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

  • NDC Code(s): 68577-122-01
  • Packager: COSMAX USA, CORPORATION
  • Category: HUMAN OTC DRUG LABEL

Drug Label Information

Updated October 1, 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 use on damaged or broken skin

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

    Stop use and ask a doctor if 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_ArtworkSecondary Package(Outer)

  • INGREDIENTS AND APPEARANCE
    BUILDABLE BLUR 
    homosalate, octisalate, zinc oxide cream
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:68577-122
    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:68577-122-011 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(68577-122)
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