Label: SUN SHADES LIP BALM PEACH MANGO- avobenzone, octinoxate and oxybenzone stick

  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None
  • Marketing Status: OTC monograph final

NOTE: Most over the counter (OTC) are not reviewed and approved by the 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 04/14

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  • Active ingredients

    Avobenzone 2.5%, Octinoxate 6%, Oxybenzone 3%

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  • Purpose

    Sunscreen

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  • Uses

    ■ 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

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  • Warnings

    For external use only

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  • DO NOT USE

    Do not use on damaged or broken skin

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  • WHEN USING

    When using this product keep out of eyes. Rinse with water to remove.

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  • STOP USE

    Stop use and ask a dcotor if rash occurs

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  • KEEP OUT OF REACH OF CHILDREN

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

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  • Directions

    ■ apply liberally 15 minutes before sun exposure

    ■ reapply at least every 2 hours ■ use a water-resistant sunscreen if swimming or sweating ■ children under 6 months of age: ask a doctor

    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 a broad-spectrum SPF value 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

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  • Other information

    ■ dermatologist and allergy tested

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  • STORAGE AND HANDLING

    ■ protect this product from excessive heat and direct sun ■ do not store at temperatures below 32°F (0°C) or above 120°F (49°C)

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  • Inactive Ingredients

    ammonium glycyrrhizate, beeswax, C12-15 alkyl benzoate, cetyl esters, ethylene/VA copolymer, euphorbia cerifera (candillia) wax, flavor petrolatum USP, simmondsia chinensis (jojoba) seed oil, stearyl dimethicone, theobroma cacao (cocoa) seed butter, tocopheryl acetate (vitamin E USP)

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  • INGREDIENTS AND APPEARANCE
    SUN SHADES LIP BALM  PEACH MANGO
    avobenzone 2.5%, octinoxate 6%, oxybenzone 3% stick
    Product Information
    Product Type HUMAN OTC DRUG LABEL Item Code (Source) NDC:54473-245
    Route of Administration TOPICAL DEA Schedule     
    Active Ingredient/Active Moiety
    Ingredient Name Basis of Strength Strength
    AVOBENZONE (AVOBENZONE) AVOBENZONE 0.1175 g  in 4.25 g
    OCTINOXATE (OCTINOXATE) OCTINOXATE 0.282 g  in 4.25 g
    OXYBENZONE (OXYBENZONE) OXYBENZONE 0.141 g  in 4.25 g
    Inactive Ingredients
    Ingredient Name Strength
    ALKYL (C12-15) BENZOATE  
    ALPHA-TOCOPHEROL ACETATE  
    AMMONIUM GLYCYRRHIZATE  
    CERESIN  
    CETYL ESTERS WAX  
    COCOA BUTTER  
    ETHYLENE-VINYL ACETATE COPOLYMER (40% VINYL ACETATE)  
    JOJOBA OIL  
    PETROLATUM  
    YELLOW WAX  
    CANDELILLA WAX  
    Packaging
    # Item Code Package Description Marketing Start Date Marketing End Date
    1 NDC:54473-245-01 4.25 g in 1 APPLICATOR
    Marketing Information
    Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
    OTC monograph final part352 02/01/2013
    Labeler - Melaleuca Inc. (139760102)
    Registrant - Melaleuca Inc. (139760102)
    Establishment
    Name Address ID/FEI Business Operations
    Melaleuca Inc. 079287544 manufacture(54473-245)
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