Label: LIP BALM SPF- octinoxate, zinc oxide stick

  • 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 4, 2016

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  • Drug Facts

  • Active ingredients

    Octinoxate 7.5%

    Zinc Oxide 6.0%

    Purpose

    Sunscreen

  • Use

    helps prevent sunburn

  • Warnings

    Skin Cancer/Skin Aging Alert: Spending time in the sun increases your risk of skin cancer and early aging. This product has been shown only to help prevent sunburn, not skin cancer or early aging.

    For external use only

    Do not use

    on damaged or broken skin

    When using this product

    keep out of eyes. Rinse with water to remove.

    Stop use and ask a doctor

    if rash or irritation occurs

    Keep out of reach of children.

    If product is swallowed, get medical help or contact a Poison Control Center right away.

  • Directions

    • apply liberally 15 minutes before sun exposure • re-apply at least every 2 hours • use a water-resistant sunscreen if swimming or sweating • children under 6 months: ask a doctor

  • Inactive ingredients

    Hydrogenated Coconut Oil, Butyrospermum Parkii (Shea) Butter, Microcrystalline Wax, Beeswax, C12-15 Alkyl Benzoate, C18-C70 Isoparaffin, Myristyl Myristate, Polyethylene, Flavor, Paraffin, Menthyl Lactate, Tocopheryl Acetate, Polyhydroxystearic Acid, Helianthus Annuus (Sunflower) Seed Oil, Sodium Saccharin, Triethoxycaprylylsilane, Limonene, BHT, Linalool, Cucumis Sativus (Cucumber) Seed Extract, Citric Acid

  • Other information

    Protect the product in this container from excessive heat and direct sun

  • Questions or comments?

    Call 1-888-212-6855

  • Package Labeling:

    Outer Label01Inner Label01

  • INGREDIENTS AND APPEARANCE
    LIP BALM SPF 
    octinoxate, zinc oxide stick
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:70533-002
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    OCTINOXATE (UNII: 4Y5P7MUD51) (OCTINOXATE - UNII:4Y5P7MUD51) OCTINOXATE75 mg  in 1 g
    ZINC OXIDE (UNII: SOI2LOH54Z) (ZINC CATION - UNII:13S1S8SF37) ZINC CATION60 mg  in 1 g
    Inactive Ingredients
    Ingredient NameStrength
    HYDROGENATED COCONUT OIL (UNII: JY81OXM1OM)  
    SHEA BUTTER (UNII: K49155WL9Y)  
    MICROCRYSTALLINE WAX (UNII: XOF597Q3KY)  
    YELLOW WAX (UNII: 2ZA36H0S2V)  
    ALKYL (C12-15) BENZOATE (UNII: A9EJ3J61HQ)  
    MYRISTYL MYRISTATE (UNII: 4042ZC00DY)  
    HIGH DENSITY POLYETHYLENE (UNII: UG00KM4WR7)  
    METHYL SALICYLATE (UNII: LAV5U5022Y)  
    PARAFFIN (UNII: I9O0E3H2ZE)  
    MENTHYL LACTATE, (-)- (UNII: 2BF9E65L7I)  
    .ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)  
    POLYHYDROXYSTEARIC ACID (2300 MW) (UNII: YXH47AOU0F)  
    SUNFLOWER OIL (UNII: 3W1JG795YI)  
    SACCHARIN SODIUM (UNII: SB8ZUX40TY)  
    TRIETHOXYCAPRYLYLSILANE (UNII: LDC331P08E)  
    BUTYLATED HYDROXYTOLUENE (UNII: 1P9D0Z171K)  
    LINALOOL, (+/-)- (UNII: D81QY6I88E)  
    CUCUMBER SEED (UNII: BT3S9L53JK)  
    CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:70533-002-571 in 1 CARTON04/03/2016
    15.7 g in 1 TUBE; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph not finalpart35204/01/2016
    Labeler - Harry's, Inc. (079239206)
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