Label: NEORA INVISIBLOC SUNSCREEN GEL BROAD SPECTRUM SPF40- avobenzone, homosalate, octisalate lotion

  • NDC Code(s): 68577-157-01
  • Packager: COSMAX USA, CORPORATION
  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None

Drug Label Information

Updated December 25, 2023

If you are a consumer or patient please visit this version.

  • ACTIVE INGREDIENT

    Active Ingredients

    Avobenzone 3%

    Homosalate 9.5%

    Octisalate 5%

  • PURPOSE

    Purpose

    Sunscreen

  • USES

    Uses

    • helps prevent sunburn
    • if used as directed with other sun protection measures (see Directions), decreases the risk of skin cancer and early skin aging cause by the sun
  • Warnings

    Warnings

    For extenal use only

    Do not useon damaged or broken skin

    When using this productkeep out of eyes. Rinse with water to remove.

    Stop use and ask a doctor ifrash occurs

    Keep out of reach of children.If swallowed, get medical help or contact a Poison Control Center right away.

  • DIRECTIONS

    Directions

    • apply liberrally 15 minutes before sun exposure
    • reapply at least every 2 hours
    • use a water-resistant sunscreen if swimming or sweating
    • Sun Protection Measures.Spending time in the sun

    increases your risk of skin cancer and early skin aging. To decrease

    this risk, regularly use a sunscreen with a Broad Spectrum SPF

    value of 15 or higher and other sun protection measures including:

    • limit time in the sun, especially from 10 a.m. - 2 p.m.
    • wear long-sleeved shirts, pants, hats, and sunglasses
    • children under 6 months of age:ask a doctor
  • OTHER INFORMATION

    Other information

    • Protect the product in this container from excessive heat and direct sun
  • INACTIVE INGREDIENT

    Inactive ingredients:

    Water, butyloctyl salicylate, dipropylene glycol, acrylates copolymer, caprylyl methicone, methyl trimethicone, betaine, ammonium acryloyldimethyltaurate/VP copolymer, hydroxyacetophenone, propanediol, phenoxyethanol, hydrolyzed wheat protein/PVP crosspolymer, dibutyl ethylhexanoyl glutamide, dibutyl lauroyl glutamide, carbomer, citrus aurantium dulcis (orange) peel oil, dipotassium glycyrrhizate, tocopheryl acetate, (vitamin E), aminomethyl propanol, caesalpinia spinosa fruit extract, tropaeolum majus flower/leaf/stem extract, disodium EDTA, carnosine, butylene glycol, pentylene glycol, silica, citrus limon (lemon) peel oil, citrus aurantium bergamia (bergamot) fruit oil, biosaccharide gum-4, kappaphycus alvarezii extract, aloe barbadensis leaf extract, lavandula angustifolia (lavender) oil, ethylhexylglycerin, potassium sorbate, citrus bioflavonoids (vitamin P), hydroxyphenyl propamidobenzoic acid, ocimum basilicum (basil) oil, pelargonium graveolens flower oil, brassica oleracea italica (broccoli) extract, ascorbyl palmitate (vitamin C), limonene, linalool, citral.

  • PRINCIPAL DISPLAY PANEL

    Primary Packaging

    Tube

  • PRINCIPAL DISPLAY PANEL

    Secondary Package Outer Package

  • INGREDIENTS AND APPEARANCE
    NEORA INVISIBLOC SUNSCREEN GEL BROAD SPECTRUM SPF40 
    avobenzone, homosalate, octisalate lotion
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:68577-157
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    AVOBENZONE (UNII: G63QQF2NOX) (AVOBENZONE - UNII:G63QQF2NOX) AVOBENZONE3 mg  in 100 mg
    HOMOSALATE (UNII: V06SV4M95S) (HOMOSALATE - UNII:V06SV4M95S) HOMOSALATE9.5 mg  in 100 mg
    OCTISALATE (UNII: 4X49Y0596W) (OCTISALATE - UNII:4X49Y0596W) OCTISALATE5 mg  in 100 mg
    Inactive Ingredients
    Ingredient NameStrength
    CITRUS LIMON FLOWERING TOP OIL (UNII: 4C38SS0J60)  
    KAPPAPHYCUS ALVAREZII (UNII: T479H08K2O)  
    CITRAL (UNII: T7EU0O9VPP)  
    EDETATE DISODIUM ANHYDROUS (UNII: 8NLQ36F6MM)  
    ASCORBYL PALMITATE (UNII: QN83US2B0N)  
    ETHYLHEXYLGLYCERIN (UNII: 147D247K3P)  
    LIMONENE, (+/-)- (UNII: 9MC3I34447)  
    CARNOSINE (UNII: 8HO6PVN24W)  
    SILICON DIOXIDE (UNII: ETJ7Z6XBU4)  
    TROPAEOLUM MAJUS FLOWER (UNII: 7FV667B00B)  
    BIOSACCHARIDE GUM-4 (UNII: 9XRL057X90)  
    ALOE VERA LEAF (UNII: ZY81Z83H0X)  
    BUTYLENE GLYCOL (UNII: 3XUS85K0RA)  
    PENTYLENE GLYCOL (UNII: 50C1307PZG)  
    HYDROXYPHENYL PROPAMIDOBENZOIC ACID (UNII: 25KRT26H77)  
    PELARGONIUM GRAVEOLENS FLOWER OIL (UNII: 3K0J1S7QGC)  
    BROCCOLI SPROUT (UNII: 128UH9LOAE)  
    LINALOOL, (+/-)- (UNII: D81QY6I88E)  
    LAVENDER OIL (UNII: ZBP1YXW0H8)  
    CITRUS BIOFLAVONOIDS (UNII: BD70459I50)  
    WATER (UNII: 059QF0KO0R)  
    BUTYLOCTYL SALICYLATE (UNII: 2EH13UN8D3)  
    DIPROPYLENE GLYCOL (UNII: E107L85C40)  
    BUTYL ACRYLATE/METHYL METHACRYLATE/METHACRYLIC ACID COPOLYMER (18000 MW) (UNII: JZ1374NL9E)  
    CAPRYLYL TRISILOXANE (UNII: Q95M2P1KJL)  
    METHYL TRIMETHICONE (UNII: S73ZQI0GXM)  
    BASIL OIL (UNII: Z129UMU8LE)  
    BETAINE (UNII: 3SCV180C9W)  
    AMMONIUM ACRYLOYLDIMETHYLTAURATE/VP COPOLYMER (UNII: W59H9296ZG)  
    PHENOXYETHANOL (UNII: HIE492ZZ3T)  
    HYDROLYZED WHEAT PROTEIN (ENZYMATIC, 3000 MW) (UNII: J2S07SB0YL)  
    DIBUTYL LAUROYL GLUTAMIDE (UNII: 3V7K3IA58X)  
    CITRUS AURANTIUM FRUIT OIL (UNII: 59JDQ5VT0T)  
    HYDROXYACETOPHENONE (UNII: G1L3HT4CMH)  
    PROPANEDIOL (UNII: 5965N8W85T)  
    DIBUTYL ETHYLHEXANOYL GLUTAMIDE (UNII: 0IAF2L30VS)  
    CARBOMER HOMOPOLYMER, UNSPECIFIED TYPE (UNII: 0A5MM307FC)  
    ORANGE OIL (UNII: AKN3KSD11B)  
    .ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)  
    GLYCYRRHIZINATE DIPOTASSIUM (UNII: CA2Y0FE3FX)  
    POTASSIUM SORBATE (UNII: 1VPU26JZZ4)  
    BRASSICA OLERACEA VAR. BOTRYTIS WHOLE (UNII: 87M72T7VW1)  
    AMINOMETHYLPROPANOL (UNII: LU49E6626Q)  
    CAESALPINIA SPINOSA FRUIT POD (UNII: EXY4496LWD)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:68577-157-011 in 1 CARTON06/01/2023
    130 mg in 1 TUBE; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC Monograph DrugM02006/01/2023
    Labeler - COSMAX USA, CORPORATION (010990210)
    Registrant - COSMAX USA, CORPORATION (010990210)
    Establishment
    NameAddressID/FEIBusiness Operations
    COSMAX USA. CORPORATION010990210manufacture(68577-157)