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

If you are a consumer or patient please visit this version.

  • Drug Facts
  • Active Ingredients:

    Avobenzone 3%

    Octinoxate 7.5%

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  • Purpose

    Sunscreen

    Sunscreen

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  • Uses:

    Helps prevent sunburn.

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  • Cautions:

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

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  • 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

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  • 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

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  • Packaging
  • INGREDIENTS AND APPEARANCE
    ADVANCED FORMULA LIP BALM SPF 25 
    avobenzone, octinoxate cream
    Product Information
    Product Type HUMAN OTC DRUG Item Code (Source) NDC:69144-002
    Route of Administration TOPICAL
    Active Ingredient/Active Moiety
    Ingredient Name Basis of Strength Strength
    AVOBENZONE (UNII: G63QQF2NOX) (AVOBENZONE - UNII:G63QQF2NOX) AVOBENZONE 3 g  in 100 g
    OCTINOXATE (UNII: 4Y5P7MUD51) (OCTINOXATE - UNII:4Y5P7MUD51) OCTINOXATE 7.5 g  in 100 g
    Inactive Ingredients
    Ingredient Name Strength
    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 Code Package Description Marketing Start Date Marketing End Date
    1 NDC:69144-002-07 7 g in 1 TUBE; Type 0: Not a Combination Product 04/10/2018
    Marketing Information
    Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
    OTC monograph not final part352 04/10/2018
    Labeler - Anthony Brands, Llc (101150147)
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