Label: MINUS-SOL FACIAL SUN PROTECTION SUNSCREEN BROAD SPECTRUM SPF 30 PLUS IVORY- octinoxate, titanium dioxide, zinc oxide cream

  • 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 March 18, 2013

If you are a consumer or patient please visit this version.

  • Drug Facts


  • Active ingredients

    Octyl Methoxycinnamate 4%

    Titanium Dioxide   5%

    Zinc Oxide 5%

  • Purpose

    Sunscreen

  • Use


    • Helps prevent sunburn
    • If used as directed with other sun protection measures (see Directions), decreases the risk of skin cancer and early skin aging caused by the sun.
  • 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 occuurs

    Keep out of reach of children.

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

  • Directions:

    For sunscreen use

    • Apply liberally 15 minutes before sun exposure
    • Children under 6 months of age: Ask a doctor
    • Sun Protection Measures: Spending time in the sun increases your risk of skin cancer and early skin aging. To decrease this risk, regularly use a sunscreen with a Broad Spectrum SPF value of 15 or higher and other sun protection measures including
    • Limit time in the sun, especially from 10 a.m. - 2 p.m.
    • Wear long-sleeved shirts, pants, hats and sunglasses
    • Reapply
    • After 80 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

    ALUMINA, C9-15 FLUCROALCOHOL PHOSPHATES, CETYL PPG/PPG-10/1 DIMETHICONE, CHITOSAN, CYCLOPENTASILOXANE, DISOPROPYLOMER DUNCLEATE, DIMETHOCONEVINYL DIMETHICONE CROSSPOLYMER, HEXYL LAURATE, IRON OXIDE BLACK, IRON OXIDE RED, IRON OXIDE YELLOW METHYLPARABEN, FRAGRANCE, POLYGLYCERY-4 ISOSTEARATE, PROPYLPARABEN, PHEXACECENE COPOLYMER.


  • Minus-sol

    Formulated with the newest technological advancement; this ultra-fine, light, silky smooth, very water resistant facial cream provides long-lasting double UV protection. It is an oil free formulation that contains an inactive ingredient (Enhanced Chitosan) which results in a smooth silky feeling.

    Distributed by:
    Aledian Corporation
    Miami Beach, FL 33140 USA

    Made in Thailand

    To report a serious adverse event
    Contact:
    1.866.Minus.Sol

    www.MinusSol.com

  • PRINCIPAL DISPLAY PANEL

    SPF 30+ Minus-Sol
    Facial Sun Protection Sunscreen Broad Spectrum SPF 30+
    Silky Smooth Cream Oil Free
    Water Resistant (80 Minutes)
    Dermatologically Tested
    Ivory
    Net Wt. 1.76 oz (50g)

  • Product Label

    Inner Package IvoryOuter Package Ivory

  • INGREDIENTS AND APPEARANCE
    MINUS-SOL FACIAL SUN PROTECTION SUNSCREEN BROAD SPECTRUM SPF 30 PLUS IVORY 
    octinoxate, titanium dioxide, zinc oxide cream
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:68411-4058
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    OCTINOXATE (UNII: 4Y5P7MUD51) (OCTINOXATE - UNII:4Y5P7MUD51) OCTINOXATE4 g  in 100 g
    TITANIUM DIOXIDE (UNII: 15FIX9V2JP) (TITANIUM DIOXIDE - UNII:15FIX9V2JP) TITANIUM DIOXIDE5 g  in 100 g
    ZINC OXIDE (UNII: SOI2LOH54Z) (ZINC OXIDE - UNII:SOI2LOH54Z) ZINC OXIDE5 g  in 100 g
    Inactive Ingredients
    Ingredient NameStrength
    ALUMINUM OXIDE (UNII: LMI26O6933)  
    CYCLOMETHICONE 5 (UNII: 0THT5PCI0R)  
    HEXYL LAURATE (UNII: 4CG9F9W01Q)  
    FERROSOFERRIC OXIDE (UNII: XM0M87F357)  
    FERRIC OXIDE RED (UNII: 1K09F3G675)  
    FERRIC OXIDE YELLOW (UNII: EX438O2MRT)  
    METHYLPARABEN (UNII: A2I8C7HI9T)  
    POLYGLYCERYL-4 ISOSTEARATE (UNII: 820DPX33S7)  
    PROPYLPARABEN (UNII: Z8IX2SC1OH)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:68411-4058-31 g in 1 TUBE
    2NDC:68411-4058-125 g in 1 TUBE
    3NDC:68411-4058-250 g in 1 TUBE
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph not finalpart35203/22/2012
    Labeler - Aledian Corporation (140038410)
    Registrant - Aledian Corporation (140038410)
    Establishment
    NameAddressID/FEIBusiness Operations
    Pan Rajdhevee Group Public Company Limited671668125manufacture(68411-4058)