Label: SUN SHADES MINERAL PLUS SUNSCREEN- octisalate and 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 February 23, 2011

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  • ACTIVE INGREDIENT

    Active ingredient
    Octisalate 5%, Zinc oxide 10%

  • PURPOSE

    Purpose
    Sunscreen

  • INDICATIONS & USAGE

    Uses

    • helps prevent sunburn
    • higher SPF gives more sunburn protection
    • for skin highly sensitive to sunburn
    • retains SPF after 80 minutes of activity in the water or sweating
  • WARNINGS

    Warnings
    For external use only

  • WHEN USING

    When using this product keep out of the eyes. Rinse with water to remove.

  • STOP USE

    Stop use and ask a doctor if rash or irritation develops and lasts

  • 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.

  • DOSAGE & ADMINISTRATION

    Directions

    • apply liberally and evenly to all exposed areas before sun exposure
    • reapply after 80 minutes of swimming or sweating and after towel drying. Otherwise, reapply at least every 2 hours.
    • children under 6 months of age: ask a doctor
  • INACTIVE INGREDIENT

    Inactive ingredients
    aleurites moluccana seed oil, ascorbyl palmitate, bisabolol, bixa orellana seed extract, butyrospermum parkii (shea butter), C12-15 alkyl benzoate, caprylic/capric triglyceride, cera alba, cetearyl alcohol, ceteth-10 phosphate, cetyl alcohol, cetyl ethylhexanoate, dicaprylyl carbonate, dicetyl phosphate, disodium EDTA, disodium lauriminodipropionate tocopheryl phosphates, glycerin, hydrogenated palm glycerides, isoeicosane, isostearic acid, macadamia ternifolia seed oil, neopentyl glycol diheptanoate, parfum, pentylene glycol, phenoxyethanol, phenyl trimethicone, polyester-7, polyhydroxystearic acid, potassium cetyl phosphate, potassium sorbate, sodium chloride, sucrose distearate, tocopherol, triethanolamine, water, xanthan gum

  • PRINCIPAL DISPLAY PANEL

    image of label
  • INGREDIENTS AND APPEARANCE
    SUN SHADES  MINERAL PLUS SUNSCREEN
    octisalate and zinc oxide cream
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:54473-164
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    OCTISALATE (UNII: 4X49Y0596W) (OCTISALATE - UNII:4X49Y0596W) OCTISALATE9.225 g  in 177 mL
    ZINC OXIDE (UNII: SOI2LOH54Z) (ZINC - UNII:J41CSQ7QDS) ZINC OXIDE18.45 g  in 177 mL
    Inactive Ingredients
    Ingredient NameStrength
    ALPHA-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)  
    ASCORBYL PALMITATE (UNII: QN83US2B0N)  
    BIXA ORELLANA SEED (UNII: O87354RZ5A)  
    C12-15 ALKYL BENZOATE (UNII: A9EJ3J61HQ)  
    CETOSTEARYL ALCOHOL (UNII: 2DMT128M1S)  
    CETYL ALCOHOL (UNII: 936JST6JCN)  
    CETYL ETHYLHEXANOATE (UNII: 134647WMX4)  
    DICAPRYLYL CARBONATE (UNII: 609A3V1SUA)  
    DIHEXADECYL PHOSPHATE (UNII: 2V6E5WN99N)  
    EDETATE DISODIUM (UNII: 7FLD91C86K)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    ISOSTEARIC ACID (UNII: X33R8U0062)  
    KUKUI NUT OIL (UNII: TP11QR7B8R)  
    LEVOMENOL (UNII: 24WE03BX2T)  
    MACADAMIA OIL (UNII: 515610SU8C)  
    MEDIUM-CHAIN TRIGLYCERIDES (UNII: C9H2L21V7U)  
    NEOPENTYL GLYCOL DIHEPTANOATE (UNII: 5LKW3C543X)  
    PENTYLENE GLYCOL (UNII: 50C1307PZG)  
    PHENOXYETHANOL (UNII: HIE492ZZ3T)  
    PHENYL TRIMETHICONE (UNII: DR0K5NOJ4R)  
    POLYHYDROXYSTEARIC ACID (2300 MW) (UNII: YXH47AOU0F)  
    POTASSIUM CETYL PHOSPHATE (UNII: 03KCY6P7UT)  
    POTASSIUM SORBATE (UNII: 1VPU26JZZ4)  
    SHEA BUTTER (UNII: K49155WL9Y)  
    SODIUM CHLORIDE (UNII: 451W47IQ8X)  
    TROLAMINE (UNII: 9O3K93S3TK)  
    WATER (UNII: 059QF0KO0R)  
    XANTHAN GUM (UNII: TTV12P4NEE)  
    YELLOW WAX (UNII: 2ZA36H0S2V)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:54473-164-06177 mL in 1 TUBE
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph not finalpart35205/01/2009
    Labeler - Melaleuca, Inc. (139760102)
    Establishment
    NameAddressID/FEIBusiness Operations
    Melaleuca, Inc.139760102manufacture
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