Label: SUN SHADES MINERAL PLUS SUNSCREEN WITH ZINC OXIDE- octisalate 5%, octocrylene 3%, zinc oxide 10.5% 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 January 27, 2023

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  • Active ingredients

    Octisalate 5%, Octocrylene 3%, Zinc Oxide 10.5%

  • Purpose

    Sunscreen

  • Uses

    ■ 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

    Do not use on damaged or broken skin

  • WHEN USING

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

  • STOP USE

    Stop use and ask a doctor if rash occurs

  • 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.

  • Directions

    ■ apply liberally and spread evenly by hand 15 minutes before sun exposure

    ■ reapply:

    ■ after 80 minutes of swimming or sweating

    ■ immediately after towel drying

    ■ at least every 2 hours

    ■ Sun Protection Measures. Spending time in the sun increases your risk of skin cancer and early signs of 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 AM-2 PM

    ■ wear long-sleeve shirts, pants, hats, and sunglasses

    ■ children under 6 months of age: ask a doctor

  • Other information

    ■ protect this product from excessive heat and direct sun

    ■ do not store at temperatures below 32°F (0°C) or above 120°F (49°C)

  • Inactive ingredients

    aleurites meluccana seed oil, ascorbyl palmitate, bisabolol, butyrospermum parkii (shea butter), C12-15 alkyl benzoate, caprylic/capric triglyceride, cetearyl alcohol, ceteth-10 phosphate, cetyl alcohol, dicaprylyl carbonate, dicetyl phosphate, disodium lauriminodipropionate tocopheryl phosphates, glycerin, hydrogenated palm glycerides, isoeicosane, isostearic acid, lecithin, macadamia ternifolia seed oil, neopentyl glycol diheptanoate, fragrance, pentylene glycol, phenoxyethanol, phenyl trimethicone, polyester-7, polyglyceryl-3 polyricinoleate, polyhydroxystearic acid, potassium cetyl phosphate, potassium sorbate, sodium chloride, sucrose distearate, tocopherol, water, xanthan gum, ethylhexyl salicylate, beeswax, trisodium ethylenediamine disuccinate, sodium hydroxide

  • PRINCIPAL DISPLAY PANEL

    Sun Shades Mineral 30 Plus

  • INGREDIENTS AND APPEARANCE
    SUN SHADES MINERAL PLUS SUNSCREEN  WITH ZINC OXIDE
    octisalate 5%, octocrylene 3%, zinc oxide 10.5% lotion
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:54473-218
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    OCTISALATE (UNII: 4X49Y0596W) (OCTISALATE - UNII:4X49Y0596W) OCTISALATE9.225 g  in 177 mL
    OCTOCRYLENE (UNII: 5A68WGF6WM) (OCTOCRYLENE - UNII:5A68WGF6WM) OCTOCRYLENE5.535 g  in 177 mL
    ZINC OXIDE (UNII: SOI2LOH54Z) (ZINC OXIDE - UNII:SOI2LOH54Z) ZINC OXIDE18.45 g  in 177 mL
    Inactive Ingredients
    Ingredient NameStrength
    TRISODIUM ETHYLENEDIAMINE DISUCCINATE (UNII: YA22H34H9Q)  
    SODIUM HYDROXIDE (UNII: 55X04QC32I)  
    ALKYL (C12-15) BENZOATE (UNII: A9EJ3J61HQ)  
    ASCORBYL PALMITATE (UNII: QN83US2B0N)  
    CETETH-10 PHOSPHATE (UNII: 4E05O5N49G)  
    CETOSTEARYL ALCOHOL (UNII: 2DMT128M1S)  
    CETYL ALCOHOL (UNII: 936JST6JCN)  
    DICAPRYLYL CARBONATE (UNII: 609A3V1SUA)  
    DIHEXADECYL PHOSPHATE (UNII: 2V6E5WN99N)  
    DISODIUM LAURIMINODIPROPIONATE TOCOPHERYL PHOSPHATES (UNII: 0K5Y9U1P6M)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    HYDROGENATED PALM GLYCERIDES (UNII: YCZ8EM144Q)  
    ISOEICOSANE (UNII: AR294KAG3T)  
    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)  
    POTASSIUM CETYL PHOSPHATE (UNII: 03KCY6P7UT)  
    POTASSIUM SORBATE (UNII: 1VPU26JZZ4)  
    SHEANUT OIL (UNII: O88E196QRF)  
    SODIUM CHLORIDE (UNII: 451W47IQ8X)  
    SUCROSE DISTEARATE (UNII: 33X4X4B90S)  
    .ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)  
    WATER (UNII: 059QF0KO0R)  
    XANTHAN GUM (UNII: TTV12P4NEE)  
    YELLOW WAX (UNII: 2ZA36H0S2V)  
    Product Characteristics
    Color    Score    
    ShapeSize
    FlavorImprint Code
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:54473-218-06177 mL in 1 TUBE; Type 0: Not a Combination Product01/01/2018
    Image of Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph not finalpart35212/27/2012
    Labeler - Melaleuca Inc. (139760102)
    Registrant - Melaleuca Inc. (079711683)
    Establishment
    NameAddressID/FEIBusiness Operations
    Melaleuca Inc.079711683manufacture(54473-218)
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