Label: ACURE MINERAL PROTECTION SUNSCREEN BROAD SPECTRUM SPF 30- titanium dioxide and zinc oxide lotion

  • 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 November 27, 2012

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  • SPL UNCLASSIFIED SECTION

    Drug Facts

  • ACTIVE INGREDIENT

    Active IngredientsPurpose
    Titanium Dioxide 9%Sunscreen
    Zinc Oxide 3%Sunscreen
  • Uses

    • helps prevent sunburn
  • Warnings

    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 occurs
  • Directions

    • apply liberally 15 minutes before sun exposure
    • children under 6 months: Ask a doctor
    • reapply:
      • after 40 minutes of swimming or sweating
      • immediately after towel drying
      • at least every 2 hours
  • Other Information

    • protect the product in this container from excessive heat and direct sun
  • Inactive Ingredients

    Aqua, Caprylic/Capric Triglyceride, Cathamus tinctorius Oleosomes, Isopropyl Jojobate, Jojoba Alcohol, Jojoba Esters, Silica, Benzyl Alcohol, Phenoxyethanol, Polyhydroxystearic Acid, Optunia ficus-Indica Stem, Glycerin, Tocopheryl Acetate, Bisabolol, Isostearic Acid

  • SPL UNCLASSIFIED SECTION

    Distributed by Better Planet Brands,
    Fort Lauderdale, FL 33316

  • PRINCIPAL DISPLAY PANEL - 28 g Tube Box

    ACURE
    ACURE FOR YOUR SKIN ACURE FOR THE PLANET

    MINERAL PROTECTION
    SUNSCREEN
    Broad Spectrum SPF 30
    ALL SKIN TYPES

    SPF
    30

    PRINCIPAL DISPLAY PANEL - 28 g Tube Box
  • INGREDIENTS AND APPEARANCE
    ACURE MINERAL PROTECTION SUNSCREEN BROAD SPECTRUM SPF 30 
    titanium dioxide and zinc oxide lotion
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:54136-030
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    TITANIUM DIOXIDE (UNII: 15FIX9V2JP) (TITANIUM DIOXIDE - UNII:15FIX9V2JP) TITANIUM DIOXIDE9 g  in 100 g
    ZINC OXIDE (UNII: SOI2LOH54Z) (ZINC OXIDE - UNII:SOI2LOH54Z) ZINC OXIDE3 g  in 100 g
    Inactive Ingredients
    Ingredient NameStrength
    WATER (UNII: 059QF0KO0R)  
    CAPRYLIC/CAPRIC MONO/DIGLYCERIDES (UNII: U72Q2I8C85)  
    CARTHAMUS TINCTORIUS SEED OLEOSOMES (UNII: 9S60Q72309)  
    HYDROLYZED JOJOBA ESTERS (ACID FORM) (UNII: UDR641JW8W)  
    SILICON DIOXIDE (UNII: ETJ7Z6XBU4)  
    BENZYL ALCOHOL (UNII: LKG8494WBH)  
    PHENOXYETHANOL (UNII: HIE492ZZ3T)  
    POLYHYDROXYSTEARIC ACID (2300 MW) (UNII: YXH47AOU0F)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    OPUNTIA FICUS-INDICA (UNII: 23Z87HTQ6P)  
    ALOE VERA LEAF (UNII: ZY81Z83H0X)  
    .ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)  
    LEVOMENOL (UNII: 24WE03BX2T)  
    ALUMINUM STEARATE (UNII: U6XF9NP8HM)  
    ALUMINUM OXIDE (UNII: LMI26O6933)  
    ISOSTEARIC ACID (UNII: X33R8U0062)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:54136-030-011 in 1 BOX
    128 g in 1 TUBE
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC MONOGRAPH NOT FINALpart35211/25/2012
    Labeler - Better Planet Brands (960253719)
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