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

  • NDC Code(s): 76147-234-11, 76147-234-13, 76147-234-14
  • Packager: StriVectin Operating Company, Inc.
  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None
  • Marketing Status: OTC monograph not 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 January 5, 2022

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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:76147-234
    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:76147-234-111 in 1 BOX12/04/2019
    144 mL in 1 TUBE; Type 0: Not a Combination Product
    2NDC:76147-234-131 mL in 1 PACKET; Type 0: Not a Combination Product12/04/2019
    3NDC:76147-234-147 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 not finalpart35212/04/2019
    Labeler - StriVectin Operating Company, Inc. (832343722)
    Registrant - StriVectin Operating Company, Inc. (832343722)
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