Label: PREVENTION DAILY TINTED MOSITURIZER OIL-FREE TINTED 30- zinc oxide and titanium dioxide cream

  • 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 May 9, 2014

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  • ACTIVE INGREDIENT

    ACTIVE INGREDIENTS:
    Zinc Oxide - 6.0%
    Titanium Dioxide 4.6%

  • PURPOSE

    Purpose: Sunscreen

  • INDICATIONS & USAGE

    Uses:

    • To help protect the skin from harmful UVA and UVB rays.
    • If used as directed with other sun protection measures, this product reduces the risk of skin cancer and early skin aging, as well as helps prevent sunburn.
  • WARNINGS

    Warnings

    For External Use Only

  • WHEN USING

    • Keep out of eyes. If contact occurs rinse with water.
    • Discontinue use of irritation or redness occurs
  • STOP USE

    if severe skin irritation develops

  • KEEP OUT OF REACH OF CHILDREN

    if swallowed, get medical help or contact a Poison Control Center right away

  • INDICATIONS & USAGE

    Directions

    • Apply to cleansed skin every morning as daily moisturizer and for ultimate protection
    • Re-apply every 2 hours when exposed to sun or as needed
  • INACTIVE INGREDIENT

    Aqua, Cyclopentasiloxane, Plankton Extract, Hexyl Triethoxysilylethyl, Polydimethylsiloxyethyl Dimethicone, Cyclohexasiloxane, Dimethicone/PEG-10/15 Crosspolymer, Arabidopsis Extract, Dimethicone/Polyglycerin -3 Crosspolymer, Aluminum Hydroxide Stearic Acid, Polyglyceryl-4 Isostearate, Cetyl PEG/PPG-10/1 Dimethicone, Hexyl Laurate, Sodium Chloride, Cetearyl Olivate, Tetrahexyldecyl Ascorbate, Micrococcus Lysate, Lecithin, Tocopheryl Acetate, Caprylyl Glycol, Phenoxyethanol, Ethylhexylglycerin, Hexylene Glycol, Iron Oxide (CI77491, CI77492, CI77499)

  • PRINCIPAL DISPLAY PANEL

    Image International Palm Beach, FL 33462 USA www.imageskincare.com

    ImagePDT306ImagePDT30

  • INGREDIENTS AND APPEARANCE
    PREVENTION DAILY TINTED MOSITURIZER OIL-FREE TINTED 30 
    zinc oxide and titanium dioxide cream
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:62742-4067
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    ZINC OXIDE (UNII: SOI2LOH54Z) (ZINC OXIDE - UNII:SOI2LOH54Z) ZINC OXIDE60 mg  in 1 g
    TITANIUM DIOXIDE (UNII: 15FIX9V2JP) (TITANIUM DIOXIDE - UNII:15FIX9V2JP) TITANIUM DIOXIDE46 mg  in 1 g
    Inactive Ingredients
    Ingredient NameStrength
    WATER (UNII: 059QF0KO0R)  
    CYCLOMETHICONE 6 (UNII: XHK3U310BA)  
    ARABIDOPSIS THALIANA (UNII: AI3L60HQ81)  
    ALUMINUM HYDROXIDE (UNII: 5QB0T2IUN0)  
    STEARIC ACID (UNII: 4ELV7Z65AP)  
    POLYGLYCERYL-4 ISOSTEARATE (UNII: 820DPX33S7)  
    CETYL PEG/PPG-10/1 DIMETHICONE (HLB 4) (UNII: 8INO2K35FA)  
    HEXYL LAURATE (UNII: 4CG9F9W01Q)  
    SODIUM CHLORIDE (UNII: 451W47IQ8X)  
    CETEARYL OLIVATE (UNII: 58B69Q84JO)  
    SORBITAN OLIVATE (UNII: MDL271E3GR)  
    TETRAHEXYLDECYL ASCORBATE (UNII: 9LBV3F07AZ)  
    EGG PHOSPHOLIPIDS (UNII: 1Z74184RGV)  
    .ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)  
    CAPRYLYL GLYCOL (UNII: 00YIU5438U)  
    PHENOXYETHANOL (UNII: HIE492ZZ3T)  
    ETHYLHEXYLGLYCERIN (UNII: 147D247K3P)  
    HEXYLENE GLYCOL (UNII: KEH0A3F75J)  
    FERRIC OXIDE RED (UNII: 1K09F3G675)  
    FERRIC OXIDE YELLOW (UNII: EX438O2MRT)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:62742-4067-21 in 1 CARTON
    1NDC:62742-4067-191 g in 1 TUBE
    2NDC:62742-4067-3170 g in 1 TUBE
    3NDC:62742-4067-47 g in 1 TUBE
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph finalpart35205/09/2014
    Labeler - Allure Labs, Inc (926831603)
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