Label: STRIVECTIN ADVANCED SPF FULL SCREEN CLEAR FINISH- avobenzone, homosalate, octisalate, octocrylene lotion

  • NDC Code(s): 54291-051-01, 54291-051-02, 54291-051-03
  • Packager: Canadian Custom Packaging Company
  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None

Drug Label Information

Updated December 11, 2024

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  • ACTIVE INGREDIENTS

    Avobenzone 3.0%

    Homosalate 9.0%

    Octisalate 4.5%

    Octocrylene 8.5%

  • 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 skin aging caused by the sun
  • 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.

  • KEEP OUT OF REACH OF CHILDREN

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

    • Apply generously 15 minutes before sun exposure and as needed
    • reapply at least every 2 hours
    • use a water resistant sunscreen if swimming or sweating
    • Sun Protection Measures. Spending time inthe sun increases your risk of skin cancer andearly skin aging. To decrease this risk, regularly use a sunscreen with a Broad Spectrum SPFvalue of 15 or higher and other sun protectionmeasures 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

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

  • INACTIVE INGREDIENTS

    Isohexadecane, Dimethicone/Bis-Isobutyl PPG-20 Crosspolymer, Butyloctyl Salicylate, Polyester-8, Polymethylsilsesquioxane/Silica Crosspolymer, Glyceryl Dibehenate, VP/Hexadecene Copolymer, Fragrance (Parfum), Myristyl Nicotinate, Glycine Soja (Soybean) Oil, Tocopherol, Argania Spinosa (Argan) Kernel Oil, Bis(Cyano Butylacetate) Anthracenediylidene, Polyglyceryl-3 Diisostearate, Oryza Sativa (Rice) Extract, Oryza Sativa (Rice) Germ Extract, Cocos Nucifera (Coconut) Oil, Brassica Campestris (Rapeseed) Seed Oil, Quercus Suber Bark Extract, Retinyl Palmitate, Glycyrrhiza Glabra (Licorice) (Licorice) Root Extract, 7-Dehydrocholesterol, Ascorbyl Palmitate, Oak Root Extract, Althaea Officinalis Root Extract, Oryza Sativa (Rice) Bran Extract, Limonene, Citral, Linalool

  • PRINCIPAL DISPLAY PANEL

    01b UC_Adv SPF Full Screen_Clear

  • INGREDIENTS AND APPEARANCE
    STRIVECTIN ADVANCED SPF FULL SCREEN  CLEAR FINISH
    avobenzone, homosalate, octisalate, octocrylene lotion
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:54291-051
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    AVOBENZONE (UNII: G63QQF2NOX) (AVOBENZONE - UNII:G63QQF2NOX) AVOBENZONE3 g  in 100 mL
    HOMOSALATE (UNII: V06SV4M95S) (HOMOSALATE - UNII:V06SV4M95S) HOMOSALATE9 g  in 100 mL
    OCTISALATE (UNII: 4X49Y0596W) (OCTISALATE - UNII:4X49Y0596W) OCTISALATE4.5 g  in 100 mL
    OCTOCRYLENE (UNII: 5A68WGF6WM) (OCTOCRYLENE - UNII:5A68WGF6WM) OCTOCRYLENE8.5 g  in 100 mL
    Inactive Ingredients
    Ingredient NameStrength
    ISOHEXADECANE (UNII: 918X1OUF1E)  
    DIMETHICONE/BIS-ISOBUTYL PPG-20 CROSSPOLYMER (UNII: O4I3UFO6ZF)  
    BUTYLOCTYL SALICYLATE (UNII: 2EH13UN8D3)  
    POLYESTER-8 (1400 MW, CYANODIPHENYLPROPENOYL CAPPED) (UNII: T9296U138P)  
    POLYMETHYLSILSESQUIOXANE (4.5 MICRONS) (UNII: 59Z907ZB69)  
    SILICA, TRIMETHYLSILYL CAPPED (UNII: VU10KU4B9S)  
    GLYCERYL DIBEHENATE (UNII: R8WTH25YS2)  
    VINYLPYRROLIDONE/HEXADECENE COPOLYMER (UNII: KFR5QEN0N9)  
    MYRISTYL NICOTINATE (UNII: 8QWM6I035C)  
    SOYBEAN OIL (UNII: 241ATL177A)  
    TOCOPHEROL (UNII: R0ZB2556P8)  
    ARGAN OIL (UNII: 4V59G5UW9X)  
    BUTYL ACETATE (UNII: 464P5N1905)  
    POLYGLYCERYL-3 DIISOSTEARATE (UNII: 46P231IQV8)  
    ORYZA SATIVA WHOLE (UNII: 84IVV0906Z)  
    COCONUT OIL (UNII: Q9L0O73W7L)  
    CANOLA OIL (UNII: 331KBJ17RK)  
    QUERCUS SUBER BARK (UNII: 8R5219271Q)  
    VITAMIN A PALMITATE (UNII: 1D1K0N0VVC)  
    LICORICE (UNII: 61ZBX54883)  
    7-DEHYDROCHOLESTEROL (UNII: BK1IU07GKF)  
    ASCORBYL PALMITATE (UNII: QN83US2B0N)  
    QUERCUS SPP. WHOLE (UNII: MF4E5I2OUQ)  
    ALTHAEA OFFICINALIS ROOT (UNII: TRW2FUF47H)  
    LIMONENE, (+)- (UNII: GFD7C86Q1W)  
    CITRAL (UNII: T7EU0O9VPP)  
    LINALOOL, (+)- (UNII: F4VNO44C09)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:54291-051-011 in 1 BOX12/04/2019
    144 mL in 1 TUBE; Type 0: Not a Combination Product
    2NDC:54291-051-021 mL in 1 PACKET; Type 0: Not a Combination Product12/04/2019
    3NDC:54291-051-037 mL in 1 TUBE; Type 0: Not a Combination Product12/13/2019
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC Monograph DrugM02012/04/2019
    Labeler - Canadian Custom Packaging Company (207062514)
    Registrant - Canadian Custom Packaging Company (207062514)
    Establishment
    NameAddressID/FEIBusiness Operations
    Canadian Custom Packaging Company207062514manufacture(54291-051)
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