FDA.reportPublic FDA data

LACURA FACE CARE Q10 DAY

Manufacturer
MAXIM Markenprodukte GmbH & Co. KG
Effective date
2017-11-30
Label type
HUMAN OTC DRUG LABEL
Version
4
Source
legacy-cache
Hydrated at
2026-08-02 01:09:38

Label at a glance#

ProductLACURA FACE CARE Q10 DAY SPF-15
Active ingredientAVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENE
Label structure11 sections

Indications and uses

HELPS PREVENT SUNBURN IF USED AS DIRECTED WITH OTHER SUN PROTECTION MEASURES (SEE DIRECTIONS) DECREASES THE RISK OF SKIN CANCER AND EARLY AGING CAUSED BY THE SUN.

Dosage and administration

APPLY LIBERALLY 15 MINUTES BEFORE SUN EXPOSURE AS REQUIRED DAILY TO CLEANSED FACE, NECK AND DECOLLETE AND MASSAGE IN GENTLY. REAPPLY AFTER 40 MINUTES OF SWIMMING OR SWEATING IMMEDIATELY AFTER TOWEL DRYING AT LEAST EVERY 2 HOURS SUN PROTECTION MEASURES. SPENDING TIME IN THE SUN INCREASES YOUR RISK OF SKIN CANCER AND EARLY SKIN AGING. TO DECRESE THIS RISK, REGULARLY USE A SUNSCREEN WITH A BROAD SPECTRUM SOF 15 OR HI...

Label contents#

Full prescribing information#

ACTIVE INGREDIENTS

OTC - ACTIVE INGREDIENT SECTION

AVOBENZONE 2%

HOMOSALATE 8%

OCTISALATE 4%

OCTOCRYLENE 1.5%

PURPOSE

OTC - PURPOSE SECTION

SUNSCREEN

USES

INDICATIONS & USAGE SECTION

  • HELPS PREVENT SUNBURN
  • IF USED AS DIRECTED WITH OTHER SUN PROTECTION MEASURES (SEE DIRECTIONS) DECREASES THE RISK OF SKIN CANCER AND EARLY AGING CAUSED BY THE SUN.

WARNINGS

WARNINGS SECTION

FOR EXTERNAL USE ONLY.

SKIN CANCER/SKIN GING 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

WHEN USING THIS PRODUCT KEEP OUT OF EYES. RINSE THOROUGHLY WITH PLENTY OF WATER TO REMOVE, ALSO UNDER THE EYELIDS.

OTC - STOP USE SECTION

STOP USE AND ASK A DOCTOR IF EYE IRRITATION PERSISTS.

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

KEEP OUT OF REACH OF CHILDREN.

DIRECTIONS

DOSAGE & ADMINISTRATION SECTION

  • APPLY LIBERALLY 15 MINUTES BEFORE SUN EXPOSURE AS REQUIRED DAILY TO CLEANSED FACE, NECK AND DECOLLETE AND MASSAGE IN GENTLY.
  • REAPPLY
  • AFTER 40 MINUTES OF SWIMMING OR SWEATING
  • IMMEDIATELY AFTER TOWEL DRYING
  • AT LEAST EVERY 2 HOURS
  • SUN PROTECTION MEASURES. SPENDING TIME IN THE SUN INCREASES YOUR RISK OF SKIN CANCER AND EARLY SKIN AGING. TO DECRESE THIS RISK, REGULARLY USE A SUNSCREEN WITH A BROAD SPECTRUM SOF 15 OR HIGHER AND OTHER SUN PROTECTION MEASURES INCLUDING:
  • LIMIT TIME IN THE SUN, ESPECIALLY FROM 10 AM - 2 PM
  • WEAR LONG-SLEEVED SHIRTS, PANTS, HATS, AND SUNGLASSES
  • CHILDREN UNDER 6 MONTHS: ASK A DOCTOR
  • ALSO SUITABLE AS A BASE FOR MAKE-UP

OTHER INFORMATION

OTHER SAFETY INFORMATION

  • PROTECT THIS PRODUCT FROM EXCESSIVE HEAT AND DIRECT SUN

INACTIVE INGREDIENTS

INACTIVE INGREDIENT SECTION

WATER, ALOE BARBADENSIS LEAF JUICE, GLYCERIN, ISONONYL ISONONANOATE, GLYCERYL STEARATE CITRATE, SORBITOL, TOCOPHERYL ACETATE, PANTHENOL, GLYCERYL STEARATE, CETEARYL ALCOHOL, SIMMONDSIA CHINENSIS SEED OIL, PHOSPHOLIPIDS, UBIQUINONE, ALGIN, SAMBUCUS NIGRA FLOWER EXTRACT, CARICA PAPAYA FRUIT EXTRACT, DISODIUM ADENOSINE TRIPHOSPHATE, SODIUM HYALURONATE, C12-15 ALKYL BENZOATE, SODIUM STEAROYL GLUTAMATE, FRAGRANCE, PROPANEDIOL, TETRASODIUM EDTA, CARBOMER, ALCOHOL, TOCOPHEROL, XANTHAN GUM, PHENETHYL ALCOHOL, LECITHIN, DIMETHYLMETHOXY CHROMANOL, ALCOHOL DENAT., ASCORBYL PALMITATE, HYDROGENATED LECITHIN, GLYCERYL OLEATE, SODIUM HYDROXIDE, CITRIC ACID, PHENOXYETHANOL, METHYLPARABEN, BENZOIC ACID, DEHYDROACETIC ACID

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

LACURA Day Cream SPF-15_BoxLACURA Day Cream SPF-15_Box

LACURA Day Cream SPF-15_LabelLACURA Day Cream SPF-15_Label

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
69078-101-112020-01-31C16284748780-19d75b9d0-9abd-f424-e053-dadaa90a57ce075f3a1d-5781-4bb3-82a5-c5024dc423fc

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIISPL versionUploaded
AVOBENZONEACTIVE INGREDIENTG63QQF2NOX2
HOMOSALATEACTIVE INGREDIENTV06SV4M95S2
OCTISALATEACTIVE INGREDIENT4X49Y0596W2
OCTOCRYLENEACTIVE INGREDIENT5A68WGF6WM2
AVOBENZONEACTIVE MOIETYG63QQF2NOX2
HOMOSALATEACTIVE MOIETYV06SV4M95S2
OCTISALATEACTIVE MOIETY4X49Y0596W2
OCTOCRYLENEACTIVE MOIETY5A68WGF6WM2
.ALPHA.-TOCOPHEROL ACETATEINACTIVE INGREDIENT9E8X80D2L02
ADENOSINE TRIPHOSPHATE DISODIUMINACTIVE INGREDIENT5L51B4DR1G2
ALCOHOLINACTIVE INGREDIENT3K9958V90M2
ALOE VERA LEAFINACTIVE INGREDIENTZY81Z83H0X2
BENZOIC ACIDINACTIVE INGREDIENT8SKN0B0MIM2
C12-15 ALKYL BENZOATEINACTIVE INGREDIENTA9EJ3J61HQ2
CARBOMER 940INACTIVE INGREDIENT4Q93RCW27E2
CARICA PAPAYA WHOLEINACTIVE INGREDIENTS0U63B0Q512
CETOSTEARYL ALCOHOLINACTIVE INGREDIENT2DMT128M1S2
CITRIC ACID MONOHYDRATEINACTIVE INGREDIENT2968PHW8QP2
DEHYDROACETIC ACIDINACTIVE INGREDIENT2KAG279R6R2
DIMETHYLMETHOXY CHROMANOLINACTIVE INGREDIENTXBH432G01F2
EDETATE SODIUM TETRAHYDRATEINACTIVE INGREDIENTL13NHD21X62
EGG PHOSPHOLIPIDSINACTIVE INGREDIENT1Z74184RGV2
GLYCERININACTIVE INGREDIENTPDC6A3C0OX2
GLYCERYL MONOSTEARATEINACTIVE INGREDIENT230OU9XXE42
GLYCERYL OLEATEINACTIVE INGREDIENT4PC054V79P2
GLYCERYL STEARATE CITRATEINACTIVE INGREDIENTWH8T92A0652
HYALURONATE SODIUMINACTIVE INGREDIENTYSE9PPT4TH2
ISONONYL ISONONANOATEINACTIVE INGREDIENTS4V5BS6GCX2
JOJOBA OILINACTIVE INGREDIENT724GKU717M2
LECITHIN, SOYBEANINACTIVE INGREDIENT1DI56QDM622
METHYLPARABENINACTIVE INGREDIENTA2I8C7HI9T2
PANTHENOLINACTIVE INGREDIENTWV9CM0O67Z2
PHENOXYETHANOLINACTIVE INGREDIENTHIE492ZZ3T2
PROPANEDIOLINACTIVE INGREDIENT5965N8W85T2
SAMBUCUS NIGRA FLOWERINACTIVE INGREDIENT07V4DX094T2
SODIUM ALGINATEINACTIVE INGREDIENTC269C4G2ZQ2
SODIUM HYDROXIDEINACTIVE INGREDIENT55X04QC32I2
SODIUM STEAROYL GLUTAMATEINACTIVE INGREDIENT65A9F4P0242
SORBITOLINACTIVE INGREDIENT506T60A25R2
UBIDECARENONEINACTIVE INGREDIENTEJ27X76M462
WATERINACTIVE INGREDIENT059QF0KO0R2

Products#

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

DailyMed product names page 1 of 1 · 39 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
69078-10169078-101-11

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 37 matching rows.

Name, UNII, Kind table
NameUNIIKind
AVOBENZONEG63QQF2NOXACTIB
HOMOSALATEV06SV4M95SACTIB
OCTISALATE4X49Y0596WACTIB
OCTOCRYLENE5A68WGF6WMACTIB
WATER059QF0KO0RIACT
ALOE VERA LEAFZY81Z83H0XIACT
GLYCERINPDC6A3C0OXIACT
ISONONYL ISONONANOATES4V5BS6GCXIACT
GLYCERYL STEARATE CITRATEWH8T92A065IACT
SORBITOL506T60A25RIACT
.ALPHA.-TOCOPHEROL ACETATE9E8X80D2L0IACT
PANTHENOLWV9CM0O67ZIACT
GLYCERYL MONOSTEARATE230OU9XXE4IACT
CETOSTEARYL ALCOHOL2DMT128M1SIACT
JOJOBA OIL724GKU717MIACT
EGG PHOSPHOLIPIDS1Z74184RGVIACT
UBIDECARENONEEJ27X76M46IACT
SODIUM ALGINATEC269C4G2ZQIACT
SAMBUCUS NIGRA FLOWER07V4DX094TIACT
CARICA PAPAYA WHOLES0U63B0Q51IACT
ADENOSINE TRIPHOSPHATE DISODIUM5L51B4DR1GIACT
HYALURONATE SODIUMYSE9PPT4THIACT
ALKYL (C12-15) BENZOATEA9EJ3J61HQIACT
SODIUM STEAROYL GLUTAMATE65A9F4P024IACT
PROPANEDIOL5965N8W85TIACT
EDETATE SODIUM TETRAHYDRATEL13NHD21X6IACT
CARBOMER 9404Q93RCW27EIACT
ALCOHOL3K9958V90MIACT
LECITHIN, SOYBEAN1DI56QDM62IACT
DIMETHYLMETHOXY CHROMANOLXBH432G01FIACT
GLYCERYL OLEATE4PC054V79PIACT
SODIUM HYDROXIDE55X04QC32IIACT
ANHYDROUS CITRIC ACIDXF417D3PSLIACT
PHENOXYETHANOLHIE492ZZ3TIACT
METHYLPARABENA2I8C7HI9TIACT
BENZOIC ACID8SKN0B0MIMIACT
DEHYDROACETIC ACID2KAG279R6RIACT

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 11 · 624 matching rows.

DailyMed ingredient, IID ingredient, UNII table
DailyMed ingredientIID ingredientUNIIDosage form / routePotencyMaximum daily exposureMatch
SODIUM HYDROXIDESODIUM HYDROXIDE55X04QC32ICAPSULE, LIQUID FILLED / ORAL1.5 mgExact identifier — unii candidate
174 equally ranked IID candidates
GLYCERINGLYCERINPDC6A3C0OXPASTE, DENTIFRICE / DENTAL18 %w/wExact identifier — unii candidate
75 equally ranked IID candidates
ALCOHOLALCOHOL3K9958V90MLIQUID / ORAL3563 mgExact identifier — unii candidate
59 equally ranked IID candidates
GLYCERINGLYCERINPDC6A3C0OXSUSPENSION / ORAL26208 mgExact identifier — unii candidate
75 equally ranked IID candidates
GLYCERINGLYCERINPDC6A3C0OXCAPSULE, COATED / ORAL14.21 mgExact identifier — unii candidate
75 equally ranked IID candidates
ALCOHOLALCOHOL3K9958V90MCAPSULE / ORAL882 mgExact identifier — unii candidate
59 equally ranked IID candidates
METHYLPARABENMETHYLPARABENA2I8C7HI9TINJECTION / EPIDURAL1 mgExact identifier — unii candidate
79 equally ranked IID candidates
SODIUM HYDROXIDESODIUM HYDROXIDE55X04QC32ISYRUP / ORAL71 mg/5mlExact identifier — unii candidate
174 equally ranked IID candidates
SORBITOLSORBITOL506T60A25RINJECTION / INTRALESIONAL45 %w/vExact identifier — unii candidate
44 equally ranked IID candidates
METHYLPARABENMETHYLPARABENA2I8C7HI9TSOLUTION / TOPICAL216 mgExact identifier — unii candidate
79 equally ranked IID candidates
SODIUM HYDROXIDESODIUM HYDROXIDE55X04QC32IINJECTION / PARENTERALADJ PHExact identifier — unii candidate
174 equally ranked IID candidates
GLYCERYL OLEATEGLYCERYL OLEATE4PC054V79PCREAM, AUGMENTED / TOPICAL3.5 %w/wExact identifier — unii candidate
7 equally ranked IID candidates
ALCOHOLALCOHOL3K9958V90MSOLUTION / DENTAL12.8 %w/wExact identifier — unii candidate
59 equally ranked IID candidates
SORBITOLSORBITOL506T60A25RTABLET, COATED / ORAL12.96 mgExact identifier — unii candidate
44 equally ranked IID candidates
SORBITOLSORBITOL506T60A25RINJECTION / INTRAMUSCULARNAExact identifier — unii candidate
44 equally ranked IID candidates
SODIUM HYDROXIDESODIUM HYDROXIDE55X04QC32IINJECTION, SOLUTION / INTRAVENOUS78 mgExact identifier — unii candidate
174 equally ranked IID candidates
CITRIC ACID MONOHYDRATECITRIC ACID MONOHYDRATE2968PHW8QPPOWDER, FOR SOLUTION / ORAL315 mgExact identifier — unii candidate
88 equally ranked IID candidates
SODIUM HYDROXIDESODIUM HYDROXIDE55X04QC32ISOLUTION / PERIODONTALADJ PHExact identifier — unii candidate
174 equally ranked IID candidates
HYALURONATE SODIUMHYALURONATE SODIUMYSE9PPT4THINJECTION, SUSPENSION / INTRA-ARTICULAR23 mgExact identifier — unii candidate
5 equally ranked IID candidates
CITRIC ACID MONOHYDRATECITRIC ACID MONOHYDRATE2968PHW8QPINJECTION, SOLUTION / INTRAVENOUS396 mgExact identifier — unii candidate
88 equally ranked IID candidates
GLYCERYL MONOSTEARATEGLYCERYL MONOSTEARATE230OU9XXE4CAPSULE, EXTENDED RELEASE / ORAL32.4 mgExact identifier — unii candidate
21 equally ranked IID candidates
SODIUM HYDROXIDESODIUM HYDROXIDE55X04QC32IINJECTION, EMULSION / INTRAVENOUSADJ PHExact identifier — unii candidate
174 equally ranked IID candidates
CITRIC ACID MONOHYDRATECITRIC ACID MONOHYDRATE2968PHW8QPINJECTION, SOLUTION / INTRA-ARTICULARADJ PHExact identifier — unii candidate
88 equally ranked IID candidates
SODIUM HYDROXIDESODIUM HYDROXIDE55X04QC32ISUSPENSION/ DROPS / TOPICALADJ PHExact identifier — unii candidate
174 equally ranked IID candidates
SORBITOLSORBITOL506T60A25RTABLET, FILM COATED / ORAL5 mgExact identifier — unii candidate
44 equally ranked IID candidates
ALCOHOLALCOHOL3K9958V90MINJECTION / INTRAVASCULAR100 %v/vExact identifier — unii candidate
59 equally ranked IID candidates
GLYCERINGLYCERINPDC6A3C0OXFILM, EXTENDED RELEASE / TRANSDERMAL306.2 mgExact identifier — unii candidate
75 equally ranked IID candidates
CITRIC ACID MONOHYDRATECITRIC ACID MONOHYDRATE2968PHW8QPSOLUTION / IONTOPHORESIS0.02 %w/vExact identifier — unii candidate
88 equally ranked IID candidates
SODIUM HYDROXIDESODIUM HYDROXIDE55X04QC32IAEROSOL, FOAM / TOPICALADJ PHExact identifier — unii candidate
174 equally ranked IID candidates
SODIUM HYDROXIDESODIUM HYDROXIDE55X04QC32ISUSPENSION / ENDOTRACHEALADJ PHExact identifier — unii candidate
174 equally ranked IID candidates
SORBITOLSORBITOL506T60A25RGUM, CHEWING / ORAL6168 mgExact identifier — unii candidate
44 equally ranked IID candidates
GLYCERINGLYCERINPDC6A3C0OXCONCENTRATE / ORAL1800 mgExact identifier — unii candidate
75 equally ranked IID candidates
SORBITOLSORBITOL506T60A25ROINTMENT / TOPICAL10 %w/wExact identifier — unii candidate
44 equally ranked IID candidates
SODIUM HYDROXIDESODIUM HYDROXIDE55X04QC32ISOLUTION / ORAL9120 mgExact identifier — unii candidate
174 equally ranked IID candidates
SODIUM HYDROXIDESODIUM HYDROXIDE55X04QC32IINJECTION / PERINEURALADJ PHExact identifier — unii candidate
174 equally ranked IID candidates
ALCOHOLALCOHOL3K9958V90MPASTE / DENTAL1.8 %w/wExact identifier — unii candidate
59 equally ranked IID candidates
SODIUM HYDROXIDESODIUM HYDROXIDE55X04QC32IINJECTION / INFILTRATIONADJ PHExact identifier — unii candidate
174 equally ranked IID candidates
SODIUM HYDROXIDESODIUM HYDROXIDE55X04QC32IINJECTION, SUSPENSION / INTRAVENOUSADJ PHExact identifier — unii candidate
174 equally ranked IID candidates
ALCOHOLALCOHOL3K9958V90MCAPSULE, EXTENDED RELEASE / ORAL8 mgExact identifier — unii candidate
59 equally ranked IID candidates
ALCOHOLALCOHOL3K9958V90MSOLUTION / RESPIRATORY (INHALATION)0.08 %w/vExact identifier — unii candidate
59 equally ranked IID candidates
CITRIC ACID MONOHYDRATECITRIC ACID MONOHYDRATE2968PHW8QPFILM, EXTENDED RELEASE / TRANSDERMAL1.38 mgExact identifier — unii candidate
88 equally ranked IID candidates
GLYCERINGLYCERINPDC6A3C0OXTABLET / PERIODONTAL0.53 mgExact identifier — unii candidate
75 equally ranked IID candidates
GLYCERYL MONOSTEARATEGLYCERYL MONOSTEARATE230OU9XXE4TABLET, EXTENDED RELEASE / ORAL529 mgExact identifier — unii candidate
21 equally ranked IID candidates
CITRIC ACID MONOHYDRATECITRIC ACID MONOHYDRATE2968PHW8QPSOLUTION / ORAL446 mgExact identifier — unii candidate
88 equally ranked IID candidates
SODIUM HYDROXIDESODIUM HYDROXIDE55X04QC32ISOLUTION / INTRAVASCULARADJ PHExact identifier — unii candidate
174 equally ranked IID candidates
ALCOHOLALCOHOL3K9958V90MTABLET, DELAYED RELEASE / ORALNAExact identifier — unii candidate
59 equally ranked IID candidates
SODIUM HYDROXIDESODIUM HYDROXIDE55X04QC32IINJECTION / INTERSTITIALADJ PHExact identifier — unii candidate
174 equally ranked IID candidates
CITRIC ACID MONOHYDRATECITRIC ACID MONOHYDRATE2968PHW8QPCAPSULE / ORAL238 mgExact identifier — unii candidate
88 equally ranked IID candidates
ALCOHOLALCOHOL3K9958V90MDROPS / NASAL10 mg/1mlExact identifier — unii candidate
59 equally ranked IID candidates
BENZOIC ACIDBENZOIC ACID8SKN0B0MIMSUSPENSION / ORAL15 mgExact identifier — unii candidate
23 equally ranked IID candidates
GLYCERINGLYCERINPDC6A3C0OXSPRAY / NASAL22.3 mg/1mlExact identifier — unii candidate
75 equally ranked IID candidates
CITRIC ACID MONOHYDRATECITRIC ACID MONOHYDRATE2968PHW8QPSOLUTION / INTRAMUSCULAR0.05 %w/vExact identifier — unii candidate
88 equally ranked IID candidates
METHYLPARABENMETHYLPARABENA2I8C7HI9TPASTE, DENTIFRICE / DENTAL0.05 %w/wExact identifier — unii candidate
79 equally ranked IID candidates
GLYCERINGLYCERINPDC6A3C0OXINJECTION, SOLUTION / INTRAMUSCULAR15 %w/vExact identifier — unii candidate
75 equally ranked IID candidates
SODIUM HYDROXIDESODIUM HYDROXIDE55X04QC32IDISC / TOPICALADJ PHExact identifier — unii candidate
174 equally ranked IID candidates
PHENOXYETHANOLPHENOXYETHANOLHIE492ZZ3TLOTION / TOPICAL1 %w/wExact identifier — unii candidate
6 equally ranked IID candidates
ALCOHOLALCOHOL3K9958V90MSOLUTION / NASAL10 mg/1mlExact identifier — unii candidate
59 equally ranked IID candidates
ALCOHOLALCOHOL3K9958V90MGEL, METERED / TOPICAL541 mgExact identifier — unii candidate
59 equally ranked IID candidates
METHYLPARABENMETHYLPARABENA2I8C7HI9TSUSPENSION / RECTAL1808 mgExact identifier — unii candidate
79 equally ranked IID candidates
DEHYDROACETIC ACIDDEHYDROACETIC ACID2KAG279R6RLOTION / TOPICAL1 mgExact identifier — unii candidate
2 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
d79b2722-55a7-4233-a524-051e6ed9d2c7075f3a1d-5781-4bb3-82a5-c5024dc423fc2017-11-30WarningsExact identifier
spl id: d79b2722-55a7-4233-a524-051e6ed9d2c7
spl set id: 075f3a1d-5781-4bb3-82a5-c5024dc423fc

Reported adverse events (FAERS/openFDA)#

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