Label: PINEAPPLE SUNSCREEN LIP MOISTURIZER- octinoxate, oxybenzone 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 December 29, 2010

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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 Pineapple

  • INGREDIENTS AND APPEARANCE
    PINEAPPLE SUNSCREEN LIP MOISTURIZER 
    octinoxate, oxybenzone lipstick
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:75866-305
    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:75866-305-014.2 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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