Label: PLAY MINERAL SUNSCREEN SPF-50- titanium dioxide, zinc oxide lotion

  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None

Drug Label Information

Updated December 12, 2024

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

  • ACTIVE INGREDIENTS

    Titanium Dioxide 5%
    Zinc Oxide 7%

  • PURPOSE

    SUNSCREEN

  • USES

    • helps prevent sunburn.
    • if used as directed with other sun protection measures (see Direction), 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 occurs.

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

  • DIRECTIONS

    • Apply generously 15 minutes before sun exposure and as needed.
    • reapply at least every 2 hours • use a water resistant sunscreen if swimming or sweating.
    • 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. [bullet] wear long-sleeved shirts, pants, hats, and sunglasses".

  • OTHER INFORMATION

    Sun alert: limiting sun exposure, wearing protective clothing, and using sunscreen may reduce the risks of skin aging, skin cancer, and other harmful effects of the sun.
    Protect the product in this container from excessive heat and direct sun.

  • INACTIVE INGREDIENT

    Alkyl Benzoate, Benzoic Acid, C12-C15, Caprylic Capric Triglycerides, Cetyl PEG/PPG-10/1 Dimethicone, Crosspolymer, Dicaprylyl ether, Ethylhexylglycerin, Glycereth-2 Cocoate, Glycerin, Isostearic Acid, Octyldodecyl Stearoyl Citrate, Phenoxyethanol, Polyhydroxystearic Acid, Propanediol, Sodium Chloride, Sodium Hyaluronate, Triethoxycaprylylsilane, Water

  • PRINCIPAL DISPLAY PANEL

    01b LVL_TubbySunscreen_tube_061819-2

  • INGREDIENTS AND APPEARANCE
    PLAY MINERAL SUNSCREEN  SPF-50
    titanium dioxide, zinc oxide lotion
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:73088-101
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    TITANIUM DIOXIDE (UNII: 15FIX9V2JP) (TITANIUM DIOXIDE - UNII:15FIX9V2JP) TITANIUM DIOXIDE5 g  in 100 mL
    ZINC OXIDE (UNII: SOI2LOH54Z) (ZINC CATION - UNII:13S1S8SF37) ZINC CATION7 g  in 100 mL
    Inactive Ingredients
    Ingredient NameStrength
    C12-20 ALKYL BENZOATE (UNII: Y15I6XI14C)  
    BENZOIC ACID (UNII: 8SKN0B0MIM)  
    MEDIUM-CHAIN TRIGLYCERIDES (UNII: C9H2L21V7U)  
    CETYL PEG/PPG-10/1 DIMETHICONE (HLB 1.5) (UNII: V2W71V8T0X)  
    DICAPRYLYL ETHER (UNII: 77JZM5516Z)  
    ETHYLHEXYLGLYCERIN (UNII: 147D247K3P)  
    GLYCERETH-2 COCOATE (UNII: JWM00VS7HC)  
    ISOSTEARIC ACID (UNII: X33R8U0062)  
    OCTYLDODECYL STEAROYL STEARATE (UNII: 3D47Q6D93C)  
    PHENOXYETHANOL (UNII: HIE492ZZ3T)  
    POLYHYDROXYSTEARIC ACID (2300 MW) (UNII: YXH47AOU0F)  
    PROPANEDIOL (UNII: 5965N8W85T)  
    SODIUM CHLORIDE (UNII: 451W47IQ8X)  
    HYALURONATE SODIUM (UNII: YSE9PPT4TH)  
    TRIETHOXYCAPRYLYLSILANE (UNII: LDC331P08E)  
    WATER (UNII: 059QF0KO0R)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:73088-101-14118 mL in 1 TUBE; Type 0: Not a Combination Product05/21/201912/12/2024
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC Monograph DrugM02005/21/201912/12/2024
    Labeler - TUBBY TODD (052545299)