Label: ADVANCED FORMULA LIP BALM SPF 25- avobenzone, octinoxate cream

  • 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 April 3, 2018

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  • Drug Facts

  • Active Ingredients:

    Avobenzone 3%

    Octinoxate 7.5%

  • Purpose

    Sunscreen

    Sunscreen

  • Uses:

    Helps prevent sunburn.

  • Cautions:

    Avoid contact with eyes. If irritation occurs and persisits, discontinue use and consult a physician.

  • Inactive Ingredients:

    Petrolatum, Cera Alba(Beeswax), Butyrospermum Parkii (Shea Butter), Persea Gratissima (Avocado) Oil, Flavor (Aroma), Resveratrol, Camellia Oleifera (Green Tea) Leaf Extract, Tocopheryl Acetate, Carthamus Tinctorius (Safflower) Seed Oil, stevia Rebaudiana Leaf Extract, Titanium Dioxide (CI 77891), D-Limonene, Citral

  • SPL UNCLASSIFIED SECTION

    With Resveratrol & Stevia

    [ Allergy Tested]

    [Dermatologist Tested]

    Developed for men.

    Borrowed by women.

    Dist. By: Anthony Brands USA New York

    R.P.MSL BL9 5NB.UK   Made in the USA

    www.anthony.com

  • Packaging

    Lip Balm

  • INGREDIENTS AND APPEARANCE
    ADVANCED FORMULA LIP BALM SPF 25 
    avobenzone, octinoxate cream
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:69144-002
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    AVOBENZONE (UNII: G63QQF2NOX) (AVOBENZONE - UNII:G63QQF2NOX) AVOBENZONE3 g  in 100 g
    OCTINOXATE (UNII: 4Y5P7MUD51) (OCTINOXATE - UNII:4Y5P7MUD51) OCTINOXATE7.5 g  in 100 g
    Inactive Ingredients
    Ingredient NameStrength
    PETROLATUM (UNII: 4T6H12BN9U)  
    YELLOW WAX (UNII: 2ZA36H0S2V)  
    SHEA BUTTER (UNII: K49155WL9Y)  
    AVOCADO OIL (UNII: 6VNO72PFC1)  
    RESVERATROL (UNII: Q369O8926L)  
    CAMELLIA OLEIFERA LEAF (UNII: 5077EL0C60)  
    .ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)  
    SAFFLOWER OIL (UNII: 65UEH262IS)  
    STEVIA REBAUDIUNA LEAF (UNII: 6TC6NN0876)  
    TITANIUM DIOXIDE (UNII: 15FIX9V2JP)  
    LIMONENE, (+)- (UNII: GFD7C86Q1W)  
    CITRAL (UNII: T7EU0O9VPP)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:69144-002-077 g in 1 TUBE; Type 0: Not a Combination Product04/10/2018
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph not finalpart35204/10/2018
    Labeler - Anthony Brands, Llc (101150147)
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