TROPICAL PINEAPPLE JUMBO LIP BALM (OXYBENZONE, OCTINOXATE, HOMOSALATE) LIPSTICK [YOYO LIP GLOSS INC.]

TROPICAL PINEAPPLE JUMBO LIP BALM (OXYBENZONE, OCTINOXATE, HOMOSALATE) LIPSTICK [YOYO LIP GLOSS INC.]
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NDC 70611-001-01
Set ID 2fd24cc7-5007-1117-e054-00144ff88e88
Category HUMAN OTC DRUG LABEL
Packager Yoyo Lip Gloss Inc.
Generic Name
Product Class
Product Number
Application Number PART352
  • 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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