Label: BUILDABLE BLUR- homosalate, octisalate, zinc oxide cream

  • NDC Code(s): 68577-134-01
  • Packager: COSMAX USA, CORPORATION
  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None

Drug Label Information

Updated October 2, 2023

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  • ACTIVE INGREDIENT

    Active Ingredients

    Homosalate 9.0%

    Octisalate 4.5%

    Zinc Oxide 7.8%

  • 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 caused by sun
  • WARNINGS

    Warnings

    For external 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 doctorif rash occurs

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

  • DIRECTIONS

    Directions

    For sunscreen use:

    • Apply liberally 15 minutes before sun exposure
    • Reapply at least every 2 hours
    • Use a water resistant sunscreen if swimming or sweating
    • Children under 6 months of age: Ask a doctor
      • Sun Protection Measures.Spending time in the sun increases your risk of skin cancer and early skin aging. To decrease the risk, regularly use a sunscreen with 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-sleeve shirts, pants, hats, and sunglasses.

  • OTHER INFORMATION

    Other information

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

  • QUESTIONS

    Questions?Call (888) 804-4318 or visit www.thrivecausemetics.com

  • INACTIVE INGREDIENT

    Inactive ingredients

    AQUA/WATER/EAU, DIMETHICONE, BUTYLOCTYL SALICYLATE, LAURYL PEG-9 POLYDIMETHYLSILOXYETHYL DIMETHICONE, GLYCERIN, PENTYLENE GLYCOL, SODIUM CHLORIDE, TRIBEHENIN, BUTYLENE GLYCOL, CETYL PEG/PPG-10/1 DIMETHICONE, METHYL METHACRYLATE CROSSPOLYMER, PHENYL TRIMETHICONE, TETRAHEXYLDECYL ASCORBATE, LINUM USITATISSIMUM (LINSEED) SEED EXTRACT, DICAPRYLYL CARBONATE, TRIETHOXYCAPRYLYLSILANE, CAPRYLYL METHICONE, DIMETHICONE CROSSPOLYMER, ETHYLHEXYL PALMITATE, ALUMINUM HYDROXIDE, MICA, QUATERNIUM-90 BENTONITE, SODIUM PHYTATE, PROPYLENE CARBONATE, HYDROXYACETOPHENONE, CAPRYLYL GLYCOL, [+/- TITANIUM DIOXIDE (CI 77891), IRON OXIDES (CI 77491, 77492, 77499), ULTRAMARINES (CI 77007)].

  • Primary Package

    Primary Package Tube_Artwork

  • Secondary Package

    Outer package

    Outer Package

  • INGREDIENTS AND APPEARANCE
    BUILDABLE BLUR 
    homosalate, octisalate, zinc oxide cream
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:68577-134
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    HOMOSALATE (UNII: V06SV4M95S) (HOMOSALATE - UNII:V06SV4M95S) HOMOSALATE9 mg  in 100 mg
    ZINC OXIDE (UNII: SOI2LOH54Z) (ZINC OXIDE - UNII:SOI2LOH54Z) ZINC OXIDE7.8 mg  in 100 mg
    OCTISALATE (UNII: 4X49Y0596W) (OCTISALATE - UNII:4X49Y0596W) OCTISALATE4.5 mg  in 100 mg
    Inactive Ingredients
    Ingredient NameStrength
    WATER (UNII: 059QF0KO0R)  
    SODIUM CHLORIDE (UNII: 451W47IQ8X)  
    TETRAHEXYLDECYL ASCORBATE (UNII: 9LBV3F07AZ)  
    DICAPRYLYL CARBONATE (UNII: 609A3V1SUA)  
    ETHYLHEXYL PALMITATE (UNII: 2865993309)  
    ALUMINUM HYDROXIDE (UNII: 5QB0T2IUN0)  
    PHENYL TRIMETHICONE (UNII: DR0K5NOJ4R)  
    FLAX SEED (UNII: 4110YT348C)  
    TRIETHOXYCAPRYLYLSILANE (UNII: LDC331P08E)  
    MICA (UNII: V8A1AW0880)  
    QUATERNIUM-90 BENTONITE (UNII: 97K5YEF88C)  
    HYDROXYACETOPHENONE (UNII: G1L3HT4CMH)  
    DIMETHICONE (UNII: 92RU3N3Y1O)  
    TRIBEHENIN (UNII: 8OC9U7TQZ0)  
    BUTYLENE GLYCOL (UNII: 3XUS85K0RA)  
    CETYL PEG/PPG-10/1 DIMETHICONE (HLB 1.5) (UNII: V2W71V8T0X)  
    PHYTATE SODIUM (UNII: 88496G1ERL)  
    BUTYLOCTYL SALICYLATE (UNII: 2EH13UN8D3)  
    PENTYLENE GLYCOL (UNII: 50C1307PZG)  
    CAPRYLYL TRISILOXANE (UNII: Q95M2P1KJL)  
    DIMETHICONE CROSSPOLYMER (450000 MPA.S AT 12% IN CYCLOPENTASILOXANE) (UNII: UF7620L1W6)  
    PROPYLENE CARBONATE (UNII: 8D08K3S51E)  
    TITANIUM DIOXIDE (UNII: 15FIX9V2JP)  
    FERRIC OXIDE RED (UNII: 1K09F3G675)  
    ULTRAMARINE BLUE (UNII: I39WR998BI)  
    LAURYL PEG-9 POLYDIMETHYLSILOXYETHYL DIMETHICONE (UNII: 25G622K2RA)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    METHYL METHACRYLATE/GLYCOL DIMETHACRYLATE CROSSPOLYMER (UNII: EG97988M5Q)  
    CAPRYLYL GLYCOL (UNII: 00YIU5438U)  
    FERRIC OXIDE YELLOW (UNII: EX438O2MRT)  
    FERROSOFERRIC OXIDE (UNII: XM0M87F357)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:68577-134-011 in 1 CARTON12/01/2022
    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 DrugM02012/01/2022
    Labeler - COSMAX USA, CORPORATION (010990210)
    Establishment
    NameAddressID/FEIBusiness Operations
    COSMAX USA. CORPORATION010990210manufacture(68577-134)
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