Label: FACE PLUS SCALP INVISIBLE DAILY SPF 30 BROAD SPECTRUM- avobenzone, homosalate, octisalate, and octocrylene gel

  • Category: HUMAN OTC DRUG LABEL

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 August 4, 2023

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  • SPL UNCLASSIFIED SECTION

    Drug Facts

  • ACTIVE INGREDIENT

    Active IngredientPurpose
    Avobenzone 3%Sunscreen
    Homosalate 15%Sunscreen
    Octisalate 5%Sunscreen
    Octocrylene 2.8%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.

  • Directions

    • Apply liberally 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.
  • Inactive Ingredients

    Isododecane, Dimethicone/Bis-Isobutyl PPG-20 Crosspolymer, Caprylic/Capric Triglyceride, Dicaprylyl Ether, Butyloctyl Salicylate, Epilobium Angustifolium Flower/Leaf/Stem Extract, Zingiber Officinale (Ginger) Root Extract, Tocopherol, Bisabolol, Linoleic Acid, Linolenic Acid, Silica, Water/Aqua/Eau, Sodium Metabisulfite, Phenoxyethanol, Fragrance (Parfum)

  • Other Information

    Protect this product from excessive heat and direct sun.

  • SPL UNCLASSIFIED SECTION

    Dist. by Mantl, Inc.
    Tustin, CA 92780

  • PRINCIPAL DISPLAY PANEL - 98 ml Bottle Label

    MANTL™

    FACE + SCALP

    Invisible
    Daily SPF 30

    BROAD SPECTRUM

    3.3 fl oz / 98 ml

    Principal Display Panel - 98 ml Bottle Label
  • INGREDIENTS AND APPEARANCE
    FACE PLUS SCALP INVISIBLE DAILY SPF 30 BROAD SPECTRUM 
    avobenzone, homosalate, octisalate, and octocrylene gel
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:73434-001
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    AVOBENZONE (UNII: G63QQF2NOX) (AVOBENZONE - UNII:G63QQF2NOX) AVOBENZONE30 mg  in 1 mL
    HOMOSALATE (UNII: V06SV4M95S) (HOMOSALATE - UNII:V06SV4M95S) HOMOSALATE150 mg  in 1 mL
    OCTISALATE (UNII: 4X49Y0596W) (OCTISALATE - UNII:4X49Y0596W) OCTISALATE50 mg  in 1 mL
    OCTOCRYLENE (UNII: 5A68WGF6WM) (OCTOCRYLENE - UNII:5A68WGF6WM) OCTOCRYLENE28 mg  in 1 mL
    Inactive Ingredients
    Ingredient NameStrength
    ISODODECANE (UNII: A8289P68Y2) 469.2765 mg  in 1 mL
    DIMETHICONE/BIS-ISOBUTYL PPG-20 CROSSPOLYMER (UNII: O4I3UFO6ZF)  
    MEDIUM-CHAIN TRIGLYCERIDES (UNII: C9H2L21V7U)  
    DICAPRYLYL ETHER (UNII: 77JZM5516Z)  
    BUTYLOCTYL SALICYLATE (UNII: 2EH13UN8D3)  
    LINOLEIC ACID (UNII: 9KJL21T0QJ)  
    LINOLENIC ACID (UNII: 0RBV727H71)  
    .ALPHA.-BISABOLOL, (+/-)- (UNII: 36HQN158VC)  
    GINGER (UNII: C5529G5JPQ)  
    TOCOPHEROL (UNII: R0ZB2556P8)  
    EPILOBIUM ANGUSTIFOLIUM FLOWERING TOP (UNII: 08H094218D)  
    SODIUM METABISULFITE (UNII: 4VON5FNS3C)  
    PHENOXYETHANOL (UNII: HIE492ZZ3T)  
    SILICON DIOXIDE (UNII: ETJ7Z6XBU4)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:73434-001-9898 mL in 1 BOTTLE, PUMP; Type 0: Not a Combination Product01/05/2020
    2NDC:73434-001-3030 mL in 1 TUBE; Type 0: Not a Combination Product01/05/202009/07/2023
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC MONOGRAPH FINALpart35201/05/2020
    Labeler - Mantl (076670408)
    Registrant - Cosmetic Lab Inc. (196409143)
    Establishment
    NameAddressID/FEIBusiness Operations
    Cosmetic Lab Inc.196409143manufacture(73434-001, 73434-001)
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