Label: ACAIFUSION LIP BALM BROAD SPECTRUM SPF 30 SUPERGOOP- avobenzone, octinoxate, octisalate ointment

  • NDC Code(s): 75936-118-01, 75936-118-02
  • Packager: TAYLOR JAMES, LTD.
  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None
  • Marketing Status: OTC monograph 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 January 5, 2017

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  • ACTIVE INGREDIENT

    Active Ingredients                                                    Purpose

    Avobezone 3%, Octinoxate 7.5%, Octisalate 5%     Sunscreen

    Uses

    -Helps prevent and temporarily chafed,chapped, cracked, or windburned skin and/or lips.
    -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

    · Keep out of reach of children. If product is swallowed, get medical help or
    contact a Poison Control Center right away.

    · Stop use and ask a doctor if rash occurs

    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.

    Directions


    - Apply liberally 15 minutes before sun exposure
    - Reapply Liberally as often as necessary.
    - 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 broad spectrum SPF 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-sleeve shirts, pants, hats, and sunglasses
    - Reapply at least every 2 hours
    - Use a water resistant sunscreen if swimming or sweating

    Inactive Ingredients-Petrolatum, Ozokerite, Beeswax, Polyester-7, Neopentyl Glycol Diheptanoate, Flavor, Sorbitan Oleate, Euphorbia Cerifera (Candelilla) Wax, Polysilicone-15, Glycine Soja (Soybean) Oil, Tocopherol, Butyrospermum Parkii (Shea) Butter, Honey, Ascorbyl Palmitate, Helianthus Annuus (Sunflower) Seed Oil, Aloe Barbadensis Leaf Extract, Ricinus Communis (Castor) Seed Oil, Red 27 Lake, Cocos Nucifera (Coconut) Fruit Extract

  • PRINCIPAL DISPLAY PANEL

    Doctor T's Supergoop

    SPF 30

    Acaifusion Lip Balm

    with Shea butter

    Broad Spectrum SPF 30

    .5 fl. oz. / 15 ml

    Tube

    Box

  • INGREDIENTS AND APPEARANCE
    ACAIFUSION LIP BALM BROAD SPECTRUM SPF 30  SUPERGOOP
    avobenzone, octinoxate, octisalate ointment
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:75936-118
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    AVOBENZONE (UNII: G63QQF2NOX) (AVOBENZONE - UNII:G63QQF2NOX) AVOBENZONE0.44 g  in 15 mL
    OCTINOXATE (UNII: 4Y5P7MUD51) (OCTINOXATE - UNII:4Y5P7MUD51) OCTINOXATE1.11 g  in 15 mL
    OCTISALATE (UNII: 4X49Y0596W) (OCTISALATE - UNII:4X49Y0596W) OCTISALATE0.74 g  in 15 mL
    Inactive Ingredients
    Ingredient NameStrength
    PETROLATUM (UNII: 4T6H12BN9U)  
    CERESIN (UNII: Q1LS2UJO3A)  
    YELLOW WAX (UNII: 2ZA36H0S2V)  
    POLYESTER-7 (UNII: 0841698D2F)  
    NEOPENTYL GLYCOL DIHEPTANOATE (UNII: 5LKW3C543X)  
    SORBITAN MONOOLEATE (UNII: 06XEA2VD56)  
    CANDELILLA WAX (UNII: WL0328HX19)  
    CARNAUBA WAX (UNII: R12CBM0EIZ)  
    POLYSILICONE-15 (UNII: F8DRP5BB29)  
    SOYBEAN OIL (UNII: 241ATL177A)  
    TOCOPHEROL (UNII: R0ZB2556P8)  
    SHEA BUTTER (UNII: K49155WL9Y)  
    HONEY (UNII: Y9H1V576FH)  
    ASCORBYL PALMITATE (UNII: QN83US2B0N)  
    SUNFLOWER OIL (UNII: 3W1JG795YI)  
    ALOE VERA LEAF (UNII: ZY81Z83H0X)  
    CASTOR OIL (UNII: D5340Y2I9G)  
    D&C RED NO. 27 (UNII: 2LRS185U6K)  
    COCONUT (UNII: 3RT3536DHY)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:75936-118-021 in 1 BOX06/28/2012
    1NDC:75936-118-0115 mL in 1 TUBE; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph finalpart35206/28/2012
    Labeler - TAYLOR JAMES, LTD. (033381850)
    Registrant - TAYLOR JAMES, LTD. (033381850)
    Establishment
    NameAddressID/FEIBusiness Operations
    Cosway Company Inc.620899877manufacture(75936-118)