Label: ADVANCED FORMULA LIP MOISTURIZER SUNSCREEN 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 March 29, 2019

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

  • ​Drug Facts

  • ​Active ingredients

    Avobenzone 3.0%

    Octinoxate 7.5%

    ​Purpose

    Sunscreen

  • Use​

    • Helps protect against sunburn.
  • ​Warnings

    ​Skin Cancer/Skin Aging Alert: ​Spending time in the sun oncreases your risk of skin cancer and early skin aging.  ​This product has been shown only to help prevent sunburn,  ​not ​skin cancer or early skin aging.

    ​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 generously 15 minutes before sun exposure.
    • Children under 6 years of age:  Ask a doctor
    • Reapply at least every 2 years.
    • Use a water resistant sunscreen if swimming or sweating.
  • ​Other Information

    • Protect the product in this container from excessive heat and direct sun.
  • Inactive ingredients

    PETROLATUM, BEESWAX, SHEA (BUTYROSPERMUM PARKII) BUTTER, AVOCADO (PERSEA GRATISSIMA) OIL, FLAVOR, RESVERATROL, WHITE TEA (CAMELLIA SINENSIS) LEAF EXTRACT, GREEN TEA (CAMELLIA SINENSIS) LEAF EXTRACT, TOCOPHEROL ACETATE, SAFFLOWER (CARTHAMUS TINCTORIUS) SEED OIL, STEVIA (STEVIA REBAUDIANA) LEAF EXTRACT, TITANIUM DIOXIDE

  • Product Labeling:

    CartonLabel

  • INGREDIENTS AND APPEARANCE
    ADVANCED FORMULA LIP MOISTURIZER SUNSCREEN SPF 25 
    avobenzone,octinoxate cream
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:69144-001
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    AVOBENZONE (UNII: G63QQF2NOX) (AVOBENZONE - UNII:G63QQF2NOX) AVOBENZONE0.03 g  in 1 g
    OCTINOXATE (UNII: 4Y5P7MUD51) (OCTINOXATE - UNII:4Y5P7MUD51) OCTINOXATE0.075 g  in 1 g
    Inactive Ingredients
    Ingredient NameStrength
    PETROLATUM (UNII: 4T6H12BN9U)  
    YELLOW WAX (UNII: 2ZA36H0S2V)  
    SHEA BUTTER (UNII: K49155WL9Y)  
    AVOCADO OIL (UNII: 6VNO72PFC1)  
    RESVERATROL (UNII: Q369O8926L)  
    WHITE TEA (UNII: O0M3396E09)  
    GREEN TEA LEAF (UNII: W2ZU1RY8B0)  
    .ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)  
    SAFFLOWER OIL (UNII: 65UEH262IS)  
    STEVIA LEAF (UNII: 6TC6NN0876)  
    TITANIUM DIOXIDE (UNII: 15FIX9V2JP)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:69144-001-071 in 1 CARTON09/08/2015
    17 g in 1 TUBE; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph not finalpart35209/08/2015
    Labeler - Anthony Brands LLC (080923952)