Label: WONDERSCREEN BROAD SPECTRUM SPF 30- zinc oxide cream

  • NDC Code(s): 44717-062-01
  • Packager: Wasatch Product Development, LLC.
  • 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 September 13, 2022

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  • ACTIVE INGREDIENT

    Active Ingredient: Zinc Oxide

    Purpose: Sunscreen

  • PURPOSE

    Uses: Helps prevent sunburn. Higher SPF gives more sunburn protection

  • KEEP OUT OF REACH OF CHILDREN

    Keep out of reach of children. If product is swallowed, get medical help or contact a Poison Control Center right away.

  • INDICATIONS & USAGE

    Stop use and ask a doctor if rash occurs.

  • WARNINGS

    Warning:

    • For External use only. Do not use on broken or damaged skin
  • DOSAGE & ADMINISTRATION

    Directions:

    • Apply liberally 15 minutes before sun or water exposure
    • Immediately after towel drying
    • At least every 2 hours
    • Children under 6 months: ask a doctor
  • INACTIVE INGREDIENT

    Inactive Ingredients: Water, Ethylhexyl Olivate, Dimethicone, C9-12 Alkane, Cocoglycerides, Hydroxyethyl Dimethicone Laurate, Pentylene Glycol, Butyloctyl Salicylate, Glycerin, Jojoba Esters, Pyrus Malus (Apple) Fruit Extract, Polymethylsilsesquioxane, Squalane, Dipotassium Glycyrrhizate, Beta Vulgaris (Beet) Root Extract, Fructooligosaccharides, Glycine Soja (Soybean) Seed Extract Diheptyl Succinate, Disteardimonium Hectorite, Phenoxyethanol, Sodium Chloride, Polyhydroxystearic Acid, Trihydroxystearin, Triethyl Citrate, Hydroxyacetophenone, Sodium Citrate, Tetrasodium Glutamate Diacetate, Sodium Dehydroacetate, Capryloyl Glycerin/Sebacic Acid Copolymer

  • PRINCIPAL DISPLAY PANEL

    DIME

    Wonderscreen

    Broad Spectrum SPF 30

    50 G

    Wonderscreen SPF 30 Box

    Pump bottle

  • INGREDIENTS AND APPEARANCE
    WONDERSCREEN BROAD SPECTRUM SPF 30 
    zinc oxide cream
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:44717-062
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    ZINC OXIDE (UNII: SOI2LOH54Z) (ZINC OXIDE - UNII:SOI2LOH54Z) ZINC OXIDE19 g  in 100 g
    Inactive Ingredients
    Ingredient NameStrength
    COCO-GLYCERIDES (UNII: ISE9I7DNUG)  
    TRIHYDROXYSTEARIN (UNII: 06YD7896S3)  
    PENTYLENE GLYCOL (UNII: 50C1307PZG)  
    DIMETHICONE 100 (UNII: RO266O364U)  
    DISTEARDIMONIUM HECTORITE (UNII: X687XDK09L)  
    SODIUM CITRATE (UNII: 1Q73Q2JULR)  
    SODIUM CHLORIDE (UNII: 451W47IQ8X)  
    HYDROXYACETOPHENONE (UNII: G1L3HT4CMH)  
    SQUALANE (UNII: GW89575KF9)  
    GLYCYRRHIZINATE DIPOTASSIUM (UNII: CA2Y0FE3FX)  
    BEET (UNII: N487KM8COK)  
    WATER (UNII: 059QF0KO0R)  
    BUTYLOCTYL SALICYLATE (UNII: 2EH13UN8D3)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    APPLE (UNII: B423VGH5S9)  
    POLYMETHYLSILSESQUIOXANE (4.5 MICRONS) (UNII: 59Z907ZB69)  
    PHENOXYETHANOL (UNII: HIE492ZZ3T)  
    TETRASODIUM GLUTAMATE DIACETATE (UNII: 5EHL50I4MY)  
    TRIETHYL CITRATE (UNII: 8Z96QXD6UM)  
    SODIUM DEHYDROACETATE (UNII: 8W46YN971G)  
    CAPRYLOYL GLYCERIN/SEBACIC ACID COPOLYMER (2000 MPA.S) (UNII: N7YC58165T)  
    POLYHYDROXYSTEARIC ACID (2300 MW) (UNII: YXH47AOU0F)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:44717-062-0150 g in 1 BOTTLE, PUMP; Type 0: Not a Combination Product02/25/2022
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph finalM02002/25/2022
    Labeler - Wasatch Product Development, LLC. (962452533)
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