Label: LACURA FACE CARE Q10 DAY SPF-15- avobenzone, homosalate, octisalate, octocrylene cream

  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None
  • Marketing Status: OTC monograph final

DISCLAIMER: Most OTC drugs are not reviewed and approved by FDA, however they may be marketed if they comply with applicable regulations and policies. FDA has not evaluated whether this product complies.

Drug Label Information

Updated November 30, 2017

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  • ACTIVE INGREDIENTS

    AVOBENZONE 2%

    HOMOSALATE 8%

    OCTISALATE 4%

    OCTOCRYLENE 1.5%

  • PURPOSE

    SUNSCREEN

  • 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.
  • WARNINGS

    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.

  • WHEN USING

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

  • STOP USE

    STOP USE AND ASK A DOCTOR IF EYE IRRITATION PERSISTS.

  • KEEP OUT OF REACH OF CHILDREN

    KEEP OUT OF REACH OF CHILDREN.

  • DIRECTIONS

    • 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

    • PROTECT THIS PRODUCT FROM EXCESSIVE HEAT AND DIRECT SUN
  • INACTIVE INGREDIENTS

    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

  • PRINCIPAL DISPLAY PANEL

    LACURA Day Cream SPF-15_Box

    LACURA Day Cream SPF-15_Label

  • INGREDIENTS AND APPEARANCE
    LACURA FACE CARE Q10 DAY  SPF-15
    avobenzone, homosalate, octisalate, octocrylene cream
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:69078-101
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    AVOBENZONE (UNII: G63QQF2NOX) (AVOBENZONE - UNII:G63QQF2NOX) AVOBENZONE2 g  in 100 g
    HOMOSALATE (UNII: V06SV4M95S) (HOMOSALATE - UNII:V06SV4M95S) HOMOSALATE8 g  in 100 g
    OCTISALATE (UNII: 4X49Y0596W) (OCTISALATE - UNII:4X49Y0596W) OCTISALATE4 g  in 100 g
    OCTOCRYLENE (UNII: 5A68WGF6WM) (OCTOCRYLENE - UNII:5A68WGF6WM) OCTOCRYLENE1.5 g  in 100 g
    Inactive Ingredients
    Ingredient NameStrength
    WATER (UNII: 059QF0KO0R)  
    ALOE VERA LEAF (UNII: ZY81Z83H0X)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    ISONONYL ISONONANOATE (UNII: S4V5BS6GCX)  
    GLYCERYL STEARATE CITRATE (UNII: WH8T92A065)  
    SORBITOL (UNII: 506T60A25R)  
    .ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)  
    PANTHENOL (UNII: WV9CM0O67Z)  
    GLYCERYL MONOSTEARATE (UNII: 230OU9XXE4)  
    CETOSTEARYL ALCOHOL (UNII: 2DMT128M1S)  
    JOJOBA OIL (UNII: 724GKU717M)  
    EGG PHOSPHOLIPIDS (UNII: 1Z74184RGV)  
    UBIDECARENONE (UNII: EJ27X76M46)  
    SODIUM ALGINATE (UNII: C269C4G2ZQ)  
    SAMBUCUS NIGRA FLOWER (UNII: 07V4DX094T)  
    CARICA PAPAYA WHOLE (UNII: S0U63B0Q51)  
    ADENOSINE TRIPHOSPHATE DISODIUM (UNII: 5L51B4DR1G)  
    HYALURONATE SODIUM (UNII: YSE9PPT4TH)  
    ALKYL (C12-15) BENZOATE (UNII: A9EJ3J61HQ)  
    SODIUM STEAROYL GLUTAMATE (UNII: 65A9F4P024)  
    PROPANEDIOL (UNII: 5965N8W85T)  
    EDETATE SODIUM TETRAHYDRATE (UNII: L13NHD21X6)  
    CARBOMER 940 (UNII: 4Q93RCW27E)  
    ALCOHOL (UNII: 3K9958V90M)  
    LECITHIN, SOYBEAN (UNII: 1DI56QDM62)  
    DIMETHYLMETHOXY CHROMANOL (UNII: XBH432G01F)  
    GLYCERYL OLEATE (UNII: 4PC054V79P)  
    SODIUM HYDROXIDE (UNII: 55X04QC32I)  
    ANHYDROUS CITRIC ACID (UNII: XF417D3PSL)  
    PHENOXYETHANOL (UNII: HIE492ZZ3T)  
    METHYLPARABEN (UNII: A2I8C7HI9T)  
    BENZOIC ACID (UNII: 8SKN0B0MIM)  
    DEHYDROACETIC ACID (UNII: 2KAG279R6R)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:69078-101-1148 g in 1 JAR; Type 0: Not a Combination Product12/12/2014
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph finalpart35212/12/2014
    Labeler - MAXIM Markenprodukte GmbH & Co. KG (317014348)
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