Label: SUN SHADES LIP BALM PEACH MANGO- avobenzone 2.5%, octinoxate 6%, oxybenzone 3% stick

  • Category: HUMAN OTC DRUG LABEL

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 28, 2018

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  • Active ingredients

    Avobenzone 2.5%, Octinoxate 6%, Oxybenzone 3%

  • Purpose

    Sunscreen

  • 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

  • Warnings

    For external use only

  • DO NOT USE

    Do not use on damaged or broken skin

  • WHEN USING

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

  • STOP USE

    Stop use and ask a dcotor if rash occurs

  • 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.

  • 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

  • Other information

    ■ dermatologist and allergy tested

  • 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)

  • 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)

  • PRINCIPAL DISPLAY PANEL

    Sun Shade Peach Mango

  • INGREDIENTS AND APPEARANCE
    SUN SHADES LIP BALM  PEACH MANGO
    avobenzone 2.5%, octinoxate 6%, oxybenzone 3% stick
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:54473-245
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    AVOBENZONE (UNII: G63QQF2NOX) (AVOBENZONE - UNII:G63QQF2NOX) AVOBENZONE0.1175 g  in 4.25 g
    OCTINOXATE (UNII: 4Y5P7MUD51) (OCTINOXATE - UNII:4Y5P7MUD51) OCTINOXATE0.282 g  in 4.25 g
    OXYBENZONE (UNII: 95OOS7VE0Y) (OXYBENZONE - UNII:95OOS7VE0Y) OXYBENZONE0.141 g  in 4.25 g
    Inactive Ingredients
    Ingredient NameStrength
    ALKYL (C12-15) BENZOATE (UNII: A9EJ3J61HQ)  
    ALPHA-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)  
    AMMONIUM GLYCYRRHIZATE (UNII: 3VRD35U26C)  
    CERESIN (UNII: Q1LS2UJO3A)  
    CETYL ESTERS WAX (UNII: D072FFP9GU)  
    COCOA BUTTER (UNII: 512OYT1CRR)  
    ETHYLENE-VINYL ACETATE COPOLYMER (40% VINYL ACETATE) (UNII: L5F16ZG4ZU)  
    JOJOBA OIL (UNII: 724GKU717M)  
    PETROLATUM (UNII: 4T6H12BN9U)  
    YELLOW WAX (UNII: 2ZA36H0S2V)  
    CANDELILLA WAX (UNII: WL0328HX19)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:54473-245-014.25 g in 1 APPLICATOR; Type 0: Not a Combination Product01/01/2018
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph finalpart35202/01/2013
    Labeler - Melaleuca Inc. (139760102)
    Registrant - Melaleuca Inc. (079711683)
    Establishment
    NameAddressID/FEIBusiness Operations
    Melaleuca Inc.079711683manufacture(54473-245)
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