Label: TROPICAL PINEAPPLE JUMBO LIP BALM- oxybenzone, octinoxate, homosalate lipstick

  • 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 6, 2016

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  • ACTIVE INGREDIENT

    Active Ingredients
    Benzophenone-3: 10%

    Ethylhexyl Methoxycinnamate: 10%

    Homosalate: 10%

  • PURPOSE

    Purpose: Sunscreen

  • WARNINGS

    Warnings:

    For external use only

    USE ONLY AS DIRECTED

    NOT A TOY

    RECOMMENDED FOR AGES 8 & UP

  • STOP USE

    Stop use and ask a doctor if rash or irritation develops and lasts.

  • ASK DOCTOR

    Children under 2 years ask a doctor

  • DOSAGE & ADMINISTRATION

    Directions:
    Apply as needed. Apply liberally before sun exposure and as needed.

  • INACTIVE INGREDIENT

    Inactive Ingredients

    INGREDIENTS/INGREDIENT: Hydrogenated Polyisobutene, Ethylhexyl Palmitate, Ceresin, Beeswax, Microcrystalline Wax, C12-15 Alkyl Benzoate, Butyrospermum Parkii (Shea Butter), Stevioside, Flavor, Silica Dimethyl Silylate, Diisostearyl Malate, Bis-diglycery, Polyacyladipate-2, Tocopheryl Acetate, MAY CONTAIN/PEUT CONTENIR: Titanium Dioxide, FD&C Blue No.1, D&C Yellow No.10, D&C Red No.28, Iron Oxides, Mica.

  • INDICATIONS & USAGE

    Uses Helps prevent sunburn

  • PRINCIPAL DISPLAY PANEL

    image of tube label

    image of tube label

  • INGREDIENTS AND APPEARANCE
    TROPICAL PINEAPPLE JUMBO LIP BALM 
    oxybenzone, octinoxate, homosalate lipstick
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:70611-001
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    OXYBENZONE (UNII: 95OOS7VE0Y) (OXYBENZONE - UNII:95OOS7VE0Y) OXYBENZONE10 g  in 100 g
    OCTINOXATE (UNII: 4Y5P7MUD51) (OCTINOXATE - UNII:4Y5P7MUD51) OCTINOXATE10 g  in 100 g
    HOMOSALATE (UNII: V06SV4M95S) (HOMOSALATE - UNII:V06SV4M95S) HOMOSALATE10 g  in 100 g
    Inactive Ingredients
    Ingredient NameStrength
    D&C RED NO. 28 (UNII: 767IP0Y5NH)  
    FERROUS OXIDE (UNII: G7036X8B5H)  
    TITANIUM DIOXIDE (UNII: 15FIX9V2JP)  
    PODOPHYLLUM RESIN (UNII: 16902YVY2B)  
    .ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)  
    HYDROGENATED POLYBUTENE (1300 MW) (UNII: 7D1YQ9Y5EZ)  
    ETHYLHEXYL PALMITATE (UNII: 2865993309)  
    FD&C BLUE NO. 1 (UNII: H3R47K3TBD)  
    YELLOW WAX (UNII: 2ZA36H0S2V)  
    MICROCRYSTALLINE WAX (UNII: XOF597Q3KY)  
    ALKYL (C12-15) BENZOATE (UNII: A9EJ3J61HQ)  
    SHEA BUTTER (UNII: K49155WL9Y)  
    STEVIOSIDE (UNII: 0YON5MXJ9P)  
    SILICA DIMETHYL SILYLATE (UNII: EU2PSP0G0W)  
    DIISOSTEARYL MALATE (UNII: QBS8A3XZGQ)  
    BIS-DIGLYCERYL POLYACYLADIPATE-2 (UNII: 6L246LAM9T)  
    CERESIN (UNII: Q1LS2UJO3A)  
    D&C YELLOW NO. 10 (UNII: 35SW5USQ3G)  
    MICA (UNII: V8A1AW0880)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:70611-001-014.2 g in 1 TUBE; Type 0: Not a Combination Product04/08/2016
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph not finalpart35204/06/2016
    Labeler - Yoyo Lip Gloss Inc. (828881792)
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