LBel

Manufacturer
Ventura International LTD
Effective date
2010-08-10
Label type
HUMAN OTC DRUG LABEL
Version
1
Source
legacy-cache
Hydrated at
2026-08-02 01:52:36

Label at a glance#

ProductLBel Couleur Luxe Rouge Amplifier XP
Active ingredientOctinoxate, Oxybenzone
Label structure9 sections

Indications and uses

Helps prevent sunburn.

Dosage and administration

Apply smoothly every morning before sun exposure and as needed. Apply lipstick following the curves of natural lip line. For added definition, use with a lip pencil. Children under 6 months of age: ask a doctor. Moderate sun protection product.

Storage and handling

Limiting sun exposure, wearing protective clothing, and using sunscreens may reduce the risk of skin cancer, and other harmful effects of the sun.

Label contents#

Full prescribing information#

Active Ingredients

OTC - ACTIVE INGREDIENT SECTION

Octinoxate (4.6 %), Oxybenzone (0.9 %)

Purpose

OTC - PURPOSE SECTION

Sunscreen

Uses

INDICATIONS & USAGE SECTION

Helps prevent sunburn.

Warnings

WARNINGS SECTION

OTC - STOP USE SECTION

Stop use if skin rash occurs.

Directions

DOSAGE & ADMINISTRATION SECTION

Apply smoothly every morning before sun exposure and as needed. Apply lipstick following the curves of natural lip line. For added definition, use with a lip pencil. Children under 6 months of age: ask a doctor. Moderate sun protection product.

Other information

STORAGE AND HANDLING SECTION

Limiting sun exposure, wearing protective clothing, and using sunscreens may reduce the risk of skin cancer, and other harmful effects of the sun.

Inactive Ingredients

INACTIVE INGREDIENT SECTION

Diisopropyl dimer dilinoleate, methyl hydrogenated rosinate, isostearyl neopentanoate, castor isostearate beeswax succinate, ci 77019 (mica), ethylhexyl methoxycinnamate, hydrogenated polycyclopentadiene, polyethylene, copernicia cerifera (carnauba) wax, euphorbia cerifera (candelilla) wax, ozokerite, ethylhexyl palmitate, isododecane, paraffin, hydrogenated polyisobutene, polyglyceryl-3 diisostearate, glyceryl isostearate, isostearyl alcohol, dipalmitoyl hydroxyproline, benzophenone-3, ceramide 3, butyrospermum parkii (shea butter), beta-sitosterol, dimethicone, silica silylate, luffa cylindrica seed oil, silica, propylparaben, methylparaben, disteardimonium hectorite, ppg-26-buteth-26, peg-40 hydrogenated castor oil, polysorbate 80, parfum (fragance), hedera helix (ivy) leaf/stem extract, trimethylsiloxysilicate, bht, tocopheryl acetate, retinyl palmitate, ascorbyl palmitate, bioflavonoids, allantoin. May contain: ci 45380:2 (red 21 lake), ci 77491, ci 77492, ci 77499 (iron oxides), ci 15850:1 (red 7 lake), ci 19140 (yellow 5 lake), ci 77891 (titanium dioxide), ci 77163 (bismuth xychloride), talc.

SPL UNCLASSIFIED SECTION

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

PR: Distributed by Ventura Corporation, Ltd. San Juan, Puerto Rico 00926.

PRINCIPAL DISPLAY PANEL - 4 g Carton

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

COULEUR LUXE ROUGE AMPLIFIER XP

amplifying lipstick spf 15

4 g e (.14 oz.)

L'BEL

Principal Display Panel - 4 g Carton
Principal Display Panel - 4 g Carton

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
14783-081-622025-05-19C16284748780-1956f9ecf-cc03-621f-e053-dbdaa90a74adCOULEUR LUXE ROUGE AMPLIFIER XP
14783-081-622019-10-21C16284748780-1956f9ecf-cc03-621f-e053-dbdaa90a74adCOULEUR LUXE ROUGE AMPLIFIER XP

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIISPL versionUploaded
OctinoxateACTIVE INGREDIENT4Y5P7MUD511
OxybenzoneACTIVE INGREDIENT95OOS7VE0Y1
OctinoxateACTIVE MOIETY4Y5P7MUD511
OxybenzoneACTIVE MOIETY95OOS7VE0Y1
.beta.-sitosterolINACTIVE INGREDIENTS347WMO6M41
allantoinINACTIVE INGREDIENT344S277G0Z1
Aluminum OxideINACTIVE INGREDIENTLMI26O69331
ascorbyl palmitateINACTIVE INGREDIENTQN83US2B0N1
butylated hydroxytolueneINACTIVE INGREDIENT1P9D0Z171K1
candelilla waxINACTIVE INGREDIENTWL0328HX191
carnauba waxINACTIVE INGREDIENTR12CBM0EIZ1
D&C red no. 21INACTIVE INGREDIENT08744Z6JNY1
D&C red no. 6INACTIVE INGREDIENT481744AI4O1
dimethiconeINACTIVE INGREDIENT92RU3N3Y1O1
dipalmitoyl hydroxyprolineINACTIVE INGREDIENTE6AHA53N1H1
ethylhexyl palmitateINACTIVE INGREDIENT28659933091
FD&C yellow no. 5INACTIVE INGREDIENTI753WB2F1M1
ferric oxide redINACTIVE INGREDIENT1K09F3G6751
ferric oxide yellowINACTIVE INGREDIENTEX438O2MRT1
ferrosoferric oxideINACTIVE INGREDIENTXM0M87F3571
isododecaneINACTIVE INGREDIENTA8289P68Y21
isostearyl alcoholINACTIVE INGREDIENTQ613OCQ44Y1
kalmia latifolia leafINACTIVE INGREDIENT79N6542N181
methylparabenINACTIVE INGREDIENTA2I8C7HI9T1
paraffinINACTIVE INGREDIENTI9O0E3H2ZE1
polyoxyl 40 hydrogenated castor oilINACTIVE INGREDIENT7YC686GQ8F1
polysorbate 80INACTIVE INGREDIENT6OZP39ZG8H1
propylparabenINACTIVE INGREDIENTZ8IX2SC1OH1
shea butterINACTIVE INGREDIENTK49155WL9Y1
silicon dioxideINACTIVE INGREDIENTETJ7Z6XBU41
talcINACTIVE INGREDIENT7SEV7J4R1U1
titanium dioxideINACTIVE INGREDIENT15FIX9V2JP1
vitamin a palmitateINACTIVE INGREDIENT1D1K0N0VVC1

Products#

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

DailyMed product names page 1 of 1 · 33 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
14783-08114783-081-61, 14783-081-62

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 31 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 9 · 502 matching rows.

DailyMed ingredient, IID ingredient, UNII table
DailyMed ingredientIID ingredientUNIIDosage form / routePotencyMaximum daily exposureMatch
propylparabenPROPYLPARABENZ8IX2SC1OHSOLUTION / INTRAVENOUS0.02 %w/vExact identifier — unii candidate
68 equally ranked IID candidates
propylparabenPROPYLPARABENZ8IX2SC1OHINJECTION / SUBCUTANEOUS2 mgExact identifier — unii candidate
68 equally ranked IID candidates
titanium dioxideTITANIUM DIOXIDE15FIX9V2JPSUPPOSITORY / VAGINALNAExact identifier — unii candidate
40 equally ranked IID candidates
ascorbyl palmitateASCORBYL PALMITATEQN83US2B0NCAPSULE / ORAL12 mgExact identifier — unii candidate
6 equally ranked IID candidates
FD&C yellow no. 5FD&C YELLOW NO. 5I753WB2F1MCONCENTRATE / BUCCALNAExact identifier — unii candidate
22 equally ranked IID candidates
polysorbate 80POLYSORBATE 806OZP39ZG8HINJECTION, SUSPENSION / INTRA-ARTICULAR4 mgExact identifier — unii candidate
78 equally ranked IID candidates
polysorbate 80POLYSORBATE 806OZP39ZG8HINJECTION, SOLUTION / INTRAVENOUS1170 mgExact identifier — unii candidate
78 equally ranked IID candidates
ferric oxide redFERRIC OXIDE RED1K09F3G675TABLET, COATED / ORAL1 mgExact identifier — unii candidate
21 equally ranked IID candidates
methylparabenMETHYLPARABENA2I8C7HI9TELIXIR / ORAL800 mgExact identifier — unii candidate
79 equally ranked IID candidates
silicon dioxideSILICON DIOXIDEETJ7Z6XBU4GEL / TOPICAL6 mgExact identifier — unii candidate
49 equally ranked IID candidates
polysorbate 80POLYSORBATE 806OZP39ZG8HSUSPENSION / SUBCUTANEOUS0.3 %w/vExact identifier — unii candidate
78 equally ranked IID candidates
methylparabenMETHYLPARABENA2I8C7HI9TFILM, SOLUBLE / BUCCAL3 mgExact identifier — unii candidate
79 equally ranked IID candidates
talcTALC7SEV7J4R1UCAPSULE / ORAL729 mgExact identifier — unii candidate
35 equally ranked IID candidates
paraffinPARAFFINI9O0E3H2ZECAPSULE, EXTENDED RELEASE / ORAL100 mgExact identifier — unii candidate
11 equally ranked IID candidates
ferrosoferric oxideFERROSOFERRIC OXIDEXM0M87F357TABLET, COATED / ORALNAExact identifier — unii candidate
10 equally ranked IID candidates
methylparabenMETHYLPARABENA2I8C7HI9TOINTMENT / OPHTHALMIC0.05 %w/wExact identifier — unii candidate
79 equally ranked IID candidates
propylparabenPROPYLPARABENZ8IX2SC1OHSOLUTION / RESPIRATORY (INHALATION)0.01 %w/wExact identifier — unii candidate
68 equally ranked IID candidates
silicon dioxideSILICON DIOXIDEETJ7Z6XBU4GEL / VAGINAL8 %w/wExact identifier — unii candidate
49 equally ranked IID candidates
titanium dioxideTITANIUM DIOXIDE15FIX9V2JPCAPSULE, DELAYED RELEASE PELLETS / ORAL24 mgExact identifier — unii candidate
40 equally ranked IID candidates
methylparabenMETHYLPARABENA2I8C7HI9TSHAMPOO, SUSPENSION / TOPICAL0.15 %w/wExact identifier — unii candidate
79 equally ranked IID candidates
propylparabenPROPYLPARABENZ8IX2SC1OHTABLET / ORAL0.2 mgExact identifier — unii candidate
68 equally ranked IID candidates
methylparabenMETHYLPARABENA2I8C7HI9TINJECTION / PARENTERAL18 mgExact identifier — unii candidate
79 equally ranked IID candidates
polysorbate 80POLYSORBATE 806OZP39ZG8HINJECTION / INTRA-ARTICULAR4 mgExact identifier — unii candidate
78 equally ranked IID candidates
propylparabenPROPYLPARABENZ8IX2SC1OHINJECTION / INTRALESIONAL0.02 %w/vExact identifier — unii candidate
68 equally ranked IID candidates
ferrosoferric oxideFERROSOFERRIC OXIDEXM0M87F357CAPSULE, COATED / ORAL0.11 mgExact identifier — unii candidate
10 equally ranked IID candidates
talcTALC7SEV7J4R1UCAPSULE, COATED, EXTENDED RELEASE / ORAL20 mgExact identifier — unii candidate
35 equally ranked IID candidates
talcTALC7SEV7J4R1USUSPENSION / ORAL234 mgExact identifier — unii candidate
35 equally ranked IID candidates
FD&C yellow no. 5FD&C YELLOW NO. 5I753WB2F1MELIXIR / ORAL0.15 mgExact identifier — unii candidate
22 equally ranked IID candidates
methylparabenMETHYLPARABENA2I8C7HI9TDROPS / AURICULAR (OTIC)0.01 %w/wExact identifier — unii candidate
79 equally ranked IID candidates
polysorbate 80POLYSORBATE 806OZP39ZG8HINJECTION / INTRALESIONAL4 mgExact identifier — unii candidate
78 equally ranked IID candidates
ferrosoferric oxideFERROSOFERRIC OXIDEXM0M87F357POWDER, FOR SUSPENSION / ORALNAExact identifier — unii candidate
10 equally ranked IID candidates
ferric oxide redFERRIC OXIDE RED1K09F3G675TABLET, DELAYED RELEASE / ORAL37 mgExact identifier — unii candidate
21 equally ranked IID candidates
talcTALC7SEV7J4R1UGRANULE / ORAL322 mgExact identifier — unii candidate
35 equally ranked IID candidates
methylparabenMETHYLPARABENA2I8C7HI9TSOLUTION / TOPICAL216 mgExact identifier — unii candidate
79 equally ranked IID candidates
silicon dioxideSILICON DIOXIDEETJ7Z6XBU4TABLET, ORALLY DISINTEGRATING, DELAYED RELEASE / ORAL69 mgExact identifier — unii candidate
49 equally ranked IID candidates
titanium dioxideTITANIUM DIOXIDE15FIX9V2JPGRANULE, FOR SUSPENSION / ORAL143 mgExact identifier — unii candidate
40 equally ranked IID candidates
methylparabenMETHYLPARABENA2I8C7HI9TSOLUTION / IRRIGATION2 %w/vExact identifier — unii candidate
79 equally ranked IID candidates
polysorbate 80POLYSORBATE 806OZP39ZG8HSUSPENSION/ DROPS / ORAL23 mgExact identifier — unii candidate
78 equally ranked IID candidates
silicon dioxideSILICON DIOXIDEETJ7Z6XBU4CAPSULE, DELAYED RELEASE / ORAL40 mgExact identifier — unii candidate
49 equally ranked IID candidates
polysorbate 80POLYSORBATE 806OZP39ZG8HSOLUTION / ORAL907 mgExact identifier — unii candidate
78 equally ranked IID candidates
talcTALC7SEV7J4R1UTABLET / RECTAL32.4 mgExact identifier — unii candidate
35 equally ranked IID candidates
methylparabenMETHYLPARABENA2I8C7HI9TSOLUTION / NASAL250 mgExact identifier — unii candidate
79 equally ranked IID candidates
silicon dioxideSILICON DIOXIDEETJ7Z6XBU4SYSTEM / TRANSDERMAL35 mgExact identifier — unii candidate
49 equally ranked IID candidates
silicon dioxideSILICON DIOXIDEETJ7Z6XBU4TABLET, FOR SUSPENSION / ORAL220 mgExact identifier — unii candidate
49 equally ranked IID candidates
methylparabenMETHYLPARABENA2I8C7HI9TINJECTION / SUBCUTANEOUS22 mgExact identifier — unii candidate
79 equally ranked IID candidates
methylparabenMETHYLPARABENA2I8C7HI9TPOWDER / ORALNAExact identifier — unii candidate
79 equally ranked IID candidates
methylparabenMETHYLPARABENA2I8C7HI9TINJECTION / PERINEURAL80 mgExact identifier — unii candidate
79 equally ranked IID candidates
methylparabenMETHYLPARABENA2I8C7HI9TINJECTION / INFILTRATION80 mgExact identifier — unii candidate
79 equally ranked IID candidates
polysorbate 80POLYSORBATE 806OZP39ZG8HINJECTION, SUSPENSION / INTRAMUSCULAR4 mgExact identifier — unii candidate
78 equally ranked IID candidates
polysorbate 80POLYSORBATE 806OZP39ZG8HELIXIR / ORAL2.5 mg/15mlExact identifier — unii candidate
78 equally ranked IID candidates
butylated hydroxytolueneBUTYLATED HYDROXYTOLUENE1P9D0Z171KSUPPOSITORY / RECTAL1 mgExact identifier — unii candidate
32 equally ranked IID candidates
ferric oxide yellowFERRIC OXIDE YELLOWEX438O2MRTTABLET / SUBLINGUAL1 mgExact identifier — unii candidate
20 equally ranked IID candidates
ferric oxide redFERRIC OXIDE RED1K09F3G675TABLET / SUBLINGUAL1 mgExact identifier — unii candidate
21 equally ranked IID candidates
polyoxyl 40 hydrogenated castor oilPOLYOXYL 40 HYDROGENATED CASTOR OIL7YC686GQ8FSOLUTION / OPHTHALMIC3 mgExact identifier — unii candidate
9 equally ranked IID candidates
propylparabenPROPYLPARABENZ8IX2SC1OHSUSPENSION, EXTENDED RELEASE / ORAL4 mgExact identifier — unii candidate
68 equally ranked IID candidates
polysorbate 80POLYSORBATE 806OZP39ZG8HTABLET, ORALLY DISINTEGRATING, DELAYED RELEASE / ORAL34 mgExact identifier — unii candidate
78 equally ranked IID candidates
polysorbate 80POLYSORBATE 806OZP39ZG8HSPRAY, METERED / NASAL0.1 mg/1mlExact identifier — unii candidate
78 equally ranked IID candidates
propylparabenPROPYLPARABENZ8IX2SC1OHOINTMENT / TOPICAL0.2 %w/wExact identifier — unii candidate
68 equally ranked IID candidates
FD&C yellow no. 5FD&C YELLOW NO. 5I753WB2F1MSUPPOSITORY / VAGINALNAExact identifier — unii candidate
22 equally ranked IID candidates
titanium dioxideTITANIUM DIOXIDE15FIX9V2JPCAPSULE, COATED, EXTENDED RELEASE / ORALNAExact identifier — unii candidate
40 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
35853f5e-edd5-0ade-e063-6294a90a2e55cb81e7ea-537e-4b3b-a931-c2cf876b6b122025-05-19WarningsExact identifier
spl set id: cb81e7ea-537e-4b3b-a931-c2cf876b6b12

Reported adverse events (FAERS/openFDA)#

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