Label: SKIN CRAVE SPF15 LIP BALM (spf15 lip balm- chemical lipstick

  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None
  • Marketing Status: OTC monograph 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 July 11, 2018

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  • ACTIVE INGREDIENT

    Active Ingredients: Purpose: Sunscreen

    Avobenzone (2.0%)

    Octinoxate (6.5%)

    Octisalate (5.0%)

    Octocrylene (1.5%)

  • PURPOSE

    Purpose: Sunscreen

  • INDICATIONS & USAGE

    Uses: Helps prevent sunburn

  • WARNINGS

    Warnings:

    • Skin Cancer/Skin Aging Alert: Spending time in the sun increases your risk of skin cancer and early aging. Thois product has been shown only to help prevent sunburn, not skin cancer or early skin aging.
    • For external use only
    • Do not use on damaged or broken skin.

  • STOP USE

    Stop use and ask a doctor if rash occurs.

  • WHEN USING

    • When using this product keep out of eyes. Rinse with water to remove.
  • KEEP OUT OF REACH OF CHILDREN

    • Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center right away.
  • INSTRUCTIONS FOR USE

    Directions:

    • Apply liberally 15 minutes before sun exposure.
    • Use a water resistant sunscreen if swimming or sweating.
    • Reapply at least every 2 hours.
  • INACTIVE INGREDIENT

    Inactive Ingredients: Sunflower oil, beeswax, extra virgin olive oil, flavor, hemp seed oil, rosemaruy extract, vitamin E, aloe vera

  • OTHER SAFETY INFORMATION

    Other Information: Protect this product from excessive heat and direct sun.

  • QUESTIONS

    Questions or Comments? 1-877-773-9800

  • PRINCIPAL DISPLAY PANEL

    PLPD

  • INGREDIENTS AND APPEARANCE
    SKIN CRAVE SPF15 LIP BALM 
    spf15 lip balm (chemical) lipstick
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:58418-295
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    OCTOCRYLENE (UNII: 5A68WGF6WM) (OCTOCRYLENE - UNII:5A68WGF6WM) OCTOCRYLENE1.5 mg  in 15 mL
    OCTISALATE (UNII: 4X49Y0596W) (OCTISALATE - UNII:4X49Y0596W) OCTISALATE5 mg  in 15 mL
    AVOBENZONE (UNII: G63QQF2NOX) (AVOBENZONE - UNII:G63QQF2NOX) AVOBENZONE2 g  in 15 mL
    OCTINOXATE (UNII: 4Y5P7MUD51) (OCTINOXATE - UNII:4Y5P7MUD51) OCTINOXATE6.5 mg  in 15 mL
    Inactive Ingredients
    Ingredient NameStrength
    SUNFLOWER OIL (UNII: 3W1JG795YI)  
    Product Characteristics
    Color    Score    
    ShapeSize
    FlavorBUBBLE GUM, GRAPE, CITRUS, CHERRY, STRAWBERRY, BERRY, MINT, PEPPERMINT, VANILLA, WATERMELON, TROPICAL FRUIT PUNCH, POMEGRANATE, ROOT BEER, MANGO, COCONUTImprint Code
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:58418-295-1515 mL in 1 CANISTER; Type 0: Not a Combination Product08/01/2012
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph finalpart35208/01/2012
    Labeler - Tropical Enterprises International, Inc. (091986179)
    Registrant - Tropical Enterprises International, Inc. (091986179)
    Establishment
    NameAddressID/FEIBusiness Operations
    Raining Rose083819404manufacture(58418-295)
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