LBEL REGRESSION JOUR

Manufacturer
Ventura International Ltd. | MF Productions Saumur (France)
Effective date
2012-05-21
Label type
HUMAN OTC DRUG LABEL
Version
1
Source
full-release
Hydrated at
2026-05-31 22:31:59

Label at a glance#

ProductLBEL REGRESSION JOUR Protective Complex with SPF 15 Facial day normal to dry skin
Active ingredientAvobenzone, Ensulizole, Octinoxate, Oxybenzone
Label structure9 sections

Indications and uses

Helps prevent sunburn.

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

Storage and handling

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

Label contents#

Full prescribing information#

SPL UNCLASSIFIED SECTION

Drug Facts

OTC - ACTIVE INGREDIENT SECTION

OTC - PURPOSE SECTION

Active IngredientsPurpose
Avobenzone (2 %)Sunscreen
Ensulizole (1 %)Sunscreen
Octinoxate (7.5 %)Sunscreen
Oxybenzone (2 %)Sunscreen

Uses

INDICATIONS & USAGE SECTION

  • Helps prevent sunburn.

Warnings

WARNINGS SECTION

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.

OTC - WHEN USING 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

DOSAGE & ADMINISTRATION SECTION

  • 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

STORAGE AND HANDLING SECTION

  • 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

INACTIVE INGREDIENT SECTION

Aqua (water), glycine soja protein (glycine soja (soybean) protein), propylene glycol, cyclopentasiloxane, cetyl alcohol, c12-15 alkyl benzoate, pisum sativum extract (pisum sativum (pea) extract), cyclohexasiloxane, triethanolamine, glyceryl stearate, mannitol, corn starch modified, phenoxyethanol, polyacrylamide, hydrolyzed adansonia digitata extract,stearic acid, peg-75 stearate, methylparaben, c13-14 isoparaffin, propylparaben, xanthan gum, parfum (fragrance), ceteth-20, pentaerythrityl tetra-di-t-butyl hydroxyhydrocinnamate, steareth-20, acrylates/c10-30 alkyl acrylate crosspolymer, disodium edta, laureth-7, cyclodextrin, dimethicone crosspolymer, dimethicone, faex extract (yeast extract), hydrolyzed algin, butylparaben, ethylparaben, chlorella vulgaris extract, isobutylparaben, maris aqua (sea water), laureth-23, laureth-4, disodium succinate, CI 42090 (blue 1)

SPL UNCLASSIFIED SECTION

US: Distributed by Ventura International Ltd. DBA Belcorp USA, San Francisco, CA 94111

PRINCIPAL DISPLAY PANEL - 5 g Jar Box

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

L'BEL

REGRESSION JOUR

protective complex with SPF 15
facial day cream
normal to dry skin

5 g e (.17 oz.)

Principal Display Panel - 5 g Jar Box
Principal Display Panel - 5 g Jar Box

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
a62a50ac-1535-4461-9768-8ae703e2e9fbProduct name120210525
9514609b-a2a9-f8ec-6ba6-3f8e5ee89877Product name120140508
bc07ef78-e82d-0c19-31f4-31f263780582Product name120140508

FDA-Initiated Inactive NDC Indexing#

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
14783-025-01LBEL REGRESSION JOUR Protective Complex with SPF 15 Facial day normal to dry skin1 g in 1 PACKETCREAM11
14783-025-03LBEL REGRESSION JOUR Protective Complex with SPF 15 Facial day normal to dry skin5 g in 1 JARCREAM51
14783-025-04LBEL REGRESSION JOUR Protective Complex with SPF 15 Facial day normal to dry skin1 in 1 BOXCREAM11
14783-025-61LBEL REGRESSION JOUR Protective Complex with SPF 15 Facial day normal to dry skin1 in 1 BOXCREAM11
14783-025-66LBEL REGRESSION JOUR Protective Complex with SPF 15 Facial day normal to dry skin50 g in 1 JARCREAM501

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
14783-025LBEL REGRESSION JOUR PROTECTIVE COMPLEX WITH SPF 15 FACIAL DAY NORMAL TO DRY SKIN (AVOBENZONE, ENSULIZOLE, OCTINOXATE, AND OXYBENZONE) CREAM [VENTURA INTERNATIONAL LTD.]1Legacy NDC, 5 package rows20120522_1c6b71d2-3f5d-485f-b571-2e046cbcef91.zip

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIISPL versionUploaded
AvobenzoneACTIVE INGREDIENTG63QQF2NOX1
EnsulizoleACTIVE INGREDIENT9YQ9DI1W421
OctinoxateACTIVE INGREDIENT4Y5P7MUD511
OxybenzoneACTIVE INGREDIENT95OOS7VE0Y1
AvobenzoneACTIVE MOIETYG63QQF2NOX1
EnsulizoleACTIVE MOIETY9YQ9DI1W421
OctinoxateACTIVE MOIETY4Y5P7MUD511
OxybenzoneACTIVE MOIETY95OOS7VE0Y1
ALKYL (C12-15) BENZOATEINACTIVE INGREDIENTA9EJ3J61HQ1
BUTYLPARABENINACTIVE INGREDIENT3QPI1U3FV81
C13-14 ISOPARAFFININACTIVE INGREDIENTE4F12ROE701
CETETH-20INACTIVE INGREDIENTI835H2IHHX1
CETYL ALCOHOLINACTIVE INGREDIENT936JST6JCN1
CHLORELLA VULGARISINACTIVE INGREDIENTRYQ4R60M021
CYCLOMETHICONE 5INACTIVE INGREDIENT0THT5PCI0R1
CYCLOMETHICONE 6INACTIVE INGREDIENTXHK3U310BA1
DIMETHICONEINACTIVE INGREDIENT92RU3N3Y1O1
EDETATE DISODIUMINACTIVE INGREDIENT7FLD91C86K1
ETHYLPARABENINACTIVE INGREDIENT14255EXE391
FD&C BLUE NO. 1INACTIVE INGREDIENTH3R47K3TBD1
GLYCERYL MONOSTEARATEINACTIVE INGREDIENT230OU9XXE41
ISOBUTYLPARABENINACTIVE INGREDIENT0QQJ25X58G1
LAURETH-23INACTIVE INGREDIENTN72LMW566G1
LAURETH-4INACTIVE INGREDIENT6HQ855798J1
LAURETH-7INACTIVE INGREDIENTZ95S6G82011
MANNITOLINACTIVE INGREDIENT3OWL53L36A1
METHYLPARABENINACTIVE INGREDIENTA2I8C7HI9T1
PEAINACTIVE INGREDIENTW4X7H8GYFM1
PEG-75 STEARATEINACTIVE INGREDIENTOT38R0N74H1
PENTAERYTHRITOL TETRAKIS(3-(3,5-DI-TERT-BUTYL-4-HYDROXYPHENYL)PROPIONATE)INACTIVE INGREDIENT255PIF62MS1
PHENOXYETHANOLINACTIVE INGREDIENTHIE492ZZ3T1
PROPYLENE GLYCOLINACTIVE INGREDIENT6DC9Q167V31
PROPYLPARABENINACTIVE INGREDIENTZ8IX2SC1OH1
SODIUM SUCCINATE ANHYDROUSINACTIVE INGREDIENTV8ZGC8ISR31
STEARETH-20INACTIVE INGREDIENTL0Q8IK9E081
STEARIC ACIDINACTIVE INGREDIENT4ELV7Z65AP1
TROLAMINEINACTIVE INGREDIENT9O3K93S3TK1
WATERINACTIVE INGREDIENT059QF0KO0R1
XANTHAN GUMINACTIVE INGREDIENTTTV12P4NEE1
YEASTINACTIVE INGREDIENT3NY3SM6B8U1

Products#

Every source-derived product name is available through these pages.

DailyMed product names page 1 of 1 · 38 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
14783-02514783-025-66, 14783-025-61, 14783-025-03, 14783-025-04, 14783-025-01

Ingredients#

Every source-derived ingredient row is available through these pages.

DailyMed ingredient rows page 1 of 1 · 36 matching rows.

Source Document#

Source XML

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.

Inactive ingredient links page 1 of 10 · 567 matching rows.

DailyMed ingredient, IID ingredient, UNII table
DailyMed ingredientIID ingredientUNIIDosage form / routePotencyMaximum daily exposureMatch
PROPYLENE GLYCOLPROPYLENE GLYCOL6DC9Q167V3SOLUTION / ORAL22602 mgExact identifier — unii candidate
81 equally ranked IID candidates
XANTHAN GUMXANTHAN GUMTTV12P4NEESOLUTION, GEL FORMING, EXTENDED RELEASE / OPHTHALMIC0.6 %w/wExact identifier — unii candidate
29 equally ranked IID candidates
PROPYLENE GLYCOLPROPYLENE GLYCOL6DC9Q167V3INJECTION, SOLUTION / INTRAVENOUS4000 mgExact identifier — unii candidate
81 equally ranked IID candidates
PROPYLPARABENPROPYLPARABENZ8IX2SC1OHGEL / TOPICAL4 mgExact identifier — unii candidate
68 equally ranked IID candidates
PROPYLPARABENPROPYLPARABENZ8IX2SC1OHENEMA / RECTAL0.02 %w/wExact identifier — unii candidate
68 equally ranked IID candidates
FD&C BLUE NO. 1FD&C BLUE NO. 1H3R47K3TBDTABLET / SUBLINGUAL0.03 mgExact identifier — unii candidate
37 equally ranked IID candidates
CETYL ALCOHOLCETYL ALCOHOL936JST6JCNSUSPENSION / AURICULAR (OTIC)1 %w/vExact identifier — unii candidate
20 equally ranked IID candidates
MANNITOLMANNITOL3OWL53L36AINJECTION, POWDER, FOR SUSPENSION / INTRAMUSCULAR164 mgExact identifier — unii candidate
65 equally ranked IID candidates
GLYCERYL MONOSTEARATEGLYCERYL MONOSTEARATE230OU9XXE4CAPSULE, DELAYED RELEASE / ORAL15 mgExact identifier — unii candidate
21 equally ranked IID candidates
MANNITOLMANNITOL3OWL53L36AGEL / OPHTHALMIC25 mgExact identifier — unii candidate
65 equally ranked IID candidates
METHYLPARABENMETHYLPARABENA2I8C7HI9TGEL / VAGINAL8 mgExact identifier — unii candidate
79 equally ranked IID candidates
GLYCERYL MONOSTEARATEGLYCERYL MONOSTEARATE230OU9XXE4LIQUID / TOPICAL1 %w/wExact identifier — unii candidate
21 equally ranked IID candidates
FD&C BLUE NO. 1FD&C BLUE NO. 1H3R47K3TBDCONCENTRATE / BUCCALNAExact identifier — unii candidate
37 equally ranked IID candidates
XANTHAN GUMXANTHAN GUMTTV12P4NEETABLET, EXTENDED RELEASE / ORAL528 mgExact identifier — unii candidate
29 equally ranked IID candidates
PROPYLENE GLYCOLPROPYLENE GLYCOL6DC9Q167V3TABLET, FILM COATED / ORAL96 mgExact identifier — unii candidate
81 equally ranked IID candidates
STEARIC ACIDSTEARIC ACID4ELV7Z65APEMULSION / TOPICALNAExact identifier — unii candidate
26 equally ranked IID candidates
MANNITOLMANNITOL3OWL53L36AINJECTION / INTRAMUSCULAR106.6 mgExact identifier — unii candidate
65 equally ranked IID candidates
PROPYLENE GLYCOLPROPYLENE GLYCOL6DC9Q167V3FILM / BUCCAL1.48 mgExact identifier — unii candidate
81 equally ranked IID candidates
METHYLPARABENMETHYLPARABENA2I8C7HI9TCAPSULE / ORAL7 mgExact identifier — unii candidate
79 equally ranked IID candidates
EDETATE DISODIUMEDETATE DISODIUM7FLD91C86KTABLET, EXTENDED RELEASE / ORAL10 mgExact identifier — unii candidate
77 equally ranked IID candidates
EDETATE DISODIUMEDETATE DISODIUM7FLD91C86KSOLUTION / INTRAVENOUS0.05 %w/vExact identifier — unii candidate
77 equally ranked IID candidates
PROPYLENE GLYCOLPROPYLENE GLYCOL6DC9Q167V3SPRAY / SUBLINGUAL36 mgExact identifier — unii candidate
81 equally ranked IID candidates
GLYCERYL MONOSTEARATEGLYCERYL MONOSTEARATE230OU9XXE4CREAM / TOPICAL836 mgExact identifier — unii candidate
21 equally ranked IID candidates
EDETATE DISODIUMEDETATE DISODIUM7FLD91C86KTABLET, FILM COATED / ORAL4 mgExact identifier — unii candidate
77 equally ranked IID candidates
METHYLPARABENMETHYLPARABENA2I8C7HI9TINJECTION / SUBCUTANEOUS22 mgExact identifier — unii candidate
79 equally ranked IID candidates
FD&C BLUE NO. 1FD&C BLUE NO. 1H3R47K3TBDSOLUTION / DENTALNAExact identifier — unii candidate
37 equally ranked IID candidates
METHYLPARABENMETHYLPARABENA2I8C7HI9TENEMA / RECTAL0.18 %w/vExact identifier — unii candidate
79 equally ranked IID candidates
XANTHAN GUMXANTHAN GUMTTV12P4NEETABLET, FILM COATED / ORAL0.08 mgExact identifier — unii candidate
29 equally ranked IID candidates
PROPYLENE GLYCOLPROPYLENE GLYCOL6DC9Q167V3GEL / VAGINAL750 mgExact identifier — unii candidate
81 equally ranked IID candidates
METHYLPARABENMETHYLPARABENA2I8C7HI9TDROPS / OPHTHALMIC0.01 %w/wExact identifier — unii candidate
79 equally ranked IID candidates
EDETATE DISODIUMEDETATE DISODIUM7FLD91C86KSYSTEM / TOPICAL126 mgExact identifier — unii candidate
77 equally ranked IID candidates
MANNITOLMANNITOL3OWL53L36ACAPSULE / ORAL1562 mgExact identifier — unii candidate
65 equally ranked IID candidates
CETYL ALCOHOLCETYL ALCOHOL936JST6JCNOINTMENT / TOPICAL7 %w/wExact identifier — unii candidate
20 equally ranked IID candidates
MANNITOLMANNITOL3OWL53L36AGRANULE, FOR SUSPENSION / ORAL6000 mgExact identifier — unii candidate
65 equally ranked IID candidates
STEARIC ACIDSTEARIC ACID4ELV7Z65APSHAMPOO / TOPICAL9.7 %w/wExact identifier — unii candidate
26 equally ranked IID candidates
METHYLPARABENMETHYLPARABENA2I8C7HI9TINJECTION / INTRALESIONAL0.15 %w/vExact identifier — unii candidate
79 equally ranked IID candidates
FD&C BLUE NO. 1FD&C BLUE NO. 1H3R47K3TBDLOTION / TOPICALNAExact identifier — unii candidate
37 equally ranked IID candidates
EDETATE DISODIUMEDETATE DISODIUM7FLD91C86KAEROSOL, FOAM / RECTAL2 mgExact identifier — unii candidate
77 equally ranked IID candidates
FD&C BLUE NO. 1FD&C BLUE NO. 1H3R47K3TBDPOWDER, FOR SOLUTION / ORAL0.04 mg/5mlExact identifier — unii candidate
37 equally ranked IID candidates
PROPYLENE GLYCOLPROPYLENE GLYCOL6DC9Q167V3JELLY / TOPICAL20 %w/wExact identifier — unii candidate
81 equally ranked IID candidates
EDETATE DISODIUMEDETATE DISODIUM7FLD91C86KLIQUID / ORAL0.5 mg/1mlExact identifier — unii candidate
77 equally ranked IID candidates
MANNITOLMANNITOL3OWL53L36ASOLUTION/ DROPS / OPHTHALMIC4.6 %w/vExact identifier — unii candidate
65 equally ranked IID candidates
CETYL ALCOHOLCETYL ALCOHOL936JST6JCNTABLET, COATED / ORAL0.25 mgExact identifier — unii candidate
20 equally ranked IID candidates
PHENOXYETHANOLPHENOXYETHANOLHIE492ZZ3TAEROSOL, FOAM / TOPICAL72 mgExact identifier — unii candidate
6 equally ranked IID candidates
PROPYLENE GLYCOLPROPYLENE GLYCOL6DC9Q167V3SUSPENSION/ DROPS / TOPICAL0.75 %w/vExact identifier — unii candidate
81 equally ranked IID candidates
PROPYLENE GLYCOLPROPYLENE GLYCOL6DC9Q167V3SUSPENSION / RECTAL90400 mgExact identifier — unii candidate
81 equally ranked IID candidates
METHYLPARABENMETHYLPARABENA2I8C7HI9TINJECTION, SOLUTION / INTRAMUSCULAR45 mgExact identifier — unii candidate
79 equally ranked IID candidates
EDETATE DISODIUMEDETATE DISODIUM7FLD91C86KSYRUP / ORAL40 mgExact identifier — unii candidate
77 equally ranked IID candidates
PROPYLPARABENPROPYLPARABENZ8IX2SC1OHOINTMENT / TOPICAL0.2 %w/wExact identifier — unii candidate
68 equally ranked IID candidates
MANNITOLMANNITOL3OWL53L36ASOLUTION / OPHTHALMIC4.7 %w/vExact identifier — unii candidate
65 equally ranked IID candidates
FD&C BLUE NO. 1FD&C BLUE NO. 1H3R47K3TBDELIXIR / ORALNAExact identifier — unii candidate
37 equally ranked IID candidates
BUTYLPARABENBUTYLPARABEN3QPI1U3FV8CAPSULE / ORALNAExact identifier — unii candidate
15 equally ranked IID candidates
GLYCERYL MONOSTEARATEGLYCERYL MONOSTEARATE230OU9XXE4TABLET, CHEWABLE / ORAL1 mgExact identifier — unii candidate
21 equally ranked IID candidates
PROPYLENE GLYCOLPROPYLENE GLYCOL6DC9Q167V3TABLET, DELAYED RELEASE / ORAL36 mgExact identifier — unii candidate
81 equally ranked IID candidates
PROPYLENE GLYCOLPROPYLENE GLYCOL6DC9Q167V3LOTION, AUGMENTED / TOPICAL2070 mgExact identifier — unii candidate
81 equally ranked IID candidates
METHYLPARABENMETHYLPARABENA2I8C7HI9TSUSPENSION / TOPICAL0.24 %w/vExact identifier — unii candidate
79 equally ranked IID candidates
PROPYLENE GLYCOLPROPYLENE GLYCOL6DC9Q167V3CREAM, AUGMENTED / TOPICAL8 %w/wExact identifier — unii candidate
81 equally ranked IID candidates
MANNITOLMANNITOL3OWL53L36AINJECTION, SOLUTION / INTRAVENOUS15400 mgExact identifier — unii candidate
65 equally ranked IID candidates
BUTYLPARABENBUTYLPARABEN3QPI1U3FV8TABLET / ORALNAExact identifier — unii candidate
15 equally ranked IID candidates
MANNITOLMANNITOL3OWL53L36ATABLET / ORAL3391 mgExact identifier — unii candidate
65 equally ranked IID candidates

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.

Matched openFDA labels page 1 of 1 · 1 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
8bb9e858-d994-4a1a-80d2-777a2dfba3e21c6b71d2-3f5d-485f-b571-2e046cbcef912012-05-21WarningsExact identifier
spl id: 8bb9e858-d994-4a1a-80d2-777a2dfba3e2
spl set id: 1c6b71d2-3f5d-485f-b571-2e046cbcef91

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.