Label: ADVANCED FORMULA LIP BALM SPF 25 BLOOD ORANGE- 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, 2023

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  • Active Ingredients:

    Avobenzone 3.0%
    Octinoxate 7.5%

  • Purpose

    Sunscreen

  • Uses:

    Sun protection measures spending time in the sun increases your risk of skin cancer and early skin aging.

  • Directions:

    Apply liberally 15 minutes before sun exposure.

  • Other Information:

    Protect this product from excessive heat and direct sun.

  • Warnings:

    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.

    For External Use Only.

  • Inactive Ingredients:

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

  • Principal Display Panel

    Advanced Formula
    Lip Balm SPF 25
    With Resveratrol
    & Stevia
    Blood Orange

    Anthony™

    7 g ℮ .25 oz
     
     
    DIST BY: Anthony Skin LLC
    Stony Point, NY 10980
    RP. MSL-BL9 5NB. UK
    STE 5385, 27 UPPER
    PEMBROKE ST, DUBLIN IE
     
    Made in the USA
    www.anthony.com

    image-01

    Label

  • INGREDIENTS AND APPEARANCE
    ADVANCED FORMULA LIP BALM SPF 25  BLOOD ORANGE
    avobenzone, octinoxate cream
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:80949-002
    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)  
    SAFFLOWER OIL (UNII: 65UEH262IS)  
    TITANIUM DIOXIDE (UNII: 15FIX9V2JP)  
    STEVIA REBAUDIUNA LEAF (UNII: 6TC6NN0876)  
    .ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)  
    RESVERATROL (UNII: Q369O8926L)  
    GREEN TEA LEAF (UNII: W2ZU1RY8B0)  
    LIMONENE, (+)- (UNII: GFD7C86Q1W)  
    CITRAL (UNII: T7EU0O9VPP)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:80949-002-077 g in 1 TUBE; Type 0: Not a Combination Product01/05/2020
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph not finalpart35201/05/2020
    Labeler - Anthony Skin LLC (117392467)
    Establishment
    NameAddressID/FEIBusiness Operations
    Fragrance Manufacturing, Inc.793406000MANUFACTURE(80949-002)
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