VANILLA SUNSCREEN LIP MOISTURIZER (OCTINOXATE, OXYBENZONE) LIPSTICK [BEACON PROMOTIONS, INC.]

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VANILLA SUNSCREEN LIP MOISTURIZER (OCTINOXATE, OXYBENZONE) LIPSTICK [BEACON PROMOTIONS, INC.]
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NDC 75866-307-01
Set ID 43dd3933-a254-466f-9414-f63c179921b9
Category HUMAN OTC DRUG LABEL
Packager Beacon Promotions, Inc.
Generic Name
Product Class
Product Number
Application Number PART352
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  • ACTIVE INGREDIENT

    Active Ingredients: Octinoxate 7%, Oxybenzone 3%

  • INDICATIONS & USAGE

    Use:  helps prevent sunburn

  • WARNINGS

    Warning: stop use if skin rash occurs

  • DOSAGE & ADMINISTRATION

    Directions: Apply and reapply at least every 2 hours for sunburn protection. children under 6 months of age: ask a doctor.

  • STORAGE AND HANDLING

    Other information: Store at 68-77F (20-25C)

  • INACTIVE INGREDIENT

    Inactive Ingredients:

    Mineral Oil, Polybutene, Ethylhexyl Palmitate, Parafin, Ceresin, Microcrystalline Wax, Petrolatum, Beeswax, Fragrance, Methylparaben, Propylparaben, BHT.


  • SPL UNCLASSIFIED SECTION

    HC301LB Dist. by Beacon Promotions Inc.

    New lm, MN 56073

    (507) 233-3278

    Made in China

  • PRINCIPAL DISPLAY PANEL

    Sunscreen Vanilla

  • INGREDIENTS AND APPEARANCE
    VANILLA SUNSCREEN LIP MOISTURIZER 
    octinoxate, oxybenzone lipstick
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:75866-307
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    OCTINOXATE (UNII: 4Y5P7MUD51) (OCTINOXATE - UNII:4Y5P7MUD51) OCTINOXATE7 g  in 100 g
    OXYBENZONE (UNII: 95OOS7VE0Y) (OXYBENZONE - UNII:95OOS7VE0Y) OXYBENZONE3 g  in 100 g
    Inactive Ingredients
    Ingredient NameStrength
    MINERAL OIL (UNII: T5L8T28FGP)  
    ETHYLHEXYL PALMITATE (UNII: 2865993309)  
    PARAFFIN (UNII: I9O0E3H2ZE)  
    CERESIN (UNII: Q1LS2UJO3A)  
    MICROCRYSTALLINE WAX (UNII: XOF597Q3KY)  
    PETROLATUM (UNII: 4T6H12BN9U)  
    YELLOW WAX (UNII: 2ZA36H0S2V)  
    METHYLPARABEN (UNII: A2I8C7HI9T)  
    PROPYLPARABEN (UNII: Z8IX2SC1OH)  
    BUTYLATED HYDROXYTOLUENE (UNII: 1P9D0Z171K)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:75866-307-014.2 g in 1 CONTAINER
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph not finalpart35212/29/2010
    Labeler - Beacon Promotions, Inc. (136344053)
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