the morning at the end of your skin care routine
- Apply with fingertips, spreading softly throughout the face until completely absorbed
- HYPOALLERGENIC
- CLINICALLY AND DERMATOLOGICALLY TESTED
PACKAGE LABEL.PRINCIPAL DISPLAY PANEL
After the age of 30
NEW REGRESSION JOUR Protective complex with SPF 15 facial day lotion normal to combination skin 50 ml e (1.6 fl. oz.) L'BEL
L'BEL REGRESSION JOUR Protective Complex With SPF 15 Facial Day Lotion Normal to Combination Skin
FDA-Initiated Inactive NDC Indexing#
| NDC | Effective | Action | Document | Indexing SPL | Related label |
|---|---|---|---|---|---|
| 43455-0003-0 | 2019-11-13 | C162847 | 48780-1 | 97449f38-bf7e-f6ea-e053-dbdaa90aa703 | L'BEL REGRESSION JOUR Protective Complex With SPF 15 Facial Day Lotion Normal to Combination Skin |
| 43455-0003-1 | 2019-11-13 | C162847 | 48780-1 | 97449f38-bf7e-f6ea-e053-dbdaa90aa703 | L'BEL REGRESSION JOUR Protective Complex With SPF 15 Facial Day Lotion Normal to Combination Skin |
| 43455-0003-2 | 2019-11-13 | C162847 | 48780-1 | 97449f38-bf7e-f6ea-e053-dbdaa90aa703 | L'BEL REGRESSION JOUR Protective Complex With SPF 15 Facial Day Lotion Normal to Combination Skin |
DailyMed Package Descriptions#
| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|---|---|---|---|---|---|
| 43455-0003-0 | LBEL REGRESSION JOUR Protective Complex With SPF 15 Facial Day Normal to Combination Skin | 1 mL in 1 POUCH | LOTION | 1 | 1 | |
| 43455-0003-1 | LBEL REGRESSION JOUR Protective Complex With SPF 15 Facial Day Normal to Combination Skin | 5 mL in 1 JAR | LOTION | 5 | 1 | |
| 43455-0003-2 | LBEL REGRESSION JOUR Protective Complex With SPF 15 Facial Day Normal to Combination Skin | 50 mL in 1 JAR | LOTION | 50 | 1 |
DailyMed Dashboard NDC Coverage#
| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|---|---|---|---|
| 43455-0003 | LBEL REGRESSION JOUR PROTECTIVE COMPLEX WITH SPF 15 FACIAL DAY NORMAL TO COMBINATION SKIN (OCTINOXATE, OCTISALATE, OXYBENZONE) LOTION [VENTURA INTERNATIONAL, LTD] | 1 | Legacy NDC, 3 package rows | 20120404_bc0b4e6b-3ad9-4c97-bb22-0363510b629c.zip |
DailyMed Socrata Ingredients#
| Ingredient | Type | UNII | SPL version | Uploaded |
|---|---|---|---|---|
| OCTINOXATE | ACTIVE INGREDIENT | 4Y5P7MUD51 | 1 | |
| OCTISALATE | ACTIVE INGREDIENT | 4X49Y0596W | 1 | |
| OXYBENZONE | ACTIVE INGREDIENT | 95OOS7VE0Y | 1 | |
| OCTINOXATE | ACTIVE MOIETY | 4Y5P7MUD51 | 1 | |
| OCTISALATE | ACTIVE MOIETY | 4X49Y0596W | 1 | |
| OXYBENZONE | ACTIVE MOIETY | 95OOS7VE0Y | 1 | |
| 2-HYDROXYETHYL ACRYLATE | INACTIVE INGREDIENT | 25GT92NY0C | 1 | |
| ALKYL (C12-15) BENZOATE | INACTIVE INGREDIENT | A9EJ3J61HQ | 1 | |
| BUTYLPARABEN | INACTIVE INGREDIENT | 3QPI1U3FV8 | 1 | |
| C12-20 ALKYL GLUCOSIDE | INACTIVE INGREDIENT | K67N5Z1RUA | 1 | |
| C14-22 ALCOHOLS | INACTIVE INGREDIENT | B1K89384RJ | 1 | |
| C20-22 ALCOHOLS | INACTIVE INGREDIENT | O4M0347C6A | 1 | |
| C20-22 ALKYL PHOSPHATE | INACTIVE INGREDIENT | L4VKP0Y7RP | 1 | |
| CARBOMER INTERPOLYMER TYPE A (55000 MPA.S) | INACTIVE INGREDIENT | 59TL3WG5CO | 1 | |
| CETEARYL GLUCOSIDE | INACTIVE INGREDIENT | 09FUA47KNA | 1 | |
| CETOSTEARYL ALCOHOL | INACTIVE INGREDIENT | 2DMT128M1S | 1 | |
| CHLORELLA VULGARIS | INACTIVE INGREDIENT | RYQ4R60M02 | 1 | |
| CHLORPHENESIN | INACTIVE INGREDIENT | I670DAL4SZ | 1 | |
| CYCLOMETHICONE 5 | INACTIVE INGREDIENT | 0THT5PCI0R | 1 | |
| CYCLOMETHICONE 6 | INACTIVE INGREDIENT | XHK3U310BA | 1 | |
| D&C BLUE NO. 4 | INACTIVE INGREDIENT | 0KSY80VYS3 | 1 | |
| DIMETHICONE | INACTIVE INGREDIENT | 92RU3N3Y1O | 1 | |
| EDETATE DISODIUM | INACTIVE INGREDIENT | 7FLD91C86K | 1 | |
| ETHYLPARABEN | INACTIVE INGREDIENT | 14255EXE39 | 1 | |
| GLYCERYL MONOSTEARATE | INACTIVE INGREDIENT | 230OU9XXE4 | 1 | |
| ISOBUTYLPARABEN | INACTIVE INGREDIENT | 0QQJ25X58G | 1 | |
| ISOHEXADECANE | INACTIVE INGREDIENT | 918X1OUF1E | 1 | |
| MANNITOL | INACTIVE INGREDIENT | 3OWL53L36A | 1 | |
| METHYLPARABEN | INACTIVE INGREDIENT | A2I8C7HI9T | 1 | |
| PEA | INACTIVE INGREDIENT | W4X7H8GYFM | 1 | |
| PHENOXYETHANOL | INACTIVE INGREDIENT | HIE492ZZ3T | 1 | |
| POLYSORBATE 60 | INACTIVE INGREDIENT | CAL22UVI4M | 1 | |
| PROPYLPARABEN | INACTIVE INGREDIENT | Z8IX2SC1OH | 1 | |
| SILICON DIOXIDE | INACTIVE INGREDIENT | ETJ7Z6XBU4 | 1 | |
| SODIUM ACRYLATE/SODIUM ACRYLOYLDIMETHYLTAURATE COPOLYMER (4000000 MW) | INACTIVE INGREDIENT | 1DXE3F3OZX | 1 | |
| SODIUM SUCCINATE ANHYDROUS | INACTIVE INGREDIENT | V8ZGC8ISR3 | 1 | |
| SORBIC ACID | INACTIVE INGREDIENT | X045WJ989B | 1 | |
| SOY PROTEIN | INACTIVE INGREDIENT | R44IWB3RN5 | 1 | |
| TROLAMINE | INACTIVE INGREDIENT | 9O3K93S3TK | 1 | |
| WATER | INACTIVE INGREDIENT | 059QF0KO0R | 1 | |
| XANTHAN GUM | INACTIVE INGREDIENT | TTV12P4NEE | 1 | |
| YEAST | INACTIVE INGREDIENT | 3NY3SM6B8U | 1 |
Products#
Every source-derived product name is available through these pages.
- LBEL REGRESSION JOUR Protective Complex With SPF 15 Facial Day Normal to Combination Skin
- OCTINOXATE, OCTISALATE, OXYBENZONE
- OCTINOXATE
- OCTISALATE
- OXYBENZONE
- WATER
- SOY PROTEIN
- ALKYL (C12-15) BENZOATE
- PEA
- CYCLOMETHICONE 6
- DIMETHICONE
- MANNITOL
- CETOSTEARYL ALCOHOL
- PHENOXYETHANOL
- SODIUM ACRYLATE/SODIUM ACRYLOYLDIMETHYLTAURATE COPOLYMER (4000000 MW)
- C20-22 ALKYL PHOSPHATE
- GLYCERYL MONOSTEARATE
- 2-HYDROXYETHYL ACRYLATE
- C20-22 ALCOHOLS
- TROLAMINE
- ISOHEXADECANE
- METHYLPARABEN
- C14-22 ALCOHOLS
- CETEARYL GLUCOSIDE
- BUTYLPARABEN
- CYCLOMETHICONE 5
- CHLORPHENESIN
- XANTHAN GUM
- PROPYLPARABEN
- CARBOMER INTERPOLYMER TYPE A (55000 MPA.S)
- EDETATE DISODIUM
- SORBIC ACID
- POLYSORBATE 60
- C12-20 ALKYL GLUCOSIDE
- YEAST
- ETHYLPARABEN
- CHLORELLA VULGARIS
- ISOBUTYLPARABEN
- SILICON DIOXIDE
- SODIUM SUCCINATE ANHYDROUS
NDC Codes#
| Product NDC | Package NDC |
|---|---|
| 43455-0003 | 43455-0003-0, 43455-0003-1, 43455-0003-2 |
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 |
|---|---|---|---|---|---|---|
| EDETATE DISODIUM | EDETATE DISODIUM | 7FLD91C86K | INJECTION, EMULSION / INTRAVENOUS | 59 mg | ||
| METHYLPARABEN | METHYLPARABEN | A2I8C7HI9T | SOLUTION / OPHTHALMIC | 0.05 %w/w | ||
| PROPYLPARABEN | PROPYLPARABEN | Z8IX2SC1OH | SOLUTION / TOPICAL | 24 mg | ||
| MANNITOL | MANNITOL | 3OWL53L36A | INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION / INTRAMUSCULAR | 113 mg | ||
| SORBIC ACID | SORBIC ACID | X045WJ989B | CREAM / TOPICAL | 14 mg | ||
| EDETATE DISODIUM | EDETATE DISODIUM | 7FLD91C86K | TABLET, ORALLY DISINTEGRATING / ORAL | 3 mg | ||
| MANNITOL | MANNITOL | 3OWL53L36A | WAFER / ORAL | 642 mg | ||
| XANTHAN GUM | XANTHAN GUM | TTV12P4NEE | SUSPENSION / ORAL | 360 mg | ||
| METHYLPARABEN | METHYLPARABEN | A2I8C7HI9T | INJECTION, POWDER, FOR SOLUTION / INTRAMUSCULAR | 3.6 mg | ||
| GLYCERYL MONOSTEARATE | GLYCERYL MONOSTEARATE | 230OU9XXE4 | TABLET, CHEWABLE / ORAL | 1 mg | ||
| SORBIC ACID | SORBIC ACID | X045WJ989B | TABLET / SUBLINGUAL | 0.16 mg | ||
| POLYSORBATE 60 | POLYSORBATE 60 | CAL22UVI4M | OINTMENT / TOPICAL | 2 %w/w | ||
| PROPYLPARABEN | PROPYLPARABEN | Z8IX2SC1OH | CREAM, AUGMENTED / TOPICAL | 2 mg | ||
| MANNITOL | MANNITOL | 3OWL53L36A | SUSPENSION/ DROPS / TOPICAL | 0.3 %w/v | ||
| XANTHAN GUM | XANTHAN GUM | TTV12P4NEE | SOLUTION / OPHTHALMIC | 0.6 %w/v | ||
| SORBIC ACID | SORBIC ACID | X045WJ989B | TABLET, CHEWABLE / ORAL | NA | ||
| PROPYLPARABEN | PROPYLPARABEN | Z8IX2SC1OH | SUSPENSION/ DROPS / OPHTHALMIC | 0.01 %w/w | ||
| EDETATE DISODIUM | EDETATE DISODIUM | 7FLD91C86K | INJECTION, SUSPENSION / SOFT TISSUE | 1 mg | ||
| XANTHAN GUM | XANTHAN GUM | TTV12P4NEE | TABLET, ORALLY DISINTEGRATING / ORAL | 0.15 mg | ||
| MANNITOL | MANNITOL | 3OWL53L36A | TABLET, ORALLY DISINTEGRATING, DELAYED RELEASE / ORAL | 1568 mg | ||
| POLYSORBATE 60 | POLYSORBATE 60 | CAL22UVI4M | SHAMPOO / TOPICAL | 14.55 %w/w | ||
| BUTYLPARABEN | BUTYLPARABEN | 3QPI1U3FV8 | TABLET, EXTENDED RELEASE / ORAL | 0.01 mg | ||
| EDETATE DISODIUM | EDETATE DISODIUM | 7FLD91C86K | TABLET, CHEWABLE / ORAL | 1 mg | ||
| GLYCERYL MONOSTEARATE | GLYCERYL MONOSTEARATE | 230OU9XXE4 | LOTION / TOPICAL | 177 mg | ||
| PROPYLPARABEN | PROPYLPARABEN | Z8IX2SC1OH | SOLUTION / INTRAVENOUS | 0.02 %w/v | ||
| BUTYLPARABEN | BUTYLPARABEN | 3QPI1U3FV8 | SOLUTION / RECTAL | 0.01 %w/v | ||
| EDETATE DISODIUM | EDETATE DISODIUM | 7FLD91C86K | DROPS / OPHTHALMIC | 0.05 %w/v | ||
| GLYCERYL MONOSTEARATE | GLYCERYL MONOSTEARATE | 230OU9XXE4 | CREAM / VAGINAL | 140 mg | ||
| GLYCERYL MONOSTEARATE | GLYCERYL MONOSTEARATE | 230OU9XXE4 | LIQUID / TOPICAL | 1 %w/w | ||
| EDETATE DISODIUM | EDETATE DISODIUM | 7FLD91C86K | TABLET, EFFERVESCENT / ORAL | 32 mg | ||
| PHENOXYETHANOL | PHENOXYETHANOL | HIE492ZZ3T | AEROSOL, FOAM / TOPICAL | 72 mg | ||
| MANNITOL | MANNITOL | 3OWL53L36A | SOLUTION / OPHTHALMIC | 4.7 %w/v | ||
| EDETATE DISODIUM | EDETATE DISODIUM | 7FLD91C86K | INJECTION / SUBCUTANEOUS | 6 mg | ||
| XANTHAN GUM | XANTHAN GUM | TTV12P4NEE | SOLUTION, GEL FORMING, EXTENDED RELEASE / OPHTHALMIC | 0.6 %w/w | ||
| PROPYLPARABEN | PROPYLPARABEN | Z8IX2SC1OH | SPRAY / TOPICAL | 0.8 %w/w | ||
| MANNITOL | MANNITOL | 3OWL53L36A | GUM, CHEWING / BUCCAL | 891 mg | ||
| MANNITOL | MANNITOL | 3OWL53L36A | SOLUTION, GEL FORMING / DROPS / OPHTHALMIC | 4 mg | ||
| POLYSORBATE 60 | POLYSORBATE 60 | CAL22UVI4M | SUSPENSION / TOPICAL | 2.85 %w/w | ||
| SILICON DIOXIDE | SILICON DIOXIDE | ETJ7Z6XBU4 | SUPPOSITORY / RECTAL | 14 mg | ||
| PROPYLPARABEN | PROPYLPARABEN | Z8IX2SC1OH | DROPS / AURICULAR (OTIC) | NA | ||
| SORBIC ACID | SORBIC ACID | X045WJ989B | SYRUP / ORAL | 80 mg | ||
| METHYLPARABEN | METHYLPARABEN | A2I8C7HI9T | INJECTION, SOLUTION / PARENTERAL | 30 mg | ||
| XANTHAN GUM | XANTHAN GUM | TTV12P4NEE | TABLET, FILM COATED / ORAL | 0.08 mg | ||
| METHYLPARABEN | METHYLPARABEN | A2I8C7HI9T | INJECTION / SUBCUTANEOUS | 22 mg | ||
| METHYLPARABEN | METHYLPARABEN | A2I8C7HI9T | PASTE, DENTIFRICE / DENTAL | 0.05 %w/w | ||
| TROLAMINE | TROLAMINE | 9O3K93S3TK | CREAM / VAGINAL | 56 mg | ||
| EDETATE DISODIUM | EDETATE DISODIUM | 7FLD91C86K | INJECTION, SOLUTION / INTRAVENOUS | 7 mg | ||
| SORBIC ACID | SORBIC ACID | X045WJ989B | AEROSOL, FOAM / TOPICAL | 6 mg | ||
| METHYLPARABEN | METHYLPARABEN | A2I8C7HI9T | INJECTION / PERINEURAL | 80 mg | ||
| MANNITOL | MANNITOL | 3OWL53L36A | INJECTION, POWDER, FOR SUSPENSION / INTRAMUSCULAR | 164 mg | ||
| SILICON DIOXIDE | SILICON DIOXIDE | ETJ7Z6XBU4 | TABLET, FILM COATED / ORAL | 166 mg | ||
| ETHYLPARABEN | ETHYLPARABEN | 14255EXE39 | POWDER, FOR SOLUTION / ORAL | 13 mg | ||
| SORBIC ACID | SORBIC ACID | X045WJ989B | GEL / TOPICAL | 2 mg | ||
| METHYLPARABEN | METHYLPARABEN | A2I8C7HI9T | SUSPENSION / AURICULAR (OTIC) | NA | ||
| METHYLPARABEN | METHYLPARABEN | A2I8C7HI9T | SOLUTION / NASAL | 250 mg | ||
| TROLAMINE | TROLAMINE | 9O3K93S3TK | AEROSOL, METERED / RECTAL | ADJ PH | ||
| PHENOXYETHANOL | PHENOXYETHANOL | HIE492ZZ3T | GEL / TOPICAL | 14 mg | ||
| BUTYLPARABEN | BUTYLPARABEN | 3QPI1U3FV8 | SYRUP / ORAL | 28.4 mg/1ml | ||
| METHYLPARABEN | METHYLPARABEN | A2I8C7HI9T | INJECTION / INFILTRATION | 80 mg | ||
| SILICON DIOXIDE | SILICON DIOXIDE | ETJ7Z6XBU4 | POWDER / ORAL | 602 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 |
|---|---|---|---|---|---|---|
| 8dfa0764-2694-4030-9ad5-d5fcbbfecc86 | bc0b4e6b-3ad9-4c97-bb22-0363510b629c | 2012-03-28 | Warnings | 8dfa0764-2694-4030-9ad5-d5fcbbfecc86 bc0b4e6b-3ad9-4c97-bb22-0363510b629c |
Reported adverse events (FAERS/openFDA)#
Adverse event summaries are temporarily unavailable. Other product information remains available.